Only a small number of MedTech devices make it to the market – how to turn your invention into an actual health-promoting product

MedTech is one of the most heavily regulated industries in the world – and for a reason. It is extremely important that the devices entering the market are safe to use. However, the amount of research, risk analysis, and risk validation The European Union Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) require can be pressuring for companies.

"Due to that, only approximately 1 out of 50 MedTech devices make it to the market", says Antti Tolvanen, Sales Director for Software & Embedded at Etteplan.

The good news is that the challenges don't usually appear out of the blue. There are common stumbling blocks that can be avoided with better planning.

"Many MedTech companies entering the market are equipped with great ideas and skills in raising money. At the same time, these companies can lack the competence in engineering and understanding regulatory requirements", summarizes Andreas Algerbo, MedTech Manager of Etteplan Sweden.

Usually, problems start to appear when the regulatory requirements are underestimated. Also, companies are not always aware that they are developing a product for medical purposes. Due to MDR and IVDR, understanding the product classification is critical.

One vital but often overlooked part of the product development process is writing, translating, and validating user manuals. All companies developing MedTech devices are required to document the product development process to regulatory bodies. In addition, a more or less finished user manual is necessary for obtaining a CE mark. According to Algerbo, companies are often surprised by user information's significant role in the product development process.

"Companies tend to leave manuals to the last minute, which makes the process longer", he says.

Nowadays, an increasing number of MedTech devices are developed by utilizing a partnership model. Trying to develop complex devices and bring them to market without assistance is not usually wise – unless the spectrum of your company's core competencies is comprehensive.

"This is especially true when dealing with cybersecurity and AI. Companies should not attempt to build security infrastructure by themselves as it is expensive, inefficient, and always requires extensive expertise", Tolvanen states.

Whether it's a security infrastructure, quality management system, or for example, the translation and validation process of a user manual, it is a good idea to find an experienced partner to help your company during the product development process. Focusing on your company's core competence will not only increase the process quality but also save money. When every step is well planned, it is easier and faster to move forward – and see your innovation in use.