Devices & Diagnostics

Austen BioInnovation Institute makes case for value-driven engineering

The Austen BioInnovation Institute in Akron is leading a national push to make the United States more competitive globally in the medical device industry. BioInnovation Institute President and Chief Executive Dr. Frank L. Douglas joined with other industry leaders on Thursday to unveil proposals to reduce the complexity of getting new products approved, boost public […]

The Austen BioInnovation Institute in Akron is leading a national push to make the United States more competitive globally in the medical device industry.

BioInnovation Institute President and Chief Executive Dr. Frank L. Douglas joined with other industry leaders on Thursday to unveil proposals to reduce the complexity of getting new products approved, boost public and private funding and attract more young talent to the biomedical field.

Douglas presented the plan for what is being called ”value-driven engineering” this week to officials in President Barack Obama’s administration.

The value-driven engineering concept means developing ”low-cost, high-value medical devices” with an emphasis on quality that benefit patients, Douglas said during a conference call with national media on Thursday.

Medical devices include a wide range of products that are used to diagnose, treat or support body function without medications. Items can range from tongue depressors to CT scanners and pacemakers.

Remain competitive

”Our mission is clear: The U.S. must remain competitive in the global medical device industry for the good of our economy and overall health,” Douglas said. He leads the cooperative effort among Akron’s three hospital systems, the area’s medical school and the University of Akron to boost medical-related economic development and job creation.

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A Deep-dive Into Specialty Pharma

A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.

According to Douglas, U.S.-based companies account for about 40 percent of the estimated $350 billion global medical device industry.

But as health-care costs continue rising, experts say the U.S. needs to move aggressively or risk losing business to other countries such as India, China and Brazil that are developing lower-cost products.

Dr. Uday N. Kumar, founder and chief medical officer of iRhythm Technologies Inc. and fellowship director of Global BioDesign Programs at Stanford University, talked about one of his company’s products as an example of value-driven engineering.

The one-time-use patch allows patients to monitor their heart rhythms over a 14-day period for about the same cost as a blood test, Kumar said. It’s designed for use mostly by primary-care physicians, who don’t have the more advanced, costly cardiac equipment in their offices.

The product is an example of finding a lower-cost way to meet an unmet need, Kumar said.

If entrepreneurs take a similar approach, he said, ”I think there are a lot of innovative opportunities that can come forth.”

National summit

The release of the value-driven engineering plan follows a national summit held by the BioInnovation Institute earlier this year in Washington, D.C.

The summit organized by the BioInnovation Institute included representatives from Johns Hopkins University; the Harvard-Massachusetts Institute of Technology; Medtronic Inc.; the National Institute of Biomedical Imaging and Bioengineering of the National Institutes of Health; Orthopaedic Research Laboratories in Cleveland; Stanford University, and the University of Akron.

The next steps will be determined during a follow-up meeting among the steering committee members in the fall in Akron, Douglas said. In the meantime, Douglas and other participants are talking with leaders in college programs, the government and industry to share their proposals.

Ultimately, a new public-private partnership could be formed to lead the effort.

Cheryl Powell is a health reporter for The Akron Beacon Journal, the daily newspaper in Akron and a syndication partner of MedCity News.