According to the National Statistics Office, the population of the United Kingdom will reach 76 million people by 2045 and nearly 25% will be 65 or older. The impact on health and social services will be important – and this will create an opportunity for innovative healthcare devices.
Your company may have an idea of such a device, but if you have no background in developing medical device products, what process should you follow and, most importantly, how long will it take? -it?
Helen Simons, quality specialist for product and technology design firm Cambridge Design Partnership (CDP), said the market you are about to tackle is the first thing to decide. “For medical devices, the two main markets are Europe and the United States, and other health authorities tend to meet those requirements, although some, such as Australia and Canada, are beginning to develop their own regulations.
“If you are targeting Europe, your product must comply with the Medical Devices Directive or the” In Vitro Diagnostic Regulation “, both of which have recently been updated to replace the previous directives.” This regulation is required by law. ” EU leaves, already blurs the waters, said Simons. “This is confusing, but it is likely that the regulation on medical devices is subject to UK legislation, but it is not clear how.”
The good news is that European and US regulations are published on the Internet and can be downloaded for free. The bad news is, if the term is appropriate, the volume of information.
James Baker, a CDP partner, said: “Let’s take the example of security: the high security standard is 424 pages with 455 clauses, and there are still 92 standards to understand why people feel discouraged.
Simons said that one of the most important standards for the development of medical devices is ISO13485. “This is a quality management standard and the medical equivalent of ISO9001, and many companies choose this approach because it provides them with a framework to meet most of the regulations, including control of the design process.” There is also ISO14971, which covers risk management , Although no standard is prescribed, it is likely that everything is fine.
Three other important standards must be consulted in parallel. “The IEC60601 standard includes a whole range of standards,” says Simons, “and the part you use depends on the type of product being developed, IEC61010 includes test equipment, while medical software is covered by IEC62304 Three approaches have risk-based approaches and levels of control, and while these standards are essential, others need to be consulted. ”
“If it’s not written, it did not happen.”
Baker said that CDP has a long history of product design in regulatory frameworks. “We’re also doing more awareness training, and this is becoming more and more relevant to 60601-1 – medical electronics – traditional mechanical products now include electronics and sensors, so companies in the mechanical industry need to plan more in integrating electronics.”
Patience is a virtue when designing for the medical sector. “The mind is important,” Baker said. “When a market opportunity arises, some companies will find the rules cumbersome and try to move quickly, so my advice is to take their time, because if you go too fast, you can project into a corner, and you may have to Rebuild the project completely The best approach is defensive design, really analyze your product, and make a decision on how the design fits. ”
So, where do you start? Mr. Simons said, “It’s very important to think about your design from the beginning because the authorities need documentation, proof that you know how you will produce it, take the idea that it did not happen if it was not written Write a statement about the purpose – who will use it, why, where it is made, this will help generate the design inputs and parts of the rules you need to follow.
Baker focused on the software development process. “With this approach, you need to show that you have considered the process from start to finish, you need to show that you have analyzed the project, how to provide the functionality, and how to test the software against the requirements reached the V-model.
Simons added, “The software must be thought of at the beginning of the project because you can not always prove that the software does what it needs to do.”
Risk management is another important element. “Wrong could lead to a hardware overhaul,” warned Simons. “If you think at this time, you can save a lot of time and money.”
Baker explained that CDP’s approach to medical design is to examine how each element of compliance is handled. “It depends on how you designed the product – for example, you might decide to remove software from safety-critical aspects and manage that element with hardware – it’s about understanding the design and the documentation you provide for proof of conformity.
Do not worry about generating too much documentation. Mr. Simons said, “The amount of paperwork that is made available is about twice as large as that of a consumer product.” A draft was linked to 20 document binders, even before production.
Security is another element of risk management. “60601 has two elements – basic safety and essential performance,” noted Baker.
“For example, it’s never safe to kill a person, and the device has to perform well, even if it’s going badly, because it could endanger people.
“The device needs to be critical, even if it’s going badly.”
“When you analyze the design, you ask what happens when a component is broken or shorted, or if the value is incorrect? At this level, you need to prove security. Ask what happens at a single point of failure as your device continues must be safe. ”
Mr. Simons added, “Although consumer electronics simply break down, a downtime medical device could be risky, so it’s necessary to perform a gentle shutdown, and think about the safety of the design.” “If you develop an implantable device, what do you do?” If it does not work?
Regulations and associated evaluation periods present a challenge that can lead to faster time to market, which may hamper innovation as companies use proven designs. “Even if you’re upset,” Simon said, “it will take at least two years to market a medical device.” Baker added, “For more complex devices, it could take four years.”
Both have pointed out that the standards are there to help you, so take the time to read them and go through the details. “Remember,” concluded Simons, “if you do not consider guidelines and standards, you have no product – you have only one concept.