MediPath Innovation Roadmap™
Stage 5 | Product Development [Clinical]
The initial stages of the MediPath Innovation Roadmap™ establish a robust foundation, covering Innovation Strategy (Stage 1), Opportunity Analysis (Stage 2), Product Development [Early Stage] (Stage 3), and Product Evaluation (Stage 4). The primary goal of these early stages is to conduct thorough due diligence, refining and enriching the concept into a product likely to be differentiated from competitors, offering significant value and benefits. This meticulous approach significantly increases the probability of successful market adoption.
For these de-risked concepts, the pivotal next phase involves the design and implementation of clinical investigations. These investigations are vital for generating both the regulatory and health economic evidence required to achieve commercial objectives. Figure 1 provides a summary of the multifaceted considerations for planning clinical studies.
[Abbreviations: REC – Research Ethics Committee, MHRA – Medicine Healthcare products and Regulatory Agency, MDR – Medical device regulations, GCP – Good Clinical Practice, CIR – Clinical investigation Report, CIP – Clinical investigation plan, PMS – Post market surveillance, CRF – Case report forms, QMS – Quality management system).
Understanding the required evidence involves a dual perspective. From a health economic standpoint, defining the value proposition for the patient, healthcare professional, and payer is critical. This evidence can be effectively collected during both early- and late-stage clinical investigations. Simultaneously, from a regulatory perspective, the evidence must clearly support the intended purpose, product benefits, and claims, demonstrating an acceptable benefit-risk ratio compared to the current state of the art. While the Clinical Evaluation Report (CER) will be discussed in more detail during Stage 6 (Regulatory & Quality Compliance), it is a logical and beneficial step during clinical investigation planning to produce a draft clinical evaluation plan and a developmental CER. This proactive approach helps to define the optimal design of the clinical investigation, including the trial type, necessary patient numbers, and the nature of primary and secondary clinical endpoints.
To execute the trial, manufacturers must carefully consider the most appropriate clinical centres and determine the optimal study design, for example, multi-site, single-arm, randomised, blinding, or crossover studies. This design process also encompasses defining the time of clinical follow-up, the number of review points, and the total time to the trial endpoint, which may be related to the device’s lifetime. Following a thorough appraisal of the evidence required to support product benefits, claims, safety and the data needed for health economic drivers, the manufacturer should identify a suitable Clinical Research Organisation (CRO) or NHS trust to manage the trial and assist with aspects of the documentation.
The clinical investigation process is comprehensive, applying not only to new products under development but also to existing products intended for use outside their current labelling or for extended claims. All such products necessitate navigating the entire application process. Figure 2 provides a detailed overview of the UK clinical trial application process.
(* Trial timelines are approximate and will vary dependant on the device and its classification).
IRAS – Integrated Research Application System, REC – Research Ethics Committee, HRA – Health Research Authority, HCRW – Health and Care Research Wales
The clinical investigation dossier submitted to the MHRA must be comprehensive. It includes a range of essential documentation such as a covering letter, the clinical investigation plan, clinical investigators’ brochure, participant information sheet and consent form, and other important regulatory documentation.
Understanding the MHRA application costs is also crucial, as these vary depending on device classification. As of the time of writing, Class I – Class IIb devices incur a fee of £15,309 and class IIb implantable and class III £32, 016. In addition, there are substantial resubmission fees. Typically, there is a 60-day assessment period to receive a response to your application, with a reduced fee applied for resubmissions if the initial application was not approved.
Historically, research and ethics approvals were managed separately. However, in a move to coordinate and streamline the application process, the MHRA and Research Ethics Committees (RECs) are conducting a pilot, with all combined applications submitted via the IRAS website.
Beyond the application itself, it is crucial to ensure that adequate insurance is in place prior to the commencement of the clinical trial. This protects both participants and the manufacturer regarding legal liability and compensation.
Finally, establishing a publication strategy before the completion of clinical trials is key. Publishing findings in high-quality, peer-reviewed scientific journals provides significant credibility to the evidence. This stronger data can then be used effectively for clinical evaluation and will also help support market adoption.
Tailor your roadmap to your device – free consultation
The Innovation, Commercialisation and Regulatory Team are offering a new service in which we walk through the MediPath™ tool, starting from an introductory half-day session to more detailed evaluations and support depending on your needs.
If you would like to discuss any of these stages or to understand how the roadmap can de-risk your innovation and accelerate the speed to market, we are offering a free 30-minute consultation. Contact us on [email protected]
Patrick Trotter PhD MBA (TechMgmt), Stefanie Lowry BSc, MSc
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