Why Patient Involvement is Critical to MedTech Safety and Compliance

What is the Role of the Patient Safety Commissioner in MedTech? 

As the first Patient Safety Commissioner in the world, my role is to promote the safety of medicines and medical devices and to support the healthcare system to value the voices of patients and the public in this regard. My role was recommended by the Independent Medicines and Medical Devices Safety Review (IMMDS), led by Baroness Cumberlege, and published in 2020. The review found that the healthcare system was disjointed and siloed, patients were not being listened to and were harmed as a result. The IMMDS envisaged my role as being ‘a central point of contact for patients, a listener and advocate, to hold the system accountable for patient safety issues related to medicines and medical devices’. I began in September 2022. 

How Can Patient Engagement Shape MedTech Policy and Innovation? 

I act as an independent advisor to the MedTech Strategy Programme Board whose aim is to ensure that the healthcare system can access safe, effective and innovative medical technologies, focusing on streamlining the pathway for products and fostering a thriving MedTech industry. It aims to ensure the right products are available in the right place at the right price. The Programme Board includes voices of industry, healthcare providers, professionals, academics and officials. But it is vital that the patient’s voice is heard clearly in the development, design, procurement and use of medical devices so as part of my advisory role, I have supported the development of the MedTech Patient Engagement Forum. The forum provides a route for patient groups to engage with the MedTech Strategy and influence and co-design policy initiatives. An example of their impact is reflected in the inclusion of patient specific questions in the value-based procurement standard guidance due to be launched early next year and involvement in the development stage for innovation passports referenced in the recently published 10-Year Health Plan. 

What are the Core Patient Safety Principles for Medical Devices? 

In 2024 I published the Patient Safety Principles which have also influenced the way that the Patient Engagement Forum has been established. They are: 

1. Create a culture of safety. 
2. Put patients at the heart of everything. 
3. Treat people equitably. 
4. Identify and act on inequalities. 
5. Identify and mitigate risks.
6. Be transparent and accountable. 
7. Use information and data to drive improved care and outcomes. 

Why Must MedTech Leaders Address Inequalities in Device Design? 

Under Principles 3 and 4 I have identified under-represented patient groups and increasing the reach of the Forum. 

This includes representatives from the RNIB and the RNID to the group to give people with sensory impairment direct access to its work. Also making introductions to the Royal College of Obstetricians and Gynaecologists to ensured improved coverage for Women’s Health groups. I have also committed to highlighting bias in medical devices and raised this issue with the MedTech programme board as part of the NHS Race and Health Observatory World Café conversation. The Forum now regularly invites over 70 individuals from 45 Patient Groups. Attendance at the quarterly Forum meetings doubled between March 2024 and January 2025. 

How Does the Medical Devices Outcomes Registry Improve Patient Safety? 

A further way to strengthen patient voice in the safety of medical devices is through the Medical Devices Outcomes Registry (MDOR), a key component of the MedTech strategy. It is a national registry designed to track high-risk medical devices and the procedures they are used in, aiming to improve patient safety and outcomes. It collects data on implants and devices, linking patients to specific devices, clinicians, and locations, ensuring comprehensive and consistent data collection across the NHS and independent healthcare sectors. This registry is part of a broader NHS England Outcomes and Registries Programme which is consolidating existing registries and implementing new data collections to address data gaps and improve patient safety. 

Why is Patient-Reported Data Crucial for Tracking High-Risk Devices? 

The MDOR has initially prioritised the collection of device data from high-volume clinical specialities, such as ophthalmology and cardiology, and also incorporates data from the Programme’s Breast and Cosmetic Implant Registry, Pelvic Organ Prolapse and Stress Urinary Incontinence registry, Orthopaedic Trauma Registry and National Registry of Hearing Implants, as well as more established registries such as the National Joint Registry and National Vascular Registry. At the end of May 2025, MDOR contained data pertaining to 1.8 million implantable devices. The Programme will continue to implement and incorporate registries of other speciality areas increasing patient coverage in pursuit of reducing variation in clinical practice, and monitoring and improving the safety and outcomes of patients. I welcome the ability to track high-risk medical devices is key, but the patient perspective is often missing. IMMDS heard from patients who had raised concerns about pelvic mesh, but their voices went unheard leading to further harm. Patient reported outcomes and experience data (PROMs and PREMs) are being developed which are vital to ensuring that the views of patients, who are the end users of devices, are included in tracking high-risk medical devices. 

What Happens When Medical Devices are Designed Without Patient Input? 

More broadly, patient involvement must be central to how we design and develop medical devices in the healthcare system. Without this input, patients must put up with devices that are not practical for their needs. Where representative patient input is absent, disastrous consequences can occur. In the research for my Safety Gap report, published in April 2025, we revealed how patients with sensory impairment could not use specific medical devices because they had been designed without them in mind. This included patients with diabetes and vision loss, making the devices unusable and impacting on patient safety and experience. 

How Should MedTech Companies Involve Patients in Product Design? 

I am regularly contacted by patients with concerns about medical devices, where the views of a wide range of patients have not been included in product design or use. It means that patients must ask someone else to help them open packages, read labels including warnings, and attach devices. This is unacceptable as it leaves patients vulnerable and feeling degraded. 

The recommendations I made to NHS England regarding the NHS App are applicable to all device manufacturers, to obtain the views of a representative group of patients when designing a new product. I am delighted by the response to these recommendations and am hopeful that the new technologies being developed will have the most vulnerable patients in mind. The Patient Engagement Forum includes patient charities who want to support the development of products which are safe and promote patient independence. Furthermore, we need very sensitive post market surveillance so we can detect where devices are not working as expected. Flagging concerns about medical devices using the Yellow Card system needs to be a swift and sensitive way to detect concerns from patients’ perspective as well as those raised by staff, so that the right actions can be taken to keep people safe. 

How Can Patient Partnership Drive Innovation in MedTech? 

A key part of my strategy is patient partnership. It changes the approach to healthcare design and delivery and supports a new approach to healthcare, where patients are not ‘done to’ but ‘done with’. This restorative practice approach has been shown to improve outcomes for patients as their needs are met from the outset. Patient involvement is not just a tick box exercise to achieve compliance. It is a way to ensure you can design the best new products effectively by working in partnership with patients and is key to a vibrant MedTech sector. As new technologies come online, such as apps, AI and robotics as part the digital shift in the 10-Year Health Plan, the opportunities are endless. 

What is the Future of Patient-Centered MedTech Development? 

With this new inclusive approach and embedding the Patient Safety Principles as your guide, patient partnership is a new and exciting reality where patient safety and patient voices are central to device design, use and surveillance. 

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.