What Should You Do When a Testing Standard Doesn’t Exist? Part 5: Forming an Industry Consortium

In part four of this series, we talked about employing a third party to build testing equipment to develop a new test method. In this part, we’ll discuss forming an industry consortium as another means to develop a test method.

OMTEC Blog post 5 imageThrough the use of Cooperative Research and Development Agreements, an industry consortium can be formed. This can be a useful means of obtaining and sharing data that are expensive to collect.

Collaboration through an industry consortium can result in test method development, new instrumentation, and innovative approaches to shared problems. The knowledge and data developed in the industry consortium can be used to educate others and to support standard development.

For example, in 2006, SRI International, Stanford University, and a consortium of stent manufacturers teamed together to investigate loads on stents in the superficial femoral artery (SFA) and to improve the durability of peripheral vascular implants. An important outcome of this collaborative effort was the identification of bending, torsion, and axial deformations that would need to be simulated in the in vivo loading experienced by the stents. The results suggested possible fracture mechanisms and also provided important parameters for future stent design.

In the final part of this series, we’ll review the options you have when a testing standard doesn’t exist and discuss your recourse if the standards community disagrees with the testing method that you propose.

For more information, please visit our website at http://www.medinstitute.com

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Meet Bill Voorhees,our Vice President and Chief Science Officer.

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I’m Bill Voorhees.  I have been employed by MED Institute for over 25 years, although I have been associated with the company from its inception, serving on its advisory board from 1983 until being hired on in 1990.  Prior to coming to MED, I spent 14 years at the Biomedical Engineering Center at Purdue (4 years as a doctoral student and 10 years as Research Faculty).

It was a natural progression to come to MED.  At the Biomed Center, we did a lot of practical, applied physiology research.  At MED we take the next step and help bring the fruits of such research to the patient.  Our role in the process comprises all aspects of product validation testing including non‑clinical in vitro and in vivo testing as well as clinical trials.  I have to admit I may be most pleased with being involved in helping conduct the first clinical trial, analyzing the resulting data, and preparing the regulatory submissions that led to FDA’s approval of the first coronary stent available in the U.S., The Gianturco-Roubin Flex‑Stent Coronary Stent.  Those were exciting times, and there are more to come as we offer our expertise in all aspects of new product approval to a new set of clients learning to navigate the medical product approval process.

To learn more about our services, please visit our website medinstitute.com.

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