The market for medical devices for home use is projected to grow more than 20% to over $7 billion by 2027, driven by increased awareness of the importance of self-monitoring, an increase in lifestyle-driven diseases such as diabetes, and – in no small part– infectious diseases such as COVID.

But the home environment is a far cry from the usual clinical setting, and it presents unique challenges in product design. Key Tech’s Rachael Scott, Sr. Engineer, and Andy Rogers, VP of Business Development, talk about the challenges and provide valuable insights.

What you need to know:

1. How to work within the regulatory frameworks (FDA ANSI/AMMI 60601 -1 safety standards HIPAA, and more)
2. Why the home environment is more demanding than a clinical setting
3. When is the best time to test and de-risk
4. Where your design can go wrong and how to prevent it

The nitty-gritty:

Begin with a good understanding of the home environment. These considerations affect your choices in electrical safety, screen size, GUI design, portability, and durability. Expect the unexpected; untrained users, children, and pets are just a few wild cards that should figure in your design. Make sure you have a way to offload and disseminate results in a user-friendly way. Interfaces are always critical, especially where HIPAA compliance is required.. Above all, get your prototypes into a home environment early in the design stages, and give them this reality check frequently.

Helpful links:

https://www.fda.gov/media/84830/download