When we work with Software as a Medical Device (SaMD) developers, we are inevitably asked two questions:
- How long will regulatory approval take?
- How much will it cost?
Ideally of course, both numbers would be low - it wouldn’t take much time and it wouldn’t divert budget away from other activities.
However, the reality is that bringing a SaMD to market is an undertaking that requires both time and investment. It won’t happen for free and it won’t happen overnight – and nor should it.
It's a process, not an event.
However, both cost and timelines can be markedly reduced through efficiency. In this context, efficiency means removing preventable barriers to progress.
In order to pursue an efficient route, we need to map out the barriers to progress that would exist even if the route to market was perfectly optimised. What are the non-negotiable phases that have to be navigated regardless of speed and skill of execution?
The route to market
To bring a SaMD to market you will need at least:
- A product that's aligned with customer need and ready for market
- Product testing that demonstrates it works as intended and solves the problem it was intended to solve
- An implemented QMS that ensures consistent quality of delivery across the organisation
- A regulatory submission that aligns with requirements
- To pass a Notified Body conformity evaluation
- To respond to any questions from the Notified Body in a timely and effective manner
- A fully granted Certificate of Conformity
While all phases must be navigated by all manufacturers in the SaMD space, the rate of progression through them varies markedly. In many cases, developers make specific choices that, while made with the best intent, end up slowing down progression rather than speeding it up.
To design the most efficient pathway to market, it is instructive to consider the opposite. If we wanted to construct the most inefficient pathway possible – and massively delay market entry – what actions would we take?
Approval pathway from hell – constructing the nightmare
To move through approval as slowly and inefficiently as possible, we could:
- Jump into the approval process without a plan and with an immature product that is likely to change multiple times before market entry.
- Delay product testing as long as possible, even though we know that testing will take time and consume budget.
- Conduct the wrong tests through lack of preparation and poor advice, ensuring that you need to loop back and run additional tests even after the product should already be on the market.
- Delay implementing a QMS as long as possible. When you do implement it, ensure that it's rushed and poorly implemented, adopting a 'box tick only' approach. This ensures that the Notified Body raises as many non-conformities as possible.
- Develop a technical file at the last minute that doesn't align with requirements and fails to consider what the Notified Body is expecting (because you haven't asked them). This also helps to raise as many non-conformities as possible.
- Realise late on that product development should have been done in tandem with the early stages of developing the regulatory submission. Attempt – unsuccessfully - to reverse engineer this into the submission just before Notified Body review.
- Conduct technical file development, Notified Body review and Notified Body question resolution in series with each step running one after the other, rather than engaging in structured dialogue early and running multiple stages in parallel.
- Get stuck in endless cycles of Notified Body review because none of the previous stages have been optimised for efficiency.
Other ways to be even less efficient would include:
- Not considering whether the chosen route to conformity is in fact the best way to meet your commercial goals.
- Viewing the whole process simply as a needless burden.
While the above is deliberately overstated, here’s the truth: many SaMD developers are guilty of at least some of these mistakes. In some cases, an honest review might reveal that it’s pretty much a full house.
In many ways, scrambling to go as quickly as possible but without the right approach simply means the process is turbulent and disjointed. Having to retrace steps and repeat earlier phases is a fast-track to a slowdown.
So – to the meat of the issue. If we’ve worked out how to go as slowly as possible… how can we go fast?
Accelerating approval – a recipe
Let’s invert the above ‘nightmare’ process and build the most efficient possible route to approval.
1. Construct a plan
"We can't afford to rush – we haven't got the time."
Time invested in developing an effective approval plan will pay dividends multiple times over.
A well-constructed plan will:
- Properly sequence events over time, eliminating backtracking and duplication
- Set realistic timelines and budgets
- Identify potential choke points and integrate solutions
- Link directly with commercial goals and the identified market opportunity
- Map out testing requirements, providers, timelines and budgets well ahead of time
- Divide regulatory approval runway into early, middle and late phases that flow together naturally
2. Implement a QMS early
Clause 7 of ISO 13485:2016 relates to Product Realisation, meaning that product development should be conducted under a quality framework. By implementing a QMS as early as possible, retrospective ‘patching’ can be avoided and the pathway to approval becomes laminar.
A QMS will be needed anyway – starting early promotes smooth progress while enabling the benefits of working under a QMS to be fully realised.
3. Do the right testing at the right time
A proper GSPR analysis and detailed SOTA literature review are the two essential ingredients to successful product testing (verification & validation). They aren’t optional and they need to be done to the right standard.
Skipping this step or leaving them too late are cardinal sins that can kill efficiency stone dead.
4. Build your technical file correctly
Team-NB data shows that only 6% of MDR technical files are fully complete upon submission to the Notified Body. Inevitably, this is an immediate source of delay.
Take high-quality advice or commission an expert consultancy to ensure your technical file is well written, complete and in alignment with requirements well before Notified Body submission.
Head off potential delays before they have any chance to materialise.
5. Work in parallel with your Notified Body
Choose the right Notified Body and begin structured dialogue at the right time. An optimised approach will see seamless flow from technical file production through dialogue and submission onto review.
Ideally, amendments and further review will be conducted in parallel rather than series, removing sequential steps and shrinking timelines.
Next steps
Bringing a SaMD to market is a challenging journey, and accelerating the standard pathway needs careful planning and a considered approach.
On a limited basis, Mantra Systems are running FREE acceleration feasibility reviews for ambitious SaMD teams looking to commercialise in the shortest time possible. We’ll construct a tailored MDR approval plan on your behalf, identifying potential roadblocks and solutions for overcoming them long before they become a problem.
Spaces are limited – for more information or to register your interest, contact our team today.
