There has been significant media coverage regarding DIY or home-hacked medical devices recently – it makes a great story. Mainstream publications such as the The Washington Post and The Guardian have jumped on the idea of people adapting and ‘hacking’ their own devices, with a continuous blood glucose meter providing a reading to a hacker’s smartphone and watch, highlighted as a prime example. The hacker also published a ‘how to’ guide for anyone else that wants to go down this route too, although with plenty of caveats.
But having the detailed instructions on how to do things at home can sometimes go horribly wrong. Making a cake should be simple. Making a medical device is not, and close enough just is not good enough.
Making a hedgehog cake should be simple
The device regulations which appear to stifle innovation are, of course, there to keep patients safe from harm. So should we be worried about people taking matters into their own hands or should we admire their determination and innovation? Should regulation be further tightened or are there opportunities for us to learn and move device development forwards?
Firstly, let’s look at some of the reasons why this is happening and why people are experimenting with DIY devices; why do they adapt or create devices which provide or administer critical care and, at the greatest extreme, risk their health and lives?
Probably the biggest reason is that people’s expectations of technology are higher than ever before. We are constantly bombarded by advances in consumer products which make use of wireless communications, powerful processors, low-cost sensors, touchscreen displays and compact powerful batteries.
These consumer products are ever more affordable and it is estimated that there will be between 8 billion and 15 billion connected devices in 2017. Many of these technologies were not available to the consumer a decade ago, but now we are exposed to powerful and adaptable tools which build an expectation for everyday modern living. Medical devices which use old technology fall short of patient’s expectations.
“…now we are exposed to powerful and adaptable tools which build an expectation for everyday modern living.”
The medical device industry, however, is slower at adopting new technologies; often because of the longer development cycle of medical devices, some technologies either did not exist at the outset of the development, or were too immature and the risk of their inclusion was considered too great.
In September 2016 the FDA approved the first auto-insulin pump, described as an artificial pancreas (Medtronic’s MiniMed 670G – a device that monitors sugar levels in people with diabetes, and then automatically injects the required dose of insulin).
This system was first advertised on Medtronic’s website in 2010 but it has only just been approved for type 1 diabetes insulin users over the age of 14, and will not be commercially available until spring 2017. Waiting 7 years for a smart solution while you are suffering with a condition would be a great motivation for a self-made solution. Check out our research on life with type 1 diabetes.
“Many manufacturers are developing very similar devices to NightScout. However, getting a medical device through the very necessary regulations can take years and the marketed devices are then costly and out of reach for many sufferers.”
– Charlotte Harris
Cost is another reason why people are tempted to modify or hack their medical devices. Medical devices are typically perceived as being expensive for several reasons. Generally they are manufactured in lower volumes than consumer products, they always have a higher safety and quality overhead and they are often priced on value not on cost of production.
The issue of pricing has come into particular focus recently as some pharma and device companies have sought to capitalise on their monopoly and hike up prices. When affordability is lost it is inevitable that people will begin to explore DIY solutions.
All this leads to a lot of frustration, and whilst most people grudgingly accept that this is the status quo, there are those who are sufficiently driven and inquisitive, and have the right skills and tools to take things into their own hands. They are typically a younger generation who are not willing to compromise on their quality of life and have a greater curiosity around understanding and managing their disease better.
So what is the big deal? If people want to play around with their own devices, what is the problem?
One of the most successful DIY device hacks was with Dexcom’s continuous blood glucose meter. First hacked in 2013, several thousand people now send their readings to a smartphone running an app known as Nightscout.
One of the original hackers, Dana Lewis, a Seattle-based data analyst, created an artificial pancreas system in 2014 with her husband Scott Leibrand, a computer network and systems engineer. Their setup includes a continuous glucose monitor, (about $1000–$1400 plus $35–$100 per week for supplies); an insulin pump (about $5500 plus $100 per month for supplies); a pocket-sized computer called a Raspberry Pi (about $35 on Amazon); and a Carelink USB stick (about $100 on Amazon).
There are now at least 85 people using a homemade artificial pancreas, citing life-changing, improved control over blood glucose levels. Also the stress levels of dealing with diabetes have been slightly improved with this new system. As Lewis stated on her website DIYPS (the do-it-yourself pancreas system), ‘There could be some correlation with increased time/energy spent thinking about diabetes compared to normal.’ Her DIY solution has alleviated some of the burden of type 1 diabetes.
There are likely to be risk considerations and mitigations that are being overlooked by the hackers, either wilfully, or through ignorance. Medical regulations are put in place for good reasons – to ensure that devices and drugs are safe and when used correctly do not put patients at risk of harm or death.
It is, therefore, easy to condemn all medical device DIYers as cavalier developers, ignorant of the risks and regulatory processes that devices go through to ensure safety or mitigate harm, but there are lessons we can learn and take forward into future products and practices.
DIY developments highlight the fact that people’s needs are not being addressed, whether at a functional level or due to prohibitive costs, and this represents an opportunity for the medical device industry.
Acknowledge cost is an issue
It is important to acknowledge that high costs are a key driver in catalysing people into DIY developments, driving them away from safer, more beneficial products. Currently it is only public outcry that is putting the brakes on price hikes, but controls should be put in place to restrict such practices.
Think beyond the now
It is clear that we need to engage more closely and proactively with patients and consumers to better understand user requirements, not just based on current practices and available technology but to anticipate future scenarios and innovations. This may require companies to be more flexible in their development and regulatory approaches, and to challenge development teams to incorporate or make provision for the inclusion of more up-to-date and future technologies.
Channel the creativity
In the right context, hackers can be a beneficial resource to developments; one that some organisations such as the NHS in the UK are exploring. They are already trying to seize on the innovation of a wider community via hack days, where diverse groups of industry experts and patients are engaged to solve a range of problems by rapidly developing ideas and technologies.
Keep the problem in perspective
It is unlikely that there will be a flood of amateur medical device developers, as the number of people with the knowledge, skills and inclination to hack advanced technology is very limited. Current regulations already prohibit distribution or marketing without the necessary approvals, mitigating a mass take-up of such products.
However, with the slow pace of medical device development we will continue to see people experimenting, exploring the boundaries and capabilities of medical devices and occasionally putting their own lives at risk to advance their medical care.
Conclusion – stay hungry
Lastly, I think it is important that we, as an industry, remain hungry to develop the best products we possibly can. OK, we all have to do that within constraints of budgets, organisational structures and regulations – whether we are a two-man start-up or the biggest multinational – but let’s strive to create a culture in which people can be passionate and committed to developing the best possible products they can.