There are, in distillation, three ways to go in the medical device industry. Many medical device companies work to treat unmet medical needs. That is the holy grail for wealth, job, and life satisfaction. It’s a very tough way to go, requiring the most resources, time, and intelligence for thought, discovery, intellectual property, research, development, extensive clinical studies, and all those regulatory hurtles. Others go in the totally opposite direction, developing me-too 510k-type devices to improve the physician’s overall environment. Somewhere in the middle are those who wish to tilt at the windmills of normalcy.

Attacking the stodgy standard of care is oftentimes the loftiest of goals. One recognizes that the status quo is truly not in the best interest of the patient. Well, “it” was fine, say ten or twenty years ago. Patients are dying because physicians have resigned themselves to a certain percentage lost simply because that’s the way it is. I’m sorry, this just isn’t right. There must be a better way. Unfortunately, the medical device developer has practice comfort or educational drift, it-was-always-done-this-way or that’s-the-way-I-learned-it, to contend with. That physician acceptance of the new, at the early, critical stages of a device’s life cycle, is oftentimes much tougher to deal with than any little U.S. FDA.

Finding something to treat a completely unmet medical need is becoming trickier and trickier since medical devices have already done so very well, become ubiquitous throughout the body. Trying to break into medical devices with 510k’s is increasingly harsh as one must try to scrape slivers of market share from entrenched big names at hyper-tight commodity prices. This leaves the most room for real meaningful success in the most difficult middle. So, I wish all of you the best of luck towards focusing on the patient, to fight the best fight for truly better care and treatment.

source: https://www.linkedin.com/groups/78665/78665-6185965652960960512