With medical regulatory design controls and risk management protocols becoming ever more stringent, beginning the development process can seem daunting. Ensuring that FDA regulations are properly adhered to at each step is no small task, and having to do so can feel stifling to innovation endeavors. MIDI’s DevelopmentDNA™ approach is designed to assist clients in navigating these essential guidelines. They utilize what they refer to as the Innovation Roadmap to guide clients towards developing truly innovative medical products that are safe for both doctors and patients alike. Following last episode’s introduction to development and FDA compliance, MIDI co-owner Chris Montalbano again visits the MIDI Innovation Vault™ to bring us to the first stop on the Innovation Roadmap: Market Exploration and Opportunity Discovery.

FDA Guidelines at the First Stop

There is no debating that the regulatory guidelines set forth by the FDA are necessary to protect the health and safety of medical device users. Even so, it can often feel as though they are oppositional to creativity, advancement, and even corporate success in the field. Fortunately, the reality is that the FDA QSR and ISO 13485 guidance is designed to cooperate with developers and encourage success wherever possible. These guidelines particularly recognize market exploration as a quintessential practice for any successful business and, to this end, make clear that regulatory controls such as design controls and risk management need not be tended to at this stage. The FDA appreciates the importance of discovering new opportunities within the market and are conscious of the operational needs of businesses as they move through the development process.

Yet, as Chris explains, it is important to recognize that the FDA does have an additional objective in mind for this introductory stop. Looking ahead on the Innovation Roadmap, the information and properties procured during the early, unconstrained stages will provide the framework for design controls and risk management processes that are to be developed at Stop 3, known as commercialization and implementation. In Chris’ words, “the FDA realizes that at Stop 3, under regulatory controls, the development team will become like a ship without its rudder if this stop one of market exploration was not performed and/or not performed effectively.”

Success in Mutual Gain

In order to properly examine the first stop on the Innovation Roadmap, we must revisit the characteristics of device innovation as were defined previously. An innovative device must have four important characteristics, the first of which being that it must either meet a previously unmet market or user need by being the first product of its kind. It may also increase the satisfaction of a specific need by improving upon an existing product. Second, the product must be reproducible at an economically feasible cost that the market will readily accept. Third, it must be effective, which includes functionality, efficacy, and ease of use. Finally, and most importantly, the device must be safe both for the user and for the public. For now, we need only focus on the first and second of these characteristics.

Stop 1 largely entails discerning how to develop a device that addresses particular market needs, benefiting users, while doing so at an economical cost that allows for the generation of profit for the company. The ultimate goal of doing so is to begin establishing a value proposition or, as Chris refers to it, a “value handshake.” This occurs between the company and external stakeholders such as patients, healthcare providers, purchasing decision-makers, insurance companies, and more, and entails positive value consistently flowing in both directions. A value proposition can be thought of as satisfying two central components: external stakeholder needs and corporate needs from a business perspective, also referred to as internal stakeholder needs.

Discerning External Needs

Per Chris, “it’s important to start with exploring methods to obtain [the] external needs, which is often what unlocks the innovation and competitive differentiation.” One important method that is often deployed to this end is the identification of target markets, which are then weighed against the company’s goals and objectives and ranked accordingly. These rankings are then used to select which markets will be focused on, allowing for the identification of external stakeholders within them, including doctors, patients, associates, and gatekeepers, among others. Once these stakeholders are identified, their specific needs may then be determined and examined so as to begin the process of developing a product that addresses them.

Under MIDI’s DevelopmentDNA™ approach, this is done through the use of VOC or voice of the customer studies, in which the environments of stakeholders are examined, and current clinical needs are discerned with the goal of exploring potential unmet needs. This is followed by user interaction analysis, which allows for firsthand observation of unspoken needs that may only be revealed through such field studies. Finally, with each external stakeholder having their own unique workflow; workflow analysis and task mapping is performed to determine their actions before, during, and after the use of a particular device.

Internal Needs and Innovative Directions

At MIDI, internal needs consist of the needs of their clients from a business perspective, with Chris describing their goal as being “to strategically position by pursuit of innovative directions which will yield profit from a defensible market position via strategic differentiation.” One tool MIDI uses to accomplish this goal is competitive market analysis tied to a system of rating and ranking device solutions and attributes as they relate to a gap analysis of unmet market opportunities or under-acknowledged clinical needs. Another such tool is SWOT analysis, or the identification of a client’s strengths, weaknesses, opportunities, and threats, which are then weighed against their competition or lack thereof, assisting in the identification of the client’s ideal go-to-market trajectory or call to action.

Once the data on both external and internal needs is collected and analyzed, MIDI then develops a market requirement document or MRD which will inform the direction clients should proceed in as they move towards the next stop on the Innovation Roadmap. Along the way, they will continue to be supported by MIDI’s forty-five years of experience of serving the medical device market using their DevelopmentDNA™ approach.

Keep your maps open! Join us on the next episode of MIDI Innovation Vault™ as we come to the second stop on the Innovation Roadmap: Technological Innovation and the R&D Process.