4 Tips to Improve Your Medical Device Regulatory Submissions

Regulatory affairs (RA) professionals in the medical device industry essentially want the same thing: to improve their submissions worldwide for a faster time to market. Alex Butler, an industry veteran, has two words for his peers — global approach. He shares some tips for achieving an effective global strategy.

“To simplify your regulatory submissions, you need to look at your organization from the perspective of all your business units, partners, affiliates and distributors across the globe,” said Butler in a webinar recently hosted by the Advanced Medical Technical Association (AdvaMed), which advocates for the industry.

Butler, MasterControl’s medical device solutions manager, presented the most common challenges faced by RA personnel and offered some tips based on his extensive experience as a product development manager for a device firm (1). He made the online presentation, “RIM ‘By Numbers’: A Quick Guide to Improving Your Global Submissions,” on Oct. 30, 2018.

Regulatory Submissions Tips

#1 Establish a single source of truth: Up to 90 percent of medical devices submitted under the 510(k) and premarket approval (PMA) programs are rejected at first review by the U.S. Food and Drug Administration’s (FDA) (2). This is partly due to incomplete or inadequate documentation stemming from paper-based and manual processes that are not connected.

“How do you get your dossier content to the right people at the right time? Who owns the output and where does it reside?” said Butler to emphasize the importance of establishing a centralized and connected platform for all stakeholders. Such connectivity is almost impossible for companies that rely on manual processes.

Companies using automated document systems face a different challenge. They typically own disparate systems that all create content and become part of the regulatory information management (RIM) process. To help the regulatory team do its work effectively, Butler recommended a platform for integrating the different systems.

#2 Create registration project transparency: In most medtech firms, the regulatory team is understaffed, usually representing only 1 percent of an organization’s staff, according to Butler. It means the team is always overburdened with simultaneous projects, which increases the likelihood of errors and slippages in submissions.

“You need to formalize project management of all product registrations. You need to know who owns the dossier at which level. Who has access and when?” he said. Registration project transparency, through a robust automated system, is a fundamental way to help an understaffed regulatory team improve project management.

#3 Nail down the moving targets: The RA team keeps track of product expirations and registration deadlines — all moving targets — across multiple markets. The team must manage all the content required for compliance.

Butler said it’s important to create a broader, cross-functional regulatory team that includes people without “regulatory” in their job titles. “Inject the right people from other departments in your regulatory team as soon as possible because 90 percent of the submission content is not created by regulatory personnel,” he explained.

#4 Know what’s changing and adapt: Regulations and standards that have recently taken effect or are about to take effect will impact the medical device industry in a major way. They include the 21st Century Cures Act, the Medical Device Single Audit Program (MDSAP), the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) and ISO 13485:2016.

Butler described the changing regulatory landscape combined with understaffed regulatory teams dealing with the changes as the “perfect storm.” Likewise, regulatory agencies and notification bodies worldwide are understaffed and struggling to address the changes.

Given this challenging situation, he said: “You can’t guarantee that your released product will not experience a hiccup in the next few years.” He advised attendees to educate their executive teams on the burdens faced by regulatory teams in the quest to launch their medical devices successfully.

References:

1. Alex Butler is MasterControl’s manager of medical device solutions. He leads the development efforts for MasterControl Registrations and MasterControl Regulatory Excellence. He’s also responsible for developing and/or improving other software solutions, namely MasterControl Customer Complaints, Bill of Materials (BOM), Projects, Risk Management, and PDM Connector. His medical device experience includes working as a product development manager for Opal Orthodontics, a division of Ultradent Products Inc., where he helped launch several Class II medical devices.
2. From the FDA’s Medical Device User Fee Amendments Quarterly Report, September 2018.