What are the top medical device regulation priorities for 2023?

Reading time 11 mins

Life Sciences Council joint statement on the future UK HealthTech regulatory system

The joint statement released by the Life Sciences Council, Medicines and Healthcare products Regulatory Agency (MHRA), Office for Life Sciences, Department of Health and Social Care, and Will Quince (Minister for Health and Secondary Care) promises a positive start to what we can expect ^[1]:

1. UK Medical Device Regulation (UK MDR) reforms are a ‘golden opportunity to drive innovation and growth
2. Patient care must remain at the centre of all reforms
3. Proposals will be published in three priority areas:
   a. International recognition
   b. Routes for innovation
   c. System capacity
4. Initial proposals will be published in February 2023
5. Proposals will define how policy concepts (e.g. recognising approvals from other trusted regulatory jurisdictions, i.e. the FDA) will work in practice
6. Explore how the regulatory framework can support sustainability, e.g. NHS Net Zero targets
7. The MHRA’s roadmap of activities, milestones and timelines to be regularly updated to give stakeholders at all levels (i.e. regulators, medical device developers, industry manufacturers and innovators) time to prepare

The Department for International Trade (DIT) will play a key role in realising the medical device regulation priorities for 2023 – particularly when it comes to attracting investment. “As seen during the pandemic, high-quality investment helped drive innovation, which in turn cuts the costs of treatment and medicines, improves healthcare outcomes, and delivers greater resilience” ^[2].

The UK received international acclaim and recognition for handling the pandemic – placing a particular emphasis on how the Life Sciences can solve many present and future healthcare challenges. Key focus areas will include:

• Encouraging R&D and Manufacturing
• Maintaining, rebuilding, and growing target markets
• Supporting up-scaling and levelling up initiatives, e.g. preventing bottlenecks
• Leveraging networks to boost demand

Furthermore, adopting digital technologies creates transformational opportunities and experiences for consumers, healthcare facilities, and providers. The uptake of telemedicine has already proven its advantages for healthcare – particularly when preventing ill health (predicting risk, helping patients manage chronic illness and encouraging well-being).

Top digital healthcare technologies to embrace in 2023

With all sectors, from private companies to government regulators, placing such a strong focus on innovation, it’s clear that organisations will have to embrace a ‘digitial first’ mindset ^[3] to stay competitive. We recently looked at interoperability and the importance that agencies such as the NHS and MHRA have placed on it for the seamless integration of information across the Health IT system. Meaning that even companies who prefer to stick to legacy methods (i.e. outdated systems) will have little choice but to:

Use the full value of the cloud: Storing and accessing data over the internet has become commonplace for most businesses, but few have considered other factors such as:

• Automation
• Scalability
• Data Analytics
• Architecture modernisation

Using real-world data (RWD): This bridges the gap between research and practice (e.g. allowing drug manufacturers to study how patients use and respond to approved medicines). It can also be used to monitor post-market safety, support R&D, design clinical trials, and conduct observational studies that help to generate innovative treatments and approaches. Sources that companies can use to generate this data include:

• Claims and billings activities
• Product and disease registries
• Medical device-generated data
• Electronic health records
• Social media

Wearable technologies, software as medical devices, and artificial intelligence (AI) will continue to transform healthcare. The biometric data these devices collect and how wearables improve healthcare administration give physicians more decision-making leverage and patients more autonomy and agency in managing their health. We recently looked at the opportunities for innovation that AI presents (e.g. technologies to detect brain tumours or cancer in their early stages). While there are certainly challenges to overcome (e.g. systemic bias), the focus that these technologies put on preventative care is a crucial driver for market growth.

Retail Healthcare (healthcare businesses conducted through retail outlets) is predicted to double in 2023 ^[4]. Initially fueled by the need for local, convenient, and accessible testing sites during the height of the COVID-19 pandemic, these outlets have continued to expand their services to include blood tests, vaccinations, and other checkups traditionally conducted at doctor’s offices. Low-cost but quality healthcare where no appointment is needed provides patients with the care they need and relieves the burden on medical/hospital staff.

