Not too long ago—a few decades to be somewhat imprecise, the healthcare industry in the United States was much less regulated than it is today, and was essentially market based. Over time, the FDA began to acquire increasing authority. "The 'drug' industry was lightly regulated from 1906 to 1938 when new drug approval for safety became the requirement for entry into interstate commerce," explains pharmacist and device attorney Larry Pilot. In 1938, FDA was given the power to regulate pharmaceuticals. The act that gave the agency that authority also defined the term “device” for the first time and imposed regulatory burdens associated with device adulteration and misbranding violations, Pilot explains. In 1962, efficacy rules were enacted, which led to a further expansion of FDA authority. Oddly enough, the medtech industry was essentially unregulated until 1976, when the Medical Device Amendments were enacted.

According to...

December 14th, 2011
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To answer that question, the "Dude" from the Coen brothers' cult classic "The Big Lebowski" was the inspiration for one of six personas that were used in a continuous positive airway pressure (CPAP) design project at the University of Cincinnati's Medical Device Innovation & Entrepreneurship Program. (In case you were wondering, the others were named "Hipster," "Metro," "Nomad," "Gramps," and "Trucker"). The six personas were used in design research involving a CPAP mask from Respironics in 2006. Although the example may be a few years old, it represents a good example of the use of personas in medical device design.   

Respironics enlisted the help of UC ...

December 14th, 2011
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Marc HendriksRecently, I had a phone conversation with Marc Hendriks, R&D and technology director at DSM Biomedical. Hendriks had just announced over Twitter that he had recently given a guest lecture at the University of California, Berkeley and I was curious about the contents of his presentation.

While giving me a summary of his biomaterials lecture over the phone, It was clear that Hendriks, who has a doctorate in chemical engineering and holds 25 U.S. patents, is a real expert on the subject. By the end of our conversation, I had an invitation to send over a few questions, the answers to which I planned on sharing with our readers. 

The result of that exchange exceded my already high expectations. I present here his in-depth response to each of the four broad questions I asked:...

December 12th, 2011
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FDAThe device classification scheme is an important component of the U.S. regulatory system for medical technology. Introduced in the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act, the system assigns devices to one of three categories: Class I, Class II, or Class III. It is widely believed that Class I is comprised of devices that represent the least risk while Class III represents the highest risk. Presumably, Class II is for devices that are moderately risky. That characterization, however, is incorrect—even though it is sometimes described that way by FDA employees and by other authorities on the matter.

“[T]he classification system is not based on the inherent riskiness posed by the devices, but on their complexity and function,” explains device attorney Larry...

December 9th, 2011
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this week in devicesThis week in devices, a Minnesota trade group signed a deal with CDRH to speed device approvals and MD+DI's full salary survey results were released. Also, Qualcomm had big news to announce, and Medtronic launched a portal for medical device innovation.

  • Trade Group Signs with FDA to Improve Medtech Approval Process (MPR)
  • The Best (and Worst) Thing About Medtech Jobs—An MD+DI Salary Survey Guide (MD+DI)
  • Qualcomm Exec Talks 2net, Device Tax (MED)
  • Millstone Hires Executive (Orthotec)
  • Recycling Pacemakers in India (EMDT)
  • Medtronic Opens Portal for Medical Device Inventors (medtechinsider)

 —Brian Buntz

December 9th, 2011
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At BIOMEDevice in San Jose, Andrew Kimmel, a partner at Knobbe Martens delivered a talk titled "IP Considerations During Product Development." Kimmel has a unique perspective on intellectual property (IP) in medtech because he is originally an engineer by training and worked for about ten years in a medical device company, where he was an inventor and worked on a number of that company’s patents. After working there, Kimmel went to law school and later became an attorney focused on IP. 

He opened his presentation with a true/false IP quiz, which is presented here:

True or false? A patent grants the inventor the right to make, use, sell, and import his or her invention. In other words, does a patent grant the inventor the right to...

December 8th, 2011
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This week, Qualcomm unveiled what could be a game-changing connectivity product designed to work with a variety of wireless medical devices. In advance of the news, I spoke with Don Jones, the company’s vice president of business development and global strategy and market development, about Qualcomm’s 2net portal and hub. He also shared his thoughts on how the medical device excise tax might impact firms focusing on wireless health products.

Read more on the MED blog.
 

Jamie Hartford

December 8th, 2011
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When designing a device or an assembly line that involves testing, it’s important to know the various forks in the road that will affect the ultimate testing costs.

Testing takes time and money. If your medical device is leak sensitive, the data you need to model is how testing various subassemblies and/or final assemblies will impact both costs and product quality.

One example is the great number of medical devices or components made from molded plastic parts that also have internal chambers. For example, think of a device with one pathway for irrigation and another for aspiration. Too often, Uson’s medical device testing team has been approached to test such devices as a fully assembled single unit. But for the device to function properly, internal wall leakage is just as important.

The lowest cost testing solution in many such cases would involve first leak testing a subassembly. Yes, leak detection equipment can be configured to do both...

December 7th, 2011
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At a conference session at Biomedevice at San Jose, president of CardioMed Device Consultants (Baltimore) Semih Oktay, PhD gave a broad overview of CDRH and FDA, drawing on his own experience at the agency as an expert mechanical engineer and scientific reviewer of cardiovascular devices.

Oktay explained that working at the agency can be very stressful and the salary opportunities are limited. The workload at the CDRH can be daunting, he explained. "They are dealing with more than 11,000 submissions every year," he said. Also consider the volume of investigational device exemptions that are submitted to reviewers, Oktay recommended. "[Reviewers] have 30 calendar days to review them," he added. On top of that, reviewers must...

December 6th, 2011
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We're getting closer to 2012, and it seems like a good time to look at what MD+DI articles resonated with you the most. This year, the stories fell into rather distinct categories.

From this list we can tell that you are interested in FDA, the world, and the costs of running your business. But you are also interested in what other companies are doing, particularly about the big three (J&J, Boston Scientific, and Medtronic). And then in some cases, you are interested in random stuff that doesn't really fit into any categories. For example, a 1998 article from Karl Hemmerich, on general aging theory and accelerated aging was among the top 50 articles this year.

Go figure.

And while you help us figure that one out, here some of the top articles from 2011, arranged by category:

Stories about the Future

• ...

December 6th, 2011
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