The medical device industry is in trouble.
I'm Rick Bollinger, Founder and CEO of Menlo Park Software. Thanks for visiting.
Official Correspondents like many of you are busy folks. Like me, you might work weekends. Especially on those less urgent tasks that pay off in the future. Like those journals and industry magazines you read to keep current.
Those of you deciding to invest a half-hour or so will find Saturday hours in my internet schedule.
Not every Saturday, and not every hour. But, enough opportunity so you can contribute and not feel guilty of taking time from fire fighting and other urgent issues.
What has happened since I left the medical device industry? It has been some years ago. But, I still get the magazines. As a 15 year veteran in management consulting I planned my retirement. I built my dream cabin. Well, I had to do something about it. Nobody else was. So, I started tracking the rise in FDA device recalls. The one pundits claimed was an epidemic of bad risk management.
But after deeper research I discovered...
① the real cause of this rise,
② a new method of risk management for you to stop it, and
③ potential software solutions to reverse it.
So I ...
► published an article on the real cause,
► drafted a prototype of the method, and
► started this campaign for my company to nail down industry problems and solutions.
You can help. Industry-wide problems are actually the collective pains of many companies. Solutions really need to address individual pains like yours. Because of this I want to interview you, and experts like you, in medical device manufacture. Maybe for a half hour or so. I would enjoy sharing technology behind potential solutions, too.
Below, find charts and links to data and articles. And, some links to take a survey and arrange an interview. If I'm right, the medical device industry is ripe for disruption. The status quo hopes I am wrong. Can you afford to bet on it?
A Medical Device and Diagnostic Industry magazine cover article, titled "Medtech’s Recall Epidemic" reported a record high number of FDA medical device recalls in 2014.
Recent FDA data says 2017 is now the most terrible year of all. (See recall chart.)
There is no epidemic. Only economics. Recalls track to new device introductions with a 95% correlation. More devices just means more recalls.
Poor risk management is not a root cause. It is just another symptom of complacency. We are stuck with the tools, methods and advice that define our status quo.
Bad inspections are also just another symptom of complacency. We need to break out of our status quo using innovation and experimentation.
I am building a vehicle to solve problems in the medical device industry. So, I am looking for experts who understand the industry and many of its problems that they also experience.
Interview and see a potential software solution and what it can do for Your biggest problem. Recalls? Compliance? Project performance? I would enjoy sharing with you information technologies behind solutions.
I have drafted a white paper with a method to make your risk management world-class. I will send it to you just for the asking.
If you were specifically invited to visit this website then you are one of a select group. A special few with a great responsibility to defend your organization from problems that plague the medical device industry.
Even if you have a good record with the FDA and few, if any, recalls and inspections, you may still fee the pressure. The ever-present uncertainty lurking just below the surface, always threatening to break out.
As a large player you need to understand FDA statistics differently, recognize the status quo, and reject band-aid measures that just keep you digging the holes deeper. Even if it makes you look crazy.
Crazy, it turns out, is the face of disruption.
You are the vanguard. You, especially, need to confront uncertainty and investigate small clues of non-standard solutions. Taxi companies did not invent Über. Hotel chains did not invent AirBnB.