Persevering through barriers: Why Medical Device innovation must continue.
In the fall of 2018, I met up with some friends who brought up the fact that one of the aspects they were struggling with was whether the company that they had just become a part of should consider rebranding itself as a medical device company. They seemed to be fraught with all of the barriers to bringing a new device to market. The notoriously challenging regulatory landscape, the insurmountable quality assurance hurdles, the substantial amount of capital needed, to say nothing of the time and effort for clinical and evidentiary burdens to prove safety and efficacy. After consideration of the facts, they decided that it was best for them not to rebrand as a medical device company. Moreover, they had been successful in their industry and continue to be successful today.
Years later, I am forced to ponder the same question on a near weekly basis. Many innovative ideas are often abandoned before they reach their true potential and will never see the light of day. And yes, a lot of ideas should never make it to market, but I believe that much needed medical device solutions make a lasting impact on the health of the multitude far outweighing the effort it takes to commercialize them. The question is, do you have the expertise, interest, and investment needed to embark on this journey?
When promising medical device ideas are abandoned due to market barriers, the true cost extends far beyond the immediate financial investment and regulatory burdens. Patient lives that could have been improved or saved are affected. Revolutionary approaches to treatment may never see fruition. The healthcare system loses potential efficiencies and cost-saving measures. Each abandoned innovation represents a missed opportunity to advance medical care.
And yet, I do not believe that launching a medical device is easy. The rewards on the back end often make the journey worthwhile…and each abandoned innovation represents a missed opportunity to advance medical care and improve patient lives. Let us remember that many of today's standard-of-care devices once faced the very same challenges.
Our industry is continuously evolving, and each opportunity should be rigorously evaluated for its potential and need. In my opinion what’s needed is a clear understanding of the problem being solved and its significance to the affected population, a realistic assessment of the resources and time required, and most importantly a flexible approach to overcoming obstacles while maintaining focus on the end goal.
We should also be cognizant of the fact that these barriers serve legitimate purposes. They ensure patient safety, maintain healthcare standards, and promote thorough validation of new technologies.
I propose that rather than viewing them as insurmountable obstacles, pioneers and innovators should see them as necessary steps in bringing safe and effective products to market. To partner with the right entity who can realize your innovation might be the most important next step to lasting patient impact. After all let us never forget why we do what we do…the patient, the patient, the patient!