There is an urgent demand for new MedTech devices that help meet the ageing population’s needs. Still, according to MedTech experts at Etteplan, it is estimated that only a handful of the MedTech ideas ever make it and become actual products.
IN SHORT
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There is an urgent demand for new MedTech equipment to better meet the needs of the increasingly ageing population.
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MedTech is one of the most highly regulated industries in the world - and not without reason. It is extremely important that the equipment coming onto the market is safe to use.
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"As a result, only about 1 out of 50 MedTech devices eventually reaches the market."
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.
“Due to that, only approximately 1 out of 50 MedTech devices make it to the market”
Taking every step seriously
“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.
“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”
Speeding up the process with a business partner
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.
TIPS
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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 required to document the product development process for regulatory authorities.
Dit is de kop
Today, MedTech devices are increasingly developed within a partnership model. It is usually unwise to attempt to design and market complex equipment without support - unless your company has a broad range of core competencies.
Dit is de kop
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 to assist your company during the development process.
