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Evolving the use case
Evolving the use case of a medical device from Gen 1 to Gen 2 can expand access to the markets the product is trying to disrupt. Across the many challenges that arise in achieving this, two that are most likely to be prominent involve bridging the regulatory gap and adapting the device usability.
One scenario for a Gen 1 to Gen 2 iteration could be the transition from a research use only (RUO) device to a clinical device, making it the first version to face the regulatory rigour of the FDA, EMA or other diagnostic regulators. Alternatively, the user group of a Gen 1 device may be limited to healthcare professionals (HCPs) working in a point-of-care setting, while the Gen 2 device may be intended for use in the home setting by laypersons. This new group will bring new usability challenges with them that need to be addressed in the updated device design.
Understanding the impact of use case changes is the first step to managing them successfully. Consulting with regulatory experts as part of the roadmap definition will help to identify the key focus areas to streamline the Gen 2 transition. This could include guidance around how to ensure that large volumes of test data on core Gen 1 functions, such as assay performance, remain applicable to the Gen 2 submission pack.
Similarly, the difference in user needs between a researcher and clinician, or an HCP and layperson, can have far-reaching implications for the design of the medical device. Capturing how these user requirements will vary from the outset is a powerful mitigation tool. Developing an early understanding of the potential implications will support appropriate design decisions during development, ensuring the device is designed for the correct end-user in each generation.
Additional features and indications
Increasing the functionality of a Gen 2 device is an effective way of leveraging and expanding the market share of its Gen 1 predecessor. The new additions may have always featured in the ultimate product vision, but may not have been critical for the MVP or equally they may be derived from new market feedback.
The extent of the device changes can vary significantly, from the addition of new assays, to increased levels of automation or throughput, to architectural changes that transform the capability of the device. Quite predictably, managing and implementing the technical complexity that a new feature set will introduce will be one of the most challenging aspects of the device’s development.
In addition to finding the right technical expertise, the system architecture (a conceptual model of the device’s components and how they relate) can also be used as a tool to understand the difference between Gen 1 and Gen 2 and to identify the core, unchanging technology that will remain in the design. The benefit here is that resource can then be freed up to focus on the parts that will
Finally, the requirements of a successful Gen 2 development will likely be well-grounded in the Gen 1 foundations. However, revisiting and challenging the requirements is still a highly valuable exercise to undertake. The real-world data and lessons from Gen 1 can be used to refine, prioritise (and possibly remove) functional requirements, which presents a fantastic opportunity to optimise the device in an evidence-based manner.
Scaling up and future proofing
Scaling up the manufacture of a Gen 2 device is an inherent and commercially critical part of its roadmap. Scale-up might include increases to manufacturing volumes, multinational distribution and more diverse supply chains, all of which will present benefits and challenges that are not always seen during the small-batch phase.
The advantages of industrialisation are numerous and can include implementing the latest, future-proofing technologies, securing supply chains and making significant per-device/component cost reductions. The introduction of additional process variation is inevitable and must be