Under New EU Medical Device Regulations, Staying Competitive Requires a Proactive Response
Safety issues with certain breast and metal-on-metal hip and implants spurred the European Union on a journey, now more than seven years long, to revise current directives regulating medical devices and diagnostics.
The new regulations, which were published in draft form this June, introduce requirements that profoundly affect the business models of all medical device and diagnostics companies.
Among the most significant reforms are stricter rules for generating clinical evidence and mandates that many more devices be submitted for Notified Body approval. These requirements will force manufacturers to factor much more rigorous clinical trials into their development timelines and budgets. Change will be particularly extensive for manufacturers of in vitro diagnostics, such as oncology genetic tests; the share of these diagnostics that will require submission to a Notified Body will jump from currently about 20% to soon 80%. Furthermore, new requirements to conduct post-market surveillance assessments, apply unique device identifier codes to all devices, and submit quality management systems for review will also add to development timelines.
All devices currently sold in Europe must be recertified under the new regulations. Although manufacturers have several years to comply with the new requirements, achieving recertification may require generating new clinical evidence and appointing a Notified Body for an audit — all of which can take considerable time. Some efficiency can be achieved using clinical data from studies in the United States to accelerate Notified Body approval, provided those data meet requirements of the new regulations.
However, to stay financially sound and competitive, manufacturers must take more proactive action. We recommend a three-pillared approach to adapting product development strategies to the new requirements.
Firstly, adaptive trial designs should be employed to acquire higher quality clinical evidence more efficiently. Adaptive designs use pre-planned adaptations to a trial to correct initial assumptions that may prove to be inaccurate. This can, for example, mitigate the risk that enrolment is too large, which would unnecessarily lengthen a trial’s duration, or too small, which would lead to an unnecessary failure due to insufficient power. Other designs can preserve millions of dollars of capital by terminating a trial early if results exceed or fail efficacy thresholds.
Secondly, as reimbursement increasingly depends on demonstrating value both in terms of patient benefit and in comparison to competitors, manufacturers must begin to evaluate health economics in parallel with clinical studies. Capturing relevant economic endpoints early in development is vital to maximising a product’s potential and accelerating its time to market.
Thirdly, clinical investigators are increasingly burdened with more complicated procedures and frequent protocol amendments. These issues can delay recruitment and lead to protocol increase non-compliance, both of which slow time to market. Manufacturers can improve operational efficiency and protect trials from quality risks and delays by adopting a risk-based approach to monitoring and a methodology, such as human factors classification, to assess the true root causes of complex errors.
Adaptive design, health economics, and risk-based monitoring provide a platform of opportunity for manufacturers to respond to the increased demands of entering the European market. Proactive and strategic responses will differentiate the companies achieving growth under the new regulations.
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