Breaking The Regulatory Burden

At first glance, the development of breakthrough innovations in the medical devices sector can seem enticing for a tech-savvy startup. A dynamic market place, the sector is set to grow at a CAGR of 6.1% from 2021 and reach $603.5 billion in 2023.

Often commanding high unit prices, medical devices enjoy an economically stable market (and bouncing back as we look to a world learning lessons from COVID-19). Add to that the prize of patents, Intellectual Property, and the potential to sell to a larger business. What’s not to like?

But dive down a little deeper. Look beyond the bare mechanics of production and assembly and you uncover a virtual hornet’s nest of regulation and the need to gather evidence at every stage from concept to development. Of course, given the importance of medical devices, no sensible person would reject the requirement for stringent regulatory and compliance protocols.

Despite the hornet’s nest, the time needed to establish significant market share over the years has become shorter and shorter. This means that when losing too much time getting your product to market, you will discover your competitor has beat you to it! So meeting your ever shortening window of opportunity becomes a matter of life and death.

Often startups will be rightly encouraged when they develop a medtech breakthrough – but as they’re new, they lack knowledge about the onerous requirements that comes with that. Preparation is key. At the start of the process it makes sense to compile and deliver a complete dossier of certification materials before hitting “the market”. The market itself can even be this “hornet’s nest”.

As many countries and regions have their own (non-normalized) regulatory requirements, meaning determining your “market” needs to be part of preparations and as such might be good to be clear in an early stage!

Many companies that are new to the medical devices scene all too often focus on their invention. With limited availability of seed funding, they will see their need to focus on spending all of their money and resources on perfecting the product.

However, those with no regulatory expertise will see a quick remedy through delegating to external consultants who are specialists in this niche and often complex area. All too often, outsourcing of this important function only begins at the end of the development cycle, when people discover they still have a long way to go before completing the dossier.

Any delays have potentially serious ramifications

So, what’s the issue? After all the effort and resources needed to get through the testing, proving, and development phases, facing a wall of regulatory requirements and retrospective records needed to gain certification can seriously cause obstacles. At worst it can halt the introduction of approved products to market. Where intense competition and market demands mean every day counts, any delays have potentially serious ramifications – not just on the success of a product but the health of the business.

To avoid these problems, we advise companies to start building their dossier from day one. This means it will develop along with your product itself, and reach completion in parallel. That’s where a product like Compass adds value. You build your testing, assurance and regulatory data records, alongside developing your product. With Compass you are able to look at content, requirements, risk management, testing protocols. All need to be integrated as required by notified bodies. This provides transparency and traceability as well as proof of compliance, showing everything you did — and so it can be demonstrated it is used as intended.

In our view, the information you deliver to notified bodies is exactly the same information you need to determine where you are in your development cycle. It will provide a clear understanding of requirements, even derive more specific user needs to enrich design inputs. Of course it is important to test all of these as is the case with outputs and design documents, all helping to translate it into a design to get the right functionality. Finally when all is written up you need to verify it all works as designed and then in the later phase of development, when you have engineered the product, you need to validate it against the user needs.

Benefits of evidence go beyond compliance but include complete oversight

With Compass, all this can be accomplished at every stage from the start, feeding the DHF to be submitted to notified bodies. Check out how Compass helps customers navigate the regulatory process in more detail here. A product like Compass will save you time, effort, and budget in the long term.

People see the requirement for records as a burden that is imposed that is of course amplified at the end when they realise how much work they needed to have done. But the benefits of evidence go beyond compliance but include complete oversight — for yourself, your investors and other stakeholders.

Often investors want to get to know how successful the product might be. If you are able to provide evidence that you’re ready this will help your cause. After all, if you are doing this for the notified bodies, why not use compelling information to provide proof to the investor, as well as your own peace of mind! Likewise your own project managers will keep on track and in this way avoid any nasty surprises such as delayed production or need for re-design.

An essential component is evidencing the product’s progress, viability, and potential success as well. So, after all compliance and records, is not such a bitter pill to swallow, if you have set up protocols from day one.

You have nothing to lose and everything to gain through collecting evidence as you go.