medical device design
Creating Cutting-Edge Solutions For Health Issues
A medical device is an instrument, preventative device, or piece of diagnostic equipment used to treat medical conditions. A device might require approval by the FDA, or other regulatory body, to prove its safety, effectiveness, and user-friendliness. While there are rules and regulations that need to be followed for your product to be approved, there are still a lot of unique devices you can create.
Designing medical devices is intensive, especially to ensure success throughout the process. Medical device designers must closely monitor various aspects, including health regulations and user experience. Every stage, from initial design to final usage, requires careful tracking and adjustment.
Examples Of Common Medical Devices Designed For Daily Use
Medical device design doesn’t just exist within the bounds of a doctor’s office. Many medical devices are designed to be easily used by the average person, as medical problems don’t just happen at doctor’s offices. Items like band-aids and contact lenses are considered medical devices and extremely helpful to many due to their availability.
Here are some examples of medical devices you’ve likely encountered in your day-to-day life:
Hearing Aids
This device is essentially a noise amplifier small enough to fit in your ear. Designers have carefully incorporated a microphone, speaker, and battery into the space of a single earbud. Modern digitized hearing aids can also be adjusted for different environments, and many offer compatibility with smartphones.
Insulin Pumps
Insulin pumps are designed to help monitor and stabilize the insulin levels of people with diabetes. These pumps use intravenous devices to both monitor and stabilize levels of insulin. This helps keep blood sugar levels where they need to be without much input from the person.
Wearable Fitness Monitors
Monitoring fitness progress was challenging until products like the Fitbit and the Apple Watch were created. These pieces of technology are designed to track heart rate, sleep patterns, and many other metrics so that the everyday person has that information at their fingertips. While not technically classified as medical devices by the FDA, the information can help many people track their general wellness without affecting their health.
Pacemakers
Pacemakers are devices that are surgically installed inside a patient’s chest to help keep your heart beating at the same rhythm. These devices send small pulses of electricity to prompt the heart to beat normally. While not used by everyone, pacemakers are carefully designed for constant use.
These devices are incredible examples of how a device can help with the day-to-day health of average people. However, these devices barely scratch the surface, as many medical devices like MRI machines or stethoscopes need trained professionals to be utilized correctly and aren’t common outside a medical office. Each of these devices needed a team to design and create it.
Design Controls In Medical Device Design
One of the most significant parts of medical device development is ensuring the designs comply with FDA rulings. Regulations held by bodies like the FDA, Health Canada, and the European Commission want to ensure devices are safe for public use. If a medical device is successful and valuable, it will be used widely. If there are significant malfunctions or design flaws, or if it doesn’t adhere to regulations, the device must either go through revisions or be scrapped.
The guidelines for design controls outlined by different regulating bodies provide a framework for the design approach. Successfully implementing this system requires a wide variety of professionals from both technical and non-technical backgrounds. These guidelines cover everything from initial design phases to distribution.
Many regulating bodies worldwide follow ISO 13485. However, the FDA uses a different clause when regulating medical devices: FDA 21 CFR 820.30. Before designing a medical device, it is crucial to get familiar with these regulations.