MIDI at Interphex
MIDI we will be attending INTERPHEX Global in NYC April 25th- 26th. We’re looking forward to the opportunities to discuss collaboration on biopharma instrumentation development. Reach out to Christopher Montalbano to coordinate a time to meet!

In case you have missed it, the PARADIGM PERCEPTION SHIFT in Medical Device Development: the INNOVATION ROADMAPâ„¢ podcast series episodes are available in the INNOVATION VAULTâ„¢.

In the first episode of this series, we provided an overview of the INNOVATION ROADMAP™ as applied to Medical Device Development. We “opened up� the map and explained the three key stops along this journey.

In Episode 2, we dove into the first Stop on the INNOVATION ROADMAPâ„¢, Market Exploration & Discovering Opportunities. The FDA-QSR & ISO-13485 guidance recognizes this as a quintessential activity for any business to perform, making it known that regulatory controls such as Design Controls & Risk Management do not have to be performed at this point. The FDA understands the importance of a company needing to explore opportunities first.

In Episode 3, Principal and Chief Creative Officer, Gregory Montalbano discussed the INNOVATION ROADMAPâ„¢ 2nd Stop, which is Technology Innovation and the R&D Process.

Stay tuned for Episode 4 coming next week, STOP 3, Commercialization & Implementation; Getting Ready for Market, under: FDA-QSR & ISO-13485. 

Listen to the podcast

In case you missed it, Episode 1 in our podcast series, “PARADIGM PERCEPTION SHIFT in Medical Device Development: the INNOVATION ROADMAPâ„¢,” launched last week.

In the first episode of this series, we provided an overview of the INNOVATION ROADMAP™ as applied to Medical Device Development. We “opened up� the map and explained the three key stops along this journey.

Stay tuned for Episode 2 coming next week as we dive into the first Stop on the INNOVATION ROADMAPâ„¢, Market Exploration & Discovering Opportunities. The FDA-QSR & ISO-13485 guidance recognizes this as a quintessential activity for any business to perform, making it known that regulatory controls such as Design Controls & Risk Management do not have to be performed at this point. The FDA understands the importance of a company needing to explore opportunities first.

Listen to the podcast.

MIDI at LSI
MIDI is enjoying the opportunity to engage with fellow MedTech Innovators, Investors, and Thought Leaders at LSI – Life Science Intelligenceâ„¢ Summit happening now. So far, it’s been a wonderful event and very well attended.

If you’re also attending, MIDI’s co-founder, Gregory Montalbano can meet with you to discuss our process and expertise for advancing your healthcare technology and product development Strategy, Design, Innovation, Engineering, and Commercialization efficiently and at scale.

Want to meet Greg at LSI? You can contact him directly or through the LSI Portal. gregm@midipd.com

MIDI Medical Product Development is eagerly anticipating the opportunity to engage with fellow MedTech Innovators, Investors, and Thought Leaders at the upcoming LSI – Life Science Intelligenceâ„¢ Dana Point Summit.

MIDI’s co-founder, Gregory Montalbano can meet with you to discuss our process and expertise for advance your healthcare technology and product development Strategy, Design, Innovation, Engineering and Commercialization efficiently and at scale.

If you will also be attending and want to meet Greg at LSI you can contact him directly or through the LSI Portal.

gregm@midipd.com

MIDI is advancing the democratization of CAR T-cell therapy with efforts focused on developing/commercializing Point-of-Care CAR T-cell fabrication shifting away from Centralized Locations. This will involve a closed-system instrumentation/disposable approach. Stay tuned for our upcoming Innovation Vaultâ„¢ Series focused on this bespoke subject and approach.

Downloadable MIDI White Paper: The Global Democratization of Point-of-Care & At-Home Diagnostic Testing

POC and At-Home Diagnostic Testing have experienced rapid growth and advancement accelerated by the past few years’ dire needs for democratized diagnostic offerings.

Do you know the critical considerations for device developers and manufacturers when it comes to creating next-generation diagnostic devices? Along with the current and emerging diagnostic testing methods and their values, MIDI’s recently released white paper will deep dive into Point-of-Care & At-Home Diagnostic Testing.

You can Download your copy of the latest MIDI White Paper here, The Global Democratization of Point-of-Care & At-Home Diagnostic Testing

Download the White Paper

MIDI has just returned from Advanced Therapies Week in Miami

We are proud to be providing advances to the biopharma industry related to CAR T-Cell biotherapy fabrication, resulting in next-generation cancer treatment solutions.

MIDI assists the biopharmaceutical community with the development of advanced instrumentation, disposables, and system architecture to support effective cell therapy development from the lab through to rapid commercialization scale-up while maintaining biologic integrity.

Utilizing our DevelopmentDNAâ„¢, agile development process, and deep knowledge of digitalization/automation, workflow is optimized and reliability enhanced. One unique area of focus is in providing a phase shift in how current autologous CAR T-Cell biopharma drugs are fabricated, moving the fabrication process from the few centralized cleanroom facilities available and scaling to many POC (Point of Care) environments thought the country. This approach involves a contiguous, closed system approach, consisting of the complete biopharma drug fabrication process in one instrument/disposable solution, which is simple to use and FDA-approved under an ISO-13485 QMS.

MIDI is proud of its team and the developments underway to make personalized regenerative medicines at scale in POC environments!

Digital Health took the Center Stage at this year’s CES 23:

MIDI attended this year’s CES event in support of client product launches. There were many examples of medical devices embodying consumer-facing technology and design aiming to personalize, improve and support the individual healthcare journey. In addition to the well-attended show, there was a noticeably expanded focus on healthcare technologies that span regulated and non-regulated health monitoring devices such as digital health panels, wearables, AI software, diagnostics, surgical, infection prevention, and smart home healthcare applications, to name a few. Based on the expanded presence of medical devices and digital healthcare at CES, medical manufacturers are taking great interest based on the desire to discover new technologies and strategic applications to better serve the customers and patients they serve, whether at home or in the clinic.

A new Innovation Vaultâ„¢ White Paper, Point of Care and At-Home Diagnostics: Applications, Key Topics, and Innovation will be coming soon. Stay tuned for your downloadable digital copy taking us on a deep dive of one of healthcare’s largest and most rapidly expanding market segments, point-of-care (POC) and at-home rapid diagnostic testing. 

To you and yours, Happy Thanksgiving from all of us at MIDI!

3 Critical Starting Points for Medical Device Design Usability Research

Medical device usability research and human factors engineering starts with device users, the use environment, and user interfaces.

“The vast majority of medical device failures stem from use errors. While this may lead some to believe that the blame lies on the user, the fact is that use errors are frequently the result of unintuitive device design choices.”

Learn more about the 3 critical starting points for medical device design usability research in Gregory Montalbano’s recent article published in the MD&O October edition.

Read the article

The MedTech Conference
MIDI’s First LIVE Show Post Pandemic
Today marks the end of Advamed’s MedTech Conference, in which MIDI has participated as an exhibitor. Being our first in-person event in some time, we’re thrilled with the outcome! It’s been a treat to see new and familiar faces, shake hands and meet with industry-leading experts at the forefront of MedTech.

We look forward to more events in the future and hope to see you out and about soon!

A new MIDI podcast series is coming to the Innovation Vaultâ„¢ next week
The Deep-Dive into Point of Care and At-Home Diagnostic Testing

In the new series, The Deep-Dive into Point of Care and At-Home Diagnostic Testing Principal Gregory Montalbano will be discussing how the Point of Care and At-Home diagnostic rapid testing market and technology has evolved post-pandemic.

This series will share MIDI’s insight into the current landscape as well as what is in store for the future. Topics will range from evolving market trends and technology innovations as well as key challenges and unmet opportunities for the democratization of global health as related to the Point of Care and At-Home diagnostic devices.

Greg will also showcase current and emerging methods of detection, from qPCR to novel CRISPR diagnostic technology whose express purpose is to improve speed, accuracy, quality, and access to diagnostic testing globally, both at the clinic and the home.

Tune in for a unique opportunity to hear from Greg how technologists and device innovators like MIDI are addressing some of the most key challenges and opportunities within the Point of Care and Home Healthcare diagnostics markets.

Stay tuned for MIDI’s next White Paper
The Deep Dive into Digital Therapeutics (DTx): Core Principals, Current Trends and Future Snapshot

Digital therapeutics is one of the largest and fastest-growing segments of the medical technology market today. These high-quality software products aimed at delivering clinical treatments outside of traditional settings and conventional methods, commonly referred to as DTx, take advantage of the convenience, personalization, and robust capabilities of personal smart devices to expand not only the availability of quality care but the scope of that care, including a far more informed, holistic view of condition management. It is hardly an exaggeration to state that DTx solutions signify the next generation of healthcare.

While developers and organizations look to join the digital healthcare revolution, several characteristics distinct to their development, approval, and commercialization are challenging even for the most experienced in medical devices. This white paper addresses the challenges, providing direction.

This latest MIDI White Paper takes a deep dive into the:

• Fundamentals of Digital Therapeutics
• Flavors of DTx Clinical Claims
• Key Considerations
• Use Cases
• Value Exchanges
  and most importantly, after a deep dive into all of the above
• Common Features of DTx Success

Stay tuned for the release of this industry-relevant deep dive coming next week!

MedTech DFX: Advanced Strategies & Supply Chain Paradigm Shift Webinar

MIDI’s recent webinar with Valtronic provided valuable insight into how MIDI and Valtronic created and pressure-tested a stalwart approach to developing/commercializing advanced medical devices that have been derisked from a manufacturing and supply chain perspective. If you weren’t able to attend, we would like to provide you with this valuable insight and knowledge to apply in your future projects. At MIDI, we’re passionate about this topic and welcome the opportunity to speak with you about any questions or ideas in this area.

If you were not able to attend and would like to have a recording of the webinar, please contact us.

Will you be at The MedTech Conference in Boston next month?

The world’s top MedTech executives will gather for the leading event in our industry, The MedTech Conference. Featuring world-class plenary speakers, cross-cutting educational programming, valuable networking, and business development opportunities, The MedTech Conference is a must-attend event for the industry’s prominent and most promising companies.

MIDI will be exhibiting at booth #623 on October 24-26th in Boston. We hope to see you there! If you haven’t already, register here.

Further Enhancing MIDI’s Capabilities – A New CFD Package

MIDI has enhanced its CFD (Computational Fluid Dynamics) capabilities to accelerate our clients’ medical device development efforts with the upgrade to SOLIDWORKS latest Flow Simulation package. This provides us with the ability to rapidly simulate fluid flow, heat transfer, and fluid forces that are critical to the success of our clients’ designs.

The new package is embedded within our SOLIDWORKS 3D CAD, enabling rapid AGILE, virtual development iterations between the 3D geometry and device performance prior to prototyping. The CFD runs at blazing speed utilizing a BOXX workstation configured with a 32-core capability. This completely maximizes the performance of SOLIDWORKS Flow Simulation providing for: high-density mesh refining/capturing, rapid solution time, high-volume particle analysis, with simultaneous modeling and simulation solving capability.

This new package will allow us to continue to provide the very best in medical device development for our clients.

Learn more about SOLIDWORKS Flow Simulation

Stay Tuned for MIDI’s Next Industry Relevant Webinar
Wednesday September 14th @ Noon Eastern

With MIDI CEO, Chris Montalbano and Valtronics, we invite you on a deep dive into Shifting the Supply Paradigm in MedDEVICE Development: Advanced DFX Strategies Creating Supply Chain Resilience.

Over the last two years medical device developers quickly realized that manufacturing strategies championed pre-pandemic neglected supply chain resilience. This high-pressure situation became an opportunity for MIDI to create and pressure-test a stalwart approach to bringing medical devices to market with minimal delays and at acceptable costs, while ensuring our clients’ long-term viability and business success in these changing supply circumstances.

