Medical devices and in-vitro diagnostic (IVD) devices are used to help diagnose, treat and assist patients in overcoming medical conditions, improving quality of life; some technology is even capable of increasing longevity. Consequentially, medical technologies are therefore highly regulated. Medical regulators seek evidence to demonstrate that these medical products have appropriate levels of safety, clinical performance and effectiveness to perform their claimed function. In turn, products should be appropriately designed and manufactured to ensure these aims are met.
UK medical device startups and university spin outs may not already be familiar with the specifics and intricacies of medical technology sector regulation, this blog will help to develop your understanding.
Why develop your product regulatory strategy?
The key to understanding how your product is regulated sits with the definition of what your product is intended to do and the scientific principals behind how it functions. This may sound simple, but small changes to how your product is described or used can have a significant impact on which regulations need to be followed, and the level of involvement regulators have in assessing your product before it can be legally sold. These nuances could mean the difference between 12-months and 5-years time to market. Defining these characteristics and establishing your regulatory strategy at the beginning of product idea generation and development are crucial considerations to ensure you develop the right product, with the right evidence needed for its regulatory process.
The availability of funding to support development is another key consideration when developing your regulatory strategy. The UK government is seeking to enable the life sciences industry in the UK to thrive and is facilitating this through various means, including grant funding to support the development of new technologies However, according to a CPI/Innovate UK grant funding panellist, approximately 8 out of 10 applications received do not appropriately consider their regulatory strategy. As a result, these companies can miss out on valuable sources of funding.
What to define within your regulatory strategy?
The following attributes are key to define as part of your regulatory strategy;
Product intended use – a technical description of what the product is used to achieve, with direct links to clinical use.
Product indications for use – a short technical description of the specific medical conditions, target patient types and disease states the product is intended to be used on or with.
Product intended patient population – which patient groups the product is targeted for us with.
Product intended use environments – what environments will the product be used in? For example; a hospital ward, a surgical theatre, care home, in a patients home.
Product intended users and skill level – for example; trained clinicians, trained patients, patients with no prior training.
Product mode of action – scientific principles behind how the product achieves its intended purpose.
Target markets – which market(s) to supply in, and which provide the most beneficial route to market.
Reviewing each of the attributes alongside an experienced regulatory professional can help to determine the best course of action to get your medical technology into the hands of patients and making a difference. It ensures the product is developed to meet the necessary regulatory requirements and expectations needed for sale, taking consideration of the possible nuances in changes to product , and considerations on strategic alternatives. For example, for certain types of medical device software and IVD tests, the UK is seen to have a favourable regulatory environment compared to the rest of Europe which can significantly reduce time to initial commercialisation of a product. The regulatory system in Great Britain is currently undergoing complex changes which is expected to remove some of this flexibility at a later date but may also provide opportunities.
All these topics and more will be discussed in our upcoming Insights to Impact Masterclass: medical device and in vitro diagnostic regulations, to enrich your understanding of the current regulatory environment and the key considerations for developing your medical technology.
About the authors
Timothy has more than ten years’ experience in qroles and has breath and depth of knowledge across regulatory engineering, clinical, design and development and quality assurance disciplines.
Tim has a passion for empowering innovation in medical devices and brings insight and pragmatism to projects bringing complex lifesaving and life enhancing products to market.
As head of regulatory affairs at BIVDA, Ashleigh supports member organisations with regulatory advice for IVDs and feeds into key discussions with stakeholders.
Prior to joining BIVDA, Ashleigh held various roles at MHRA working on policy, post-market requirements and compliance of medical devices and IVDs. She also sits on various expert advisory groups relating to diagnostic regulation and has been named as an In Vivo 2023 Rising Leader.
The Insights to Impact Masterclass: medical device and in vitro diagnostic regulations will be taking place on 29 June 2023. During the masterclass, Timothy and Ashleigh will cover:
– Engagement with regulatory professionals who are actively working in the Medical Device and IVD regulatory fields
– Up to date and accurate information about key regulatory topics in both the Medical Device and IVD fields
– Update on recent changes to UK regulations.
Sign up here to join the masterclass.
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