Overcoming product development challenges in MedTech

The requirements placed on MedTech products in particular are extremely high. This is due to regulations that these products are required to follow, such as the European Union's Medical Device Regulation (MDR). It is therefore crucial to make a requirement specification early on. However, more and more companies are taking an agile approach to requirements, handling them more as if they were assumptions. Once verified, the assumptions are converted into requirements. This approach allows you to take small incremental steps and to avoid surprises in the end.

However, it is important to keep in mind that this approach is successful when you do not have all the facts. When developing MedTech products there will always be certain requirements that must be handled as just that, requirements, given certain regulations and standards.

Managing risks is at the core of the development process. It is a matter of proving that the product's benefits outweigh its risks and that it is safe. When you identify a risk, you should primarily try to eliminate the risk by redesigning the product. If this is not possible, always attempt to build protections around the risk. Should this also fail, issue a warning for the remaining risks. Though it is impossible to eliminate all risks, the success of your development process depends on how well you manage them. It is also vital to integrate risk management into the process early on. A risk discovered late in the process can critically impact the project delivery and result in delays and substantial costs. In the worst case scenario, you may have to start all over again. The earlier a risk is identified, the easier it is to manage. 

To succeed with your product development, it is of the utmost importance to verify all possible requirements. In addition to verifiying requirements, you also need to validate your product. It is one thing to make sure that the product has been produced correctly, it is another to validate it to ensure you have developed the right product. Successful validation is dependent on having a deep understanding of the customer and their needs.

Waiting until the end of the development phase to perform tests on your product can be detrimental to the outcome. It is therefore important to perform tests from the very start, to continue testing frequently throughout the project and to involve all disciplines in the testing.

For your product development to succeed, it is crucial to continuously communicate throughout the entire process. MedTech products are most often developed in multidisciplinary teams, a fact that only serves to emphasise the importance of effective communication. To avoid setbacks, stakeholders, team members, etc., must be continually updated and understand all aspects of the project.

It is also important to keep an open and curious mind and to dare question your requirements.

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