This webinar will focus on the Design for Excellence (DFX) methodology operationalized under MIDI’s ISO-13485 Quality Management System (QMS) called DevelopmentDNA™ and its specific advantages. A deeper dive is taken into advanced DFSC strategies post-pandemic as well as special considerations for Printed Circuit Boards (PCBs).

Mark your calendars and reserve the date. Registration details are coming soon.

MIDI’s Innovation Vaultâ„¢ Podcast is on your favorite platform

The Innovation Vaultâ„¢ podcast series are available on Apple Podcasts, Google Podcasts, Soundcloud and Spotify. Listen, subscribe and tell us what you think. We’re eager to hear your thoughts!

Enjoying the recent podcast series topic? Stay tuned for the upcoming blogs and white paper detailing Digital Therapeutics (DTx) by subscribing to our Innovation Vaultâ„¢.

Subscribe here

Would you like to be a guest on the Innovation Vaultâ„¢ Podcast? Contact us.

Will we see you at The MedTech Conference?

From October 24-26, 2022, the world’s top MedTech executives will gather for the leading event in our industry — The MedTech Conference.
Featuring world-class plenary speakers, cross-cutting educational programming, valuable networking, and business development opportunities, The MedTech Conference is a must-attend event for the industry’s prominent and most promising companies.

MIDI will be exhibiting at The MedTech Conference in October. Register, mark your calendars, and visit us at booth #623.

Register for the event here

MIDI’s latest white paper is now available for direct download!

MedTech DFX: Advanced Strategies & Supply Chain Paradigm Shift, is now available. We invite you on a deep dive into Shifting the Supply Paradigm in MedDEVICE Development: Advanced DFX Strategies Creating Supply Chain Resilience.

Over the last two years, medical device developers quickly realized that manufacturing strategies championed pre-pandemic neglected supply chain resilience. This high-pressure situation became an opportunity for MIDI to create and pressure-test a stalwart approach to bringing medical devices to market with minimal delays and at acceptable costs while ensuring our clients’ long-term viability and business success in these changing supply circumstances.

This white paper focuses on the Design for Excellence (DFX) methodology operationalized under MIDI’s ISO-13485 Quality Management System (QMS) called DevelopmentDNA™ and its specific advantages. A deeper dive is taken into advanced DFSC strategies post-pandemic as well as special considerations for Printed Circuit Boards (PCBs).

Programmatic strategies, standard operating procedures, and special considerations are shared and detailed in a proven path to success allowing MIDI to quickly and efficiently bring clients’ medical devices to market.

Download your copy of the white paper here

MIDI’s next podcast series:
Digital Therapeutics (DTx): Core Principals, Current Trends & Future Snapshot
Digital health has evolved, from isolated remote monitoring technologies ten years ago to ubiquitous fitness devices and wellness apps that we enjoy today.

Now the future of true medical digital health is here…..today…. and moving faster than ever creating an increasingly crowded digital healthcare market. This digital revolution has generated new healthcare business model opportunities as well as global regulatory and market/operating model challenges for healthcare and life science markets.

Digital Therapeutics (DTx) is healthcare’s next wave. DTx is an emerging subset of evidence-based, clinically evaluated software products and services.

In MIDI’s DTx podcast series we will explore the clinical, financial, operational value, and healthcare benefit of DTx’s value proposition for biopharma, MedTech, and various healthcare stakeholders. We will review the DTx business model and ecosystem that intends on delivering deliver better healthcare outcomes for the market and patients its serves.

Stay tuned for the first podcast episode of the series coming soon!

MIDI launched a Groundbreaking Device with Nevoa at APIC

MIDI Product Development is proud to be partnered with Nevoa in the development of a next-generation transformative automated whole-room atomizing disinfection system for the Healthcare Industry called the Nimbus. This next-generation system’s advanced disinfection technology is 99.9999% effective against pathogens on surfaces and in room air for both healthcare and hospital settings. It is fully autonomous and supported with #IoMT (Internet of Medical Things).

The Nimbus system was revealed at the APIC Conference last week with great success. MIDI is proud to have been part of Nevoa’s journey and this amazing team.

We are excited to be exhibiting at our first in-person event since the COVID-19 pandemic!

From October 24-26, 2022, the world’s top MedTech executives will gather for the leading event in our industry — The MedTech Conference.
Featuring world-class plenary speakers, cross-cutting educational programming, valuable networking, and business development opportunities, The MedTech Conference is a must-attend event for the industry’s prominent and most promising companies.

MIDI will be exhibiting at The MedTech Conference in October. Register, mark your calendars, and visit us at booth #623.

Register for the event here

MIDI will be launching a GROUNDBREAKING Device at APIC

The device is designed to mitigate HAI (and COVID) infection spread in Hospitals. It is fully autonomous and supported with #IoMT (Internet of Medical Things). The next-generation system can be seen at the APIC 2022 Annual Conference on June 13th- 15th in Indianapolis.

Keep a lookout in the coming weeks for the reveal of this technology and booth location.

In Q1, MIDI is proud to have renewed its 2022 Partnership and Membership with ARROW and AdvaMed!

ARROW Aces Partner
Arrow Electronics guides innovation forward for over 175,000 of the world’s leading manufacturers of technology used in homes, business and medical markets.

A global provider of devices, services, and solutions, Arrow aggregates electronic components and enterprise computing solutions for customers and suppliers. The company maintains a network of more than 336 locations worldwide.

MIDI is proudly renewing our ARROW ACES Partner status for 2022.

Learn more about ARROW

AdvaMed

AdvaMed is a trade association that leads the effort to advance medical technology in order to achieve healthier lives and healthier economies around the world. AdvaMed’s membership has reached over 400 members with a global presence. Member companies include thought leaders, medical technology innovators, medical majors and will now include MIDI. The Association acts as the common voice for companies producing medical devices, diagnostic products and digital health technologies. MIDI is proud to continue our contributions to the AdvaMed community.

Learn more about AdvaMed

Webinar TOMORROW – The Innovation Roadmapâ„¢ for Medical Device Development: Fostering Innovation & Optimum Programmatic Direction Under Strategic Regulatory Deployment

Thursday, March 24th, 2022 | 12:00 p.m. ET / 9:00 a.m. PT

Tomorrow at 12 pm ET, join us as MIDI Medical Device Development Corp. and RQMIS Inc. present an AdvaMed hosted webinar event: “The Innovation Roadmapâ„¢ for Medical Device Development: Fostering Innovation & Optimum Programmatic Direction Under Strategic Regulatory Deployment”. Presented by Christopher Montalbano, CEO, MIDI Medical Device Development Corp., and Barry Sands, President, RQMIS.

The Innovation Roadmapâ„¢ is a development approach designed to yield innovation and competitive differentiation while conforming with the FDA-QSR & ISO-13485.

A properly formatted Innovation Roadmap™ can change a medical device development team’s perception as related to realizing the FDA’s recommendations and prescriptions are structured to yield innovation not inhibit. This is a PARADIGM SHIFT we take a deep dive into within this webinar while exploring the roadmap.

In this AdvaMed event, MIDI & RQMIS will help you:

• Learn the 3-Step Innovation Roadmapâ„¢ for optimized medical device development including Discovery Researchâ„¢, MVP R&D, and AGILE Commercialization under ISO-13485.
• Understand how regulatory controls can be leveraged in the development process to produce a device that is truly innovative.
• Learn how to utilize a development process which results in a device that will be reliable, safe, and effective for its users while infusing competitive differentiation.
• Learn the key engineering/design disciplines and tools deployed to achieve innovation success.
• Review of Case Studies that demonstrate implementation of these innovation principles yielding advanced medical devices.
• Q&A

Register here

Whole Room Disinfection Technology

MIDI will be announcing the launch of a state-of-the-art automated whole room disinfection technology at APIC, the world’s largest infection prevention technology show.

The system was developed by MIDI to fight both HAI’s (Hospital Acquired Infections) and COVID in hospitals and healthcare settings. It is fully autonomous and IoMT (Internet of Medical Things) controlled via an App. Data metrics are available to hospital management via the cloud for compliance tracking.

The reveal will come shortly from MIDI and its client.

Upcoming Webinar – The Innovation Roadmapâ„¢ for Medical Device Development: Fostering Innovation & Optimum Programmatic Direction Under Strategic Regulatory Deployment

Thursday, March 24th, 2022    |     12:00 p.m. ET / 9:00 a.m. PT

On March 24th, join us as MIDI Medical Device Development Corp. and RQMIS Inc. present an AdvaMed hosted webinar event: “The Innovation Roadmapâ„¢ for Medical Device Development: Fostering Innovation & Optimum Programmatic Direction Under Strategic Regulatory Deployment”. Presented by Christopher Montalbano, CEO, MIDI Medical Device Development Corp., and Barry Sands, President, RQMIS.

The Innovation Roadmapâ„¢ is a development approach designed to yield innovation and competitive differentiation while conforming with the FDA-QSR & ISO-13485. 

A properly formatted Innovation Roadmapâ„¢ can change a medical device development team’s perception as related to realizing the FDA’s recommendations and prescriptions are structured to yield innovation not inhibit. This is a PARADIGM SHIFT we take a deep dive into within this webinar while exploring the roadmap. 

In this AdvaMed event, MIDI & RQMIS will help you:

• Learn the 3-Step Innovation Roadmapâ„¢ for optimized medical device development including Discovery Researchâ„¢, MVP R&D, and AGILE Commercialization under ISO-13485.
• Understand how regulatory controls can be leveraged in the development process to produce a device that is truly innovative. 
• Learn how to utilize a development process which results in a device that will be reliable, safe, and effective for its users while infusing competitive differentiation.
• Learn the key engineering/design disciplines and tools deployed to achieve innovation success.
• Review of Case Studies that demonstrate implementation of these innovation principles yielding advanced medical devices.
• Q&A

Stay tuned for registration details for this webinar.

MIDI’s next white paper is coming soon

Incubators and Accelerators have become prominent within MedTech due to their evident and quick-to-realize value. In essence, they help bring people together and give startup and emerging companies access to otherwise hard-to-obtain resources. Before any MedTech entrepreneur begins pursuing support and engagement from an Incubator or Accelerator, it’s essential to clarify precisely what a particular organization’s program can do for them.

MIDI’s upcoming white paper details the startup journey complete with a startup roadmap. This white paper will be an inclusive guide for any medical startup including an industry summary of startup programs and how to effectively navigate the roadmap. 

Watch for the release of the White Paper next Wednesday, March 2.

We noticed that during our recent end-of-year news announcement many people were on holiday. Just in case you missed it we wanted to share the exciting MIDI news happening here in the new year.

MIDI enters the New Year expanding its rapid prototyping capabilities to better serve its clients’ needs when performing Medical Device Development Services under its DevelopmentDNAâ„¢, ISO-13485 compliant, device development approach. This will allow the MIDI Team to respond with enhanced capabilities/speed, under AGILE Development Sprints for its clientele in 2022.

A second SLA printer and second FDM printer are being onboarded within MIDI’s prototype lab as we share this news. Both are the latest generation supporting large build volumes. See the new printers below.

Formlabs; Form 3L SLA Printer, Form Cure L, Form Wash L, Build Volume, 13 x 8 x 12

Stratasys; F370 FDM Printer, Build Volume, 14 x 10 x 14

The increase in printing capacity and larger build volumes will allow MIDI’s AGILE Development Sprints to be deployed with enhanced briskness. We look forward to continuing to serve your medical device development needs with our enhanced capabilities in 2022 and beyond.

MIDI enters the New Year expanding its rapid prototyping capabilities to better serve its clients’ needs when performing Medical Device Development Services under its DevelopmentDNAâ„¢, ISO-13485 compliant, device development approach. This will allow the MIDI Team to respond with enhanced capabilities/speed, under AGILE Development Sprints for its clientele in 2022.

