Dr Nicola Thorn, CEO of AND Technology Research, outlines why she feels the requirements of some regulations have brought about some insurmountable barriers for innovations, and highlights areas that can be changed.
Medtech is undoubtably one the fastest growing fields within technology. Level of investment has grown 235% during the last two years alone. From personalised medicine, algorithm aided diagnostics, augmented reality application for operative planning, and self-driven healthcare the applications of technology to improve our health and ability to access the correct care are vast.
However, healthcare, naturally, is also one of the most tightly regulated markets in technology. Patient safety is always at the forefront of the regulators thinking, and with it comes an expansive selection of standards, requirements, and compliance. And this does not even mention the cross compatibility of these standards between different governing bodies, a gulf enlarged by UK leaving the EU.
The large disparity between the world of agile technology and the imposing regulations is only getting bigger, both practical and philosophically. It was well-proven that iterative and dynamic approaches to development can produce better technology. On the other hand, it is also well proven that without strict regulation systems can be under tested, under governed, dangerous and result in patient harm, sometimes to multiple patients at a time.
The latest release of EU Medical Device Regulation (MDR) reflects needs of digital health and software requirements. For instance, the MDR introduces requirements that companies test and understand the limitations of the software platforms being used to develop medical products. You can no longer run a medical software product on a cloud platform without thorough review. But these platforms are a staple, if not a necessity for developers and innovators trying to develop products often on a shoestring budget.
Even ignoring any manufacturing compliance, designing a product within the medical regulation, requires millions of pounds, and compliance with a myriad of lengthy international recognised. 60601-1, the electric basic safety assessment standard, for example holds over 400 individual clauses, each with detailed requirements for approval. And this is just 1 part of a wider 60601 standard which includes over 50 others. Of course, not all will apply to any given medical product, but an expert knowledge of the relevance and how to prove compliance is needed.
Currently, sourcing regulatory experts and contractors is the most common way to tackle the regulatory journey. In fact, 60% of regulatory affairs work is outsourced, which is expected to rise to over 65% by 2028. Of this, 39% is for medical devices equating to approximately £4 billion. The spend on compliance on medical devices is thought to be up to 10 times that for non-medical device to reach certification in the EU/UK.
This huge investment, leading to huge capital strains and increase in development cycles are killing the incredible rate of innovation being seen within the medtech industry.
A new approach is needed, one that doesn’t compromise on patient safety, but also doesn’t stifle the fast pace of innovation. One that allows technologies to meet the requirements of compliance quickly.
This must come from three areas:
1) Better guidance on the application of the standards to agile development processes
The two worlds, agile development, and waterfall regulation are often described as the opposite to each other. Innovators are often confused by how they can meet the waterfall planning, long lists of product requirements and prescribed validation whilst maintaining the core principle of agile development, which focuses away from these. However, get it right, and it can provide the perfect combination of iterative design, and manageable governance. Auditing bodies and regulatory consultants need to provide better guidance on how small dynamic teams of engineers can manage the workload effectively.
2) Utilise technology to help innovators better understand the requirements
Just like the medtech sector itself, new products can help change the landscape for innovators. Utilising decision support algorithms, natural language processing, visualisation tools and classification algorithms can help companies identify, understand, and capture their evidence of compliance. Whilst e-QMS systems exist, there is little in way to aide innovators in generating the documentation and tracking testing. These suites are often very expensive, and still require expert knowledge to operate.
3) Consolidate the sources of information
Even when you have understood what regulation applies, where do you find information on ethics approvals, submissions requirements, relevant contact within the notified bodies and authorities, medical codes? A consolidated set of information that is digestible is needed to help innovators understand the journey from creation to successful submission.
We at AND have worked with customers over 40 years to turn pioneering ideas into reality and have put all our regulation experts into Tento+. Tento+ is an online dashboard that enables innovators to analyse the product characteristics and provide an understandable and comprehensive overview of the regulatory requirements. It offers all the above, easy guidance access, machine learning algorithms trained to identify what standards are needed and consolidate all the sources of information into one place.