Andrew DiMeo is among a growing number of executives and entrepreneurs who believe that North Carolina’s biotech, life science and university infrastructure can be used to grow a strong medical device industry.

To further that goal, DiMeo will moderate a panel discussion on Nov. 15 at the Council for Entrepreneurial Development’s next BioTech Forum titled “The Drug-Device Intersection: Combination Devices and NC’s Life Science Future. He also helped launch a new organization called the North Carolina Medical Device Organization. DiMeo has a strong background in Biomedical Engineering and medical device product development.

To better explain the ideas driving the medical device initiative, DiMeo recently agreed to answer a series of questions from the CED’s Robert Albright.

Andrew, what exactly is a combination product?

Combination products can be defined as those comprised of two or more regulated components that are physically, chemically or otherwise mixed as a single entity, or, two or more separate products packaged together. The combinations can be drug/device, device/biologic, drug/biologic, or drug/device/biologic. Some examples of combination products include: drug-eluting stents, heparin-coated catheters, antibiotic bone cements, bio-artificial skin, orthopedic implants with growth factors, insulin injector pens, metered dose inhalers, transdermal patches, and diagnostics requiring a drug or biologic.

How is the FDA regulation of combination products similar or different to the regulation of pharmaceuticals, devices, or other biotechnology?

The primary similarity is that the same three agencies used to regulate biologics, drugs, and devices are used for combination products, the CBER, CDER, and CDRH respectively. The difference is in the assignment of the product. The FDA has an office of combination products that determines what agency a product will be assigned to. The office uses a proposed rule issued this past May that in affect determines the mode of action of a combination product that provides its most important therapeutic action. For example, a drug eluting stent is regulated as a device because the primary mode of action is opening the artery, while the secondary action is inflammation prevention with the drug.

Are there certain types of products that are “hot” right now and seeing a lot of research or activity?

There are many hot research areas, including binding technologies and combination diagnostics. One field that I find particularly interesting is regenerative medicine, also known as tissue engineering. These products have a lot of promise, from biomaterials that carry drugs to bio-artificial organs, blood vessels, and tendons.

What role do you see medical devices having in the Triangle’s future? How is this related to combination products?

The Triangle region has well-organized and vibrant pharmaceutical and biotechnology sectors. I believe medical devices are an important component of the Triangle’s future, as well as the surrounding urban areas, offering potential business opportunities in research, development, and manufacturing. By strengthening the regions medical device sector, this potential can be maximized. In addition, a stronger medical device sector may set the stage for the region to be a combination product leader through collaborations across the device, drug, and biologic sectors.

What do you see as this area’s greatest strength and weakness relating to medical devices and combination products?

The current organization of North Carolina’s medical device sector is not up to par when compared to the biotechnology and pharmaceutical sectors. This weakness is something that is currently being addressed. On the flip side, North Carolina has a multitude of strengths that ultimately contribute to the overall economy. Just scratching the surface from the Research Triangle region reveals some powerful examples. This area has many emerging companies developing new devices as well as technologies to improve device and drug/biologic combination.

In addition, Duke, UNC, and NC State all have premier Biomedical Engineering and Business programs. The students emerging from these programs are future researchers and business leaders who will continue to advance the local life science community.

Ultimately, I believe the greatest strengths are the commitment to entrepreneurial spirit, the research ongoing at local and statewide universities, and the quality of the state’s workforce.

To learn more about the forum, see: secure.cednc.org/programs/industry_forums/biotech_forum/register.htmls

NC Medical Device Organization: www.ncmedicaldevice.org