This week a second SLA printer and second FDM printer are being onboarded within MIDI’s prototype lab. Both are the latest generation supporting large build volumes. See the new printers below.

Formlabs; Form 3L SLA Printer, Form Cure L, Form Wash L, Build Volume, 13 x 8 x 12

Stratasys; F370 FDM Printer, Build Volume, 14 x 10 x 14

The increase in printing capacity and larger build volumes will allow MIDI’s AGILE Development Sprints to be deployed with enhanced briskness. We look forward to continuing to serve your medical device development needs with our enhanced capabilities in 2022 and beyond.

From all of us at MIDI, we hope you have a wonderful Thanksgiving!

MIDI Webinar – December 1st
Join MIDI CEO, Christopher Montalbano, and Barry Sands, President and Founder of RQMIS for a detailed webinar presenting The Innovation Roadmapâ„¢ for Medical Device Development: Fostering Innovation & Optimum Programmatic Direction Under Strategic Regulatory Deployment.

DATE: Wednesday, December 1st, 2021

TIME: 12:00 PM EDT / 9:00AM PT

Register For The Webinar

New Episodes Dropping Next Week
The current series of podcast interviews, The Ultimate Medical Accelerator & Incubator Lab Interviews, reveals to the MIDI Innovation Vault listeners the specific and unique inner-working of each Accelerator and Incubator organization’s program as well as the individual value-proposition offered to their entrepreneurial members.

Greg Montalbano, MIDI Principal, discusses with each organization’s Director, various topics involving mentoring and support methods offered to their members, whose technology applications span from medical devices, digital health, diagnostic applications, Biotech, and more.

Podcast guests from accelerator and incubator programs across the industry include

• Columbia University BioMedX Program Director – Meghan Pinezich IndieBio Director – Stephen Chambers and Chief Science Officer – Julie Wolf
• MedTech Innovator CEO – Paul Grand
• New York States Center for Biotechnology Director – Diane Fable
• University of Pennsylvania Penn Health-Tech Executive Director – Katie Reuther
• eHealth Ventures Co-founder – Steven Shapiro
• Texas Medical Center Director of Innovation and the prior Head of Houston’s Jlab – Tom Luby

Greg will ask the Directors to share their industry knowledge, experience, insight, and best advice for MedTech start-ups covering topics such as:

• Their organization’s individual value proposition, methods, and approach when selecting, mentoring, and supporting an entrepreneurial group member.
• How their group offers entrepreneurs a development community that scales through industry and venture partner networks.
• The specifics of what attributes their accelerator and incubator organizations look for in a start-up member.
• Recommendations on how a start-up can begin on their path to be part of an accelerator or incubator program….and how to differentiate your application.
• As well as descriptions of MedTech and Biotech innovation initiatives and breakthroughs that are expected from their entrepreneurial members.
• These topics and more will be explored and revealed such that you, the MIDI Innovation Vault Podcast listener can achieve a deep understanding of each accelerator or incubator inner-working methods, process, and value proposition that is offered to their entrepreneurial members.

Stay tuned, the next two episodes with New York States Center for Biotechnology Director, Diane Fable and University of Pennsylvania Penn Health-Tech Executive Director, Katie Reuther, will be available Wednesday, December 1st.

Check Out The First 4 Episodes

MIDI Celebrates 50 Years

A note from MIDI’s Principal, Gregory Montalbano

This week, MIDI is celebrating 50 years of medical device innovation, development, and blending clients’ medical technology, science, and MIDI’s creative ingenuity to profoundly change the trajectory of health for humanity across the globe.

Our company began its journey as a hopeful start-up product development consulting firm founded by my father, Anthony Montalbano, in 1971. Today, MIDI is premier turn-key medical and life sciences product development consulting corporation servicing clients globally. Our team comprises multi-disciplined innovators and doers achieving advanced results within rapid timelines under the most stringent regulatory constraints. 

MIDI Fun History Fact: 

Did you know, MIDI worked on the design, engineering, and commercialization of the world’s first MRI scanner? You can see more MIDI details at www.midipd.com.

At MIDI, we have a generational history of bringing innovation and competitive differentiation to our client’s development programs. Our proven process of innovating products, devices, and systems for complex global markets, technologies, end-users, and regulatory bodies sets us apart in our highly competitive industry. 

MIDI’s rich history, in addition to the opportunity to work with brilliant clients, suppliers, and employees, adds to our celebration of 50 years in business.

Our industry has evolved quite a bit over the past five decades. However, MIDI’s core value proposition of client collaboration, innovation, transparency, and ingenuity has remained the same and will continue to set us apart.

MIDI’s journey of medical innovation will continue far into the future. Our company’s culture and enthusiasm continue to grow as we uncover, discover, and develop new technology and medical device applications. MIDI’s culture, principles, knowledge, and expertise that have been forged over the past 50 years have made us ready for every new future development challenge. We will continue for the next 50 years to collaborate, create, evolve and refine our abilities and process to generate and deliver innovative next-step solutions for the clients we serve.

MIDI is excited to be exhibiting at its first in-person trade show post-pandemic

The world of medicine, including MIDI, meets at MEDICA 2021. A must for anyone who wants to experience tomorrow’s healthcare market live. The world forum MEDICA 2021 will take place in Messe Dusseldorf from November 15th through 18th. We’re looking forward to seeing you at the world’s largest medical tradeshow, MEDICA, next month!

Register here

In Memory of Our Founder and Father

Chris and Greg Montalbano are the co-owners of MIDI a Medical Device Development Firm which was founded by their father Anthony P. Montalbano in 1972. Unfortunately, Anthony recently passed. It is now a time for reflection and we are writing this tribute in recognition of the full and complete life he enjoyed. His sons explain;

He was a talented man and an amazing mentor. He was a: designer, engineer, artist, sculptor, wood-worker, house-builder, technical fisherman, scuba diver & archer to name a few of his skills and favorite hobbies. He created and managed a successful product development firm for many decades. With quick brushstrokes he could conceptualize design approaches that you can still see being used to this day! If you are ever being cared for in a hospital or doctors office, you will see his creative work and legacy. His entire life he worked magic with his hands. Some of the most amazing examples include bust sculptures he handcrafted and cast out of bronze for our entire family. The accuracy and 3-dimensional detail is outstanding! We are sure Dad, Michelangelo, and Leonardo are consulting with each other on artisanal methods and product development techniques at this very moment.

Where are IoMT-based wearables going next? 

The September issue of Medical Design & Outsourcing (MD&O) 2021 handbook features Chris Montalbano in a review of IoMT-based wearables. Learn more about the three significant trends shaping the Internet of Medical Things (IoMT) space. Additionally, once the concerns and trends are addressed, how to move into development commercialization with an understanding of proper sensor technology solution that will provide a device with desired capabilities.

Read the full article

Upcoming Webinar

Advancing Public Health with Wearables: Strategic Development of IoMT Biosensing Lifestyle Devices for the AdvaMed community

On September 15th at noon Eastern join us as MIDI and Valencell present  “Advancing Public Health with Wearables: Strategic Development of IoMT Biosensing Lifestyle Devices� for the entire AdvaMed community. Presented by Christopher Montalbano, CEO, MIDI Medical Device Development Corp., and Ryan Kraudel, Vice President, Marketing, Valencell, Inc., this webinar will examine the way in which wearables advance the public health when a strategic device development approach is utilized to integrate and harmonize: Lifestyle, IoMT, Biosensing, and Physiological Sensing.

In the webinar, MIDI & Valencell will help you: 

• Understand how wearable IoMT devices utilizing Bio-Sensors and Physiological Sensors translate into enhanced healthcare and wellness lifestyles.
• Learn how to optimize the selection of sensor (or sensor cluster) through a proven 4-Step approach of User Experience Monitoring, Body Assessments, Key Body Metric Capture, and Sensor Selection.  
• Learn the 3-Step Innovation Roadmapâ„¢ for optimized wearable device development including Discovery Researchâ„¢, MVP R&D, and AGILE Commercialization under ISO-13485.
• Review of Case Studies that demonstrate implementation of these innovation principles yielding advanced wearable IoMT healthcare sensing devices.

MIDI’s Interactive Roundtable Session performed for AdvaMed’s Accel Community

MIDI is providing a Roundtable Session for AvaMed’s Accel Community with a focus on;  Advanced Medical Device Commercialization. 

This session will provide the opportunity to learn more about:

• MIDI’s DevelopmentDNA^TM stage-gate development commercialization process.
• Integration of an FDA Overlay within DevelopmentDNA^TM
• How to infuse innovation and competitive differentiation into your device design

MIDI is proud to have provided a bespoke webinar to the JLABS and CDI (Center for Device Innovation) residents on July 27th

The session focused on Advanced Medical Device Commercialization. The agenda covered:

• Detail on MIDI’s DevelopmentDNAâ„¢ stage-gate development commercialization process and the methods by which it infuses innovation + competitive differentiation into medical devices. 
• Integration of an FDA overlay within DevelopmentDNAâ„¢ addressing FDA-QSR & ISO-13485.
• Case Studies
• Q&A

MIDI is excited to be exhibiting at its first in-person trade show post-pandemic

The world of medicine, including MIDI, meets at MEDICA 2021. A must for anyone who wants to experience tomorrow’s healthcare market live. We hope to see you at the world’s largest medical tradeshow. The world forum MEDICA 2021 will take place in Messe Dusseldorf from November 15th through 18th.

We hope you’ll join us.

Register here

Forest Devices recognized by FDA for AlphaStroke

MIDI’s AlphaStroke development team is proud of the recent FDA designation that the AlphaStroke technology is a Breakthrough Device. 

Forest Devices collaborated with the MIDI team in performing ground-up development of the AlphaStroke system which performs objective real-time electronically-determined stroke testing using a custom-developed proprietary AI-driven platform. This EMS portable disruptive technology device will be setting a new stroke testing standard for first responders as well as reducing or eliminating patient disabilities, rehabilitation, and even death from stroke.

This designation is one to be extremely proud of. With this kind of start, we look forward to seeing what’s next for AlphaStroke.

Read more here

A new Innovation Vault Podcast series

The latest podcast series, Advancing Public Health with Wearables;
Strategic Development of IoMT Biosensing Lifestyle Devices is coming soon!

In this series, we will take a deep dive into the development of wearables. Starting with an overview of IoMT Wearables, then performing a deep dive on IoMT Sensor Landscape, additionally revealing the methods of Commercialization & Implementation. Be prepared for a comprehensive playbook on IoMT biosensing lifestyle devices.

Stay tuned for the first episode next week

WEBINAR RECAP- Advancing Public Health with Wearables: Strategic Development of IoMT Biosensing Lifestyle Devices

MIDI’s latest webinar was a success with over 900 registrants tuning in to the presentation of “Advancing Public Health with Wearables: Strategic Development of IoMT Biosensing Lifestyle Devicesâ€�. Christopher Montalbano, CEO, MIDI Medical Device Development Corp. and Ryan Kraudel, Vice President, Marketing, Valencell, Inc., took a deep dive into the way in which wearables advance the public health when a strategic device development approach is utilized to integrate and harmonize: Lifestyle, IoMT, Biosensing and Physiological Sensing.

