TÜV SÜD Product Service was celebrating its 25th anniversary 2014. The first private-sector spin-off from TÜV Bayern started operations in 1989 with 57 “pioneers”. Today, the company spans a large global network of 4,500 experts, 436 of whom work exclusively in the Medical Device field, at 28 offices and 13 testing laboratories in 15 countries.
Dr Susanna Kerschl has been among them right from the very start. From the company's development from a German test laboratory to its status as one of the world's leading Notified Bodies with around 20 accreditations for Medical Devices, from the paradigm shift in the international registration of medical devices to crises and curiosities – she's seen it all. Today, Dr Kerschl is in charge of Customer Relations and Key Account Management. An interview with one of the pioneers.
E-ssentials: 25 years ago, when Medical Device testing and certification came under the umbrella of TÜV SÜD Product Service the key aspect was on performing safety testing of electrical medical equipment and associated disposables. What are the key aspects today?
SK: The focus of today′s registration and approval procedures is no longer on product testing, but on the auditing of quality management systems and the review of the devices' documentation including design dossiers and technical documentation. As a result of globalization, our services no longer refer to just one country or region, but may cover the regulatory requirements of various markets depending on our client′s requirements.
E-ssentials: In the past 25 years TÜV SÜD Product Service has issued thousands of certificates for all types of Medical Devices. Which ones stand out in your mind?
There were indeed some curiosities, including a virility stimulator, a belt with Chinese herbs to stimulate the Qi energy force, and a love swing. By the way: we certified the virility stimulator, but rejected the other two products for lack of clinical data. The first Medical Device for which we issued an EC certificate in 1992 was a pacemaker. In the early 1990s we were commissioned with testing the first ventricular assist device (VAD), which comprised a pneumatically driven implantable artificial heart.
This was one of our trickiest projects. The system was urgently needed, but had failed an actually rather unimportant part of the test. You have to keep in mind that we move in a highly regulated sector in which patient safety comes first. However, at the same time we also have the ethical responsibility to do our part to give patients access to innovative and life-saving devices. Compared to the testing of other products, our work is highly sensitive, as Medical Devices may involve considerable hazards for both patients and users.
E-ssentials: You have worked closely with the Medical Device industry for 25 years. How have you personally experienced changes in this sector?
SK: In the Medical Device industry there is a constant coming and going. In consolidation processes, many of the small-sized highly specialized start-ups are soon absorbed by big players and new start-ups appear on the scene. I′ve also seen some highly innovative products that were initially launched with great success, but then unfortunately disappeared from the market very quickly due to changes in application and medical practice. These devices are a real loss.
E-ssentials: What trends do you see for the future?
SK: Worldwide the number of regulations is increasing and the requirements that are imposed on products, manufacturers and us are becoming stricter, making our task more complex. In my opinion this trend will continue to grow in the near future in spite of major harmonization efforts. As a testing organization, we too will have to adjust to the trend. However, these types of development frequently offer both risks and opportunities. Take the introduction of the Medical Devices directives, for example. Without them, we would not have been able to offer our registration services throughout Europe and evolve from a German test house to a global certification and testing organization.
E-ssentials: What are TÜV SÜD Product Service′s plans for the coming years?
SK: We want to maintain our position as the world′s number 1 – an ambitious objective. To reach our goal, we intend to further drive internationalization. Today, we are represented in 15 countries with key markets in Germany, China, Japan and the US. From these locations, we currently support registration in Europe, Canada and many other markets. Our plan is to further expand our activities in these and other markets rapidly and enhance our customer focus by adding activities throughout the value chain, such as pre-certification services, to our portfolio of services.