4 MIN READ

What are your ‘respiratory’ development challenges?

Have you ever had the feeling that the biggest challenge for the respiratory industry is ‘having a clear idea of what to do in the first place’? If so, you are not alone.

Since we developed our first medical device project in 1988, we have been fortunate enough to work with lots of different people in the respiratory sector. Every now and then we like to poll our industry friends to get their views on trending topics.

Our (unscientific) surveys always lead to interesting findings and discussions. In the past, we have invited opinions on topics such as: “What is the future of inhaled drug delivery devices?” or, “How would you self-inject?”

From our 22 years working exclusively in the medical industry, we know that good device design is not only an engineering and technology development effort; it also includes a progression of activities from understanding the patients and business needs at one end, to industrialisation of the finished product for commercial sale on the other end.

So, back in December, at the Aerosol Society’s annual ‘Drug Delivery to the Lungs’ (DDL) conference in Edinburgh, we asked delegates who stopped by our stand to let us know ‘where were their device development challenges’? The 6 stages are:

1. Requirements definition
2. Concept generation
3. Proof of principle
4. Detailed Design
5. Pilot Manufacture
6. Industrialization

medical device development challenge

At DDL our visitors got up-close-and-personal with our stand by placing a sticker next to the development stage they felt presented them with the most challenges. Any one from the industry was welcomed to take a sticker whether they were respiratory focused people, device engineers, formulation scientists to programme directors and specialist consultants. Here’s what we found out:

medical device development challenges

It seems that by far most challenges for new inhalation product development occur at the very beginning of the process with requirements definition. For many visitors we spoke to, this means correctly understanding the patient or user needs at the outset (from disease profiling to understanding use scenarios). For others this development phase also meant understanding the product ‘life-cycle’, a current hot-topic for smart devices, where the data infrastructure and device re-usability all form part of the ‘big picture’ for implementing new technologies into medical devices.

Some people we spoke to also felt that the biggest challenge came from making good decisions when understanding and defining requirements. This group also mentioned that facilitating innovative and collaborative decision-making with all stakeholders can be particularly complicated.

Coming in second place were challenges linked to the industrialisation phase (or production scale-up). At Team, we know this challenge needs specialist expertise and skills as it typically involves multiple teams and companies working together.

In some ways, it should come as no surprise that the requirements definition and industrialisation stages are the most challenging for device developers. The choices that are made at the beginning of the development process will have a big impact on the final product design and its ultimate success. It is, after all, in these critical stages that the complexity of the user needs, the commercial constraints, and the regulatory processes need to align.

If you are having problems or need some support with either defining requirements or industrialisation, please contact us. We have expert teams in both areas (and the stages in-between) who can help you out!

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