If you missed it you can watch the recording here

Don’t Miss It – The Role of Usability Research and Human Factors in Medical Device Design, The White Paper
MIDI’s latest white paper, The Role of Usability Research and Human Factors in Medical Device Design is a hit with over 140 downloads since May 5th. In this paper you will learn more about:

-The origin Story of Medical Device Usability Research & Human Factors Engineering
-The Fundamentals – Usability Research and Human Factors for Medical
Device Development
– The Essential Baseline Components – Device Users, Use Environment and User Interfaces
-The FDA Considerations – Usability and Human Factors to Support Safe
and Effective Use
-The Standards Organizations for Usability and Human Factors Considerations – AAMI, ANSI, ISO and IEC
-The First Step – Beginning your Usability and Human Factors Regulatory and Standards Roadmap
– The Top Three Main Guidance Documents – IEC, CDRH and ANSI/AAMI
– The ANSI/AAMI HE75 – Overview and Methods
-The Usability Research Methods – Generative and Evaluative Research

Register to get the White Paper in our Innovation Vault

You can also find our library of other White Papers on topics like the Innovation Roadmap and Infection Prevention there.

WEBINAR – Advancing Public Health with Wearables: Strategic Development of IoMT Biosensing Lifestyle Devices

On  April 29th, join us as MIDI Medical Device Development Corp. and Valencell, Inc. present  “Advancing Public Health with Wearables: Strategic Development of IoMT Biosensing Lifestyle Devices�. Presented by Christopher Montalbano, CEO, MIDI Medical Device Development Corp. and Ryan Kraudel, Vice President, Marketing, Valencell, Inc., this webinar will examine the way in which wearables advance the public health when a strategic device development approach is utilized to integrate and harmonize: Lifestyle, IoMT, Biosensing and Physiological Sensing.

Join us Tomorrow (noon EDT) for our live webinar! Register here

The Role of Usability Research and Human Factors in Medical Device Design, The White Paper

MIDI’s latest white paper will be avaiable next week. Stay tuned for the release of The Role of Usability Research and Human Factors in Medical Device Design. In this paper you will learn more about:

• The origin Story of Medical Device Usability Research & Human Factors Engineering
• The Fundamentals – Usability Research and Human Factors for Medical
  Device Development
• The Essential Baseline Components – Device Users, Use Environment and User Interfaces
• The FDA Considerations – Usability and Human Factors to Support Safe
  and Effective Use
• The Standards Organizations for Usability and Human Factors Considerations – AAMI, ANSI, ISO and IEC
• The First Step – Beginning your Usability and Human Factors Regulatory and Standards Roadmap
• The Top Three Main Guidance Documents – IEC, CDRH and ANSI/AAMI
• The ANSI/AAMI HE75 – Overview and Methods
• The Usability Research Methods – Generative and Evaluative Research

2020 in Review

COVID-19 has had a significant impact on the world this year from both a healthcare and economic perspective. As winter moved into spring, MIDI rose to the occasion, using our essential service status, to rapidly engineer and deploy solutions to market for our clients. Learn more about MIDI’s anchor 2020 development initiatives some of which are COVID-19 detection or COVID-19 mitigation related.

• Rapid SARS-CoV-2 Device/Disposable to be used in high-trafficked POC locations; i.e. airports, colleges, sporting events.
• Disinfection Fogging Device to combat HAI’s (Hospital Acquired Infections) and COVID-19 in hospitals and beyond healthcare environments.
• UVC-LED System to combat HAI’s from spreading room-to-room via foot-traffic.
• Early Stroke Detection Device. A worlds first, low-cost, handheld device that will be utilized within ambulances by EMS technicians.
• Micro-Laparoscopic Surgical Stapling Device.
• Advanced MRI Imaging System with unprecedented HFE (Human Factors Engineering) advantages for both the patient and radiologist.

As we move into the end of 2020, despite the challenges this year has brought, we continue to find ways and innovate which we couldn’t do without our partners. We’re excited about MIDI’s ongoing COVID-19 development initiatives and the positive impact they will have on rapid detection and infection prevention in 2021.

Partnering with ARROW 

Arrow Electronics guides innovation forward for over 175,000 of the world’s leading manufacturers of technology used in homes, business and medical markets.
A global provider of devices, services, and solutions, Arrow aggregates electronic components and enterprise computing solutions for customers and suppliers. The company maintains a network of more than 336 locations worldwide.
MIDI is proudly now an ARROW ACES Partner.   Learn more about ARROW

UAE & Saudi Arabia

Marketing and sales campaign in UAE and Saudia Arabia; MIDI has a campaign deployed in these 2 Middle Eastern locations to assist and capitalize on the massive growth and investments occurring in their medical tourism industries.
 Learn more about Healthcare in UAE

Coming Up!

Stay tuned for our latest White Paper: Paradigm Shift in Medical Device Development: The Innovation Roadmapâ„¢: Embracing Regulatory Controls to Incite Innovation. You’ve followed along on the Innovation Roadmapâ„¢ through our podcast and blogs, now its’ time to bring it all together. The White Paper will be available soon.

As we enter the 4th quarter of 2020 we reflect on the year so far and what is left to accomplish. The year has given us many opportunities to use our expertise in various subjects and execute on projects we believe will play a role in the wellbeing of those affected by the hardships of this year and beyond. We’re proud of the work we’ve done so far, the partnerships we hold, and what’s to come from MIDI.

For more detail on our recent work follow our podcast and blog series.

COVID Conversations with Rensselaer Polytechnic Institute

MIDI has been working intimately with companies related to infection prevention within healthcare. In this recorded interview Principal, Chris Montalbano, outlines a Blue Ocean approach on how technology can manifest itself into new, unique devices addressing everyday life environments. He also provides an example of a unique technology born of the RPI Incubator that is now manifesting itself within a cutting-edge infection prevention device, created by MIDI and used in a healthcare setting, but more importantly, beyond: airports, office environments, cruise ships, hotels, and more. Listen to COVID Conversations with RPI

MIDI is joining AdvaMed

MIDI is joining AdvaMed AdvaMed is a trade association that leads the effort to advance medical technology in order to achieve healthier lives and healthier economies around the world. AdvaMed’s membership has reached over 400 members with a global presence. Member companies include thought leaders, medical technology innovators, medical majors and will now include MIDI. The Association acts as the common voice for companies producing medical devices, diagnostic products and digital health technologies. We’re looking forward to contributing to the AdvaMed community.  Learn more about AdvaMed

Here at MIDI we’re forging on in the world of medical innovation and product development. As we are faced with months on end of global pandemic, the world needs innovation now more than ever. In response, we’re buckling down, embracing our lasting partnerships and creating in our areas of expertise to do our part in this battle. 

We welcome you to follow along with updates of our recent work, shared knowledge and findings, and looking toward the future of innovation. Please join the conversation and share your perspective on the topics at hand by emailing us feedback or connecting on social, we greatly appreciate your input. 

Are you listening to the INNOVATION VAULTâ„¢ podcast?

In our current podcast series, Paradigm Perception Shift in Medical Device Development: the INNOVATION ROADMAPâ„¢, we open up the map and share a detailed look into each roadmap stop sharing our experience and expertise to help guide you in yielding innovation. Listen to the latest episodes

Embracing regulatory controls can help you map medtech innovation

The September issue of Medical Design & Outsourcing (MDO) features Chris Montalbano in a review of MIDI’s INNVOVATION ROADMAPâ„¢. Learn more about how using a properly formatted “roadmapâ€� can help a medical device development team realize that the regulations (FDAQSR & ISO-13485) are structured to yield innovation rather than stunt it. Read the full article

MIDI is joining AdvaMed

AdvaMed is a trade association that leads the effort to advance medical technology in order to achieve healthier lives and healthier economies around the world. AdvaMed’s membership has reached over 400 members with a global presence. Member companies include thought leaders, medical technology innovators, medical majors and will now include MIDI. The Association acts as the common voice for companies producing medical devices, diagnostic products and digital health technologies. We’re looking forward to contributing to the AdvaMed community.  Learn more about AdvaMed

On June 1st, Chris Montalbano hosted a webinar for his alma mater, Rensselaer Polytechnic Institute, on how MIDI is helping combat the COVID-19 Global Pandemic.  Paradigm Shift Required: Infection Prevention was one part of the COVID conversations series RPI is putting on.

MIDI has been working intimately with companies related to infection prevention within healthcare. In this webinar, Chris outlined a Blue Ocean approach on how technology can manifest itself into new, unique devices addressing everyday life environments. He also provided an example of a unique technology born of the RPI Incubator that is now manifesting itself within a cutting-edge infection prevention device. It was created by the team at MIDI and is used in a healthcare setting, but more importantly, beyond – airports, office environments, cruise ships, hotels, and more.

As MIDI’s staff continues to move forward developing new and innovative medical technologies that improve the safety, health, and cleanliness of the world, our thoughts and support go out to our healthcare heroes on the frontlines of the #COVID19 pandemic. It was brought to our attention that local area healthcare workers on the #frontlines were having to resort in protecting themselves by wearing garbage bags, due to a shortage of PPE (personal protective equipment). The MIDI team put great effort and expense into sourcing and procuring a large quantity of Tyvek Disposable Coveralls to donate to these healthcare facilities. Corporations and individuals alike need to do all we can to help save lives and do our part both locally and globally because…..We Are All In This Together.

This month MIDI Principal, Chris Montalbano, was invited to PITTCON 2020 as a Guest Speaker in Chicago. Chris presented “Embracing Regulatory/Design Control Constraints as a Viable Innovation/Development Strategy“. The presentation encompassed the preparation necessary for a new medical design for market readiness and to achieve 510(k) success. Chris discussed that the product development process deployed needs to incorporate medical regulatory and design control requirements. While this approach is often viewed as a “means to an end,” Chris revealed the true design innovation potential that results from the proper structuring and application of control methodologies within a unique systems approach. A case study was presented tied to MIDI’s unique Systems Approach/Methodology to inspire and encourage participation. In the case study, a direct correlation was revealed between the regulatory/design control methodology and innovation outputs in areas, such as but not limited to:

− Market Augmentation (unmet needs)
− Technology Enhancement
− Usage Ceremony & HMI Advancement
− DFX (DFM & DFA, cost competitiveness)
− IP Generation (market protection)

Principals Greg and Chris hosted a roundtable entitled “Demystifying Medical Device Commercialization� at JLABS @ M2D2 in Lowell, MA today.  MIDI has a close working relationship with the JLAB community, recently hosting successful medical device commercialization events at JLABS-NYC & JLABS-Houston.  Today’s one-on-one sessions focused on:

• Reviewing the steps to MIDI’s proprietary device development commercialization process:  DevelopmentDNAâ„¢
• Describing how a properly organized approach can yield device innovation & competitive differentiation.
• Explaining how Design Controls and Risk Management are woven into the commercialization process to achieve FDA approval.
• Answering those “burning questionsâ€� as related to current development processes underway.

The sessions proved very engaging by all that attended!

Principals Greg and Chris exhibited this month in Boston at the MedTech Conference that brought together more than 3,000 attendees to network, conduct business, gain access to capital and share insights.  Greg and Chris  had one-on-one meetings with investors, medtech companies, start-ups, academics and other industry stakeholders during the conference. MIDI was among over 125 exhibitors that made the MedTech Conference Exhibit Hall a bustling environment to source new solutions, network with peers and participate in forward-looking discussions.

This month MIDI Principals, Chris and Greg exhibited at the MD&M East show at the Jacob Javits Center in NYC. For the past 36 years, MIDI and other executives attending the show discussed the latest innovations in medical device design.  MIDI was among the east coast’s most comprehensive showcase for the latest in medical device development and hands-on innovations driving tomorrow’s life changing designs. Thousands gathered to gain critical knowledge and a better understanding of the latest industry innovations and emerging technologies. Attending MD&M East is imperative to keep up-to-date on the latest medtech innovations and knowing where the industry is focusing its investments.

MIDI exhibited again this year at BIOMED 2019 in Boston. There was record attendance at the show and MIDI Principals Chris and Greg were on-hand to discuss MIDI’s innovative Medical Product Development platforms with the innovators that stopped by our booth. The attendees learned about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets. MIDI has been attending UBM BIOMED shows for the past 11 years. And every year new connections and new collaborations are created. It was a great show and we look forward to BIOMED 2020!

