Medical Device Consulting Firms Adapt Engagement Strategies Amid Regulatory Compliance Challenges

There has been a noticeable change in the types of projects for which medical device manufacturers seek consultation in anticipation of submitting their products to relevant authorities. The trend seems to be shifting away from comprehensive consulting and toward engagement designed specifically to address timing concerns. Device manufacturers are looking for ways to ensure timely submission that does not get interrupted because of missing documentation, validation problems or design changes that could interfere with the commercialization schedule.

The nature of consulting that used to focus on providing broad quality-systems guidance is evolving into work aimed at meeting particular deadlines. Consulting teams are increasingly being engaged early in the process to review technical file materials, results of clinical evaluation and design history data prior to their handover between departments in order to address compliance-related risks associated with delayed submission.

This problem is most acute for manufacturers that significantly increased their product development activities in recent years without increasing the size of their internal regulatory teams. In some cases, there are multiple submission efforts underway at the same time, each requiring significant attention. Consulting firms are filling this gap; however, consulting engagements often resemble stabilization more than strategic guidance.

Device makers are also becoming more selective about how consulting services are acquired in response to cost constraints imposed by procurement teams concerned about development expenses. As a result, consulting projects tend to be split up into separate tasks focused on audit preparation, risk management or submission remediation.

This trend is having a major impact on how consulting firms staff projects. Senior regulatory consultants are increasingly spending a significant portion of their billable time participating in internal review processes where quick changes to submitted materials are required before the deadline imposed by the authority. Some consulting firms noted that technical writing and document tracing have become more common services than strategic consultation with manufacturers on regulatory matters.

A different challenge faces smaller manufacturers. Often times, venture-backed firms realize the amount of work necessary to prepare for review only at late stages of development. This leads to engaging consultants amid tight deadlines and after the submission materials have been scattered through multiple platforms and vendors.

These constraints are not limited to delaying submission only. Engineers tasked with developing the product may need to review and revise their original assumptions while quality teams scramble to organize their records that have not been compiled in compliance with regulatory guidelines. Consulting engagements thus turn into crisis management sessions.

Manufacturers may also reconsider whether their fragmented approach to consultants results in greater coordination risk. Having one vendor handle quality issues, another managing clinical studies and yet another dealing with technical file documents can lead to inconsistent review practices within a single submission application. As a result, buyers are showing interest in consulting firms capable of coordinating regulatory workflows even if they cannot perform all of the technical consulting tasks.

The consulting industry is thus becoming less easy to segment. Traditionally regulatory-focused advisers are gradually merging with quality system consultants and product development firms. Medical device manufacturers are increasingly focusing on whether their consultants are able to operate in compliance with existing engineering schedules rather than provide advice.

Medical device consulting is unlikely to shift away from regulation-focused projects because of continuing relevance of compliance-related issues. However, the nature of consulting engagements has changed to the point that buyers seem less interested in advisory services and more focused on minimizing unnecessary delays.