Defining the Building Blocks of Medical Device Innovation

Two cornerstones of successful medical-device product development are a sound strategy and value proposition, according to Andrew DiMeo Sr., PhD, owner of DiMeo LLC, a consulting firm in Raleigh, NC, which provides leadership, business advice, and mentorship to biomedical innovators.  

DiMeo, who will host a session on medical innovation in June at MD&M South in Charlotte, NC, shared some personal observations on the topic with MD+DI.

Why is it important for medical innovation to embody a sound strategy for success?

DiMeo: My favorite analogy for this question is to consider the difference between a cook and a chef. If meals were Class III medical devices, we’d all want to eat at Michelin Star restaurants.

At home, I’m a cook. I like to perfect smoking meats and making pizzas. I don’t have any quality controls in place, but my methods seem sound enough. What I’ve observed in medical innovation are product development teams that operate like cooks in a kitchen instead of chefs at esteemed restaurants.

 What are some challenges in implementing a solid strategy?

DiMeo: The industry has a self-imposed stigma around controlling a process of innovation. FDA never said that design has to be a stage-gate process. There’s nothing about a rigorous and controlled process that stifles creativity. Sticking to the analogy, I’d argue that Michelin Star chefs are among the most creative, and yet follow the highest standards of quality at the same time.

The same is entirely possible for medical innovators. The first step is realizing that creativity is compatible with control. The next step is acting like a chef: professional and taking innovation seriously. Medical innovation is not a casual weekend overnight brisket on the smoker.

 How can medical device innovation enhance its value proposition?

DiMeo: Medical innovation is the value proposition. I define innovation as increasing the benefit/cost ratio. For medical innovation, what that means is increasing the health-outcomes/cost-of-care ratio.

 How can both value and quality be incorporated into medical device innovation?

DiMeo: There is a perception that value and quality are at odds with each other. In practice, the activities of quality management, business strategy, and stakeholder value proposition are often not aligned.

I’m proposing a new framework -- mission-driven innovation -- that helps innovators harmonize these activities. The result is akin to the sympathetic vibrations of tuning forks. When synchronized, the resonance produces a stronger signal.

 What do you envision as the future of medical device innovation?

DiMeo: We are living in the middle of a healthcare inflection that is moving from reactive care to proactive life quality. The medical device industry will be part of this transformation. Devices that “early detect” the onset of a foot ulcer, for example, will dwindle, as new devices are invented to prevent the causes of foot ulcers from happening in the first place. Even for post-trauma, the notion of “retain what health we have because it’s only downhill from here” will be replaced with a new paradigm of improving health.

I’m especially excited about the future of holistic health. We are shifting from a narrow focus on physical health to a broader lens that includes mental, social, and emotional health. As for me, in the age of the loneliness epidemic and a massive shift to remote work, I have turned my attention to making a difference in that space.