By GREG MONTALBANO

I’ve been developing clients’ med-tech devices, in all possible applications, for 28 years, and my company has been doing it for 47.

No, I didn’t invent a time machine (yet). As the second-generation owner of MIDI Medical Product Development, I’m helping to carry on Long Island’s long tradition of medical-product development.

Our clients and their corresponding R&D mindsets have certainly shifted over the years, with more focus on supporting independent, entrepreneurial, lean startups with emerging technologies. From 1972 to 2009, some 95 percent of MIDI’s clients were Fortune 500 companies. But over the past 10 years, roughly half of our clients were lean med-tech startups and emerging companies, many newly graduated from incubators and accelerators in locations as far apart as Houston and Hong Kong.

Over the past decade, there has been an explosive, exponential growth of med-tech emanating from independent startups worldwide. So how do the Fortune 500 med-tech and pharmaceutical companies effectively respond to this R&D shift – how do they capitalize and drink from the seemingly infinite well of startup innovation existing outside their organizations?

Some of the best answers to these and other questions can be found in Johnson & Johnson’s multi-location startup arm, known as JLABS, and the Houston-based Texas Medical Center Innovation Institute, where I serve as an external innovation advisor.

Med-tech startups face significant barriers, and for the past six years, JLABS and the TMC have provided capital-efficient, flexible business-accelerator and incubator platforms for emerging companies looking to address the most challenging needs in the healthcare industry.

Johnson & Johnson thought leaders were looking for solutions on how to shift the corporate R&D mindset. Born of pure insight, the startup partnering program embedded at the TMC – one of nine JLABS around the globe – is meant to tap into innovation happening outside J&J.
Greg Montalbano: Solving med-tech problems in Houston.

Greg Montalbano:
Solving med-tech problems in Houston.

The medical center was the perfect synergistic partner to connect JLABS to startups in the TMC’s own incubator programs, and to a multitude of local hospital groups, organizations and providers – direct access to healthcare voice-of-the-customer information.

The primary end deliverable for JLABS is to build and expand an external medical-device and pharma portfolio of innovation and value. In addition to R&D space and equipment and on-site IT and business-logistics support, the program includes a year-round commercialization curriculum and a roster of specialists and advisors who mentor the scientists and entrepreneurs about turning their research and early applications into viable companies.

The JLABS and TMC initiative has been wildly successful, with well over 500 companies circulating through the TMC incubator and JLABS accelerator programs. JLABS has not only become closer to the entrepreneurial community, but has also given Johnson & Johnson early positioning on new med-tech under development.

Being a part of the JLABS and TMC process, culture and support system is very rewarding for me as a med-tech developer and business owner. The innovation engine that the TMC has built in partnership with JLABS is an amazing accomplishment that’s quickly building up the Houston metropolitan area as the “med-tech Silicon Valley� for emerging companies.

This initiative will pay many dividends for the TMC, Johnson & Johnson, the Houston regional economy and the medical industry.

So, here’s my question for you, Long Island: Are you ready, willing and able to achieve that level of med-tech success? A Long Island innovation consortium is needed and MIDI is ready to participate!

Greg Montalbano is a principal at Smithtown-based MIDI Medical Product Development, a JLABS mentor and a member of the Texas Medical Center Innovation Institute Advisor Network.

Principal Greg Montalbano was invited to consult students under the tutelage of Stony Brook University Department of Biomechanical Engineering Associate Professor, Wei Yin.  Specifically, Greg got to review 80-plus medical mock-ups and/or “design reports� submitted by pending graduates in Yin’s Design in Biomedical Engineering class. The seniors earn their stripes in May, and the annual senior design project culminates a semester-long challenge in which those imminent grads identified specific healthcare needs and developed devices or software to meet them. “They’re very ambitious, they’re very energetic and their eyes are wide open to the kinds of entrepreneurs they want to be.�, said Greg.  To read the entire article, click HERE.

MIDI is proud to have been selected by JLABS to host an internal Lunch & Learn session in Houston this month. MIDI presented ” Advanced Medical Device Commercialization “, with break-out sessions and one-on-one collaborative meetings to the J&J community.   Chris and Greg, MIDI Principals, are Texas Medical Center Innovation External Institute Advisors.  Some of the topics they discussed were:  Understanding the proven-process method for medical device development & gaining knowledge into the key criterion of successful development team skill sets that deliver innovation tied to FDA compliance.

For those not part of the J&J community, we will present an encore Webinar of this session on April 26^th at 2pm (EST).   If you are interested in registering for this Webinar, click HERE.

Innovate Long Island saluted its 2019 Innovators of the Year at the Crest Hollow Country Club in Woodbury on March 28, 2019. More than 500 guests turned out to honor the New York tri-state area’s leading-­edge researchers, inventors, entrepreneurs and executives. MIDI Principals Gregory Montalbano and Christopher Montalbano, were among the recipients of this year’s prestigious award. The Montalbano brothers, operating from their cutting-edge Smithtown-based MIDI Medical Product Development Innovation Center, were honored to be recognized for their contributions to Long Island’s innovation community. “There are leaders gathered from all over the tri-state area who have innovation in their DNA and we are proud to be recognized along with them”, says Chris Montalbano.

By GREGORY ZELLER //Step right up: And meet the FlooRX, a UV-powered, IoT-enabled device designed to kill infectious pathogens that cling to footwear, brought to you by inventor Rachel Dombrowsky and her friends at MIDI Medical Product Development.

After 30 years in the healthcare business, Rachel Dombrowsky understands very well the dangers of hospital-acquired infections. Also, shoes kind of gross her out.

So Dombrowsky embarked on an ambitious “science project,� literally on the ground floor: Floors are the most “unappreciated pool of pathogens� in a hospital environment, she noted, “more contaminated than bedrails or even toilets� – and yet, little scientific progress has been made when it comes to stopping germs from attaching themselves to footwear and hitching rides from one area of a hospital to another.

The risks of HIA (which also stands for “healthcare-associated infections�) are familiar to Dombrowsky, president and CEO of the Oyster Bay Senior Campus, which maintains multiple assisted-living facilities catering to the elderly, the memory-impaired and other senior populations.

“I’m very aware of the need to protect my residents in their environment, which is a congregant care environment, and to make sure that when one person comes down with something, it’s not transferred to any other place in the building,� Dombrowsky told Innovate LI.

And yeah, there was that shoe thing.

“My other inspiration was I always had an aversion to wearing my shoes in my home after wearing them in hospitals and assisted-living facilities and in the street,� she added. “And I didn’t like when other people [wore them in the house], but I didn’t have much control over that.�

Rachel Dombrowsky: Foot soldier.

Through her 2015 startup Harbor Innovations, an Oyster Bay-based medical-device company, Dombrowsky started tinkering. She focused immediately on ultraviolet light and primarily targeted C. diff – Clostridium difficile, which according to the innovator is “one of the hardest pathogens to kill, because it has a very hard shell … and it lasts about five months on a surface.�

Her initial attempts – combining UV lightbulbs inside  casing that looked a bit like a bathroom scale, with angled louvers from an air-conditioner unit to keep the UV light out of her eyes – weren’t very stylish, but they did the trick.

“It did kill C. diff,� Dombrowksy noted.

Now, with the help of one of Long Island’s most innovative product-development specialists, Dombrowsky is preparing to introduce the world to FlooRX – a next-generation, IoT-enabled, nickel-thin device capable of eradicating C. diff and a host of other footwear-focused pathogens, including e coli, MRSA and the fungal infection Candida auris.

Harbor Innovations partnered with Smithtown-based MIDI Medical Product Development on the sleek upgrade, which instead of full-size ultraviolet bulbs incorporates UV light-emitting diodes – offering the same germicidal benefits, according to MIDI Principal Chris Montalbano, only in a wafer-thin design and with “the digital control you need to create a smart system.�

“Others in the industry are already using UV bulbs to kill these pathogens, but MIDI took it to the next level,� Montalbano said. “Rachel took the idea of using them to sanitize feet, and MIDI used our DevelopmentDNA process to understand the user community and search for unique technologies to apply in this unique way.

“We now have unprecedented ability to easily insert this into architectural construction at hospitals, whether renovations or new (construction).�

Chris Montalbano: Extra steps.

Not only does the LED upgrade eliminate “the spatial constraints of full-size bulbs� (meaning you can basically create a floor-based device that users must only step on), but it facilitated direct control of which UV diodes are activated and which aren’t – “mitigating UV spillage,� Montalbano noted.

“This product also has unprecedented Internet of Things connectivity,� he added. “Hospitals not only want to kill infections on the feet, they want to know which critical-care facilities are complying and which aren’t.�

The FlooRX, which has earned a U.S. patent for Harbor Innovation, has undergone numerous clinical trials – spanning hospitals and assisted-living facilities, conducted by both Dombrowsky and MIDI – and is now gearing up for its first mass-production run. More trials are planned, but already discussions are underway with “a medical-grade contract manufacturer,� according to Montalbano.

Partnering with MIDI was the best move Harbor Innovations could have made, according to Dombrosky, who said the FlooRX racing to market is “nothing like� what she cobbled together on her own.

“I have never made as good a decision as when I came to MIDI,� the inventor said. “When I walked into their office, I knew I was in the right hands at the right time.

“It’s really been a joy working with them, but now that we’re going into contract manufacturing I’m actually a little sad,� Dombrowsky added. “It’s time to let the baby go!�

As a TMCx Institute Advisor, Principal Gregory Montalbano, and Principal Christopher Montalbano, this month attended TMCx’s Demo Day in Houston, Texas. 23 medical devices were pitched at the TMCx Demo Day. Entrepreneurs who are finishing up a four-month stint in the TMC Innovation Institute’s accelerator program showcased their progress in getting their devices in front of medical personnel and bringing them to market. The TMCx accelerator provides startup companies with shared workspace, a curriculum tailored to the needs of health care entrepreneurs and the guidance of over 200 advisors, that included Gregory and Christopher, from the front lines of the industry. The program’s goal is to quickly and effectively connect entrepreneurs to stakeholders.

This month MIDI Principals, Chris Montalbano and Greg Montalbano presented and exhibited at the MedTech/ ADVAMED Conference/Show in Philadelphia. The MedTech Conference is the leading gathering in North America of global MedTech executives. The conference attracts more than 3,000 attendees from 30 different countries to network, conduct business, gain access to capital and share insight into emerging trends and best practices in MedTech. The MedTech Conference also gives MedTech industry leaders the opportunity to interact with policymakers, members of the media, investors, legal experts, consultants, distributors and other important stakeholders to help grow and transform their businesses. Chris and Greg were among the many Executives at this Conference from around the world discussing the timeliest issues and opportunities. “There are industry leaders gathered from FDA; M&A organizations; and international experts from around the world that we meet who are crucial to the medical technology industry�, says Chris Montalbano.

This month MIDI Principal, Gregory Montalbano, exhibited at the MD&M East show at the Jacob Javits Center in NYC.  Attendees stopped by MIDI’s booth to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets. MIDI has been attending UBM Canon MD&M shows for the past 35 years.  During each show new contacts are made and with medical device OEMs doubling-down on innovation, they’re relying increasingly on outsourcers to fill in the gaps in their core capabilities. Choosing the right service provider, like MIDI, is critical, and the best way to vet a potential partner is to meet face-to-face.  MIDI has forged many partnerships throughout the years and continues to build upon our 50-year reputation as a trusted partner to many startups, innovation hubs and corporations.

