29.11.2018 - 11:17

Talk with the winner of “ERP system of the Year” in the Medical technology category

The new EU Medical Device Regulation (MDR) poses huge challenges for enterprises with respect to their strategic software application planning and IT environment. Jens Fröhlich, Medical Technology Sector Manager at oxaion gmbh, provides initial answers to the questions SMEs will have to prepare themselves for in the future and how they can be supported.

Many exhibitors at T4M are affected by the new EU Medical Device Regulation (MDR). What effects does MDR have on the IT of companies in the medical technology industry?

The challenges to the validation of the used computer systems as well as the requirements for UDI (Unique-Device-Identification) are not to be underestimated. Both require certain possibilities in the ERP systems used that many suppliers simply do not offer.  The implementation of a new ERP system takes up a lot of time as well as financial and human resources. Documentation, too, plays a major role. With an integrated, audit-proof document management system (DMS), we have positioned ourselves quite well.

Do enterprises have to prepare for deep changes in their processes? If so, what would you recommend?

Especially the validation of relevant computer systems (ERP, DMS, CAQ, MES) brings along functional requirements and changes in the existing processes. I’m thinking of the documentation demands during introduction and operation but also in our daily work whenever new work flows become necessary or suddenly play a role with dedicated requirements to user permissions, audit trails or electronic signatures and companies are not used to it. I recommend to explore as early as possible what effects the changed demands will have and how to best implement them in the company’s environment. This can well be supported by a new ERP software.

Could smaller enterprise simply be overtaxed by the validation of their computer systems? What support is available to SMEs?

For smaller companies that have not yet had anything to do with computer system validation, this topic is certainly difficult. We therefore designed two very different implementation concepts for medical technology companies. First, the classical route with oxaion open as the industry solution for medical technology or second, our new concept for smaller enterprises, oxaion easy Medizintechnik. In both cases, we offer support in the form of all necessary documents and templates which differ considerably according to the implementation concept. In any case, we will not leave the companies alone.

You will surely sometimes hear: “We still have time until the implementation of MDR is mandatory in May 2020.” What do you answer to that?

I think that companies have realised by now just how serious the situation is and that a solution is not easy at all if you consider the financial means and resources involved, or worse still, the lack of time that should actually be dedicated to products and sale. It is not for nothing that associations also try to influence politics in order to delay the launch of MDR. Eventually, companies will just have to do it. That does not mean that I like everything that was decided.

Your ERP software oxaion has been chosen ERP System of the Year in the field of medical technology. What sets oxaion apart?

Our logo states “open, flexible, different” and I believe that this sums it up quite well. We decided to focus strategically on medical technology which includes to take our software and our employees along on this path. It also defines the orientation of the software with its corresponding functions and the necessary documentation. Looking for the challenges the industry faces is part of it, as well as finding out what drives the customers and the market and how we can help. Oxaion easy Medizintechnik as well as our planning for future extensions demonstrate this quite clearly. At the same time, we provide a special solution to smaller enterprises in medical technology.

With oxaion easy, you provide a specific, “small” solution to SMEs. Could you please explain briefly why this solution is so particularly suitable for smaller and medium sized companies?

Oxaion easy Medizintechnik is a pre-configurated software version of oxaion open that is pre-set and equipped with certain modules and functions. All essential functions like materials logistics, production, financial accounting, CRM, DMS and a validation package are included. This validation package comprises all necessary oxaion documents you need for a validation. The pre-configuration and the validation package reduce the internal effort by 50% and the validation effort by 70%. 
Your website states that validation provides a great chance to digitize processes further and to make them fit for the demands and framework conditions of the future.

Do your customers agree to that already or do you still have to convince them?

Right now, companies mostly see the effort involved in the regulatory requirements foremost. That is understandable, as too much is at stake for the companies. However, digitizing the company will not be possible without a good ERP system. ERP is at the heart of the company IT and all processes within the company are affected. I believe, as soon as the companies understand the benefit, digitisation will also progress in medium sized medical technology companies. At oxaion, we have the right tools for it like the communication platform Crossfeed (key word Social ERP) as well as the opportunity to link our ERP with production facilities or web applications.

What were your reasons for exhibiting at T4M? Who would you like to talk to above all?

Naturally, we have been following the development at the trade fair locations. Our network partners, VDMA AG Working Group Medical Technology and Medical Mountains quickly made the decision for Stuttgart, and we followed the lead for various reasons:  Our company’s headquarters are in Ettlingen near Karlsruhe in the state of Baden-Württemberg that is home to an important centre of medical technology. T4M is a format that we trust to continue the long tradition of successful trade fairs in the field of medical technology. However, this need not be a fundamental decision against any other locations.

What prerequisites must be fulfilled for you to consider your participation in T4M as successful?

For us, interesting talks and contacts with medical technology companies are of utmost importance. It will be exciting to see how the new trade fair manages to attract professional visitors and “get” them to Stuttgart.

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