I recently saw an advertisement for ChooseNoblesville.com making the statement that Noblesville, IN (a suburb of Indy) is home to 4 of the largest Indianapolis area medical device and medical product developers. This claim caught my curiosity. I could think of a couple of medical device companies in Noblesville but not four. So I just had to ask who.
The response:
Are these companies really 4 of the largest Indianapolis area medical device companies?
FDA, PMA, SAE, V&V, CPT… I see acronyms tossed around all the time when researching for my blog and have no clue what most of them mean. I have never dared mention my lack of understanding to anyone for fear that I might come across as dim-witted, but last week I saw an article in MedCityNews that made me feel like maybe I was not alone. The author lists the above acronyms as the Top 5 Anxiety Provoking Med-Tech Acronyms (APMAs). In case you are as clueless as I was, here’s the rundown:
Food and Drug Administration
Pre-Market Approval
Serious Adverse Event
Verification and Validation
Common Procedural Technology
Is there an acronym that really makes you PO’d?
Add your (least) favorite med-tech acronyms to the APMA Hall of Shame by clicking here.
I think I am going to form my own support group called PWDUAAAAI. (People Who Don’t Understand Acronyms and Are Afraid to Admit It)
The medical device review process adopted by FDA has won many critics for years for being too complicated, vague and slow, especially when compared to the European device approval process. In an internal report, the U.S. Food and Drug Administration is defending its approval process for medical devices, while trashing some of the regulatory practices used by its European counterparts. FDA officials are critical of a number of EU standards, noting that European regulators seek less evidence and allow “private, for profit companies” to sign off on product approvals in member countries. Even if the EU system is quicker, it is far from better, the report argues. U.S. companies have repeatedly argued that they lose valuable time and money waiting for FDA approval as they seek to improve the lives of patients they serve.
I am reminded of when my two sons get in a fight. I am usually alerted to the battle when someone screams, “He hit me!!” to which the other one replies, “Well, he kicked me first!” as if that negates any responsibility he had in the altercation. Whether or not the EU has an effective process really has nothing to do with the FDA’s efficiency. I believe the FDA needs to take care of their own problems and not worry about what the Europeans are doing, or, as I tell my sons, “take responsibility for your own actions and keep your hands and feet to yourself.”
I had a call earlier this week from Mary. Mary started her career in the medical device industry. Several years ago, she put her career on hold to raise her kids. Now that Mary’s kids are older, she has an interest in getting back into the medical device field. Mary started networking in her local business community. Several of the contacts she made suggested that Mary contact Creo Quality for what to do next.
I’m glad Mary called. We’re happy to help. Interestingly, Mary’s question was one we’ve heard many times before. It just hit me that since Mary and others have had this question, maybe I should spend a little bit of time writing down my response for others to review too.
Mary is interested in networking and meeting medical device professionals in Indiana. I suggested that she check out the following:
I also shared with Mary that we try to post many of these events on the CQ blog.
Please join us for a lively discussion directed by Jody Roth about “Key Regulatory Trends in 2011 Biological Approvals” at the next RAPS Indiana Chapter event. The event will be held on May 14th, 2012 from 4:00pm-6:00pm at the IUETC Ice Miller Room. To register, click here.
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Sens. Richard Burr (R., N.C.) and Tom Coburn (R., Okla.) recently rolled out a new bill designed to significantly improve the regulation of drugs and medical devices at the FDA. The bill, called the “PATIENTS’ FDA Act” is “a bill to help make sure that the FDA fulfills its mission to ensure that patients have access to cutting-edge, life-saving drugs and devices as quickly as possible.”
The basic premise behind this piece of legislation — as expressed by Senators Burr and Coburn — is that the FDA needs to be subject to a great deal more Congressional oversight if it is to fulfill its public health mission in a predictable and timely manner and to keep medical innovation and job creation (related to the development of new drugs, diagnostics, and medical devices) from going overseas.
I found Forbes take on the bill interesting.
Avik Roy states “A lot of the Burr-Coburn plan involves requiring the FDA to do things it’s already supposed to be doing. But there are areas where Congressional action would be especially useful: in improving the accountability and transparency of FDA decisions; in modernizing the FDA’s use of information technology, given the enormous amount of clinical data it must track; reforming the agency’s clumsy conflict-of-interest rules; and making sure the agency is always thinking about the costs, as well as the benefits, of retarding innovation.
The basic problem with the FDA is its perverse incentives. The agency gets punished by Congress and the public when an approved product runs into safety problems, whereas nobody complains about the patients who are harmed when an important new medicine is stalled by the agency. As former FDA Commissioner Andrew von Eschenbach recently put it in the Wall Street Journal, “Until FDA reviewers can be scientifically confident of the benefits and risks of a new technology, it is their duty is to stop it—and stop it they will.””
The entire legislation is 55 pages in length, although the summary is a mere 7 pages. Something to keep on your bedside table to lull you to sleep at night…
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