The medical devices market is challenging for companies. Not only do they have to work with increasingly complex technologies, but they also have to navigate tough quality and regulatory hurdles.
It is an attractive market and the effort it requires, although considerable, is worthwhile. But, in order to avoid costly teardowns and redesigns, engineers need to have a clear understanding of the regulations they need to comply with.
If you are looking to sell product into Europe, a thorough understanding of EU regulations and standards is crucial and the primary sources of medical device standards are the International Organisation for Standards (ISO) and the International Electrotechnical Commission (IEC).
Each issues international standards which will, potentially, apply everywhere, but medical devices must also have certified approvals from the nations in which they may be sold.
In Europe, companies looking to place a product in the market legally must meet the requirements of the EU Medical Device Directive.
“The underlying Medical Device Directive has been around for many years,” explains Rob Smith, technical director at Docobo, a provider of telehealth products and services. “It covers anything from a plaster to an MRI scanner. It is broad in its coverage, incorporating electronics and software. It is a general principle; a set of rules, that will determine what your device is – is it delivering therapy or obtaining information for a clinician to make a decision in order to make an intervention?”
“Many companies fail to appreciate the complexity of getting a medical design approved,” suggests Collette Johnson, medical director with Plextek Consulting. “Alongside strict safety rules, they also need to be aware of rules that are associated with issues such as manufacturing procedures and the traceability of resources. That’s especially important for SMEs, who will be looking to outsource production.
“The main standards are dictated by ISO 13485, which addresses the quality system requirements. Underneath that sits EN60601, a standalone standard that talks specifically about safety.”
EN 60601 is a family of standards that covers the safety, essential performance and electromagnetic compatibility of Medical Electrical Equipment and Safety and covers a range of medical devices, such as defibrillators, monitors, lasers and incubators. In fact, there are more than 80 specific standards within EN 60601 that will be relevant to specific devices.
“EN 60601 itself is quite open,” says Smith. “It is the specific device standards which are tighter.”
The EU Medical Devices Directive is currently undergoing revisions; not only will there be amendments to existing electrical and diagnostic standards but, with the rapid growth in wearable technologies and in the Internet of Things, it will also encompass digital health.
“It will look to cover a wider range of products; things that, until now, have been open to interpretation. We expect it to be tightened up, more prescriptive, with the onus on industry bodies to manage, maintain and regulate standards,” suggests Smith.
“There is a great deal of regulatory complexity and standards are updated regularly,” Johnson says, “which means you need someone within your organisation, such as a quality manager, who has responsibility for keeping abreast of new regulations.”
Smith agrees, but suggests that employing a quality manager may not be possible for smaller companies. “We use consultants every six months to track changes. For a company our size, it is the most cost effective way of monitoring updates.”
Information on regulations is readily available, but it is the company’s responsibility to be aware of changes to them.
In the UK, the British Standards Institution (BSI) has an important role to play in informing companies of updates to regulations and providing training in understanding the labyrinthine medical regulatory environment. BSI provides a subscription service so members can receive updates and changes to relevant standards – most companies don’t want to have to check for updates manually or compare standards in different countries, but need to be aware that even the smallest iterations to regulations can impact a design.
There is less push when it comes to the EU in terms of information about amendments, so the onus again will be on the company to keep abreast of changes.
“In this market, standards dictate everything,” Johnson suggests. “You have to look at every aspect of a device. In the case of a glucose monitor we worked on, we found 60 different regulations to address before it could get to the market. And that is in a relatively simply device classified as 2A.”
There are four distinct classifications for medical devices, all of which bring with them different levels of complexity. This, in turn, will impact on the standards that are relevant.
Devices are classified as 1, 2A, 2B or 3, where 1 includes bandages and plasters; 2A includes electronic devices, but only those taking measurements or readings, and not diagnosing an illness; 2B includes diagnostic systems, while 3 covers devices that will be internal to the body.
“As an electronics design consultancy,” says Johnson, “we get companies coming to us with ideas or a product originally intended for the non-medical sector that needs to be developed. Many have no idea how much work is involved in developing products for the medical market; even in a simple device, getting the approvals required can add nine months to the time to market.
“From the idea – and as soon as possible from the development stage – you need to set up a technical filing system to house what is called a technical file. Everything has to be traceable from day one and recorded in that file. You then have to look at the system you’re designing – what are its key aspects?
“If we take the example of the glucose monitor, if it is linked into a mobile phone, we would have to look at the monitor and the electronics in the mobile device. How is the data sent between devices, how does the phone take a reading and where is the data stored – in the cloud, for example. We then look at each part of the system and determine which standards needed to be addressed.”
You also need to consider which market you will be going into – the EU, Far East or the US – and, if the device includes wireless capability, different wireless standards will have to be identified and installed.
A recent and significant change is that consideration now has to be given to the device’s usability – how do people use the device, is it intuitive, or could the user’s disease prevent them from using it correctly.
While IEC 62366 refers to usability only, the US FDA currently requires the issue is addressed when filing a medical device. Europe provides guidance, but expect that to become a formal requirement in the revised EU Medical Devices Directive.
The medical devices market is growing and the opportunities are there; just be aware of the regulations and standards relevant to your products and, most importantly, engage with clinicians and patients – those who will be using the technology.