Why the approval of new medical devices is costing more and taking longer, and why innovation can only be guaranteed in the long term through close co-operation with customers.
The world of medical technology is fascinating, and the technological progress made in recent decades is impressive. Medical technology companies work together with users, doctors and scientists to develop innovative products, therapies and treatment procedures – for the benefit of patients. Modern treatment methods, which include electromechanical gait therapy and robot-assisted therapy for the upper extremities, would be inconceivable without the use of technology and would make quality assurance in therapy considerably more difficult, if not impossible.
The downside of medical technological progress is exaggerated promises of healing and sometimes false statements about the safety and performance of medical devices. In particular, the scandal surrounding a French breast implant manufacturer in 2010 has led to a loss of confidence in medical technology. At the time, the company illegally brought breast implants onto the market, which were implanted in around 500,000 women worldwide and which caused serious health problems. No wonder: instead of using high-grade medical silicone, the company filled their implants with commercial industrial-grade silicone to increase profits [8, 10, 13, 18].
This resulted in a significant tightening of the regulatory requirements for bringing medical devices to market. Patient protection and patient wellbeing are the highest priority in medical device law [6, 11, 14, 17]. The regulatory system for medical devices required to ensure this has actually existed for over 15 years [1, 12]. However, such scandals put European legislators under enormous pressure, forcing them to amend the regulations. On 25th May 2017, a new European Medical Device Regulation (MDR)1, was introduced. It intends to increase patient safety in future. To this end, the regulation provides for stricter clinical evaluation and measures for uniform Europe-wide monitoring of medical devices on the market, among other things . The existing legislation based on Directives 90/385/EEC2 and 93/42/EEC3 will remain in force until 26th May 2021. This will mark the end of the transitional period during which manufacturers can still obtain certification for medical devices under the old law .
The additional safety measures of the MDR will have an impact on the development of the entire medical technology sector [5, 15]. Small and medium-sized enterprises (SMEs) are affected in particular . They are considered the innovators and drivers of the industry and account for over 90 percent of medical technology companies [2, 3, 4]. They will feel the negative effects of the MDR particularly strongly and face a major challenge in meeting stricter regulatory requirements [7, 15].
What effects do the additional safety measures have on the development of new medical technology? In times of demographic change, increasing digitalisation and betterinformed customers, expectations are high for product development and marketing . Rapid development is desired above all in order to be able to react to current challenges in medicine and remain competitive. About one third of medical devices on the market have been available for less than three years . It is not yet possible to fully predict the effect that the implementation of the MDR will have on the medical technology market as a whole. However, the effect of rising costs and the increased time required for certification is undisputed. It will be difficult to reconcile the quality targets associated with the regulation and the demand for rapid development of innovative products. The more complex testing and approval procedures will inhibit the agility and innovation capacity of companies [4, 9].
As a result of the stricter and more elaborate test procedures, manufacturers will have to plan considerably more time for the certification of their products in future. The implementation of the new requirements will also require more quality assurance staff. Inevitably, fewer resources will be available for research and development. The new regulations will prolong the period of time until patients benefit from new technologies. There is also the question of how the additional costs will be financed. After all, companies will have to recoup the additional costs incurred by the certification in some way. The bottom line is that patients will benefit from the increased safety of medical devices in the future, but will have to wait much longer and probably have to pay more for them .
The changes in the market, already heralded by the new EU regulation, will be unstoppable despite industry protest. SMEs in particular will have to continue to be skilful in overcoming challenges in the development, production and distribution of medical devices in future. But what strategic approach should SMEs take in future to remain competitive? In the era of MDR regulations, it is important to recognise product trends as early as possible, for innovations, existing medical devices and services alike. Customers play a central role here. The more willing they are to work closely with medical technology and the more clearly they formulate their requirements, the easier it will be to predict which new, innovative products will be in demand in the future. Manufacturers can then pool their resources and focus their research and development on the needs of customers. This will save a lot of time and money and ensure the timely availability of new products despite longer approval processes.
So join in and help shape the future!
