MediPathTM Innovation Roadmap – Product Evaluation
In the previous stages of the MediPath™ Innovation Roadmap we considered Innovation Strategy (Stage 1), Opportunity Analysis (Stage 2), which was aimed at how to understand the market and competitors, how to identify unmet needs and translate these into product design and to develop and validate concepts.
In Stage 3 (Product Development-Early Stage) we discussed the process of developing the value proposition to align with reimbursement, developing a regulatory strategy and ensuring the product development process is aligned with the Quality Management System (QMS) (ISO 13485) and application of risk management (ISO 14971). Stage 3 also included articulating the indications and claims that would be used on the IFU and any marketing material and the technical process of prototyping with consideration to key parameters such a sterilisation, stability and packaging, with a view to how the manufacturing can be scaled up without compromising performance or safety.
Preclinical characterisation and the use of standards
In stage 4 (Product Evaluation) the emphasis is on preclinical testing of the performance and safety of the device. This stage is critical for product validation and verification and the outputs will ultimately be important parts of the technical documentation required for regulatory approval. It typically involves characterization of materials, the design and the testing of models in which prototypes can be tested to predict performance and safety. These might be bespoke assays or methodologies, but the manufacturer at this stage should check whether there are any formal or harmonized standards or common specifications that the device needs to show conformity. These might be electrical (e.g. the IEC 60601 series), with respect to sterilisation (the specific standard will be dependent on the sterilisation method), standards associated with medical device software (IEC/TR 80001 series) and importantly standards associated with the biological evaluation of medical devices (ISO 10993 series).
Such standards might not be specifically mentioned in national regulatory guidance documents, but they can be important in demonstrating the performance and safety of the device. During the design of testing methodologies, it is also prudent to check the requirements of individual regulatory jurisdictions. For example, for the EU markets the Medical Device Regulations (EU 2017/ 745), the In Vitro Diagnostic Regulations (EU 2017/ 746), and the associated General Safety and Performance Requirements (GSPRs) are a good standing point. In addition, the related Medical Device Coordination Group (MDCG) documents are all important in understanding the regulatory process but also the type of evidence needed during the product evaluation phase. For the US market it is prudent to check the requirements specific to the type of device as defined in Title 21 of the code of Federal Regulation (FDA- US market). Specific test methods are often required as special controls for moderate to high-risk medical devices.
Product evaluation testing typically involves in vitro benchtop testing, preclinical animal models and often the inclusion of a scientific rationale to support the use of previously collected data can be useful in reducing the technical burden. In addition, providing a rationale for the exemption of performing such types of tests by way of literature reviews can also be used in parts of the technical documentation such as biological evaluation reports. For medical device software, such as digital therapeutics, or those that can predict clinical risk that are often difficult to test preclinically, it may be useful to use data obtained from sources such as the UK Biobank. This does not necessarily replace the need for gathering clinical data, for the device under evaluation, but can help in articulating the scientific principles of action and reduce risk by providing some confidence that the device is likely to work.
It is up to the manufacturer to identify the test methodologies that are needed, and effort should be made to ensure that the testing is appropriate. Clearly a phased approach can be used with preliminary screening to increase knowledge and reduce risk with ‘look and see’ experiments used to assess performance, safety and stability.
Using early testing for product improvement and defining the design freeze
Often the product evaluation stage identifies issues, hurdles or problems that R&D activities are required to resolve. This might mean changes to the formulation and design to improve performance, safety or stability. Furthermore, it is prudent to conduct formative human factor analysis to ensure the user will be able to use the device and to use feedback for product improvement. This can also assess the appropriateness of draft labelling that will be used on the instructions for use (IFU).
The product evaluation phase is not linear and often involves cyclical reiterations that are all designed to optimise the performance and safety of the device. The output of the product evaluation phase is design freeze and design transfer, the provision of data to support verification and validation and critically to allow progression towards clinical evaluation. The product evaluation stage also acts as an additional stage gate for Go- No Go decisions before the costs escalate with clinical investigations and the regulatory burden providing huge financial barriers with respect to gaining market access.
Intellectual property
It should also be highlighted that the product evaluation stage is the one most likely to identify performance benefits and to show that patentable design elements can improve product performance and /or safety. Such testing data that can support patent applications and can also be used in future publications and marketing material to support sales. It is during this period that investment in intellectual property by way of patent filings should be considered, although the precise timing of patent applications is dependent on the individual circumstances of the application, the competitive environment and the availability of finance to maintain the patent. The inability of many organisations to pay patent maintenance fees is often a reason why intellectual property rights are lost and this can be a particular issue if the technology is protected by multiple patents. Hence discretion and informed decision making should be used in decided what to patent and when to patent.
Product evaluation is not simply an “academic exercise” it is a key part of the product development journey and getting it right the first time will ultimately reduce the time and cost to market.
The clinical development phase and more detail regarding the documentation required for regulatory and quality compliance will be provided in future articles of the MediPath™ Innovation pathway.
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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