This month MIDI Principal, Christopher Montalbano, exhibited with MIDI’s client, HealthierStep, at APIC 2018 in Minnesota. Attendees stopped by HealthierStep’s booth to learn more about FLOORX- the floor-based sanitizing station that kills over 90% of harmful pathogens in just 10 seconds. FLOORX will save lives and money for the healthcare industry. FLOORX does not simply combat HAIs in the most high-pressure of environments – with its patented, cloud-based operating platform, FLOORX makes for a more efficient hospital. FLOORX records staff compliance and overall usage, observing data metrics by station and staff member, and updating data bases tracking people, devices, departments, and even facilities.

This month MIDI Principal, Chris Montalbano, was invited as a Guest Speaker to the BIOMEDevice Show in Boston.  Chris presented “Case Study: Product Innovation While Embracing Regulatory Control as a Viable Development Strategy“. The presentation encompassed the product development preparation necessary for a new medical design to successfully achieve market readiness (i.e. 510k) via design controls, while simultaneously innovating utilizing a stepped DevelomentDNA^TM methodology.  While the regulated design control process is often viewed as a “means to an end,” the presentation revealed the true design innovation potential that results from the proper structuring and application of control methodologies within a unique DevelopmentDNA^TM systems approach. The case study directly correlates this systems-approach strategy which embraces the regulatory process revealing output yielding competitive differentiation.

This month MIDI Principals Chris and Greg attended the MD&M West show in Anaheim, CA but the MIDI trade show booth missed the event! The booth left New York but never arrived in California. MIDI made the best of the situation by attracting visitors with a sign designed by Greg. It wasn’t long before attendees were interested in knowing who the man with the sign was! Chris and Greg were still able to provide the attendees with the scope of services provided by MIDI and MIDI’s background of over 50 years experience servicing domestic and international clientele representing medical, life sciences and home healthcare markets.

This month at the BIOMEDevice show at the San Jose Convention Center in CA, Greg Montalbano (MIDI Principal) was a featured speaker on the subject of “Secrets of Disruptive Innovation”. The discussion outlined how truly disruptive innovative medical device technologies achieve success. Topics included:
• What it takes to disrupt the dominant care paradigm
• When to proceed with a disruptive design
• When to play by the rules and Real-life examples of disruptive medical devices.
Here you can see Greg moderating the panel discussion at the show.

Last weeks MD&M (Medical Device & Manufacturing) show held at the Jacob Javits in New York City was a tremendous success for the MIDI Team. Here you can see Chris Montalbano (MIDI Principal) providing insight on their DevelopmentDNATM medical product development process explaining how it provides device innovation and competitive differentiation for it’s clientele while conforming to the FDA-QSR & ISO-13485 so clients can achieve their FDA 510k device filing. Additionally Chris was chosen as one of the shows keynote speakers, presenting on; Designing for Excellence utilizing Early Stage Value Engineering within it’s DevelopmentDNA™ process.

Join MIDI at the 2017 Medical Design & Manufacturing East conference, booth #1140, June 13-15, at the Jacob Javits Convention Center (New York). Stop by to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets.

MIDI understands the product development & technology challenges of the medical industry. We offer our clients our expertise as well as our DevelopmentDNA™ process which affords us the ability to uncover, identify, and understand varying program development inputs and generate actionable innovative results. MIDI’s DevelopmentDNA™ provides Innovative Design, Concrete Reliable Engineering, Design Controls Procedures [ISO13485, FDA QSR, FDA 510(k)], Manufacturing Production Solutions and Product Branding. This process allows MIDI to respond with intelligent, informed, targeted development programs emanating from top level strategies, ensuring our client’s Predictable Success.

We look forward to seeing you at MD&M East !

Product placement: MIDI principal Christopher Montalbano makes a new friend at BIOMEDevice Boston.
MAY 16, 2017

By GREGORY ZELLER //

They’ve been to bigger shows, but for partners Christopher and Gregory Montalbano – the road warriors of Long Island medical-product innovation – this was as good as it gets.

Forget, for a moment, whatever you know about New York-Boston enmities. The Northeast archrivals may disagree on everything from sports teams to clam chowders, but when it comes to medical innovation, they’re kindred spirits – especially with Long Island emerging as a serious biotechnology corridor.

The Island’s med-tech chops took a quantum leap forward exactly one year ago last month, when the Montalbanos – partners at MIDI Medical Product Development – opened their state-of-the-art Innovation Center, a humming hub of next-level design and hard-core testing. Since then, the brothers have hit the road relentlessly, spreading the word about the Smithtown center and MIDI’s other development-related services at some of the nation’s busiest medical-product conferences and showcases.

They’ve been to the really big ones, including Medical Device & Manufacturing West, a February convention that attracted some 20,000 engineers and investors to California. And there are more major-league conferences on the horizon, including next month’s MD&M East, a three-day tech-a-thon at Manhattan’s Jacob K. Javits Convention Center, where Christopher is slotted as one of the keynote speakers, addressing “medical value engineering and development.�

But last week, it was Beantown, for BIOMEDevice Boston. Self-promoted as “New England’s largest med-tech event,� MD&M’s annual Boston showcase is a sort of little brother to the others – it attracts closer to 4,000 engineers and execs – but it’s smack dab in the Goldilocks Zone for the brothers Montalbano: just right.

“This particular show is much more intimate,� Gregory Montalbano told Innovate LI. “It is extremely focused, relative to innovation, emerging sensor technologies and the healthcare Internet of Things, and how to incorporate them into medical-product development and life-sciences projects.

“And because it’s smaller, you’re able to get a lot more facetime with industry leaders.�

And that’s the rub for these enterprising innovators, who see Boston’s bubbling biotech corridor as fertile hunting grounds. They might have met fewer med-tech entrepreneurs or executives from larger healthcare conglomerates than they met in Anaheim or will meet in Manhattan, but the Boston show helped MIDI establish a foothold in one of the hottest biotechnology corridors in all the land.

“It’s definitely [a smaller show],� Gregory noted. “But having a booth at this show and mixing it up with that region’s med-tech leaders was definitely worthwhile.

“We have some clients in Boston, but we would like more,� he added. “That area is saturated with med-tech, and there’s plenty of innovation and development opportunities to go around. As we create more space for ourselves in this industry, we definitely want to expand our base in Boston, and really capitalize on all the innovation happening there.�

That said, the Montalbanos are New Yorkers, born and raised on Long Island, and the heart of their burgeoning product-development empire is here.

The brothers are thrilled to occupy advisory board seats at the Long Island Bioscience Hub – the science syndicate featuring Cold Spring Harbor Laboratory, Brookhaven National Laboratory, Stony Brook University’s Center for Biotechnology and Northwell Health’s Feinstein Institute for Medical Research – and to serve as “biomedical accelerator advisors� for the Columbia-Coulter research partnership.

And they will definitely enjoy a home-field advantage in June, when the MD&M traveling show makes its annual stop at the Javits Center.

“Our vision, our ultimate goal, is to move med-tech forward in the New York area,� Gregory noted. “That doesn’t mean we’re not looking at Boston or Silicon Valley, because we are. Growth and expansion are always our goals. But equally important to us is expanding our capabilities specifically in Greater New York.�

That was the thrust behind the opening of the 6,500-square-foot Innovation Center in Smithtown’s Village of the Branch, which over its first 12 months has attracted several “high-end collaborative projects,� according to Gregory. Confidentiality clauses prevent the MIDI principals from discussing virtually all of the goings-on inside their prototyping facility, though sometimes they can barely contain their excitement.

“There are many highly confidential programs involving Internet of Things, electro-stimulation and advanced diagnostic equipment utilizing technologies that have never been used in this industry before,� Gregory gushed. “Ultimately, some of these products are going to seriously disrupt diagnostic testing relative to cost reductions and the speed of end results.

“The center has really facilitated the next chapter of our own development.�

And the pages only turn faster through the MD&M events, even the smaller ones, which not only provide networking opportunities that could drum up new product-development business but give MIDI’s minders plenty of chances to help academia build med-tech momentum – while keeping them abreast of the latest developments in advanced sensors, patient-compliance software and med-tech’s various back-end channels.

“It’s a combination of all these things,� Gregory said. “When we attend these shows, I definitely know we’re on the right path, but there’s always something new to learn, always a new application related to software or embedded systems or new user interfaces, something that moves the industry forward.

“There’s always something that can help generate better results, which is basically to make people healthier,� he added. “The day you stop learning is the day you retire from the industry.�

This spring Chris Montalbano (Principal of MIDI) served as a Biomedical Judge & Adviser for Columbia-Coulter’s Translational Research Foundation, assisting various teams interested in commercializing their biotechnologies by applying relevant experience and expertise within this market. The process afforded participants a holistic perspective to think past their technology to the broader challenges involved with biomedical commercialization. By engaging and allowing the team’s access to early advisement its participants receive specific guidance and strategic direction on the challenges they may face during the development path to market.

Last week the event concluded with judging, where selected teams receive Coulter Funding to advance their nascent ideas from conception to proof-of-concept. The program aims to better position these ideas for partnering with a commercial entity that will invest the necessary resources to bring the concept to market.

On April 28^th,  Greg Montalbano (Principal of MIDI) served as keynote speaker for a Senior Graduating Biomedical Engineering class at Stony Brook University.  The graduating students were provided with insight on the commercialization path for medical devices.   A full spectrum of development steps/methods for this path, from; R&D through to production, including FDA 510k requirements was reviewed and received by the students giving them further perspective for their future careers.

Join MIDI at the 2017 BIOMEDevice conference, booth #223, May 3-4, at the Boston Convention Center. Stop by to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets.

MIDI understands the product development & technology challenges of the medical industry. We offer our clients our expertise as well as our DevelopmentDNA(tm) process which affords us the ability to uncover, identify, and understand varying program development inputs and generate actionable innovative results. MIDI’s DevelopmentDNA(tm) provides Innovative Design, Concrete Reliable Engineering, Design Controls Procedures [ISO13485, FDA QSR, FDA 510(k)], Manufacturing Production Solutions and Product Branding. This process allows MIDI to respond with intelligent, informed, targeted development programs emanating from top level strategies, ensuring our client’s Predictable Success.

We look forward to seeing you at BIOMED !

Nearly a year after giving itself a massive home-field advantage, MIDI Medical Product Development is putting in some roadwork.

Last week, it was Medical Device & Manufacturing West, a California showcase that annually attracts more than 20,000 medtech engineers and executives – a virtual mothership to the Smithtown-based medical maker. In May, it will be BIOMEDevice, an MD&M event in Boston promoted as “New England’s largest medtech event,� then MD&M East in June at Manhattan’s Jacob K. Javits Convention Center.

In between, according to principal Christopher Montalbano, is as much interstate networking as he and his brother and partner Gregory Montalbano, who manned the MIDI booth at MD&M West in Anaheim, can manage.

 It’s not that the brothers don’t like Long Island. This region is “up and coming� in the medical-device market and shares a “high concentration of medical need� with New York City, Christopher Montalbano told Innovate LI.

And things are cooking at MIDI’s 6,500-square-foot Innovation Center, Montalbano added, with the headquarters/manufacturing hub – which opened last spring and boasts dozens of engineers, software developers, industrial designers and user-interface specialists – “at capacity� and “a line of technologists waiting to be reviewed.�

But “it all ties into funding,� according to Montalbano, and so the brothers keep hitting the bricks.

Both are part of the Stony Brook University Center for Biotechnology review board, the body responsible for selecting early-stage companies worthy of center funding and other resources. They’re both also members of the Biomedical Innovation Advisory Team at the Columbia-Coulter Translational Research Partnership, a funding/mentoring effort dedicated to improving patient care, established by Columbia University and the Wallace H. Coulter Foundation.

“These technologists and scientists all require funding, and that’s what the Stony Brook and Columbia-Coulter program are all about,� Montalbano noted.

For MIDI, it’s about a front-row seat to medical innovation – and piling up new opportunities to assist those scientists with “developing new biomedical technologies, choosing new commercialization directions and other implementation assistance,� Montalbano added.