Remote Patient Monitoring (RPM) and the need to report, monitor, and analyse patients wherever they might be and in real time will also impact medical device regulation priorities for 2023. The global RPM market reached USD 1.3 billion in 2022 and is forecasted to reach USD 3.0 Billion by 2028, exhibiting an annual compound growth rate (CAGR) of 15.4% during 2023-2028.

How is the collection of RWD and biometric data (e.g. weight, blood pressure, blood sugar, blood oxygen levels, heart rate and cardiovascular performance) regulated?

Data collection and medical device regulation priorities for 2023

The HealthTech industry needs insights from big data (large data sets that are analysed computationally to reveal patterns, trends and associations relating to human behaviour) to advance and stimulate innovation. At the same time, these data sets must be protected against privacy infringement and cyber attacks. Finding the balance between enabling big data for R&D and protecting it against misuse is crucial.

In July 2022, the UK introduced the Data Protection and Digital Information Bill that proposes significant changes to the UK’s framework on privacy:

• Businesses must designate a ‘senior responsible individual’ to be accountable for data collection compliance. This individual must be part of the business’s senior management – as opposed to previous regulations that called for the appointment of an independent Data Protection Officer
• Businesses will no longer need to conduct data protection impact assessments (DPIAs). Instead, they will need to implement an “assessment of high-risk processing”
• Removal of the need for data controllers outside the UK to appoint a UK-based representative
• Currently, only “strictly necessary” cookies may be used without consent. The new bill expands the category of cookies that don’t need permission to be dropped (e.g. cookies that collect data for statistical analysis). Users still need to be allowed to opt-out
• ‘Recognised legitimate interests’: provided a business can demonstrate that data processing is “necessary” for one of the recognised legitimate interests, it will no longer be required to balance its legitimate interest against the data subject’s interests, rights, and freedoms
• A risk-based approach to the international transfer of personal data
• Increases to the maximum amount of fines under The Privacy and Electronic Communications (EC Directive) to align it with the UK General Data Protection Regulation (GDPR) Act 2018

The Bill has only proceeded through its first reading in Parliament, so there will likely be amendments to its current form before it becomes law. It is also possible that a government led by a new prime minister may take a different approach. However, it’s encouraging that the intentions behind proposed reforms seek to solidify the UK’s position as a world leader in digital health without diverging too far from EU medical device regulations and international standards – making compliance more streamlined.

A final thought on digital healthcare trends and priorities in 2023

While there are certainly challenges on the road ahead (e.g. interoperability, data security, ethics and how to regulate software and AI), the opportunities for business growth and innovation outweigh them. Regardless of how proposed reforms will affect those engaged in developing technologies that support healthcare, the medical device regulation priorities for 2023 remain the same: developing world-class products and services that have a positive impact and keep users safe.

Do you have thoughts on the digital healthcare priorities and trends for 2023? Please feel free to get in touch, and let’s chat!

1. Medicines and Healthcare products Regulatory Agency. (2022, December 16). Life Sciences Council Joint Statement on Medical Devices Regulatory Reform. GOV.UK. https://www.gov.uk/government/news/life-sciences-council-joint-statement-on-medical-devices-regulatory-reform
2. Life sciences – what’s next for this top UK sector: a Board of Trade paper (web version). (2022, November 28). GOV.UK. https://www.gov.uk/government/publications/board-of-trade-report-life-sciences/life-sciences-whats-next-for-this-top-uk-sector-a-board-of-trade-paper-web-version
3. Three trends that will impact the life sciences industry in 2023. (2022, November 30). https://pharmaphorum.com/views-and-analysis/three-trends-that-will-impact-the-life-sciences-industry-in-2023/
4. Schibell, N. (2022, November 11). Predictions 2023: Retail Health, Decentralized Trials, And Wellness Are On The Front Lines. Forrester. https://www.forrester.com/blogs/predictions-2023-healthcare/