הדס מנדל היא מנכ"לית חברת Refine ומנהלת מקצועית של קורס MedInnovation המתמקד ביזמות וחדשנות בתחום הטכנולוגיה הרפואית. הקורס יפתח ב-10.6.3 באוניברסיטת תל אביב.
Medical Device Regulations – How far away is the future?
About five years ago I participated in a Regulatory Affairs Masters Program in Northeastern University in Boston. As a final assignment, in one of the more insightful courses, we were asked to reflect on course content and discuss the future of the medical device world from a regulatory perspective.
Recently, I took a look at what I wrote and a thought crossed my mind. While not a lot has changed since, so much has changed. I made some adjustments, and decided to share it.
I believe that a blend of three basic elements define the regulatory world and determine its future. These are the pace of rapidly evolving Innovative Medical Technologies, the Regulatory Philosophy and approach adopted by regulatory authorities, and the most basic one, Human Nature. These three are mixed together. In certain cases they contradict each other. Sometime they simply clash. They affect processes within the industry, they manipulate public demand for and consumption of medical products, they influence congressional legislation, and they determine regulatory review and decision making processes.
1. Medical technology is constantly and rapidly evolving. The pace is unbelievable and the innovation, sometimes, simply cannot be perceived. A few years ago the example I used was the amazing progress made in nanotechnology and tissue engineering. Seems that, today, mobile Health technologies and applications take the lead. These can be taken from idea to product within a few months. A pace unfamiliar to the medical industry, leaving the regulators lagging far behind.
2. The Regulatory Philosophy applied by regulatory authorities has to keep up with these rapid advancements. It seems as if regulatory authorities are competing against time and, at this point, are left somewhere way back in the race. The regulatory philosophy must first adopt an updated relevant definition of medical device and, accordingly, an updated relevant regulatory approach. Easy to say. Not so easy to implement.
3. Human nature: Private interests, especially financial interests, affect us all: manufacturers, government, FDA, lawyers, legislators, patients, health institutions, physicians, and regulatory professionals. In order to determine the type of influence "human nature" has on the regulatory world many questions, which are rather subjective, must be addressed. I can list about 15 such questions, but I think all can be summed into one: To what extent are loop-holes in regulations exploited by manufacturers? Or, in other words, might the lagging of the regulatory world behind technology development result in market distribution of medical devices with questionable safety?
So how can these elements be combined together in an effective, fruitful way, ensuring innovative technology is introduced to market in a responsible manner without compromising patients’ safety? This requires cooperation between the industry and the regulatory authorities, sharing information that will allow the design of a regulatory system which will better suit future (and maybe even current) technology.
Yet, before planning the future, we, as industry professionals, should confirm that we are aware of the past and the present. We must educate ourselves, we must learn from the past, both from successes as from mistakes and tragedies. The thin line separating between employing the system and exploiting loop holes in the system should be identified. Financial interests should be weighed against public safety and wellness concerns. We must collaborate and share information and plans with regulatory authorities in a trustful manner in order to enable the creation of a regulatory system that will not hinder or delay further development.
Establishing a regulatory system that has all the necessary tools to assess and evaluate new and novel technology is essential and, in the long run, is in the best interest of all parties involved. Each and every one of us should take responsibility and act as if every step he takes may result in personal consequences.