“The networking is very important, not only with clients but with suppliers and other manufacturers in the biomedical and biotech industries,� he said. “The engineering departments of various medical-device companies get a look at what’s out there, including what resources are out there, us being one of them.

“We get to see the latest happenings, and we’re usually the ones who can help them bring it through and commercialize it.�

 There’s plenty of that already happening in Smithtown, where MIDI’s “DevelopmentDNA� – the company’s “unique and effective,� customizable product-development methodology – is routinely applied to numerous projects.

One recent client came, “funding in hand,� according to Montalbano, looking to prototype a germicidal device to sterilize hospital hallways; another current and “very confidential� design project involves wearable bioelectronic devices. From medical lasers to DNA sequencers to room-sized vascular imaging systems, the 50-year-old firm has its fingerprints on dozens of blueprints.

“We select them based on where our clientele is mostly based,� Montalbano noted. “There’s a great concentration in the Boston area. We find the Boston/New England area down to New York City and Long Island has a high concentration, along with the southern West Coast.�

While MIDI continues to ramp up its bioelectronics focus – another Next Big Thing involves a microchip that could completely redefine the speed and accuracy of lab-based biological sampling – the evolution of the Innovation Center, which celebrates a year of operation in May, has really broadened the company’s vision, Montalbano said.

“Our new facility has really allowed us to expand the portfolio of the type of projects we’re able to take on,� he noted. “Our core research and development has been enhanced and we’re doing a lot more front-end, groundbreaking activities related to product commercialization.�

That includes whole design teams dedicated to things like human-machine interfaces, spatial optimization and workflow analysis – critical areas as big thinkers on Long Island (and elsewhere) kick their medical-product machinations into higher gears.

“We see a definite uptick in the medical industry on Long Island,� Montalbano said. “There’s a lot more interest and state funding coming to the Long Island corridor, with the governor providing significant funding to enhance biotechnology in this area.

“You also see major players, such as (Melville-based) Canon Biomedical, growing here, both through acquisition and natural growth,� he added. “We’re feeling good about the prospect for continued growth of medical on the Island.�

Join MIDI at the 2017 Medical Design & Manufacturing West conference ,booth #2883, February 7-9, at the Anaheim Convention  Center. Stop by to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and  technologies for our clients in the medical, life sciences, and home healthcare markets.

MIDI understands the product development & technology challenges of the medical industry. We offer our clients our expertise as well as  our DevelopmentDNA(tm) process which affords us the ability to uncover, identify, and understand varying program development inputs  and generate actionable innovative results. MIDI’s DevelopmentDNA(tm) provides Innovative Design, Concrete Reliable Engineering,  Design Controls Procedures [ISO13485, FDA QSR, FDA 510(k)], Manufacturing Production Solutions and Product Branding. This  process allows MIDI to respond with intelligent, informed, targeted development programs emanating from top level strategies,  ensuring our client’s Predictable Success.

We look forward to seeing you at MD&M West !

With design in its DNA, MIDI Medical Product Development has a long commercialization history. With its new Innovation Center, the veteran Smithtown maker is focused squarely on Long Island’s future.

Two months after cutting the ribbon on its new 6,500-square-foot headquarters and Innovation Center – a buzzing design and manufacturing hub staffed by 30 MIDI engineers, software developers, industrial designers and user-interface experts – the 44-year-old company is expanding its own parameters while advancing on a key ancillary objective: Long Island as medical-product mecca.

That’s a primary function of the Innovation Center, noted Gregory Montalbano, half of a second-generation tag-team now managing the circa-1972 startup launched by patriarch Tony Montalbano.

Noting cutting-edge biotech and medical-science   research at Stony Brook University and other Long Island institutions, Montalbano sees the coming of an Island-wide product-development ecosystem – and along with his brother, Christopher Montalbano, is positioning MIDI as a primary hub.

“We feel medical innovation is becoming a real staple of Long Island industry,� Gregory Montalbano told Innovate LI. “In the coming years, it will replace the Grumman-type manufacturing industries of the past.�

So in May the brothers Montalbano opened the Innovation Center, which shares its 17,300-square-foot Village of the Branch building with a 10,800-square-foot Northwell Health diagnostic imaging center. The MIDI facility – which features engineering studios, prototyping labs, high-end industrial 3D printers and an array of next-level software suites – performs scientific-product R&D for clients as large as GE Healthcare and as small as the biotech startup next door.

“It’s really here to service our clients,� Montalbano said of the center, “and to foster commercialization of the companies and research spinning out of Stony Brook.�

The connections between MIDI and SBU are many, including seats for both brothers on the advisory board of the Long Island Bioscience Hub, a grand commercialization effort featuring SBU, Cold Spring Harbor Laboratory, Brookhaven National Laboratory and the Feinstein Institute for Medical Research. Strong ties with university researchers and commercialization officers give MIDI a steady stream of regional clients, Montalbano noted.

“We have a very nice relationship with Stony Brook with regards to our ability to have various clients from the university, and also to help define and develop new technologies for clients we meet through the Bioscience Hub,� he said.

Besides the Innovation Center, MIDI is best known for its DevelopmentDNA, a proprietary commercialization methodology that covers everything from conceptualization to high-tech prototyping to federal compliance.

Depending on a client’s size and exact needs, MIDI can jump into the commercialization process at virtually any point, starting with “voice of the customer interviews� and other market research designed to help MIDI develop efficient and customer-friendly products around a client’s technology.

“Ultimately the end design and engineering fits the user’s needs like a hand in a glove,� Montalbano said.

DevelopmentDNA also keeps a staunch eye on safety-compliance protocols, no mean feat when dealing with medical products. The commercialization program is designed to satisfy stringent FDA quality-system and International Organization for Standardization regulations – an absolute must for entrepreneurs bringing new medical products to market, Montalbano noted.

“Every medical product, from a diagnostic instrument to a surgical implant, needs to comply with this process,� he said. “And it’s not a simple process.

“Our DevelopmentDNA process is not only our innovation engine, but it also helps clients comply with these very detailed processes,� Montalbano added. “These are strict processes that mitigate risk and ensure usable, effective and safe products.�

The process has served customers of all sizes. DevelopmentDNA played a part in the creation of the Surgical Microkeratome – a precision instrument that uses water-jet technology to cut micron-thick slices in the cornea, facilitating corrective laser-eye surgery – for VISX, a small California startup later acquired by Illinois-based Abbott Medical Optics.

It also helped international medical-product giant Siemens commercialize the Immulite 2000, a freestanding, super-advanced immunoassay analyzer that can analyze 200 patient blood samples per hour.

“They had the core analyzation technology, we worked to commercialize both the analyzer and the liquid and solid disposables,� Montalbano noted. “That one definitely hit on all cylinders, as far as our development capabilities.

“Sometimes we’re involved in very early development, where it’s nothing but a technology in a laboratory,� he added. “Sometimes the client is a little farther along. Either way, we have to balance our technological skills with meeting quality-safety requirements and an orientation toward the end user.�

Such end-to-end product-development expertise, calling on so many different disciplines, might not be what Tony Montalbano envisioned when he launched Montalbano Innovation Development Inc. four decades go. But for his sons, who inherited the family business from the retiring founder 25 years ago, it’s the best bet to keep MIDI in the middle of Long Island’s innovation economy.

“We’re competing with innovation centers on the West Coast and in Boston,� Montalbano said. “But we envision Long Island garnering that same reputation in the next five years.

“Pharmaceuticals and biotech companies will be coming to Long Island to do that kind of business,� he added. “And it will just grow from there.�

By GREGORY ZELLER

A more than 40-year-old Long Island based company cut the ribbon on a brand new facility last Thursday.

The medical product development consulting firm MIDI officially opened a new headquarters and innovation center on Main Street in Smithtown in the Village of The Branch as a place to research and develop medical technology. MIDI has worked with clients such as Johnson & Johnson, GE Healthcare, Siemens and also will serve as a resource for Stony Brook University medical students in their new home.

“We strongly believe in creating growth opportunities for the medical and biotech industries on Long Island and in the greater New York area,� MIDI Principal and Huntington resident Gregory Montalbano said in a statement. He and his brother Christopher Montalbano are the principals of the Long Island-based firm which was started by their father Anthony in 1972. “Our new Innovation Center will foster new technology and product commercialization efforts for innovations obtained through academic research as well as for concepts developed by our local, national, and international commercial clients.�

The innovation center is equipped with a research, design and engineering studio, a prototyping lab and three-dimensional printing capability for the roughly 30 engineers, designers, software programmers and researchers. MIDI has supported the development of medical technologies over the years including the first commercial MRI scanner, surgical devices, a partial-body MRI, a three-dimensional dental scanner and countless others.

Gregory Montalbano suggested in an interview following the ribbon cutting ceremony Thursday that medical innovation could become a staple of Long Island industry in the coming years, replacing the manufacturing industry, which has slowly left Long Island, he said. Most similar facilities to MIDI’s innovation center are located on the west coast or in the Boston area, according to the firm, though the Montalbanos envision Long Island garnering that reputation in the future.

“Long Island is, in my opinion, becoming a very high-tech medical and bioscience hub,� he said. “In five to ten years, I feel that it will be very prevalent and people will be coming here in order to do that type of business and it’ll just grow from there.�

The look of other buildings along Main Street were taken into account in designing the innovation center, according to Kevin Harney, the principal of Stalco Construction, who served as the general contractor for the building.

“The architecture of the new $5 million, one-story building reflects the colonial feel of the historic Village of The Branch neighborhood, which dates back to the late 1600s,� Harney said in a statement. “The building’s façade features brick face, columns and other ornamental architectural elements prevalent in the landmark structures neighboring the new development.�

Chairman of the Planning Board of The Village of The Branch John Carro thanked MIDI and Stalco for maintaining that consistency.

“What’s very impressive, and we got a tour of the inside, is the high-tech inside of the building, but yet when you go to the outside, you see it matches the 1860s façade of all of the buildings along Middle Country Road here,� Carro said. “We appreciate that design and their working with the village in presenting their building in the proper manner.�

U.S. Rep. Lee Zeldin’s (R-Shirley) sent a spokesperson to convey his excitement in the opening of the new facility and the possibilities it presents in the field of medical research and development. State Assemblyman Michael Fitzpatrick (R-St. James) attended the event and expressed a similar sentiment.

by Alex Petroski – June 2, 2016

Join MIDI at the 2016 Medical Design & Manufacturing East conference, booth #966, June 14-16, at the Jacob Javits Convention Center (New York). Stop by to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets.

MIDI understands the product development & technology challenges of the medical industry. We offer our clients our expertise as well as our DevelopmentDNA™ process which affords us the ability to uncover, identify, and understand varying program development inputs and generate actionable innovative results. MIDI’s DevelopmentDNA™ provides Innovative Design, Concrete Reliable Engineering, Design Controls Procedures [ISO13485, FDA QSR, FDA 510(k)], Manufacturing Production Solutions and Product Branding. This process allows MIDI to respond with intelligent, informed, targeted development programs emanating from top level strategies, ensuring our client’s Predictable Success.
We look forward to seeing you at MD&M East !

MIDI, a global leader in medical product development, announced today their relocation to a newly constructed Medical Center of Excellence, centrally located on Long Island, within Smithtown’s Village of the Branch.

The 15,100 square foot facility is accelerating MIDI’s rapid growth and presence in the medical/healthcare product development industry. The site was chosen based upon its pristine location, professional environment, and proximity to their collaborating partner Stony Brook University Medical Center.

It is in an optimum location for both access to key healthcare researchers and caregivers, only 15 minutes away from Macarthur Airport (Islip Airport), and 10 minutes away from all major highways.

“We chose this location to provide for synergistic collaboration amongst our research peers, and to allow for rapid access to caregivers, which will result in the amplification and acceleration of new product development for our clientele,� said Chris Montalbano, Principal of MIDI.

