A 24-hour hacking event to be held in Sweden this year is designed to make developers aware of the many opportunities available in the health app market. The Health Hack Day will take place on 18–20 May 2012 and is organized by the Swedish companies Psykologifabriken and Hoa's Tool Shop. During a period of 24 hours, divided into three days, the teams selected to participate will work on creating a prototype for a health app. Organizers hope that the event will connect developers with great ideas to investors, leading to the development of new commercial products.

Read more in a medtechinsider blog post on the event.

February 9th, 2012
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Nanomaterials have achieved major importance in the health care industries. These are already used in surgical gowns, bedding, and portable items to minimize the risk of pathogen growth and transfer. Nanomaterials are increasingly used for diagnostic procedures, most significantly, according to the Nanotechnology Institute, in the diagnosis of arteriosclerosis and Alzheimer’s disease. The capabilities of semiconducting nanocrystals (quantum dots) have led to advances in optics technology that have enabled health-care professionals to view almost any part of or specific organ in the human body. Nanomaterials also have a major role in the circuitry of microelectronic instruments. What has not been developed as fully is the use of nanomaterials as potential sensors for therapeutic procedures. 

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February 9th, 2012
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Calling all designers, engineers, and meaterials experts. Stop what you are doing and put your collective brains to one of the a travesty of medical device development. The condom is woefully lacking and it needs your help.

CondomThat is the rallying cry I heard when I read an article from Paul R. Abramson and L.J. Williamson extolling the many vices of condom technology.

The authors don’t care about fancy new tricks, like Viagra in a condom. But they do care that so much money has gone into HIV prevention vaccines (with humdrum results)—when building a better condom could be so effective in actual prevention....

February 9th, 2012
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On 19 January 2012, the Chinese Ministry of Industry and Information Technology (MIIT) unveiled a new Five-Year Plan for the Development of the Pharmaceutical and Medical Device Industries. This plan sets forth key objectives related to government investment in the pharmaceutical and medical device sectors. Maintaining robust growth, promoting innovation, improving quality and safety, safeguarding the supply of essential drugs and increasing international competitiveness are the primary goals. Here are some highlights from the new five-year plan:

•    MIIT aims to increase the gross industrial output of its drug and medical device industries by 20% annually. It wants to see more than five domestic companies achieve global sales of US$8 billion by 2015.

•    MIIT has pledged to spur development of more than 50 medical devices.

•    Green development objectives are promoted for the pharmaceutical and...

February 8th, 2012
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Almost every day, another advertisement or article is released that espouses the need to get ready for product testing to the new IEC 60601-1 Third Edition. Industry has been experiencing some pressure to apply this expensive standard to their practices.

Grant Ramaley

However, regulators and government agencies have renewed concerns about the risk management system. Concerns over credibility of certification to continue to emerge, especially because IEC 60601-1 is a standard intended to be applied to all electro-medical devices traded internationally. This has recently reached the attention of many other regulators who had previously remained on the sidelines of issuing opinions on standards. The...

February 7th, 2012
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Although there has been some improvement in capital markets, access to capital is still a central concern in 2012, said G. Steven Burrill, CEO of venture capital firm Burrill & Co., in opening remarks at the third annual Burrill Digital Health Meeting, in Burlingame, CA.

By Svilen.milev (Own work) [CC-BY-SA-3.0 (www.creativecommons.org/licenses/by-sa/3.0) or GFDL (www.gnu.org/copyleft/fdl.html)], via Wikimedia Commons

“As a result of financial turmoil, capital is more expensive and...

February 7th, 2012
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Innovation is the lifeblood for companies competing in the fast growing $350B medical device industry.  To keep up, companies are shifting their new product development processes away from internal R&D to an Open Innovation model that allows them to secure new ideas from outside parties. For lots of reasons, some legal, some financial, and some simply human nature, open innovation can be somewhat trickier than it sounds.

Wouldn’t it be great if there was a software platform that simplified this process? Well, there is, and if you’re attending the MD&M show next week in Anaheim, Calif., you can hear more about it and get yourself a demo.

e-Zassi, a company that offers a subscription-based, integrated online business network to the medical device industry, has developed an Open Innovation software platform specifically designed to address the unique needs of the  patent-centric medical device industry. Unlike many business sectors,...

February 6th, 2012
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this week in devicesAmong stories in this edition of "This Week in Devices," EMDT's Norbert Sparrow covers further developments in l'affaire Pip—the recent breast implant scandal—and the resulting calls for more regulatory scrutiny.

  • Devices Are the Future of Drugs (EMDT)
  • Biomet, Zimmer, Stryker, Wright Medical, Among Top 25 Medical Device Players (Orthotec)
  • Leverage Commercial Off-the-Shelf Tools to Create Verifiable Hardware and Software Solutions (MED)
  • Russia to Release New Medical Device Regulations (medtechinsider)
  • AdvaMed Chief Ubl Calls New MDUFMA Deal a "Game-Changer" (Massdevice)

 —Brian Buntz
 
 
 

 

February 4th, 2012
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Image from the Texas Heart Institute

Last year, heart surgeon Billy Cohn, MD explained in a ABC News video that ventricular assist devices “work really beautifully to support a weak left heart. But no one had ever used one to replace a heart, or use two of them to replace both sides of the heart.” Cohn and his partner O.H. “Bud” Frazier at the Texas Heart Institute in Houston had made a device that does just that. And, at the time, the technology had been successfully implanted into a patient.

Looking back on their efforts, Cohn...

February 3rd, 2012
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Mark Kramer answers 5 questions on combination products and the regulatory hurdles manufacturers can face.

Mark Kramer Regulatory Strategies Inc1. What is a combination product?

A combination product is a combination of different types of regulated products, i.e., a drug and a device, a drug and a biologic, a device and a biologic, or a combination of a drug, device and biologic. FDA recognizes 3 types of combination products, where the components are (1) physically/chemically combined into a single entity (like a drug-coated catheter), (2) packaged together, or (3) separate products brought together through their labeling (“cross labeling”). The US is unique in recognizing cross labeled components as combination products, and these sometimes raise challenging regulatory issues.

2. How does FDA...

February 3rd, 2012
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