Medical Device Daily Executive Editor

MINNEAPOLIS – So you’re running – or perhaps funding – an early-stage medical device company. You obviously face plenty of challenges, but which among them are (or should be) front-of-mind?

To Geoff Pardo, a member of a panel assessing “Pre-FDA Approval Challenges” during last week’s Medtech Investing Conference at the Radisson Plaza Hotel in downtown Minneapolis, one of the most important involves the regulatory path of the technology on which the company is focusing its efforts.

Pardo, a principal with Spray Venture Partners (Newton, Massachusetts), said, “If the regulatory path is not well-defined, you need to know the timeline that will be involved.”

Making decisions on such things as an in U.S./outside U.S. regulatory path or animal/human studies, he said, is a matter of “balancing the business risks with the regulatory requirements.”

Noting that “there are a lot of choices you can make” in deciding on the regulatory path, he cited such basic early decision points in U.S./outside U.S. regulatory paths and animal/human trials.

For Amir Nashat, a Polaris Venture Partners (Waltham, Massachusetts) principal, “you need to develop a close relationship with the regulatory folks early on.” That helps, he said, with the “give and take with the FDA on what’s possible and what’s not.”

He also endorsed the “outside U.S.” strategy, saying it is “one that works.”

Linda Alexander, president of Alquest (Minneapolis), a medical technology-specific contract research organization, the goal should be “to meet the [regulatory] requirements in a minimal way in order to get to market faster.” That means one of the key things to look for “is how creative the person is who is in control of the process.”

As had Nashat, she emphasized the building of relationships with those who are key to the regulatory process. “Meet with the FDA early and often,” Alexander said. “Know who the people are [and] approach them when you begin to have information they will need in order to make their decision.”

Pardo added: “The FDA usually knows what it’s talking about; you want to listen to them.”

One thing that’s important in preparing for a regulatory submission, Alexander said, “is to know the downside of the technologies that are already out there. That’s a key, she said, “in addressing with the agency how you are going to impact the market.”

Citing what she hinted is an all-too-common failing on the part of some early stage companies, she told the entrepreneurs in the audience: “You want to remain the expert on your product; you don’t want the FDA to help you develop [it].”

Urging such companies to “rely heavily on experts,” Nashat said such companies should “work with companies experienced in the regulatory process,” adding that many of them often have previously worked at the FDA.

“It’s helpful to kind of pre-test your idea” on such people, he said.

Fellow panelist Chantal Carson, section manager for medical and laboratory devices at Underwriters Laboratories (Northbrook, Illinois), said, “Start early in the design process to understand what the requirements are going to be” when you get to the FDA. “Those people [who know about the regulatory side of things] need to be involved early on in the development process.”

Noting that “regulatory is just part of the process,” Nashat said that while a regulatory person “should be one of the first hires, you then need to hire a marketing person in order to understand what the physician wants.”

Responding to an audience member’s suggestion that getting a humanitarian device exemption (HDE) for your product allows it to be marketed for a de novo indication, Alexander said: “That’s a really good call – part of the ‘creative thought’ process I was talking about earlier.”

She added that a de novo application “can usually get by with a somewhat lesser clinical study than, for example, a premarket approval [PMA] application.”

An HDE is a particularly good approach, Alexander said, “when you have a very small potential market for your product.”

In offering closing cautionary comments, Pardo noted that a company might want to take the more arduous PMA route to approval for competitive reasons, “to keep those who come behind you from just doing a 510(k)” and jumping more quickly into the marketplace.

Carson, whose firm is one of 14 companies accredited by the FDA as third-party reviewers, touted that process as a path to shorter review times. “Turnaround time is much quicker,” she said, “an average of 74 days with third-party reviewers rather than 91 days by the agency itself.”

For her part, Alexander noted: “In order to gain approval for a medical device, you need to be closely connected to the physician community.”