Medical Device Daily

ATLANTA — Although the medical device industry is smaller than the pharma industry, it is growing, and just like pharma “the cost of doing business” in the medical device sector as it grows increasingly larger and more complex, said David Mullis, PhD, director of regulatory affairs in the College of Pharmacy at The University of Georgia at Gwinnett (Lawrenceville, Georgia).

Mullis, a presenter at the inaugural American International Medical Summit here, told attendees what device manufacturers well know: that while it takes up to 15 years and many millions of dollars to push a drug into the commercial market, the timeline for commercializing medical devices is much shorter, and the dollars required therefore generally smaller.

But devices, he said, offer the same drilling-for-oil paradigm – that of “high risk, high reward.”

Walking a breakout session of attendees at the conference through the regulatory maze for both devices and drugs, Mullis cautioned: “Think of the FDA as your customer,” because that agency is ultimately the prime mover in charge of what may be a company's success or failure. And he emphasized the controlling role of Center for Devices and Radiological Health for devices, since backed by expert physicists and bio-medical engineers.

Pushing the comparison with drug regulations further, he said that an investigational new drug application roughly parallels an investigational device exemption, but he cautioned that the IDE path is like “speaking a different language.”

And he said that whether a company is involved in drug development or medical device development, it's essential to get a handle on the regulatory arena – which means avoiding any assumption that you can get a complete handle on it.

“Companies that think they can read the FDA's mind [are mistaken], and they're going to be in a lot of trouble,” Mullis said.

He reminded the audience concerning the importance of Good Laboratory Practices, and that the related guidances defining organizational and managerial procedures and activities in drugs also apply to medical devices and biologics.

For those just getting into the business of developing a medical device, he said the initial thing to do is to focus on the “design concept” of a product and its “potential uses,” as well as to identify key “testing requirements.”

Also, any individual or companies in that position should initially ask themselves, “How can the device fail?” That in turn, he said, necessitates performing a “formal hazard analysis” of the product.

Another speaker at the conference was Karen Coleman, consumer safety officer, Office of Regulatory Affairs, in the Division of Emergency and Investigational Operations at the FDA. An expert on regulatory evaluations and audits of medical device companies, she noted that occasionally a medical device developer may have a design concept sketched out “on a napkin,” (the device manufacturers in attendance probably thinking that happens more than occasionally) and that they must eventually take that flimsy sketch to formal design input.

She advised that this step will mean becoming totally familiar with “design controls,” including device product stages and development differences.

Along the path of the clinical trial process, she said to “document, document, document.”

“In the beginning [of a clinical trial], a prototype device may be used,” but this documentation must define the various changes and additions – another important contrast with drugs, since drug “differences” relate primarily to dosage.

“At some point, you're going to have to freeze the design,” she said, and that any changes made must get FDA approval.

Coleman listed a variety of pitfalls in terms of the various inspectional challenges she has faced in almost 30 years with the agency. These included:

  • the inability of a company to duplicate its studies of a product;
  • fraudulent study findings as the result of selective reporting and/or missing records;
  • sloppy maintenance of patient compliance;
  • and unexplained design changes.

She said that the FDA increasingly is finding that it is dealing with “virtual manufacturers.” While “virtual” increasingly suggests some level of non-real or computer-only existence, Coleman used the expression to mean that the company is likely to be contracting out of virtually all of the manufacturing responsibilities required by the FDA.

However, she said that all-too-often the players in such a scenario may be operating simply on “handshake agreements,” and she cautioned companies that the lead company needs to have a contract with all the other companies, all of the various responsibilities of each party clearly spelled out.

While Mullis used the metaphor of the FDA as customer, William Kitchens, managing partner with the law firm of Arnall Golden Gregory (Atlanta), opted for describing the FDA as spouse.

He noted that unlike other government-regulated industries, once a company decides to enter the medical device or drug arena, it will be like a marriage – but one with little chance for divorce.

“You are going to have a lifelong partnership with the FDA,” he said. “Your partnership will be continuous and you want it to be constructive.” So if there is a divorce, it will be nasty.

But he then offered the rather dark reverse side of such a partnership. He noted that the Food, Drug and Cosmetic Act is a “criminal statute,” and that the FDA will, in fact, “send slow learners to jail.”

Also on the legal front, he said “Protect your intellectual property.”

And underlining what those in the medical device industry have clearly learned, he said that the FDA maze is “not for the timid.”

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