Medical Device Daily

The “basics” of medical device development aren’t exactly linear – such as “A-B-C’s,” as this writer simplistically suggested – but rather is circular, or a cycle, in Bernie Liebler’s view.

Liebler, who is director of technology and regulatory affairs at the Advanced Medical Technology Association (AdvaMed; Washington), said that a new effort by the organization would show – borrowing from David Feigel, former director of the FDA’s Center for Devices and Radiological Health, he acknowledged – “how the medical device life cycle works.” And a proposed development model for this life cycle will help to make clear how device commercialization is different from the more linear process for pharmaceuticals.

Liebler is the association’s lead staff person who will head a new working group to oversee creation of a “Medical Devices Development Model,” serving to lay out the device development process in a meaningful way for those doing so, not only now but also in the future.

This working group, dubbed the Critical Path Coordination Group, was given official approval last week at the annual meeting of the association’s board of directors, by the board’s Committee on Technology and Regulation. And the group’s name suggests that its task is presumed to match up in some fashion with the FDA’s Critical Path initiative.

The effort to produce a model for device regulation and commercialization “is not as new as it may sound,” Liebler told MDD, pointing to the FDA’s launch of the Critical Path scheme last year as jump-starting AdvaMed’s intention to comment on what that scheme will look like.

In response, he said he “pulled together an ad hoc group of [association] members – people I knew who were interested in this – and we met a couple of times and produced the input, the comment [to the Critical Path initiative] that we submitted last July.”

A key idea from this beginning, Liebler said, was to develop a “formal” device model, and the go-ahead to form the Critical Path Coordination Group was a way of also formalizing the ad hoc group’s efforts. Liebler also noted that AdvaMed does “all of [its] work with formalized working groups.”

In general, he said that the outcome of the group’s work will be something that describes the life cycle of devices – from first idea to commercialization and then feedback from device sale and use to create next-generation devices – while also providing a kind of usable backbone for the proposed Critical Path initiative of the FDA, it is hoped.

“We consider the model [developed] will be a critical path, [describing] better ways to bring products to the market quicker” and that it will attempt to outline basic ways that could be used “to get the [development] process rolling faster.”

Liebler also noted that reference to the end product as “a model” is a kind of “shorthand.” In fact, he said, “it’s going to be several models, if for no other reasons than there are Class I, II and III devices and different risk levels.”

In reporting launch of the Critical Path Coordination Group, AdvaMed stressed the need for specifying regulatory and commercial pathways distinct to devices rather than drugs.

“Too often, laws affecting FDA are crafted under the assumption that all product development follows the more uniform drug model, which does not accommodate the unique characteristics and diversity of the medical technology sector,” said Janet Trunzo, AdvaMed executive vice president, technology and regulatory affairs, in a statement from the association.

“[T]he industry needs to clearly demonstrate how we differ from the drug development model. The ultimate goal is to streamline the development process so that patients have quicker access to safe and effective advanced medical technologies,” she said.

The Coordination Group will not produce the work itself but will contract the work to “an academic group,” with graduate students providing research aid, Liebler said.

He said that the hoped-for timeline involves identification of those who will do the work and project launch by the end of the summer, and then completion of a first phase portion of the project by year’s end. Rather than leaving the timeline open-ended, he said, “We’re going to need to circumscribe the first stage sufficiently.”

One barrier to this fairly swift timeline, however, may be funding.

As to these financing sources, Liebler said he “can’t be sure at this point,” and that “ultimately, it may come back to the [AdvaMed] members” for support.

As a large end goal, he said that the new working group wants “to work with FDA collegially on a highly professional way to look to the future in terms of what’s coming down [for the industry] and making it work better.”

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