This article is an excerpt from the Regulatory strategy as a competitive advantage ebook.

Table of Contents

• The regulatory revenue opportunity
• Regulatory responsibilities
• Limitations of the "cost-center" approach to regulatory affairs
• Regulatory as a revenue function
• Competitive advantage #1: Faster time to market
• Competitive advantage #2: Cost avoidance
• Competitive advantage #3: Out-pacing competitors
• Why invest in regulatory/revenue alignment?
• Getting started - 3 steps to move towards a revenue-aligned RA team

It is well known that medical technology (medtech) companies are highly regulated, given the potential risks their products present. Understanding and complying with the complex regulations in each country is, therefore, a necessary part of marketing and selling medical devices. To realize any revenue from a medical device, it must not only demonstrate compliance with all applicable regulations, it must also receive and maintain market clearance from each country in which it is to be sold. No market clearance means no revenue. Given the key role regulatory compliance plays in revenue attainment, regulatory teams, tools, and processes present a significant opportunity for differentiation for organizations willing to invest in them.

For the majority of medtech companies, however, regulatory departments have traditionally been treated as operational cost centers, with departmental improvements focused on cost reduction and efficiency improvements. Limited investment in people and tools, and limited interest in digital transformation, have left regulatory teams across the medtech industry underfunded and under-resourced.  

This has led to great resourcefulness within the RA community, where most members can point to heroes within their team who worked long hours to meet a submission deadline, headed off a disaster by uncovering a pending expiration, created ad-hoc systems to organize information and streamline communication between the RA and QA teams for smoother audits, or have otherwise gone above and beyond their typical responsibilities.

Regulatory teams, however, have the potential to be a revenue-driving competitive weapon for companies that are willing to look at them a little differently and invest in regulatory performance above regulatory cost-effectiveness. Well-supported regulatory teams can provide a true competitive advantage by providing the resources and direction to:

• Capture market share by being first to market with novel devices.
• Avoid lost revenue by effectively tracking and planning for registration renewals/updates.

• Out-pace competitors and grow market share by adapting to regulatory changes more quickly and taking advantage of competitors’ non-compliance or inability to enter a new market.

We believe we are entering a new era for regulatory affairs within the medtech industry. One in which RA teams have a seat at the table when go-to-market, competitive positioning, and strategic decisions are being made.  

In the medtech industry, regulatory affairs (RA) teams have a broad range of responsibilities across the product lifecycle:

Premarket regulatory strategy

Obtaining market clearance for a new medical device is the primary activity typically attributed to RA teams. It is not unusual for a regulatory team to be given market entrance projects with little warning, but ideally, the RA team would be brought in as early as possible to contribute to go-to-market discussions.

Premarket regulatory strategy, at a minimum, involves:

• Determining the most appropriate pathway to market approval. For example, a 510(k) or PMA submission in the U.S.
• Working with quality, product, and other teams to gather information needed for market submission.
• Establishing communication with applicable regulatory bodies and third-party approved auditors.

• Compiling and submitting required documentation for market approval. This includes managing follow-up activities, questions, and requests for additional information throughout the approval process.

Forward-thinking organizations often look to bring in RA teams even earlier in the process. As regulatory experts, RA professionals can provide unique insight into product development plans. In consultation with R&D teams, can help to refine product strategies, and steer development in areas that will reduce regulatory hurdles when new products are ready to be commercialized.  

Maintaining regulatory compliance for existing products

While the primary focus of regulatory teams is often considered to be new market submissions, the majority of their time is actually spent on maintaining compliance for products that are already in-market. Even in situations where market registrations do not expire, constant vigilance is required to ensure that devices remain compliant with current regulations. These efforts take a considerable time for a typical RA team because information is often spread across disparate systems, where it can be difficult to find and confirm.

Maintaining regulatory compliance for approved devices includes:

• Staying on top of changing standards and making changes as required to existing technical files and other documentation.
• Submitting appropriate documentation updates when there is a change made that could potentially affect the efficacy or safety of the product, such as a material switch or facility change.  
• Understanding pending regulatory changes and proactively addressing any that have an impact on devices currently in-market.
• Tracking registration expirations and preparing for timely re-submissions to ensure there is no lapse in market clearance.

Post-market activity

Post-market surveillance and vigilance activities are required by most countries and should involve the cooperation of the quality and regulatory teams. Ensuring that changing post-market reporting requirements are understood and complied with is an important regulatory responsibility.

Regulatory teams typically play a role in:

• Post-market surveillance of adverse events, complaints, and any issues associated with a device in the field.
• Assembling and submitting any required periodic safety reports to country/regional health authorities.
• Post-market vigilance and reporting of serious events to the appropriate regulatory agencies.
• Any required communication with regulatory authorities regarding adverse events or concerning trends in product quality.

Ask any RA professional, and they are likely to tell you that they work long hours and are often scrambling to meet looming deadlines...

To continue reading this ebook, download the full version.