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Paul M. Stein
September 2016
Busting Standard of Care
2 min reading time

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

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Posted by Paul M. Stein
Asked on September 26, 2016 12:00 am
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Rodney Chin, PhD It takes very special & rare people to drive beyond the status quo. Re-establishing or expanding the standard of care is extremely difficult in the current business environment !
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Paul M. Stein So, how can it be done, especially when third-party payers are additionally satisfied with the current cost of doing business?
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So very true.
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Julie Omohundro Are you equating PMA devices with devices that treat completely unmet medical needs, 510(k) devices with those that treat already met medical needs, and De novos with "the most difficult middle"?
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Austin Gilbert Medical devices focusing on patient outcomes is a must. With the global population aging at an accelerated rate, focusing on anything other than patient outcomes would be a mistake
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Provider, Insurance, Industry, Gov, they all have their say. But very little do they hear from patients. Perhaps we need to re-assess the standard of care... from whose point of view(s). One things for sure - think $$ first - it's death on the arrival.
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Paul M. Stein I believe that the PMA devices are the primary ones that are in the most difficult middle, although there will more than likely be a few de novo devices.
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Julie Omohundro Paul, then I guess I'm not sure what you mean by the "middle."
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Paul M. Stein It's not the device, it's the indication; changing entrenched standard of care, how and where ever.
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Should be interesting when reimbursement is based on outcomes.
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