Perhaps most important in the healthcare field is thorough and active research, as a crucial
part of device development and implementation. And only with the proper tools and methodologies will the resulting product be successful and innovative. As we continue on our journey along the Innovation Roadmap on MIDI Innovation Vault™, Chief Creation Officer and CEO of MIDI Medical Product Development, Greg Montalbano, provides insight into the intricacies of Stop 2: Technology Innovation in the Research and Development process.

The FDA on R&D
To influence a paradigm shift in the realm of medical device regulatory controls, and the attitudes surrounding them, is a consistent goal of MIDI’s development strategy. With decades of medical device development expertise, MIDI’s DevelopmentDNA™ approach delivers client and end users innovative, successful medical products that are developed in stringent compliance with the FDA QSR and ISO 13485 principles of medical device design. As discussed in previous episodes, the FDA and the regulations they set forth are not intended to impede business success or innovation. Indeed, the FDA appreciates the necessity of both Stop 1’s market exploration and Stop 2’s technology innovation as essential exercises for any business to implement”, of which regulatory controls are not required to be implemented at these stages. It only allows for the flexibility to explore unhindered technologies, methodologies and development opportunities. The goal of any regulatory agency is to protect the health and safety of medical device users. As it pertains to Stop 2, Greg explains, “the FDA prescribes the methodology of achieving an effective and safe device,” while also providing recommendations for early, exploratory phases of the development and R&D processes.

Stop 2: Swath of Requirements
Diving into Stop 2 with this information in mind, the technological innovation kicks off with high-level information collection utilizing MIDI’s Discovery Research methodology. This methodology described by Greg is MIDI’s “innovation engine for identifying, collecting and qualifying the numerous challenges, technology vectors and influencing agents as related to multiple facets of a medical device’s success.” At this stage, data is gathered regarding the project’s developmental and technological parameters and the ever-important needs of the
end-user, observed in their environment. This information will serve as the basis for the device’s development and ultimately will determine its success. As ease of use is closely tied to the overall efficacy of a product, a proper user experience is an absolute must for one to be considered successful or innovative. To this end, MIDI encompasses all criteria to encourage “meaningful product [relationships] and positive experiences” supported by safety and
comfort, paired with intuitive user experience and a well-planned Human-Machine Interface (HMI). Even as advanced technology and innovative development platforms propel the healthcare and life science markets forward, the fulfillment of user needs will ultimately be the determining factor of a product’s success, no matter how cutting-edge it may be.

Client requirements and device requirements are also essential elements explored at this stage. At this point the Innovation Roadmap is deployed in determining the client’s next step regarding future strategy and requirements. Using this stepped methodology, whose thoroughness allows for the discovery of technological and device innovation opportunities, MIDI generates “innovative and appropriate” medical device requirements, strategy and direction for clientele.
Further examined in this stage is the technical specifications of the product, as the Discovery Research methodology is used to identify concepts related to technology applications. As a client journeys along the Innovation Roadmap, MIDI provides direction in discovering technological and intellectual property opportunities that afford material and patent process protection for the client’s project. In Greg’s words, “we strive to generate sustainable value, IP protection, device efficacy and profitability for our clients.”

Planning Ahead
After the compilation of the Discovery Research data, a Systems Analysis Report is generated, that allows MIDI’s team of experts to formulate and prioritize future actions and document data uncovered during the R & D process. Through this Systems Analysis refinement process, a clear understanding is forged of the client’s marketing, design and engineering needs. This allows for the development of prioritization methods before any progress occurs from the R & D process, allowing for the narrowing down of a targeted approach towards the device itself.

With the information gathered, the next step is understanding the product’s future and identifying opportunities for competitive differentiation. This begins “innovative exploratory design conceptualization studies with technology research,” a phase in which requirements are examined and directions are proposed that will serve those various needs. Numerous breadboard concepts, fabrications and tests are utilized to explore and validate the routes proposed and to be deployed in internal and external usage studies. This creates a “quality feedback loop” for refinement of concepts and prototypes.

Once these aspects are secure, as well as the documentation that meets the needs of the end-user, manufacturer, technological and device efficacy requirements, thus begins the processes of commercialization and implementation at Stop 3 on the Innovation Roadmap. In Stop 3, regulatory design controls become a significant part of the development process.

Stay tuned for the next exciting episode of MIDI Innovation Vault. We will be joined by Chris Montalbano and a special guest expert to discuss the third stop on the Innovation Roadmap, where the FDA’s influence is felt in full force.