Perfect timing for Active Medical Devices: Rouven Rosenheimer joins TÜV SÜD
“Better sooner than later” has been Rouven Rosenheimer’s motto from birth. Born a leapling, i.e. on February 29, he prefers to celebrate his birthday in non-leap years early rather than later. His philosophy also extends to his professional life: the communication electronics expert and medical devices engineer embarked on an early career in the design and development of surgical lights. Since January, 38-year-old Rosenheimer has held responsibility for the Active Medical Devices Business Line in his position as Senior Account Manager. In this interview, he outlines why he considers success to be first and foremost a question of timing.
Mr. Rosenheimer, what goals have you set yourself in your new role?
When I was still working in industry, I was usually bored by the presentations given by sales staff from testing and certification organizations. I had neither the time nor the inclination to listen to everything they had to say, then sit down and work out precisely which of the services from their huge portfolios we needed, and when. But TÜV SÜD also has a huge and comprehensive portfolio of test services, and can do much more than some of our customers are aware of. I plan to gradually raise awareness of this potential. However, my aim first and foremost is to provide customized service offers that benefit customers and their products phase by phase––right from the start and right through the life cycle of a device, not just shortly before approval is needed. I see medical devices from the manufacturer’s perspective and know where the customer stands at any given moment in time. I also understand the design and development process and the technology involved in devices. This is my greatest advantage.
You hold some patents for surgical lights which you successfully helped to develop, test, and approve. In your opinion, what are the critical points in today’s design process?
Some manufacturers only think of approaching us when the product is finished and they need certification. I consider this a major risk. After all, the course is set early on in the concept phase, or during the definition of design requirements at the very latest. Important aspects include preparing an insulation concept, and thinking about the place of use as a basis for deriving suitable design requirements, such as clearance and creepage distances. Similarly, key performance characteristics of a product must be assessed within the risk management process and implemented in suitable design measures. Consequently, the requirements of the relevant target markets should be assessed in detail at this early stage and not only ex post, shortly before approval.
In addition, there are a great number of smart medical devices available today, along with devices that are a combination of medical devices, IT devices, and standard consumer products. In many cases, the individual modules are supplied by different manufacturers. This adds further complexity to the topic. At TÜV SÜD we are aware of the relevant requirements and monitor them; we have inhouse specialists in all disciplines, from EMC to IT security and transportation. We can perform all types of function tests, battery tests, environmental simulations, and transport tests. In short, we provide all the services that help customers to rule out the need for ex post design changes and thus ultimately reduce their time to market.
At present, fast-paced development is not limited to devices and products, but also applies to standards and global directives. How do you approach these far-reaching changes?
I believe change is important; it takes us forward. In any case, evading change is no longer possible. Challenges are best tackled by forming a realistic picture of the situation and finding solutions as quickly as possible. This is how I have always approached challenges. At TÜV SÜD, I now aim to help my customers clearly see the actions they need to take. After all, we are all facing the same challenges, and those who address them earlier will be a decisive step ahead in the end.
Thank you very much, and the best of success in your new role.