Fine-Tuning Your Medical Device – Learning from Philips Sleep Apnea Case

A medical device that is supposed to help patients with their health conditions can instead cause new problems for the patients. We have learned about this from the case of Philips’ sleep apnea machine, which forced the company to withdraw millions of their sleep apnea and ventilator devices because of technical malfunctions in 2021.

However, in April 2023, Philips again urged the customers to send back 1,200 repaired sleep apnea devices for further inspections, due to some technical problems that can pose certain health risks for the patients. From this case, we can understand that it is very important for companies to fine-tune their medical devices to ensure that they are suitable for long-term use.

The Most Common Causes of Medical Device Failures

It’s best to understand the risks of failures in your medical device and avoid them at all costs. Here are the most common causes of medical device failures:

• Bad product design. How you design the medical product will affect how the product will work, meaning that whether the product will be comfortable to use will also be affected by its design. The bad product design might lead to the failures of your medical device, especially when you use it for the long-term.
• Lack of risk assessment. How risky is it to use the medical device on the patients? This is the first question that you will need to answer, and until you can answer this question with complete confidence of the low risk use of the device, you shouldn’t take it into production.
• Not enough testing before mass production. Testing is also another phase of the medical device development that you need to undergo before releasing the device to the public. Not enough testing and prototyping can cause failures in the medical product, especially the failures caused by unforeseen circumstances. Use prototype tooling to avoid this problem.
• Bad assembly design. How you assemble the medical device will also affect the quality of the device itself. It will determine how secure the device is when it gets assembled and how each device component can work well with each other. So, a bad assembly design can also ruin the device’s function and cause problems later on.
• Bad material choice. In the case of the Philips sleep apnea machine, the foam materials get degraded over time and cause bad problems for the patients. Some materials, such as foams and rubbers, which can degrade over time, will not be able to provide you with the best long-term use, and they can cause problems that can be fatal for the users.

Fine-Tuning Your Medical Device Development Process – How You Can Avoid Failures

1. Spend more time to test your device. Device testing is not some pastime you can do just to fill your schedule, as it is an important part of your medical device development. The testing process will reveal various issues you need to fix about the medical product, so that you can fix them before launch. You can use the services of good rapid prototyping companies for the best results in your prototyping and testing.
2. It’s best to focus your device development on your users. Instead of focusing the device development on how it can make profits for the company, the users need to be your first priority. Develop the device so that your users can use it with comfort, and be sure to aim for the highest satisfaction for your users.
3. Streamline your product design. Don’t make your medical device design too complicated, as it will only ruin the function of the device later. Make the design as simple and as streamlined as possible, and cut down on various complex shapes or geometries if you don’t really need them.
4. Pick high-quality and durable materials. You also need to ensure that you only use the durable and high-quality materials for the device, while providing official replacement for the degradable materials, such as foams or rubbers.
5. Collect feedback and respond fast to it. Always collect the feedback from real users and be quick in responding to them. Use the feedback to increase the quality of the device further.

Conclusion

Learning from the case of Philips sleep apnea and ventilator devices, it’s best for you to perfect your medical device by testing it and figuring out the risks of using it before releasing it to the public. Make sure that your device is sustainable for long-term use without causing any health problems for the users.

TEAM Rapid can walk you through the entire prototyping process for a wide range of industrial projects, including medical, pharmaceutical, and other related industries.