Join MIDI at the 2016 Medical Design & Manufacturing West conference ,booth #1489, February 9-11, at the Anaheim Convention Center. Stop by to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets.

MIDI understands the product development & technology challenges of the medical industry. We offer our clients our expertise as well as our DevelopmentDNA™ process which affords us the ability to uncover, identify, and understand varying program development inputs and generate actionable innovative results. MIDI’s DevelopmentDNA™ provides Innovative Design, Concrete Reliable Engineering, Design Controls Procedures [ISO13485, FDA QSR, FDA 510(k)], Manufacturing Production Solutions and Product Branding. This process allows MIDI to respond with intelligent, informed, targeted development programs emanating from top level strategies, ensuring our client’s Predictable Success.

We look forward to seeing you at MD&M West !

The 15,100-square-foot facility is considered a landmark project of Whitetop Mountain, the Long Island-based commercial real estate firm behind the project. (Rendering from Peter Wilks)

Development has begun in the Village of The Branch community of Smithtown, paving the way for a new medical facility unlike any other in the township. Long Island-based developer Whitetop Mountain Professional Properties and Islandia-based developer Stalco Construction announced they had broken ground earlier this week on a new 15,100-square-foot medical and research building at 226 Middle Country Road worth roughly $5 million. The new facility will soon be home to two tenants, North Shore-LIJ Health System’s diagnostic imaging center and the headquarters and product research and development facilities of MIDI, a medical, life sciences and home health care product development consulting firm.

“We are excited to begin the development of the new building, which will complement other medical services facilities already established in the area,” said Christopher Montalbano, Whitetop principal. Fellow Whitetop principal Gregory Montalbano said the building was a key move for his group that should usher in state-of-the-art services in Smithtown.

“226 Middle Country Rd. is the cornerstone of Whitetop Mountain’s strategy of developing properties for the medical services and product research and development industries,” Gregory Montalbano said. “Our firm focuses on building a portfolio of real estate facilities designed specifically for health care, research and professional services tenants in the greater New York region.”

The structure will house state-of-the-art medical services and research and development facilities. The foundation will feature reinforced-concrete footings and foundation walls. The building will have a steel structural system and six-inch metal frame exterior walls with brick veneer as well as colonial-looking trim to reflect the heritage of the neighborhood, the developer behind the project said.

“The architecture of the new one-story building will reflect the colonial feel of the historic Village of The Branch neighborhood, which dates back to the late 1600’s,” said Alan Nahmias, president of Stalco. “The building’s façade will feature brick face, columns and other ornamental architectural elements prevalent in the landmark structures neighboring the new development.”

BY PHIL CORSO

A rendering of new medical research site on Middle Country Road in Smithtown which will also house MIDI, a Ronkonkoma-based health care consulting firm. Photo Credit: Whitetop Mountain Professional Properties

Construction has started on a $5 million medical research building in the Village of The Branch in Smithtown, which will house a North Shore-LIJ Health System diagnostic imaging center and will be the new headquarters for MIDI, a Ronkonkoma-based health-care consulting firm.

The developer of the 15,100- square-foot facility — located at 226 Middle Country Rd. — is Whitetop Mountain Professional Properties, which shares ownership with MIDI. The one-story building is expected to be completed by December, said Gregory Montalbano, a principal at Whitetop and a co-owner of MIDI.

“Our family has developed several commercial and medical properties in the past, and Whitetop was formed specifically for this project,” Montalbano said.

MIDI — short for Montalbano Innovation & Development Inc. — provides product research and development services for early-stage health-care and biotech products.
Clients include large companies such as GE Healthcare, Siemens and Johnson & Johnson.

North Shore will occupy 5,100 square feet in the facility and expects to move in sometime in January or February following a regulatory licensing process, said Cynthia Kubala, vice president of imaging services for North Shore-LIJ. The new location, which will provide MRI, CT scanning and ultrasound procedures, will be the eighth such location the health system has opened on Long Island.

The new facility is being built by general contractor Stalco Construction of Islandia.

Join MIDI at the 2015 Medical Design & Manufacturing East conference, booth #830, June 9-11, at the Jacob K. Javits Convention Center (NY, NY). Stop by to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets.

MIDI understands the product development & technology challenges of the medical industry. We offer our clients our expertise as well as our DevelopmentDNA(tm) process which affords us the ability to uncover, identify, and understand varying program development inputs and generate actionable innovative results. MIDI’s DevelopmentDNA(tm) provides Innovative Design, Concrete Reliable Engineering, Design Controls Procedures [ISO13485, FDA QSR, FDA 510(k)], Manufacturing Production Solutions and Product Branding. This process allows MIDI to respond with intelligent, informed, targeted development programs emanating from top level strategies, ensuring our client’s Predictable Success.

We look forward to seeing you at MD&M East !

Join MIDI at the 2014 Medical Design & Manufacturing West conference ,booth #3428, February 11-13, at the Anaheim Convention Center. Stop by to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets.

MIDI understands the product development & technology challenges of the medical industry. We offer our clients our expertise as well as our DevelopmentDNA™ process which affords us the ability to uncover, identify, and understand varying program development inputs and generate actionable innovative results. MIDI’s DevelopmentDNA™ provides Innovative Design, Concrete Reliable Engineering, Design Controls Procedures [ISO13485, FDA QSR, FDA 510(k)], Manufacturing Production Solutions and Product Branding. This process allows MIDI to respond with intelligent, informed, targeted development programs emanating from top level strategies, ensuring our client’s Predictable Success.

We look forward to seeing you at MD&M West !

Join MIDI at AdvaMed 2013, booth #343, September 24-25 at the Walter E. Washington Convention Center.  Stop by to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets.

MIDI understands the product development & technology challenges of the medical industry. We offer our clients our expertise as well as our DevelopmentDNA™ process which affords us the ability to uncover, identify, and understand varying program development inputs and generate actionable innovative results. MIDI’s DevelopmentDNA™ provides Innovative Design, Concrete Reliable Engineering, Design Controls Procedures [ISO13485, FDA QSR, FDA 510(k)], Manufacturing Production Solutions and Product Branding. This process allows MIDI to respond with intelligent, informed, targeted development programs emanating from top level strategies, ensuring our client’s Predictable Success.

We look forward to seeing you at AdvaMed!

Join MIDI at the 2013 Medical Design & Manufacturing East conference ,booth #3235, June 18-20, at the Pennsylvania Convention Center. Stop by to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets.

MIDI understands the product development & technology challenges of the medical industry. We offer our clients our expertise as well as our DevelopmentDNA™ process which affords us the ability to uncover, identify, and understand varying program development inputs and generate actionable innovative results. MIDI’s DevelopmentDNA™ provides Innovative Design, Concrete Reliable Engineering, Design Controls Procedures [ISO13485, FDA QSR, FDA 510(k)], Manufacturing Production Solutions and Product Branding. This process allows MIDI to respond with intelligent, informed, targeted development programs emanating from top level strategies, ensuring our client’s Predictable Success.

We look forward to seeing you at MD&M East !

Join MIDI at the 2013 Medical Design & Manufacturing West conference ,booth #4467, February 12-14, at the Anaheim Convention Center. Stop by to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets.

MIDI understands the product development & technology challenges of the medical industry. We offer our clients our expertise as well as our DevelopmentDNA™ process which affords us the ability to uncover, identify, and understand varying program development inputs and generate actionable innovative results. MIDI’s DevelopmentDNA™ provides Innovative Design, Concrete Reliable Engineering, Design Controls Procedures [ISO13485, FDA QSR, FDA 510(k)], Manufacturing Production Solutions and Product Branding. This process allows MIDI to respond with intelligent, informed, targeted development programs emanating from top level strategies, ensuring our client’s Predictable Success.

We look forward to seeing you at MD&M West !

Join MIDI at the 2012 Medical Design & Manufacturing West conference ,booth #3347, February 14-16, at the Anaheim Convention Center.  Stop by to learn more about MIDI’s in-depth experience and capabilities with the development of product systems and technologies for our clients in the medical, life sciences, and home healthcare markets.

MIDI understands the product development & technology challenges of the medical industry. We offer our clients our expertise as well as our DevelopmentDNAâ„¢ process which affords us the ability to uncover, identify, and understand varying program development inputs and generate actionable innovative results. MIDI’s DevelopmentDNAâ„¢ provides Innovative Design, Concrete Reliable Engineering, Design Controls Procedures [ISO13485, FDA QSR, FDA 510(k)], Manufacturing Production Solutions and Product Branding. This process allows MIDI to respond with intelligent, informed, targeted development programs emanating from top level strategies, ensuring our client’s Predictable Success.

We look forward to seeing you at MD&M West !

Don’t listen to the naysayers. The time to jump into healthcare IT is now, said Frank Moss, director of the new media medicine at MIT’s Media Lab. Creative technologists working in mobility, social networking, nano devices, should seek health IT opportunities. Now.

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Innovation is in danger, according to Ernst & Young’s 2011 “Pulse of the Industryâ€� report. Several factors put the development of new technology at risk—low hospital margins, a lack of funding, reimbursement limitations, and more regulatory scrutiny of devices. Emerging companies are finding it more…

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Performing reviews on surgical simulators for a new project. Very cool haptics feedback tied to hardware & software design.

MIDI’s principals (Chris & Greg Montalbano) had the pleasure of performing as panelists speakers at the 2011 Medtech Conference this past week. Many subjects of medical product innovation were discussed/covered ranging from VOC techniques and design input methods to the future of medical technology and product development 10 years out.

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Venture capitalists spent 9 percent more on 18 fewer deals during the second quarter this year, compared with Q2 2010, according to the PricewaterhouseCoopers MoneyTree report.

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Working on a series of innovative products for Home Healthcare Market involving physical therapy. Gathering data @ VOCs to turn insight into actionable design strategies.

MIDI is performing Next Generation Workflow/Task Analysis on eye surgery systems

A Must READ : Article is about the FDA’s “inconsistent application of reasonable standards for safety” in clearing medical devices for the U.S. market and possible reform.

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This is a link to a survey outlining how users are willing to pay a slight premium for a more user-friendly device and that they are taking a more active role in the choice of their drug delivery device.

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Good article on the issues of battery powered medical devices………

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Performing indepth on-sight dental industry interviews and observational research at everyones favorite place to go…the dentist’s office!

Performing VOC (voice of the customer) Study today for open heary surgery procedure at Tisch Hospital (NYC). VOC’s will include Observational Research, Work Flow Studies, and stakeholder interviews.

June is virtually here…don’t forget to stop by our booth at MD&M East at the Javits Center, we will be offering in-booth presentations on our DevelopmentDNA process of Medical Product Development.
Feel free to stop by our booth, #843.

The U.S. Food and Drug Administration announced steps to help reduce the risk of exposure to improperly reprocessed devices that can lead to the transmission of disease.

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This is a very facinating article on a commercial nanoelectronic breakthru that will enable hand-held electronics to harvest energy from body movements, eliminating the need to use batteries or other electrical inputs….very cool.

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This article talks about how as a country we need to innovate our way toward a new health care business model reduceing costs while improving both quality and accessibility…

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I like this article…color can provide differentiation, branding, and assist in intuitive user interface for its users…lets not forget easing patient apprehension.

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This is a good article on helping identify seven signs can indicate future quality problems. The writeup also offers guidance in addressing your challenges. Check it out.

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Check out the proposed bill would strengthen the amount companies can recoup for investing in R&D from the current 14% up to 20%. Increasing the credit to 20% would boost economic output by $90 billion!

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Medical device sales are lagging overseas. Can China reverse this trend?

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The mobile phone will become a major force in transforming the future of our health and healthcare.

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Interesting Article about: “Three Steps for Inventing the Future”

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