Regulation
its focus on risk management throughout the product lifecycle. By systematically identifying, assessing, and mitigating risks, companies can enhance the safety and efficacy of their medical devices, ultimately improving patient outcomes and reducing adverse events. This proactive approach also minimises the likelihood of costly recalls or product failures, safeguarding both the company’s reputation and financial stability. When in the initial stages of development,
cash flow can be difficult and rounds of investment grants are needed. Implementing a full QMS at this point can be hard due to the amount of time and costs involved but, as stated earlier, the benefits are multifield. At a minimum, it is advisable to implement a design process, including a risk management procedure which would be in line with ISO 14971 and a clinical procedure including clinical evaluation.
Accessing the NHS: key steps Navigating the NHS involves engaging with various Trusts, each with their unique requirements. Successfully getting your medical device into the NHS involves understanding these specific criteria. Here’s a quick guide to help you through the process: 1. Identify relevant Trusts: Determine which NHS Trusts are relevant to your medical device based on the type of healthcare services it supports. For example, if your device is related to mental health, you may need to reach out to Mental Health Trusts.
2. Research contact information: Look up contact information for the relevant Trusts, including phone numbers, email addresses, and websites. You can often find this information on the NHS website or by searching online.
3. Reach out to Trusts: Contact the Trusts directly to enquire about accessing their services with your medical device. You may need to speak with administrative staff, procurement departments, or clinical leads depending on the nature of your request.
4. Provide Information: Be prepared to provide information about your medical device, including its purpose, specifications, regulatory status, and any relevant clinical evidence or certifications e.g., ISO 13485 or CE/UKCA certification. This will help the Trust assess the suitability of your device for their needs.
5. Demonstrate value: Highlight the benefits of your medical device in improving patient outcomes, streamlining processes, or reducing costs. Providing evidence of the device’s effectiveness and value proposition can increase the likelihood of NHS Trusts considering its adoption.
6. Follow procurement processes: If the NHS Trust expresses interest in your device, they may have
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specific procurement processes that need to be followed. This could include completing vendor registration forms, participating in competitive tendering processes, or undergoing product evaluation and testing.
7. Negotiate terms: Once a Trust has expressed interest in your device and completed any necessary evaluations, negotiate terms for deployment, pricing, support, and maintenance. Be prepared to address any concerns or questions raised by the Trust during this process.
8. Deploy and Support: Once an agreement is reached, work with the NHS Trust to deploy your medical device within their healthcare system. Provide training and ongoing support to ensure the device is used effectively and safely by healthcare professionals.
Digital clinical safety assurance is the process by which health IT used by care professionals is assured as safe and meets the required national standards. These standards are the DCB0129 and DCB0160, which relate specifically to clinical safety and are published under section 250 of the Health and Social Care Act 2012. Compliance with these standards is mandatory under the Act. NHS Digital recommends that DCB 0129 - Clinical Risk Management: its Application in the Manufacture of Health IT Systems and DCB 0160 - Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems are adopted whenever ‘digital products’ are developed or deployed to support health or social care services. These standards serve as guidelines for clinical risk management, aiming to minimise the possibility of harmful outcomes. The only situation where this recommendation might not apply is when software is directly integrated into a physical medical device, such as software-based drug dosing calculations implemented in an infusion pump.
Expert help As health systems search for innovative solutions to tackle disease and medical conditions, the industry is undergoing dynamic growth. Breakthrough technology is emerging every day, transforming the way medical care is delivered, making it more accessible, efficient and cost-effective. The UK’s medical device industry presents
a valuable yet challenging landscape for companies, characterised by opportunities for growth and success alongside the need for meticulous planning, compliance and strategic partnerships. At LFH Regulatory, we understand that
navigating the process of introducing your innovation or device into the UK market can
be intricate. That’s why we are committed to simplifying the journey of regulation and compliance as much as possible. Our team of experts is dedicated to working closely with you, comprehensively understanding your objectives and challenges to ensure your path toward compliance is stress-free and successful. CSJ
References 1. Accessed at:
https://www.jonexglobal.com/ post/the-uk-medical-device-industry
2. Accessed at:
https://www.trade.gov/country- commercial-guides/united-kingdom-medical- technology
3. Accessed at:
https://assets.publishing.service.
gov.uk/media/659d3539aaae22001356dc3c/ Roadmap_towards_the_future_regulatory_ framework_for_medical_devices__Jan_24.pdf
4. Accessed at:
https://www.gov.uk/government/ publications/medicines-and-medical-devices- bill-overarching-documents/factsheet- medical-devices-overview
About the author
Laura Friedl-Hirst is the Managing Director & Principal Consultant at LFH Regulatory, the organisation she founded in June 2019 and one that has grown vastly since it was established. Her vision was to create a consultancy and a team of consultants that have a pragmatic approach for navigating companies to their end goals. She is as passionate then as she is now about creating a culture that is open, approachable, and flexible; she also promotes a great work-life balance. After gaining a BSc (hons) in Medical Biology at The University of Huddersfield, she completed a placement year at DePuy and was introduced to the world of regulatory affairs. Since then, she has gained over 12 years’ extensive industry experience working with varying sized organisations and with a diverse range of medical and in vitro diagnostics. Laura has a breadth of knowledge and expertise that spans over regulatory, quality, clinical and design & development.
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