Device manufacturers and healthcare professionals may seem like two sides of a coin.
They have their own roles, interests and challenges.
However, some of those challenges could be, well, less challenging, if both reached out to the other a bit more.
Let’s take a look at a few benefits of why medical device manufacturers and healthcare professionals should come together more.
It improves medical device safety
Medical device safety is not limited to the device being technically flawless.
Safety involves the usability of the device too. How the device, user, task and use environment go together determines medical device usability.
While the Medical Device Regulation (MDR) 2017/745 urges manufacturers to show how their devices follow usability requirements, manufacturers are not able to do it all on their own.
If device manufacturers and professional users catch up regularly, the former can get a more up-to-date picture of the complex technical-medical-human interaction and device risks. The latter can get valuable support for using the devices safely according to their intended use.
As a result, manufacturers and users can reach common benefits. For example, increase training attendance, build device use competence and confidence, reduce user errors and incidents, and develop risk management. In other words, improve medical device safety.
It makes incident handling faster and more meaningful
Reporting incidents, handling them carefully and restoring patient, device and user safety are important, but…
The reality is that incident handling is typically frustratingly slow. Device manufacturers are not always notified when an incident has taken place. When they are, they don’t always get enough information, or the device sent to them, to perform and complete proper incident investigation. Professional users, on the other hand, are sometimes left waiting for a long time to hear from the manufacturer, unsure if the device is still safe to use.
While the MDR sees incident communication running one-way from healthcare workers to manufacturers and competent authorities, there are advantages for both manufacturers and professional users if it runs both ways.
By being in touch actively, both parties can understand the other one’s needs and timelines better. It will perhaps remind them that they’re both working for the same goal of fixing patient safety. Meeting in the middle helps to step up the incident handling process and increase the motivation for reporting incidents.
It helps deal with constant changes
The COVID-19 pandemic and its backlog, healthcare staffing crisis, energy crisis, supply and demand gap, the MDR transition along with implementing MDR legislation in many member states.
No one can avoid the disruptions completely. Not even device manufacturers and healthcare professionals. However, many of the blows can be softened.
An ongoing dialogue between manufacturers and professional users can help healthcare organisations for example to plan for possible device shortages and adjust to new regulations without stressful surprises. By learning first-hand about the changes in the device use environment, manufacturers can manage device risks better. For example, taking part in tailoring device trainings and orientations would provide healthcare organisations with some much needed buffer against the tough times.
It opens the door to MDR Article 59 derogation
Talking about adjusting to new regulations:
To help manufacturers and healthcare organisations control exceptional circumstances (such as those caused by MDR teething troubles), the MDR offers a few solutions.
One of them is MDR article 59.
It gives member state competent authorities (CAs) the power, based on a justified request, to grant a temporary permission to place on the market or put into service medical devices which don’t have a conformity assessment conducted but which are critical to public health or patient safety or health.
The part where it gets interesting for device manufacturers and healthcare professionals is the fact that the Finnish CA and a few other member state CAs require the device manufacturer and the healthcare organisation to make the justified request together.
So manufacturers and healthcare units should definitely join forces if a derogation request is topical. Here’s a special opportunity for both parties to come together!
It helps avoid devices shortages and derogation processes
Let’s face it. No one looks forward to device shortages or uncertain derogation processes that bring at best only a temporary relief.
Keeping good devices on the market is more welcome.
But how to make it happen?
Hint: cooperation between device manufacturers and healthcare professionals helps.
Under the MDR, manufacturers are expected to collect and analyse user experiences of their devices much more than earlier. If they don’t, the risk of losing the devices’ CE certification grows. The conformity assessment organisations who decide if CE certification is granted, consider post-market surveillance (PMS) essential evidence from manufacturers. It is used to justify why the devices should continue on the market.
Cooperation between device manufacturers and healthcare workers is crucial in arranging collection of user experiences. While this may take some time from the busy healthcare professionals’ workday, the benefit of providing user feedback for the manufacturers is worthwhile.
Device manufacturers and healthcare professionals should come together more, because it improves medical device safety, makes incident handling quicker and more motivating, helps manage constant changes, opens the possibility to use MDR Article 59 derogation, and supports keeping good devices on the market.
Can you think of any other examples? I’d be happy to read your comments.
Are you a device manufacturer, or do you represent a healthcare organisation?
Would like to apply these ideas in your work, or develop your stakeholder relationships in some other way?
You’re just not sure where to start or how to move ahead?
Please send me a message and I’ll help you.
