By interacting with FDA as early as medical device conception, and taking advantage of one or more FDA programs, manufacturers can shorten their time to market and significantly reduce expenditures.

At the upcoming MD&M East show in New York City in May, Janet Kwiatkowski, MBA, MSRA, president and CEO of MAE Group, will give a talk entitled “Importance of Early Dialog & Interaction with the FDA.”

MAE Group, based in Manchester, NH, provides regulatory and technical services to medtech companies to bring medical devices to market globally.

Kwiatkowski shared some highlights of her presentation with MD+DI.

Why is it important for a medical device manufacturer to have an early dialog with FDA?

Kwiatkowski: To establish a strong rapport and credibility with FDA, and to gain guidance and direction from a technical perspective.

You also want to engage with the FDA team that you will be working with throughout the process to market clearance or approval.

At what stage of device development should this interaction begin?

Kwiatkowski: As early as possible in the medical device development process, ideally during the concept phase.

What are some of the programs offered by FDA to help device companies?

Kwiatkowski: There is direct and expedited access to FDA for novel technology devices, including Humanitarian Device Exception, De Novo, Breakthrough Designation, Safer Technologies Program (STeP) Designation, and Emergency Use Authorization. There is also the Early Payor Feedback Program. If you have a novel medical device technology, two important programs are Breakthrough Designation and Early Payor Feedback Program. Breakthrough Designation helps patients get medical devices faster. The program expedites the development, review, and assessment of medical devices that treat or diagnose life-threatening conditions. The Early Payor Feedback program is a voluntary opportunity for medical device manufacturers to obtain payor input on clinical trial design or other plans for gathering clinical evidence needed to support coverage decisions.

Can you embellish on the significance of reimbursement?

Kwiatkowski: The Early Payor Feedback Program allows you to engage with government and private payors, so you understand what the insurers will require as part of their cost-benefit analysis to determine if a novel technology will receive reimbursement.

By understanding what factors payors assess in their determination for coverage, you can incorporate important factors in your pre-market strategy for market authorization, such as clinical evidence, quality of life, and comparison to existing treatments.

What are the benefits of engaging with FDA early on?

Kwiatkowski: It allows you to establish a solid working relationship with FDA based on collaboration. Plus, reduce risks by navigating through complex regulatory pathways; derisk, to the extent possible, with investors specific to the regulatory path to market; mitigate uncertainty related to device classification; and improve clinical trial design.

All of this adds up to reduce time to market approval.

Are there any missteps that device firms make with FDA engagement?

Kwiatkowski: Typically, engagement occurs either too early or too late in the manufacturer’s commercialization process. This can be pre-proof of concept; or a manufacturer submits a product application, only to find out that a major element of a test or study has either not been conducted or a specific element was not addressed to FDA requirements.

Obviously, these scenarios delay time to market and stunt revenue growth.

Source:MD+DI