Lisa SuennenLisa Suennen is the managing member and co-founder of Psilos Group (Corte Madera, CA), a healthcare-based venture capital firm that has nearly $600 million under management. When asked what her job description is, Suennen offers a simple summary: “take smart investors’ money and give them back more while leaving great companies in our wake.”

Suennen became a venture capitalist in the healthcare space after holding a number of senior executive roles at Merit Behavioral Care. Before that, she worked in the technology industry, which she notes was unfulfilling for her. “Maybe it was the sector I was in, but technology for technology’s sake was not interesting in terms of thinking about what I am going to leave behind. I wanted to work for a company that also makes a difference in people’...

May 9th, 2012
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After 25 years of doing business in country, Johnson & Johnson (China) Investment Ltd. made its first acquisition of a domestic medical device company earlier this month. On May 2, J&J China announced the purchase of Guangzhou Bioseal Biotech Company, Ltd, which specializes in porcine plasma-derived biologics for controlling bleeding during surgery. Bioseal will work closely with Ethicon, a J&J company, which already markets hemostasis products in China.

To find out more about the rationale behind the purchase, Helen Zhang, Associate Editor of China Medical Device Manufacturer (CMDM), interviewed Karen Jiang, Senior Media Affairs Manager, Johnson & Johnson Medical. Among other things, the acquisition will provide Ethicon with an alternative biologics source for a pipeline of biologics/combination products, Jiang told her.

Read the full interview in the...

May 8th, 2012
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Today I have a guest blogger: Dean Hooper, of Ximedica. Dean sent me some thoughts about how building profiles of the people who will use devices should be integrated with risk analysis. Profile building is a key task of himan factors professionals.

Stephen B. Wilcox, Ph.D., FIDSA

Historically, risk analysis was typically siloed from human factors (if indeed, human factors was even represented within a given organization). However, it’s now generally accepted that the consideration of device users (particularly as it relates to use errors) is crucial for assessing risks. For example, the risk-analysis standard, ISO 14971...

May 8th, 2012
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The Corporate Whistle Blower Center is encouraging representatives of the medical device industry to step forward if they believe their company is actively engaged in unethical practices or selling defective devices. The Corporate Whistle Blower Center is an advocacy group that offers whistleblowers an alternative to government or the media (which the group says are often ineffective) in packaging the information they have against a company. In a statement released today via ...

May 7th, 2012
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This Week in Devices [5/4/2012]

 

 

“Like” This if You’re an Organ Donor

  • After a San Diego man found an organ donor via Facebook the social networking site thinks it would be a great idea if all of its users reported their organ donor status. (via Reuters)

Making or Buying Growth. That is the Question

  • CFO reports on a study showing that medical device companies tend to create more value for shareholders by...
May 4th, 2012
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The tCoil device uses an alternating magnetic field on the exterior unit to create alternating current on a second coil under the skin. That, in turn, charges a subcutaneous battery pack that keeps the pump running. (Credit: Jeff Fitlow/Rice University)

Heart pump implants are a viable option for heart-failure patients except for one problem area—they require charging, which is done through wires. Aside from the obvious aesthetic issues, these chargers also present a problem for patients in that the portal through the skin, linking the heart and...
May 3rd, 2012
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Should medical device companies seek regulatory approval in Europe before the United States? It's a question that every company must contend with. Initial clinical testing is a key aspect of obtaining regulatory approval for medical devices. But in the United States, the process is a lengthy one.

Carolyn Knight Brain track dot comFDA, on average adds 3-6 extra months, and Institutional Review Boards (IRB) add an extra 3-6 months to the time it takes for a medical device to receive approval just for the initial clinical testing in the United States. This 6-12 month waiting period prompts medical device makers to test them out in European countries instead of the United States. CDRH regulates medical devices in conjunction with the FDA. Needless to say, whether you are looking for regulatory approval for a Class I, II, or III device,...

May 3rd, 2012
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I recently spent some time in Japan, meeting with OEMs, suppliers, and associations in the medical device space. One of the more eye-opening—and frankly quite candid—discussions was with Kunimasa Katayama, president of the Advanced Medical Device Developing Laboratory, also known as AdMed. Katayama mostly acts in a consultant role now, but he has a great perspective, seeing as that his former role was as the General Manager of Terumo Medical Corp., one of the largest medical device manufacturers (about 10,000 employees) in Japan. He left the company this past January. In addition to consulting to the medical device industry, Katayama offers advice to industry, government, and academia, and he is conducting research on the medical device industry, lecturing, and writing books.

The first surprise was the candor with which Katayama spoke. I expected him to be more reserved, but he answered all of my questions...

May 3rd, 2012
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Survey alert: We’ve partnered with Cambashi to conduct a survey to understand the habits of design engineers in the medical device arena. If you’re reading this, then you likely qualify. The survey is titled Quality in Medical Device Supply Chain. Please take a few minutes to fill it out.

The results of the survey will be unveiled here at MD+DI. In addition, a presentation will be given at MD&M East in Philadelphia that provides an analysis of these results, while at the same time permitting attendees to ask questions related to the survey.

The results of the survey will let designers benefit from the experiences of their peers, including what the considerations are along the...

May 2nd, 2012
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Deborah Kilpatrick Cardio DXDeborah Kilpatrick, PhD, is senior vice president at genomic diagnostics company CardioDx, which has been recognized in the Wall Street Journal Technology Innovation Awards, TIME Magazine's Top 10 Medical Breakthroughs, and the 2012 Edison Awards. Deborah was formerly at Guidant Corporation as a Director of R&D and New Ventures, and she currently has various advisory roles for the Georgia Institute of Technology, the Dystonia Medical Research Foundation, and the Association of Women in Science. In 2011, Deborah co-founded the inaugural MedtechVision conference, focused on highlighting women leaders from all facets of the medtech sector.

MD+DI: How did you get your start in the medical device and technology industry?

...
May 2nd, 2012
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