It is possible to conceive complex medical devices in such a way that they can be used multiple times. However, it has yet to be considered during product development. This is common practice at Pioneer Medical Devices.
The healthcare market is very much in favour of solution-oriented services which focus on resource utilization as well as on cost reduction whilst providing better quality. The pharmaceutical and consumer goods manufacturer Johnson & Johnson also came to that conclusion at the end of 2011 and acquired SterilMed, one of the leading providers of medical device reprocessing services in the USA.
Robert Schrödel, CEO of Pioneer Medical Devices, explained: “The Berlin-based company Pioneer Medical Devices is the first company in Germany to unite manufacturing and reprocessing of medical devices under one roof. This is the only way to create complex medical devices in such a way that they can be used multiple times.”
M & K: Your most recent medical devic- es are shaver blades which are used in arthroscopy: Pioneer’s MasterCut l.S.S. distinguishes itself by its CE integrated reprocessability. Please explain why you attach particular importance to this aspect.
Robert Schrödel: If we – against the backdrop of a steadily increasing demand for healthcare services – do not want to be forced to ration, i. e. to decide who will get certain service and who will not, we will have to implement fundamental changes. I just want to mention the keyword “break-through technologies”.
In the present case, the renunciation from single use and throw-away mentality at high cost is achieved by a new design, enhanced materials of high quality and a CE integrated approval of the medical devices for multiple use.
Pioneer Medical Devices operates two state-of-the-art facilities for specialised reprocessing which also provide for validated reprocessing of single-use medical devices of third party manufacturers. Moreover, Europe's largest production and reprocessing centre for medical devices will be opened by mid 2012 in Aschersleben, located in the federal state of Saxony-Anhalt in the central eastern part of Germany. Pioneer describes itself as the first company in Germany which has integrated the idea of reprocessability of complex medical devices (class 3) directly into product development. What has been the reason for taking this particular step?
Schrödel: Yes, we are the first company which has been approved as manufacturer and, at the same time, reprocessor of complex medical devices, which are categorised as “critical C” devices in technical terminology. The motivation was to make available the benefits of this concept in preferably all countries in Europe in order to counteract the growing trend of using materials of inferior quality and other reprocessing limits.
The products are conceived right from the beginning in such a way that they can be approved for multiple use. In our case, the CE mark includes the saleability of the products, the so-called right of placing on the market, in all 27 EU member states. In addition to the benefits of sustainability and a better management of resources, a rather essential aspect is the price of the pro- ducts which is significantly below that of so-called single-use or disposable medical devices.
Thanks to the pay-per-use system, resources can be sustainably managed and costs can be reduced...
Schrödel: This is correct. The pay-per-use concept unites even several benefits. The first to mention are noticeable cost savings due to the use of shaver blades of limited reprocessability and other complex medical devices.
The second benefit concerns the automated monitoring of products in stock at the hospital and in the logistics chain. Third, hybrid functions can be avoided by elimination of stocking up new single-use products and, in parallel, reprocessable medical devices.
Are there already experience reports available?
Schrödel: The system is currently being introduced to the first customers so that still little practical experience can be reported. It can be easily understood that an automated monitoring of stocks eliminates many causes, for example by automatically monitoring the shelf life and periods of use and avoiding of costs for disposal of expired medical devices.
You consider the combination of Pioneer’s MasterCut I.S.S. with the pay-per-use system to be ground-breaking. How does this concept match with the overall portfolio of the company?
Schrödel: The introduction of the new innovative MasterCut I.S.S. product line is an expression of an integrated com- prehension of sustainability, efficiency increase and resource management. These three content determinants are at the same time the maxims of our corporate philosophy which all our products and services have to match.
What service areas does Pioneer specialise in? Which ones do you want to expand in the future because hospitals do need them?
Schrödel: Pioneer exclusively offers products and services which are adapted to the aforementioned determinants. Moreover, Pioneer’s innovations like MasterCut or Master2cout shall be a contribution to a further development of healthcare standards at a high level without causing additional costs – with the aim of keeping health affordable.
About the person
Robert Schrödel is CEO of Pioneer Medical Devices AG. He is a member of the German Healthcare Management Club (CDGW), president of the European Association for Medical Device Reprocessing (EAMDR), member of the board of trustees of the sanoris Foundation for Healthcare Research as well as co-founder and member of the management board of the World Virtual Institute Preventive & Regenerative Medicine. In 2007, he was awarded as “Entrepreneur of the Year 2007”.
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