Skip to content

Five missteps to avoid when starting to develop MedTech devices

A groundbreaking meter for biohackers? A handy gadget for surgeons? On the surface, the process of developing a MedTech device looks no different compared to other devices. However, due to heavy regulations and the high level of expertise required (specification, verification, and documentation) during the process, only a small number of MedTech products currently make it to the market. Setbacks can be avoided with better planning and assistance.

We sat down with our experts and gathered the five most common pitfalls in the design and manufacture of medical technology products and ways to avoid these.

1. Underestimating regulatory requirements

Companies that develop medical devices for the European market must follow MDR or IVDR (Medical Devices Regulation/In-vitro Diagnostics Regulation) to ensure safety. 

One simple but often overlooked step is to identify whether your device actually is under the applicable scope of MDR or not. Rather than guessing, it's wise to take regulations by the horns at an early stage.

2. Leaving manuals to the last minute

Technical documentation plays a crucial role in all stages of MedTech devices design and production. However, user manuals creation is often left too late. Manuals and instructions are necessary for the device to obtain the CE mark, and they play a significant role in marketing, too. 

MedTech companies must translate user information in the languages of the intended markets and validate the translations to avoid risks caused by misunderstandings. This can prove to be very time-consuming, so an early start in the process is a good idea!


3. Not taking cybersecurity seriously

The importance of cybersecurity is constantly increasing as more and more devices are connected to the internet. The demands for cybersecurity are even higher when AI is involved. 

It is wise to keep in mind that after the recently published General Product Safety Regulation proposal becomes effective in the EU, it will no longer be feasible to any products into the market without appropriate cybersecurity features. Market authorization procedures will become a struggle if a connected MedTech device is found lacking in cybersecurity measures.

4. Forgetting to integrate DfMA (Design for Manufacturing and Assembly) early in the development process.

Design for manufacturing and assembly (DFMA, DFM/A or DFM/DFA) processes allows companies to develop high-quality products at lower production costs quickly. No wonder it's gaining momentum.

DFMA combines two methods, Design for Manufacturing (DFM) and Design for Assembly (DFA). This combination enables efficient manufacturing and easy product design for assembly. In DFMA, the product design is informed by how it will finally be manufactured and vice versa. The design can be developed in accordance with manufacturing capabilities while eliminating multiple revisions and design changes that cause program delays and ultimately more costs.

5. Failing to prepare for the post-market surveillance

Companies need to follow and improve their product's safety and usability even after being brought to market. In addition, keeping the product's cybersecurity up to date can also mean redesigning the product itself or rewriting user manuals to comply with the device's intended use. Companies developing MedTech devices are also required to document and justify the upgrades they make to guarantee the safe use of the product. 

Due to increased demands on post-market surveillance, companies now need to have a post-market surveillance plan. Finding a partner with experience in MDR, post-market surveillance, and the clinical evidence required for the process will help avoid setbacks.

Setbacks can be avoided, time to market can easily be reduced and generally ensure market entry through better design and assistance. It will give your company a great benefit to find a partner with expertise in regulatory, R&D, design, MDR, connectivity and cybersecurity.