Richard Armstrong, Director, Registries and Real World Evidence at NEC Software Solutions explains why sharing health registry data with the medical technology (MedTech) industry can raise the standards of patient care.
Medical device manufacturers have been adjusting to new responsibilities since the summer.
In June 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) strengthened its post-market surveillance regulations. The updated regulations require manufacturers to track their products, collect data on their performance, report incidents and take action when issues arise.
The aim is to improve patient safety by making it easier to flag up problems with medical devices.
It means that patients who use a health monitoring device, or who have had a medical device implanted during surgery, can be assured these devices are subject to ongoing surveillance. This will certainly bring added peace of mind to someone undergoing a hip replacement or having a cardiac stent fitted.
Tighter MHRA regulations could also lead to improvements in the design of devices based on patient outcomes data.
However, the problem is that manufacturers don’t have enough information on their products once they leave the warehouse, unless something serious goes wrong.
Could health registries help to get that all important information into the hands of manufacturers?
The role of a health registry
In fact, registries are already collecting data which MedTech manufacturers need to track their products in real world settings. A health registry is so much more than a database, it is a system that collects and monitors data on medical treatments, with the expert input of medical professionals.
Registry data helps to evaluate outcomes to improve the quality of patient care.
There’s been an increase in the number of registries since the Cumberlege Review investigated how patients had suffered avoidable harm from medical devices. The review highlighted the need for a comprehensive device surveillance system.
Some registries started operating long before the Cumberlege Review, and have been systematically collecting and analysing data on medical device performance and surgical procedures for some time. One example is the National Joint Registry (NJR) which has been monitoring performance outcomes in joint surgery for more than 20 years.
These registries are already providing a rich source of data to clinicians, hospital authorities and medical researchers, but MedTech manufacturers have often not been fully benefitting from registry data.
Barriers to data sharing
The barriers to sharing data with the MedTech industry have been difficult to overcome. There are certain legal, technical, and cultural challenges which stand in the way of using data and real world evidence to improve patient outcomes.
There are legitimate concerns about the open exchange of registry information with manufacturers, even with privacy laws in place, and protocols around anonymising data. Any data breach could result in a loss of trust, reputational damage and legal consequences.
On a practical level, data sharing is complex. Health registries often collect data in different systems and formats, and according to different standards. This makes it difficult for manufacturers to access and interpret the data, and there is also a risk that some data may be incomplete or inconsistent, making it unreliable.
Culturally, data sharing can be problematic too. Medtech is a competitive industry, and so there can be a reluctance for registries (largely housed in public sector or academic bodies) to share data which might give commercial advantage.
The prospect of information about a new design of pacemaker or biosensor getting into a competitor’s hands could make manufacturers wary of launching new-to-market devices. And when innovation is hindered, it is the patients who lose out.
Although there are understandable concerns about sharing registry data with the MedTech industry, the benefits of unlocking valuable clinical insight are too important to ignore. And with the new MHRA regulations in place, now is the time to find a more effective way to provide manufacturers with the information they need.
The power of data unlocked
Fortunately, we’re seeing the arrival of more secure and collaborative approaches which will make it easier for registries and MedTech manufacturers to share data without the inherent risks.
One example of this is the health data partnership which draws up agreements been data controllers, including registries and manufacturers. This way, a partnership model builds stronger relationships between all the stakeholders – hospitals, patients and manufacturers – so data can be shared more effectively.
To protect confidential personal details and sensitive commercial data, a health data partnership can design secure data management policies, and act as an interface between a data controller and a manufacturer.
The legal processes involved in medical data are highly complex, but a partnership takes on and manages all the necessary contractual relationships to provide a one stop shop for the manufacturer. It’s an effective way to remove sources of possible conflict, because all parties have agreed how the data will be accessed and used.
By simplifying and securing the way data is shared, a health data partnership affords manufacturers the opportunity to access better quality, clearly reported data on how their products are performing.
Health registry insight for the MedTech industry
One of the key advantages of health registries is that they collect medical device data on the point of use. If a surgeon scans a code on a shoulder joint at the time of a surgical procedure, the data goes straight into the system, so the performance of that joint can be tracked in the future.
Heath data partnerships can offer a more complete picture of the patients who are using or receiving medical devices. That’s because registries can be set up to include additional data residing in a hospital system, such as MRI scans, test results or medication records. These are backed up by expert interpretation from clinicians.
If manufacturers have access to better quality information about how their products are performing, they can focus their product development on devices which will improve patient outcomes. And should any issues arise, registry data can help identify patients for recall so that adverse effects can be mitigated.
Medical device manufacturers need to keep innovating so they can meet the changing needs of patients. Registry data gives a big picture view of market trends, patient demographics and treatment patterns. This can help to inform safe and effective product development.
Ours is an ageing population experiencing multiple health conditions, so health data will become more important than ever. Registry data will be instrumental in joining up information on the operations and procedures a patient has undergone, not just those in one specialism.
This will provide a clearer view of patient comorbidities, which helps in planning treatments more effectively, especially for patients with multiple, complex conditions. Having a reliable source of data on the health of the nation gives a wider context on individuals in a population, and the population as a whole.
With a mechanism to share health data more effectively, manufacturers in the MedTech sector will have the evidence they need to evaluate the safety and effectiveness of their products, and to fulfil the new MHRA regulations.
Developing secure mechanisms for sharing anonymised data evidencing the long-term outcomes of treatment with the manufacturer of any devices used is critical to better patient care and a more informed future for public health.
To find out more about sharing health registry data with the MedTech sector, download our white paper: Unlocking the Power of Registry Data: How Health Data Partnerships Can Drive Safer, Smarter Patient Care here: www.necsws.com/UnlockingThePowerOfRegistryData