 Altenstetter C (2003). EU and Member State Medical Devices Regulation. International Journal of Technology Assessment in Health Care 2003; 19(1): 228-248.…
 BMBF (Bundesministerium für Bildung und Forschung) (2019). KMU-innovativ: Medizintechnik. Accessed 27/12/2019: www.bmbf.de/de/kmu-innovativ-medizintechnik-608.html.
 Bundesanzeiger (2018). Bekanntmachung: Richtlinie zur Förderung von Zuwendungen für “KMU-innovativ: Medizintechnik”; Bundesanzeiger, 19 September 2018. Accessed 27/12/2019: www.bmbf.de/foerderungen/bekanntmachung-2010.html.
 BVMed (2019). Branchenbericht Medizintechnologien 2019. Accessed 27/12/2019: www.bvmed.de/download/bvmedbranchenbericht- medtech.pdf.
 Engler M (2019). Gesetze für Usability Engineers: Die Medizinprodukteverordnung (MDR) – Neue Aufgaben für das Usability Engineering. In: Fischer, H. & Hess, S. (Hrsg.), Mensch und Computer 2019 – Usability Professionals. Bonn: Gesellschaft für Informatik e.V. and German UPA e.V.
 Felber A, Müller J (2004). Sicherheit im Umgang mit Medizinprodukten. Gynäkologe (2004) 37: 45.
 Gemke G (2017). Die neue Medizinprodukteverordnung EU. Ästhet Dermatol Kosmetol 2017; 9: 15.
 Glinski C, Rott P (2019). Regulating Certification Bodies in the Field of Medical Devices: The PIP Breast Implants Litigation and Beyond. European Review of Private Law 2019; 27(2): 403-428.
 Gödde S (2017). Gesetzesvorschriften der europäischen Union zu Medizinprodukten. München, GRIN Verlag 2017.
 Lampert FM, Schwarz M, Grabin S, Stark GB (2012). The “PIP scandal” – Complications in Breast Implants of Inferior Quality: State of Knowledge, Official Recommendations and Case Report. Geburtshilfe und Frauenheilkunde 2012; 72(3): 243-246.
 Maisel WH (2004) Medical Device Regulation: An Introduction for the Practicing Physician. Ann Intern Med. 2004; 140: 296-302.
 McAllister P, Jeswiet J (2003). Medical device regulation for manufacturers. Proc Inst Mech Eng H. 2003; 217(6): 459-67.
 McCulloch P (2012). The EU’s system for regulating medical devices BMJ 2012; 345 :e7126.
 Mellert F, Mallek D (2009) Medizinprodukte und Patientensicherheit aus der Perspektive des Klinikers. Bundesgesundheitsblatt (2009) 52: 584.
 Menean F, Menean N, Rometsch F et al. (2020). Maßnahmen zur Umsetzung der europäischen Medical Device Regulation bei klein- und mittelständischen Herstellern von Medizinprodukten. In: Pfannstiel M, et al. (eds) Consulting im Gesundheitswesen 2020. Springer Gabler, Wiesbaden.
 Schonhoff M, Heinze A, Carrillo J et al. (2019). Development and manufacturing of a custom made implant regarding the new European Medical Device Regulation. Current Directions in Biomedical Engineering 2019; 5(1): 253-256.
 Schrappe M (2005). Patientensicherheit und Risikomanagement. Med Klin 2005; 100; 478-485.
 Sorenson C, Drummond M (2014). Improving Medical Device Regulation: The United States and Europe in Perspective. Milbank Quarterly 2014; 92: 114-150.
 Veira-Schnitzler S (2012). Empfehlungen für das strategische Marketing von Medizinprodukten. Der zweite Medizintechnik Monitor identifiziert Schwa?chen und verwandelt sie in Potenziale. 2012: 1-3. Accessed 27/12/2019: www.medtech-pharma. de/userdir/cms/docs/infoletter/2012-4/120828_healiz__PM_ Medizintechnik_V2.pdf.
 von Merzljak S (2017). MDR: Mehr Patientensicherheit gleich weniger innovative Entwicklungen? Merzljak Healthcare Marketing 2017. Accessed 27/12/2019: www.merzljak.de healthcare-marketing-blog/eu-medizinprodukteverordnung-mdrchancen- risiken.