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On Wednesday, 16 October 2019 (16.15 - 18.00) Hansjörg Riedwyl, CEO of ISS AG in Biel, will give a guest lecture at the University of St. Gallen, Dufourstrasse 50 (room 09-011). The topic will be "Apps and other Software as Medical Device".

Digital health interventions offer many new opportunities to all involved, but there are also hurdles to consider. This means that digital health interventions can become medical devices according to medical device regulations and these regulations are dramatically changing. It is therefore crucial for managers and developers to understand the borderline between Software as Medical Device (SaMD) and a "normal" software application.



With the application of the EU-MDR, the OEM/PLM relationships that have been frequently practiced so far will be a thing of the past. So far, the OEM ("Original Equipment Manufacturer") has been able to concentrate on the development and manufacture of its products and sell them without a name to a PLM ("Private Label Manufacturer") who was the sales expert. All he had to do was apply his own label. For development questions, the supervising auditor was referred to the OEM, who gave him access to the Technical Documentation (TD) and his know-how.

The EU-MDR now does not distinguish between PLM and other manufacturers. There are only manufacturers and a manufacturer is someone who places a medical device on the market - regardless of whether he has manufactured it himself or purchased it from other companies.

The crux: the previous PLM now has to provide the complete technical documentation as a manufacturer. The necessary information on materials, processes and production comes from the former OEM, who in turn wants to protect his know-how. MedicalMountains GmbH explains in the strategy paper, on which ISS-AG has co-authored, how this area of tension can be defused.

The possible procedures described include co-branding, cooperation models and the redesign of products. However, there is "no universal silver bullet" and the approaches presented also contain risks. For MedicalMountains GmbH and the co-authors, it is important to name and weight advantages and disadvantages. In the end, the business partners must find an individual solution to which the authors contribute objective decision criteria. Ultimately, this also means that the authors advise against certain further concepts, namely the trustee model.

(Source: Article from 18 September 2019 "Future OEM/PLM constellations: Strategy paper shows ways out of the area of conflict")

Link to the paper

Hansjörg Riedwyl, CEO of ISS AG, Integrated Scientific Services, will have the opportunity to speak at the Event “Medtech 2020 and Beyond: Tips for Survival in Europe’s New Medtech Environment”, which will take place Wednesday, October 30 at the Hotel Bellevue Palace in Bern. The event addresses management and business development and focusses on strategic impact of the new EU Medical Devices and in Vitro Diagnostic Regulations. The event covers a variety of topics related to the regulations, speakers come from regulatory bodies and the industry. (source).

Hansjörg Riedwyl will talk about challenges for SMEs under MDR / IVDR. See here for the detailed schedule

On October 23rd, 2019 the MDR Support Panel will take place in the new sitem-insel building, Freiburgstrasse 3, 3010 Bern. The background to this event is the adoption of the new EU legislation in the field of medical devices (MDR), for which regulatory issues in particular have not yet been clarified.

The topic will be the regulation of third countries. As adoption of the framework agreement is not guaranteed, Swiss companies will have to develop a Plan B in order not to lose access to the EU internal market.

As a speaker, Hansjörg Riedwyl will present and discuss practical approaches to solutions with regard to possible coping strategies for Swiss industry. He will also take a stand on questions at the panel discussion.

Admission is free and registration is done with this form.

Further information can be found here.

Many business models in the Tuttlingen region are based on OEM/PLM constellations. Here the MDR (EU 2017/745) is a special challenge. At a symposium, the various aspects and possibilities were discussed and supplemented with concrete examples from practice. In a keynote speech, Hansjörg Riedwyl presented five different strategic options and made assessments on feasibility and the risks involved.

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