Medical Device Consulting

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.

Manufacturers are increasingly seeking post-market assistance as pressure mounts on complaint handling, reporting workflow optimization and corrective action documentation following the launch of medical devices into commercial sales. In contrast to traditional premarket engagements, this consulting work is fundamentally different and represents new criteria for evaluating consulting firms. At least several medical device manufacturers currently rely on slim compliance teams in order to keep up with increasing portfolio size and geographic spread, but may find it challenging to maintain consistent review processes amid increasing numbers of incoming reports and investigations. Temporary consulting roles may be required in these situations to provide additional oversight during product reviews, document investigations or plan out corrective actions. Post-market consulting typically becomes noticeable after the emergence of certain pressures caused by inefficient review process. This could include such issues as complaint backlog, assessment delays and inconsistencies in report documentation. Device manufacturers are likely to turn to external experts as soon as they realize that existing review workflows do not work anymore. Smaller companies also have to deal with similar issues as they enter commercialized medical device market for the first time. Often, they do not appreciate the amount of effort and staffing that would be needed to manage rising reporting volumes. Product development teams that invested years into creating medical devices will find post-market documentation challenging. Consultants will also find themselves having to coordinate between various departments. While quality departments will have to investigate reports, engineers could be called upon to make technical assessments, while customer support will be responsible for receiving the complaints. Any delay on one end could result in other processes being put on hold. These trends in turn change client expectations. Manufacturers need consultancy that will allow them to structure their review processes in a way that minimizes escalations and clarifies decision-making responsibility. As a result, this kind of consultation is not merely about implementing one-time changes but creating sustained oversight capacity as part of a product launch. Moreover, post-market assistance may involve even more specialized expertise. Some consulting companies are seeing growing demand for services related to software-based devices and connected monitoring systems. Such products generate a large number of reports, but companies may not understand which incidents will need investigation or reporting. There may be many support lines where such data could be received. While the medical device manufacturing industry continues to remain cautious in adding permanent staff due to inconsistent economic conditions across many healthcare markets, external consulting could be implemented much quicker during the time of need. This in turn increases risk for the consulting firm as well, as all acquired knowledge will leave as soon as the project ends. Clients are getting increasingly wary of claims of medical device expertise without knowledge of post-market review processes. Having regulatory and technical skills will not fix any delays unless consultants will be able to perform tasks in accordance with internal procedures and coordinate between departments. Medical device consulting engagements in this market will also become increasingly process-oriented. Many clients want consulting help with routing of investigation, sequencing of documents and review schedule rather than just suggestions for improving overall compliance. This is because many manufacturers already have the policy in place but need to solve process issues. Consulting firms that were previously focused on submission strategy may find that they now compete for post-market consulting business of equal value. Commercial success comes with sustained obligation for compliance and manufacturer will not shy away from seeking external help once it starts putting pressure on internal operations.

There has been a rise in the procurement scrutiny applied to medical device consulting budget expenditures due to changing views on the relationship between external advisory assistance and overall development cost. While device companies continue using consultancy services extensively when preparing for regulatory clearance, quality review and remediation, the procurement teams apply much more rigorous scrutiny towards the nature of work, staffing models and billing structures. Such developments arise against the backdrop of cautious expenditure control in healthcare manufacturing, given the ongoing challenges with high development costs and unpredictable revenue generation due to changes in reimbursement rates and purchase patterns. Consulting costs that were usually paid under the assumption of providing indirect development assistance now face stricter deliverable requirements and shorter review time. In particular, some buyers ask consultancies to clarify the scope of their work with reference to the actual number of submission cycles or review and document preparation iterations prior to further billing of the work performed. This practice can lead to friction because the development process associated with medical devices always involves multiple unforeseen modifications and adjustments. Firms providing regulatory assistance in such cases have to offer much more narrow and technically-focused consulting engagements. For example, manufacturers of devices can hire several independent specialists working separately on design controls, risk assessment and quality review instead of one advisory team performing all these tasks. Such a business model is more costly at the initial stage but allows controlling overall budget expenditure. In addition, negotiations on consulting costs become more complicated for companies with significant reliance on senior specialists because their expertise remains very expensive. On the other hand, buyers try to reduce their expenditure on external labor while avoiding any risks related to delayed submissions or failed audits. The aforementioned situation creates an interesting dynamic for procurement teams in many ways. Firstly, the tendency leads to a gradual reduction in the involvement of consultants in early development process stages because manufacturers do not need help at this point. Secondly, buyers are likely to delegate documentation-related work to internal staff while relying on external advisors to perform only assessment and preparation work. This way, the time frame for consultancy interventions becomes significantly shorter. The above-mentioned trend has a different impact on startup device manufacturers because they cannot operate without external advisory assistance due to limited staff expertise. However, cost constraints can make these companies compress consultation period and decrease overall project scale even if technical documentation has not yet achieved stability. To address this challenge, firms providing consulting services offer combined packages where senior reviewers will be supplemented by less experienced personnel in terms of document formatting, review and tracing of technical specifications and other documentation. This solution is acceptable for most buyers as long as quality control is ensured. However, issues related to consistency and coherence may occur if team members change too frequently. Some manufacturers also evaluate benefits and risks of dealing with large consulting firms in comparison with specialist agencies. Currently, buyers prefer turnaround speed, technical knowledge and reviewer continuity over mere corporate reputation in terms of selecting consulting agencies. Long-term advisory relations do not seem as stable as several years ago. Overall, the discussed developments should not be considered as evidence of changing attitude among buyers to medical device consulting expenditure. Buyers still require outside expertise and assistance with complicated tasks of regulatory and quality preparation and remediation work. However, manufacturers try to use consultancy budgets much more efficiently.