How do you turn your invention into a product that truly promotes health?
New MedTech devices are in urgent demand to better meet the needs of the increasingly aging population. Yet, Etteplan's MedTech specialists estimate that only a handful of MedTech ideas end up turning into actual products.
MedTech is one of the most highly regulated industries in the world - and for good reason. It is extremely important that the devices that come onto the market are safe to use. The amount of research, risk analysis and risk assessment required within the European Union in terms of Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) can create a lot of pressure for companies.
"As a result, only about 1 out of 50 MedTech devices ends up on the market," said Antti Tolvanen, Sales Director for Software & Embedded at Etteplan.
The good news is that problems usually don't just fall out of the sky. There are common stumbling blocks that can be avoided through better planning.
Taking every step seriously
"Many MedTech companies entering the market have great ideas and fundraising skills. At the same time, these companies may lack expertise in engineering and an understanding of regulatory requirements," summarizes Andreas Algerbo, MedTech Manager at Etteplan Sweden.
Usually the problems arise as a result of underestimating the legal requirements. Also, companies do not always realize that they are in the process of developing a product for medical purposes. In view of MDR and IVDR, understanding the product classification is crucial.
However, one crucial part of product development that is often overlooked is the writing, translation and approval of user manuals. All companies developing MedTech equipment are subject to the requirement to document the product development process for regulatory authorities. In addition, a more or less completed user manual is required to obtain a CE mark. According to Algerbo, companies are often surprised at the large role that user information plays in the product development process.
"Companies tend to put off writing the manuals until the last minute and this prolongs the process," he says.
Accelerating the process with a business partner
Today, MedTech devices are increasingly being developed within a partnership model. It is usually unwise to attempt to design and market complex devices without support -unless your company has a broad range of core competencies.
"This is especially true for things like cyber security and AI. Companies are better off not trying to build their own security infrastructure, as it is expensive and inefficient and always requires extensive knowledge," Tolvanen explains.
Whether it is a security infrastructure, a quality management system or, for example, the translation and approval process of a user manual, it is a good idea to find an experienced partner who can assist your company during the development process. By focusing on your company's core competency, you will not only increase the quality of the process, but also save money. When each step is planned well, it simplifies and accelerates the progress and thus the commissioning of your innovation.