Switzerland has a long standing record of successful medical innovation and today hosts an increasing number of companies in the med tech industry, from small startups to global giants. However, rapid innovation in this industry is challenged by the continually evolving regulatory landscape.
We had the opportunity to talk to Anders Emmerich, the CEO of Aligned AG, about his view of the current innovation situation in Switzerland.
Mr. Emmerich, is rapid innovation in the med-tech industry an inherent impossibility?
Not at all. Just this year we have seen a virtual explosion of new health related products, centered around smartphones, wearables and apps and we have no reason to believe that it is going to slow down.
But I understand what you mean with your question. It is true that regulations, norms and standards put pressure on the development team since they require a level of documentation and documented proof rarely seen in other industries. As a matter of fact, our experience shows that up to 30% of the total device development effort is about documentation and none of the companies we have spoken to finds this to be reasonable. So if you experience the same, you are certainly not alone.
So what is wrong then?
Swiss manufacturing quality is excellent. The knowledge and expertise in the Swiss engineering workforce is also outstanding. However, sometimes all this excellence misses the target by not looking in the right direction.
It often strikes me that the level of optimization in device manufacturing and development is seldom matched in the documentation area. Surface coatings, manufacturing details and device driver sub-routines are getting analyzed into the smallest detail, but the documentation process is left largely unchecked. There is an enormous potential for savings and rationalizations to be made in this area.
Give us an example.
With an rising number of regulations and increasing complexity of the devices, the number of design control items to keep track of increases steeply. The work-load of enforcing the corresponding documentation consistency increases exponentially. That requires tools and methods that can handle this level of documentation complexity.
Tools, like our ALM solution Aligned Elements, is there to handle all the day-to-day menial efforts, such as automatic version control, recording the audit trail, automatic calculations in risk assessments, lead you through approval processes and collecting signatures.
At the same time, our tool ruthlessly scan the documentation for inconsistencies and make them apparent well before the auditor lays his hands on your files. This will save a considerable amount of time, money and effort, freeing your engineers from menial documentation tasks and remarkably lower the risk of having to confront an auditor with a leaky technical file.
So documentation tools are the answer to the ever slowing innovation process?
No. A tool alone will never make the sufficient improvements. The success of a documentation tool like Aligned Element is heavily relying on Quality Management System in place. And this is a tricky one. Without a QMS you will never get to the market. But a cumbersome QMS can be a significant source of those 30% I talked about. It takes experience and knowledge to chisel out an efficient yet sufficient QMS.
But isn’t the additional requirements posed by regulatory risk management an important factor on increasing the documentation burden?
That depends. The risk perspective is there to make us build safe devices. It should ideally be an innovation driver. However, many manufacturers are so convinced that they already make excellent (and safe) devices that they fail to take regulations like ISO 14971 to heart. The risk management documentation then only becomes an necessary evil that subsequently does not receive the attention needed to make it efficient. So then you end up doing it wrong AND slow.
Companies also fail to see that risk management and design control management cannot be separated. And still manufactures insist in keeping risk management and design control management in separate systems! The traceability will invariable tie these two aspects together and the level of manual checks required to keep the data consistent will rise sharply. This is something we have been very careful to integrate in our solution.
What do you see in the future for Swiss medical device innovation?
I think that the documentation aspect of med-tech product development is going to get increased attention and that it will become an important competitive dimension in the industry. If you can outsmart your competitor and perform a more efficient documentation process, you will shorten your time-to-market at a lower cost.
About Aligned AG
Aligned AG provides Aligned Elements, an ALM system to ensure compliant
development documentation for regulated products in the Medical Device
Interview with Aligned AG