” Horizon 2020? More like Horizon 2029!” This was the reaction of one of my friends when I shared an article about a breath analyser that is meant to detect gastral cancer in its user. Just one of the examples of impactful Horizon 2020 projects going on around Europe.
Having worked in the field of printed electronics and high-tech medical technology (MedTech) for almost a year already, it is easy to forget sometimes that the things we are working with are so advanced that to the lay person they seem like magic. And in my friend’s defence, it will probably be around the year 2029 before the product mentioned will be widely available in hospitals around the globe and it might see several iterations before that. Which is why a long-term outlook is needed when you work with medical technology, which can be frustrating at times.
These days it seems that regulation is one of the biggest hurdles for new MedTech innovations. The extensive quality control processes and clinical trial requirements mean that even a relatively simple device or innovation can take 3 to 4 years to reach market maturity and even then, it was a comparatively fast process. One of the ways to avoid this delay has been to not class a device as a medical device or go for a classification that is exempt from regulations. This allows robust devices to reach consumers faster than they normally would, such as some ECG devices being FDA exempt.
For the more disruptive technologies, it is often not so easy. Devices which potentially pose the largest benefit for people’s health are often the ones that are subject to the most extreme regulations. Afterall if a device is, for example, supposed to detect cancer, the difference between 98% and 99% reliability is extreme. But the shadow side is that even if a device proves to be 99.99% or even 100% reliable right from the start, it will still have to be subjected to the same laborious process, potentially depriving patients of a life saving solution.
Not everything is gloom and doom however and there are ways to significantly speed up certification processes. Making smart choices when it comes to picking materials, having a well-documented production processes and keeping regulations in mind when you start your designs can save a lot of time and money and in this field, lives.
As a contract manufacturer of medical devices, Screentec Oy has invested a lot of time and effort into its quality control systems. This is a constant process and after getting out ISO 13 485 certification back in 2017, we have only increased our quality standards with the goal of offering our customers the best quality products. Not only that but working with materials that are ISO 10 993 certified can be a massive time saving factor, especially when they are taken into consideration right from the start of a project.
Our experience has taught us that designing for certification right from the start of a project can help you predict possible hurdles in the process and help you properly prepare for them or in some cases even avoid them. This is why we pay close attention to the documentation during the entire project. Having all the documents in place is one of the best ways of ensuring the certification process goes smoothly and as fast as possible.
These measures combined mean that the device will see certification sooner and will most likely need fewer different iterations and design changes during the road from first design to mass production. One does have to keep in mind that even under ideal circumstances, certification can still take quite a while as the certification process for medical devices is handled by a 3rd party, which tend to need a set amount of time to process the request for certification.
Screentec Oy is ISO 13 485 certified and we strive to ensure that the certification processes for new products by our customers goes as smoothly as possible.