MedTech Regulations: The Opportunities and The Challenges
I recently attended the London MedTech Integrates event, where emerging and current trends across MedTech were being actively discussed. In this article, I delve into the key themes and findings the talk ‘Regulation, Regulation, Regulation’ covered. The talk itself was facilitated by Stephanie Caird, Mills & Reeve, and included a panel of Steve Lee and Phil Brown from ABHI, Sandeep Konduru, CEO of Remcare, Samantha Westgate, CEO of Perfectus Biomed Group, and Nick Hex, YHEC.
Despite not being a regulatory professional, as a specialist regulatory recruiter, I actively keep myself informed on current challenges, trends, and the future potential of the regulatory landscape in Medtech. As an industry-specific discussion, the talk I attended provided a valuable insight into the most current and influential trends surrounding regulations in the MedTech industry.
Keep reading to find out more about:
- The challenges surrounding regulatory approval
- Opportunities for competitive advantage in the UK
- Key considerations for regulatory approval
The challenges surrounding regulatory approval
The challenges companies face when trying to gain regulatory approval was the first topic approached by the panel.
Sandeep Konduru started off by discussing his own company’s experience; the Remcare product is a patient-based smartphone app that allows remote collection of clinical data and patient communication. Different geographical markets classify this product differently. In some markets this could be classified as a medical device, and in others it may not be. This is something that can affect whether a company decides to launch their product in a certain market and illustrates the importance of a broad awareness of global regulatory requirements.
This led on to a discussion about cost of gaining regulatory approval. The regulatory approval process can cost a company a lot of time and money, and implementation is complex.
While the MHRA can provide regulatory advice, there are still gaps in the access to advice, especially for smaller companies. Over the last 15-20 years, regulatory requirements have undergone an immense transformation, and the cost and resources needed to gain these approvals continue to escalate. The panel touched on methods to manage rising costs by reframing regulatory compliance as a business process and holistically planning regulatory pathways from the inception of a product’s development.
Regulatory pathways are multifaceted and fundamentally complex, with factors including different classifications and market requirements, meaning companies need to thoroughly consider their direction. Often companies choose to target the hardest markets first as these require a lot more data and evidence, which can then be used for other markets. This process can help avoid duplication and improve cost efficiency
An additional challenge that arose from this discussion was, ‘How can a company see regulatory approval as a value add instead of a cost?’
In response, the panel developed their point on seeing regulatory approval as an essential business process to product development. If a company starts thinking about regulatory approval right from the beginning, they can factor in it little by little, and the overall cost can be minimised.
The panel also informed the audience that the MHRA have released a consultation on their fees to seek the views of stakeholders on proposals for changes to the Medicines and Healthcare products.
Regulatory Agency’s statutory fees. This could mean a decrease in their fees, enabling their advice to be more accessible and affordable.
Opportunities for competitive advantage in the UK
Making the UK a more attractive market, especially after Brexit, was something that the entire panel agreed on as a core priority across MedTech. The UK is considered a prime location for Clinical Evaluation Reports by the US, providing an example of a good opportunity to maximise. It was suggested that MedTech companies across the UK should align their focus on creating easy to tap in innovation hubs for clinical evaluation.
The recent MDR transition has been a big focus for many companies recently, with a lot of time, money and resource spent on becoming compliant.
But has this acted as a barrier to innovation?
The panel suggested that there is an opportunity for the UK to establish a framework for innovation, which, in turn, could lead to R&D professionals feeling more supported. Additionally, investing in and developing software and algorithms to make key data more accessible could act as an additional route to minimising the negative impact of regulatory approvals on innovation.
Making the MDSAP acceptable in the UK was another route highlighted in the talk to improve the competitivity of UK-based MedTech organisations. The MDSAP currently benefits many companies as it allows the conduct of a single regulatory audit of a quality management system that satisfies the requirements of multiple regulatory markets. The MDSAP is currently employed across the US, Australia, Brazil and Canada. Implementing the MDSAP in the UK could pave the way forward for a more harmonised global pathway to regulatory approval. The panel implied that there are currently aims to facilitate regulatory approval across multiple markets, but a definite route is yet to be established.
Key considerations for regulatory approval
Following on from the above, the panel then collaboratively outlined key considerations for medical device companies surrounding regulatory approval and requirements - these were as follows:
- Plan out a regulatory pathway. Consider the following: What evidence is needed? What does the evidence mean? How do you intend to get the evidence?
- Consider the practical aspects. What funding do you need? How do you intend to get the funding? What is the time scale for this project?
- Decide on your markets. Where first? What data and evidence does each market require?
- Think back to the product. Understand what the product is and why it is helpful. Relate to patient outcomes and improving care.
- Finally, consider your data collection – it’s essential that data collection is not over-complicated.
With the discussion lasting just 50 minutes, an impressive number of challenges, opportunities, and future considerations were covered. It remains evident that achieving regulatory approval for the MedTech industry has reached a crucial pinnacle where costs and requirements face significant tension. As requirements become increasingly more stringent, organisations are having to invest more resources to achieve approval.
As I reflect back on the discussion, my main takeaway is that companies need to proactively consider regulatory costs and factor them into projects and overarching plans in the same way as other business processes. In today’s ever-evolving market, organisations must remain informed and flexible to ensure that regulatory approval works to reinforce, rather than hinder, innovation and business continuity.
Considering the regulatory landscape from a recruiter’s perspective, while more consistent regulatory requirements would positively impact organisations, would this trend reduce the number of regulatory professionals required? Will medical device manufacturers no longer require internal regulatory departments and instead turn to consultancies and contractors to achieve approval in all markets?
While a holistically streamlined future remains a distant hope, current trends indicate upcoming shifts across the regulatory market that could see more companies achieving competitivity by reframing their regulatory processes.
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