10/02/2021

It’s like a familiar song now – regulation can’t keep up with innovation, but there is a sharper, more distressing edge when its medical technology racing ahead of the law.

As the COVID vaccine illustrates, the traditional regulatory approval processes for life saving or changing medical technology take time – for good reason. In the past, afflicted individuals had no choice but to wait out the regulatory process, but the wider community benefit of safety was seen as outweighing those individual costs.

Today, with the growing sophistication of consumer technology, use of open source software and the use of social media for instruction, the response to regulation not keeping up with technology is DIY. A recent example is the grass roots push for self-administering tools for diabetes.

The #WeAreNotWaiting movement

Frustration has been building amongst people living with diabetes (PWD) and their families at the slow pace of research, innovation and technological developments for new and better medical solutions. Currently PWD need to constantly monitor and manage the level of insulin in their bodies. There had been hope that medical device companies would quickly and resourcefully develop the ability for glucose monitors and insulin pumps to ‘speak’ to each other and automate the process of insulin delivery into the body. This is known as a closed looping system. But to date, there are few commercially developed devices globally and when available, costly.

In response, PWD, including regular mums and dads, developed their own ways of making glucose monitors and insulin pumps connect to each other and shared their DIY solutions to others in the community using the internet: the #wearenotwaiting movement.

A typical online story starts with a parent, after discovering the painful news that their young child had acquired a lifetime illness, realising that there is no medical device to assist their child manage insulin. Out of desperation for a better life for their child, they became a self-learned researcher and engineer, delving into the world of the DIY looping systems, testing different ones distributed on the internet: In the story featured in Melbourne University's Regulation of Innovation Tech in Health webinar, parents tested 3 devices over 18 months on their small child. If they find or build a successful device, the parent’s story usually ends with an explanation that as well as the usual benefits of automation (increased consistency, optimisation and reliability), the benefits of DIY looping extend to an improved and carefree quality of life for their child.

The policy dilemma

There are always two sides to a DIY creation story. On one level, the DIY initiative is an expected outcome of technological innovation. The DIY movement illustrates a gap in the market and puts pressure on professional developers to simplify and reduce costs of these commercial products.

Yet, the risks associated with DIY medical products are not insignificant. Medical devices are highly regulated for a slew of valid reasons (an obvious one being safety) and hence processes are slow moving.

With a lack of published research that supports the safety and effectiveness of DIY closed-loop systems, healthcare professionals are voicing concerns about the potential risks of the open source software and lack of regulatory approval. These concerns are also intertwined with fears of legal consequences or disciplinary action should the healthcare professional choose to advise people on diabetes management based on data obtained from DIY closed-loop systems or if a patient came to harm from either hyper- or hypoglycaemia as a result of using a DIY system. Insurance companies are also deterred from offering this type of cover due to the unfamiliar range of risks not mainstream in other practices.

#WeAreNowListeningRegulation

Although one answer to the DIY innovation push is addressing slow regulatory processes, the larger answer may lie in collaboration by bringing the “patient scientists” into the regulatory process.

Recently, the FDA in the US has working to create new pathways for commercial and community organisations to work together on medical technology development. The world of medical regulation can be densely populated with working groups and committees but as these are often (to borrow the PWD terminology) a closed loop between regulators, medical professionals and the medical companies. In its toolkit for Collaborative Communities, the FDA explained its new approach as follows:

“The hallmark of a Collaborative Community is a continuing forum where public and private sector members proactively work together to solve both shared problems and problems unique to other members in an environment of trust and openness, where participants feel safe and respected to communicate their concerns….We will enable our customers to take a more active role in the advancement of smart regulation and the rise of Patient Scientists — those scientists, health care professionals, engineers and others who focus on serving the unmet and developing needs of patients and who incorporate their own experiences as or with patients into their work in industry, health care, and government. Admittedly, these goals take a more holistic approach to improvement than our priorities of the past.”

Last year, Medtronic, a commercial medical device company announced its partnership with Tidepool, a community-based developer, to deliver an officially supported, FDA-regulated Loop application. Medtronic recognised that “collaboration with Tidepool is a way to further drive industry innovation”. This is a first-of-its-kind project with promising results.

#DIYMedicalHeretoStay

The growing sophistication and capability of technology and the internet will blur the boundary line between commercial products and DIY applications. There are sound policy justifications that underpin the current medical devices regulatory model, but we also need to consider the extent to which those regulatory process implicitly protect the ‘professionalisation’ of medicine (and the legal processional is not necessarily any different here in how it benefits from regulation). A ‘Whack-A-Mole’ approach which tries to close down each attempt at a DIY medical innovation ultimately seems futile given technological change. A more open approach which tries to more constructively harness the passion, commitment and anguish of ‘patient scientists’ may provide a more sustainable approach.

Authors: Kelly Cai, Anna Belgiorno-Nettis and Peter Waters

""

""