Having successfully designed and delivered over 50 medical devices, we understand that SaMD is only a small component of a regulated solution. This means mistakes made during the development phases can be difficult to rectify and may slow down the ability to scale effectively, especially when the product has gained market momentum. It’s therefore crucial to plan thoroughly as often there’s only one opportunity to succeed.
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What is SaMD?
SaMD (Software as a Medical Device) is software capable of running on general computing platforms devices – i.e. not on specialist medical hardware. It may be embedded in or connected to some kind of device, but it is the software that performs the medical function. Used in health and, sometimes, social care settings, it is subject to the same controls as any other medical device.
The development of SaMD tends to be ahead of much existing regulation, which is designed mainly for more conventional medical devices. In the coming years, there will be some adjustments to ensure that regulation keeps pace with the need to foster innovation whilst improving care and managing the risks to patients.
In our experience, there are five fundamental principles to follow when embarking on designing and developing SaMD.
1. Your solution must solve an entire problem
It is tempting to take a technology-led approach to developing SaMD. This often results in narrow solutions that fail to address the user’s complete problem, thereby delivering limited value.
We recommend a user-centred approach, using technology as an enabler to solve the user’s problem completely, rather than relying on technology for the core value proposition.
It’s especially crucial to consider other, potential unintended consequences. Solving one facet of the problem may just create another, unintended problem. An example of this would be the creation of false positives in the early detection of cancers that increase unnecessary demand for biopsies or CT scans.
2. Can you measure the real impact?
Developing a functional solution in healthcare, particularly in SaMD, is not enough. In order to secure approval from both a CMO and CFO, it is crucial to also demonstrate its effectiveness. This can be a demanding process that may require extensive and costly studies or clinical trials. It is entirely possible to create an effective product, but be unable to prove its benefits.
For example, a trial to establish whether a solution decreases maternal deaths by 25% would need to involve every pregnancy in England over a two-year period, which is clearly not feasible.
By thoroughly evaluating how you need to demonstrate the impact of your solution before beginning development, you can ensure that you are creating something genuinely game-changing that justifies the investment.
3. Do you understand how your SaMD fits within the users’ and data journeys?
Whilst your new solution may perform extremely well in testing, it’s important to consider whether it can provide the expected benefits in real-world scenarios? One of the key reasons why solutions fail in their transition from testing to implementation is a lack of understanding of the data and user journeys.
Take for example a wearable device that uses gait analysis to detect Parkinson’s disease at an early stage. In testing the device gets brilliant results as it detects the disease in its early stages.
However, it may not provide the expected benefit of early diagnosis. Why not? Because users need to recognise that they might have something wrong before they think of using the solution, which negates a lot of the benefit.
Similarly, data can play a crucial role in the success of your solution. If it’s not available in the right or at the right time, the expected benefits may not be realised. Before committing to your solution, it’s important to assess how it fits into the existing or future user and data journeys.
4. Are you confident your SaMD solution can scale?
Having a valuable solution that is well-received by healthcare providers and their teams is a great start, but it's not enough to guarantee success. To truly make an impact, your SaMD must be able to reach a substantial scale.
It's common for healthcare solutions to be developed and tested in one setting, but this doesn’t mean they can be implemented in other locations or by other providers. By considering scalability from the very beginning, you'll be able to ensure that your SaMD not only solves a specific problem but also has the potential for commercial viability.
Plan for your SaMD being used not just in one location, but across the entire healthcare system from the start.
5. Accelerate time to value where you can
Bringing SaMD solutions to market can be a lengthy process due to the need for evidence generation and meeting regulatory requirements. To maximize revenue, consider exploring your options where possible.
For instance, if you are developing a tool that assesses individual's risk of complications, you could first deploy it at the population level to forecast demand and capacity.
By addressing an adjacent, non-regulated issue, you can start generating revenue while accumulating evidence of effectiveness, and effectively be paid to de-risk your product.
Game-changing SaMD solutions
The development of SaMD presents a unique set of challenges. It's therefore critical to adopt the right approach to develop SaMD, which delivers tangible benefits and high impact at scale, while keeping up with the fast-changing healthcare landscape.
The key to success lies in understanding the importance of user adoption, data integration, and impact measurement. Anticipating unintended consequences and ensuring scalability is also crucial for long-term success.
By following these principles and keeping the end-user in mind, you can create SaMD solutions that are genuinely game-changing and have a lasting impact on improving patient outcomes and streamlining healthcare processes.
To find out how we can help you scope and assess your SaMD initiatives for success, book a discovery call with the Zühlke team today.
