Ten tips for planning medical device development
Head of human factors
& regulatory affairs
Drawing upon a remarkable track record of achievements with SBRI, Innovate UK, and other prestigious funding bodies, we have successfully secured over £2.5 million in funding for various projects. In light of these accomplishments, Alistair is pleased to share 10 invaluable tips for crafting compelling and fruitful collaborative funding applications.
“To achieve great things, two things are needed:
A plan and not quite enough time”.
Gaining competitive advantage early on in medical device development projects
Despite appearing challenging to plan, integrating the usability and regulatory aspects of a medical technology with the commercial, clinical, and functional aspects from the beginning of a project reduces repetition. As a consequence, this often saves time downstream, giving organisations a distinct competitive advantage.
In cross-functional medical product development projects involving drug delivery, physical devices, electronics, patient data, apps and software, a solid plan with basic resources in place forms a good foundation for managing ever-growing complexity across different technical disciplines. It’s like preparing a fancy multi-course meal for a date – if you don’t prepare in advance, and you don’t check specific requirements beforehand, you could end up with your kitchen on fire, cold food, and the object of your affection in anaphylactic shock.
But if everything goes to plan – you might just get lucky (lucky enough to get another date, that is).
Our top 10 tips
1. Clarify the underlying vision of the clinical benefit – and stick to it
Have a clear, written-down vision for the product that stops people going off on tangents. The way in which this is achieved might change along the way, but the underlying vision shouldn’t. The device design specification and clinical evaluation plan should describe the clinical benefit the device brings to the intended user, and not just the technical features.
2. Capture, trim and prioritise stakeholder requirments
Stakeholders often have contradictory requirements during medical product development projects. When capturing design inputs, it’s sometimes tempting to make sure nobody’s voice is left unheard. Similarly, at other times it can be easy to just listen to the “shoutiest” voice. The real skill is in understanding which of these requirements can drive the first minimum viable product and which can be left for version 2.0. It’s better to spend some time upfront prioritising and confirming requirements before implementing the bulk of development, rather than rushing, changing requirements on-the-fly, and redoing work at a cost. Doing your research will help you know (and evidence) what is and what isn’t necessary, especially when backed up with tip #1.
3. Assemble a team of experts with the same vision
Having a core team of knowledgeable experts (clinical, design, technical and regulatory, amongst others) that share the same vision for your product and can communicate their expertise to a lay-person really goes a long way. This includes clinicians who have day-to-day experience; they can provide early “power-user’ feedback for prototypes and champion your product throughout the course of its development.
4. Define the regulatory context and applicable markets
Understand the regulatory jurisdictions, scope, and path to compliance for your product. This will usually involve compiling a qualification and classification rationale that focuses the regulatory requirements relevant to your product.
5. Map the gaps and make checklists
The devil is in the detail here. Perform a gap analysis relating to the relevant regulatory requirements (e.g. MDR/IVDR General Safety and Performance Requirements). Develop an understanding of which harmonised standards can act as a framework for demonstrating compliance to these and estimate how much (or how little) time you have to commission testing. This will ensure you’re prepared for your notified body conformity assessment. For medical device development projects, ISO 10993 biological safety testing and IEC 60601 medical electrical safety testing are just some of the examples where you may need to factor in more time than you think, not just in terms of test-house lead times, but also in terms of remediation.
6. Get notified body and competent authority feedback early
Not all medical or IVD devices are the same. If they were, nothing new or better would ever be developed. As such, regulations aren’t always able to keep up with the pace of every new permutation of device development. This is particularly the case for those involving emerging technologies or certain combinations of hardware and software. Slight changes to the embodiment of a system can result in different interpretations of the device classification. Getting early feedback from FDA/MHRA and being precise in your communication when describing your product is critical. Remember that detailed, illustrated specifications help and that this early feedback isn’t always final. Question everything with supporting rationales and objective evidence!
7. Champion the user and plan usability from the beginning
Defining the intended use and detailing the sequence of use of the product early allows you to identify use-related risks. Executed in a methodical way, this enables you to perform pre-formative studies earlier. This ultimately leads to a product that is safer, pleasurable and easier to use. Just remember to factor in enough time and cost for preparation of your usability engineering file, test subject recruitment and usability testing!
8. Prepare to convince the gatekeepers
In situations where you need to deploy your device in a clinical investigation or healthy volunteer study within an NHS trust, you need to understand the requirements of gatekeepers such as those in infection control, data security, and medical physics. Get to know their concerns and the regulations they operate under. Get their feedback early on – you’ll encounter less resistance at a critical time if you do.
9. Have options ready for when things go wrong
Outcomes from testing may result in your product (or an aspect of it) not performing as intended. It make even fail outright. Having alternative design options, materials, and manufacturing methods (along with their regulatory and commercial implications) examined early in the medical device development phase can allow you to recover more quickly from setbacks such as these.
10. Be agile in implementing and revising the plan and know when to cut your losses
Despite all of the above, don’t be overly rigid in planning. Be open to opportunities that might significantly benefit the development. Conversely, you may also need to consider dropping a project completely if there isn’t a real route to a return on your investment and a pathway to adoption. It’s far better to realise this earlier rather than later!
This list isn’t exhaustive. Want to learn more about how Lucid’s experience can help accelerate your med-tech development? Get in touch at firstname.lastname@example.org
Jan began his career with Lucid in 2007 as a product designer. As Head of Human Factors and Regulatory Affairs, he works with Lucid’s ISO13485 accredited team of designers, engineers and clinical experts to develop connected medical devices for Lucid and their clients.
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