Permobil

Karin Leire

The medical device regulation recently celebrated its first year anniversary, as the company I represent celebrated its 55^th anniversary. A manufacturer of assistive technology, founded by Per Uddén – a man that was passionate in his mission to support persons with disabilities to have the disability compensated as far as possible with the same technical standard as those we all use in our everyday lives. In 1957, that meant a powered wheelchair – a seat, wheels, a heavy battery, a joystick and there through the ability to leave your home and be present where he or she wanted to be present.

How I described the wheelchair, from back in 1957, it probably how many of us still look at a wheelchair. Going back to the wheelchair ever since Per Uddén's time, and still ongoing, the medical device however continues to evolve and compensate for the disability to a greater and greater extent. A powered wheelchair of today does not only compensate for the inability to walk - the transportation from one place to another – but it compensates for movements within seated and standing position, through power actuators within the seat. It allows you to position the body in the position needed for clinical reasoning (to avoid pressure injuries, improve circulation, for example) and for functionality to do normal activities as brushing your teeth, reaching into a cupboard or go fishing. The power wheelchairs also include software and connectivity to monitor the performance of the device and enable swift service, as we know how critical the chair is for the user to enable them living their lives to the fullest.

The health economical value of a powered wheelchair is clear. It does not only meet the health related needs and reduces the burden on our health care, but it also enables active participation and an ability to study or work and contribute to society.

In many ways, the code of conduct from pharmaceuticals is being applied onto medical devices and for high classified medical devices, I think it does work rather well. At registration, there is a demand for proprietary clinical data, trials where the device has been tested against standard of care and the registration is connected with reimbursement and change – an improvement – in the standard of care.

"The 2006, UNCRPD states people with disabilities are autonomous individuals with the human right to actively participate in society. Let’s live up to that"

As MDR was introduced, I was enthusiastic. Finally we’d include a proper benefit-risk ratio evaluation, a health economical analysis and encourage an evidence-based development process among manufacturers. One year in, however, not much has changed. For assistive technology, I would say there is a disconnect between the regulatory approval and any kind of change in standard of care. If I generalize, the regulatory approval only tells that the product is safe. In fact, the greatest workload and risk comes when you as a manufacturer are to approach the national or regional decision makers with your device. One of our greatest challenges is that product performance isn’t addressed sufficiently. In tenders as in Sweden or the product reimbursement categories as in Germany, the expectance on the products is set on a basic level, meaning that you end up in a pure price discussion for in our case a product with wheels, a battery and a joystick, where the ultimate looser is the user as their needs will not be met.

I embrace increased requirements introduced through MDRs, and would like to go even further. For products that are classified low due to a low risk, more attention should go on the performance of the device and there through distinguish high and low performing products from each other. It’s painful to see observe how too many decision makers for medical device provision, and in particular assistive technology, are not knowledgeable enough on which implications their decisions have got on patients’ health and quality of life.

The 2006, United Nations Convention on the Rights of Persons with Disabilities (UNCRPD) states people with disabilities are autonomous individuals with the human right to actively participate in society. Let’s live up to that.