Playing by the rules: Regulatory requirements for connected medical devices

IDC’s MD, Stephen Knowles, advises about the regulatory requirements for connected medical devices

There is a lot of interest in connected medical devices. Could you explain the regulatory process for connected medical devices with data transmission?

SK:  The important thing is to always understand what you are measuring and how accurately you can measure it. So making sure the usability of the device is good, making sure the data is accurate and the user is using it correctly are fundamental first points. There is no point in transmitting data to a doctor or healthcare company if it isn’t accurate.

One of the big things you have to decide when you develop the medical device is what you are going to do with the data. If you are monitoring a heart rate remotely are you able to use the data to get help if the device detects an emergency? Or is the device monitoring long term to see how the patient progresses and the data is purely for monitoring to see if the patient is improving?

In each situation, if you want to make a medical decision on the basis of the data you have to be sure the medical device is complying to standards, is accurate and patients know how to use it properly so that they can get reliable results. These regulatory standards ensure that the medical device is just as good as any other medical device.

Data transmission doesn’t demand a lot of regulation, as long as you can show the data was in the device and has been accurately transmitted to the data centre remotely. If you have remote devices that work the other way around - with decisions made remotely and sent to the device to alter its operation and the patient’s treatment - that increases the level of regulatory requirements.

There is a big difference between medical devices for medical treatment and medical wellbeing and healthcare apps, which do not require rigorous testing.

Regulatory research for medical devices is normally carried out in the first phase of a development. What work is included in this?

SK: We start to think about regulatory requirements at the very first stage of the project. Key to the regulatory process is having a product requirement specification and a user requirement specification that defines what the user wants the product to do, what benefits the product will provide to the user, how they are going to use it and how you can make it easy for them.

The other key thing is to understand what classification of medical device it is. Medical devices are classified according to the risk level; in Europe they are separated into Class 1, Class 2A, Class 2B, and Class 3.

Timing is important for business; people want their product to be launched in the quickest time possible. What do you think about the relationship between marketing timing and the long regulatory process when developing products?

SK: The amount of regulation, testing and documentation to check the immediate standards and compliance with regulations can vary depending on the complexity of the product.

For simple products, the process can be very quick. If you are developing a complex machine or piece of equipment, then the process is more complicated. Following the correct regulatory route is essential. It may seem inconvenient to take an extra six months or year going through all the tests and approvals but planning this at the beginning can help.

IDC’s design engineers undertake the testing in addition to the design and development of the product. How does this help ensure the design complies with regulatory requirements?

SK: Understanding how to test and verify the product needs to be considered at an early stage of the project.

The product design specification outlines everything you want that product to do. If for example, you are developing a drug infusion pump, you would say it needs to not weigh more than 300 grams, it should be able to deliver between 5ml and 20ml per hour, etc. Once you have all of the specifications, you think about how to prototype and manufacture the product and how to verify the design and test it.

Time for testing can vary a lot between different types of products. Generally, simple products with fewer functions are much quicker to take through the process. The more features a product has, particularly with complicated electronics, the more testing required to meet standards. Typically projects need to plan for a few months of testing and certification with medical regulatory authorities.