The relationship between a medical device, the user of the device and the patient is both critical and fragile. Globally $450 billion of revenue is generated from the sales of medical devices. The biggest medical device markets in Europe (Germany, France, the United Kingdom, Italy and Spain combined with the wider EU directly employ more than 760,000 people.
That means the definition of medical device success in the post-market will be a combination of complex factors defined by the stakeholders involved. The biggest challenge will be the on-going implementation of new medical device regulation by MedTech companies who must streamline their process to mitigate the effects of greater regulatory controls.
1: The Medical Device Innovator
With medical technology companies approaching market access through increasingly complex regulation, and device success having been historically measured through the lense of patient outcomes - it is high time for a change of perspective on both the deliverables and the KPIs of medical device success. Successful device deployments in healthcare should be analysed from multiple perspectives including those of the developer (medtech), the distributor, healthcare oversight and of course patient.
Average European medical devices takes between 5-10 years to gain CE marking, however the lifecycle is typically 18-24 months before an improved product becomes available. According to the MDR, MedTech companies must rigorously monitor clinical performance and collect clinical evidence. Regulation will help shape a clear understanding of what medical device companies believe to be their success KPIs. This can be divided into two separate areas
With a clear understanding of a clinical need, innovators know the path through ideation,
classification, clinical trials to CE marking and market access is long and arduous.
Post-market Success: With MDR post-market surveillance has come sharply into focus as MedTech companies must understand the links between risk management, postmarket surveillance and clinical evaluation.
With new standards in place, post-market medical device success has been elevated in significance and criticality.
2: The Device Distributer
For the past two decades the MedTech industry has become an important to delivering effective healthcare to aging populations globally with increasingly diverse needs. These complex devices now impact our daily lives, and innovative developments in MedTech are crucial for sustaining health. European countries exporting their devices to the other markets will rely on distributors to manage customer relationships. So how does post-market success impact medical equipment distributors?
Global market access is achieved hand-in-hand with resellers as they are the portal to customer data. European designed devices deliver patient care to all corners of the world, but gathering rigorous post-market data is not easy due to complex procurement relationships that include distributors. Building an digital ecosystem where distributors are engaged in both device and user success is the solution to better shared knowledge and empowered stakeholders.
Post-market Success Platform for MedTech
The eco-system for stakeholders involved with a medical device in the post-marketWhy choose Rekonnect
3: The Healthcare Oversight
Post-pandemic renewed focus on welfare and development of healthcare professionals has become an area of scrutiny. Improvements to technology are useless if the device users themselves are not cared for. High turn-over of staff in healthcare has long been a stumbling block to measuring assimilation and competency with complex devices as permanency in staffing is almost unachievable.
In 2021 turnover of nurses rose to 18%, meaning staff most commonly in contact with complex medical devices are most likely to leave their roles. Reasons for this include ageing workforce, difficult working conditions, poor lifelong learning, skill mismatches and weak career development. The need to centralise and develop durable knowledge among medical professionals, staff in healthcare clinics, hospitals and their administrators has become paramount.
Conclusion: Combine Medical Device & User Success with Rekonnect
Rekonnect is the first medical device success platform that combines post-market surveillance, data collection, event reporting, digital training and user management in one centralised interface. The solution that both the medical technology industry and healthcare need - Rekonnect is easy, and flexible offering qualitative training regardless of where in the world the product and the healthcare facility are located.