What is the future for DIY medical devices?

Many of the often simple fixes that Anna discusses in her talks, such as string to reduce the weight of hoses attached to patients, or devices to stabilise tracheas that were more comfortable than the commercially available alternatives, were workarounds developed to address poor fitting designs. In order to empower these nurses, last year, Anna and the team at MIT set up a series of ‘medical maker spaces’ in hospitals globally. These spaces are equipped with tools more at home in a model maker’s workshop ranging from basic hand tools (such as screwdrivers and hand saws) through to more expensive, state of the art, prototyping equipment (such as 3D printers and laser cutters).

These ‘maker spaces’ are also equipped with ‘selfie-stations’ to allow ideas and solutions generated to be captured, documented and shared. This makerhealth movement is proposed by Anna as an alternative to so called ‘black box’ medical device design in the established supply chain. Such that products are generated by healthcare providers, shared, and then replicated in hospitals across the globe. And the vision is not simply limited to healthcare specialists. Anna sees a future of patients arriving, not just with ‘Google diagnoses’, but with prototypes and 3D printed objects that they have developed to improve their care and quality of life – such as clips made to manage their catheter tubing. 

The second talk, given by José Gómez Márquez, also of MIT at the Little Devices Lab, was a presentation along a similar theme (José presented a similar talk at Stanford Medicine X 2013 that is available to view online). The focus of José’s presentation was ‘how do we empower the populations who actually use the medical devices to make them themselves’. Unlike Anna’s talk, the message was not just about addressing unmet needs, but also about saving cost. In his online talk, José uses the example of a fairly standard cauterizing pen. He questions the $25 price tag, given that a teardown reveals approximately $3 worth of materials.

There is clearly something exciting about the vision presented in both talks. The idea of better medical devices, informed by end-user experience, is of course compelling. Likewise, given the funding challenges facing nearly all healthcare systems, the so called ‘democratisation’ of medical devices and the global access to cheaper products looks to offer a great hope for the future. From a human factors perspective the makerhealth movement is both very exciting and very scary. The exciting bit is that it’s truly user-centric. Because these devices are developed by people with clinical experience, they build on an understanding of the user requirements (the particular user developing the device at least) and the context of use. The scary bit comes in when we consider the steps that have been missed in a best-practice medical device development and manufacturing process, and the effect that this could have on the safety of the product.

These best-practice processes are configured to look beyond a single user, in a single context and environment to develop devices that are safe and effective for a wide range of users, behaviours, usage scenarios, and environments, for their entire life time. To achieve this one needs a medical device development process that conforms to the required regulations to deliver safe and effective products, such a process should include for example; systematic and detailed risk assessments, simulated use trials, careful materials selection, thorough analyses, production representative prototypes and rigorous testing. The manufacturing process also requires controlled development to deliver consistency but also to understand and analyse the possible effects of the manufacturing variation that cannot be avoided. Once manufacturing starts, the supply of material must be controlled, devices must be checked during the assembly process and then regularly sampled and tested, to check that sufficient consistency is being achieved, as part of ensuring the designed in safety and effectiveness is maintained. To those from a medical device development, or safety critical, background the idea that a product can be developed sidestepping these stages and then shared with the world to replicate in an uncontrolled way is nothing short of terrifying. And that is without even considering the very real issue of intellectual property rights: the risks of infringing other’s patents and how to protect the new designs to avoid exploitation.

In his online talk, José reminds us, of course, that the maker movement is in fact not entirely new. He uses the example of Dr Andreas Gruentzig, who developed the first balloon angioplasty prototypes in his kitchen after work, or Earl Bakken, who made the first wearable pacemaker in his garage. But the clear point of difference is the separation between early concept design and subsequent controlled detailed design and manufacture that has been disregarded in the modern maker movement. Although the products developed by Gruentzig and Bakken were created in kitchens and garages they were then developed as medical devices with suitable safety practices and controls.

Returning to the question posed by José Gómez Márquez in his Stanford X talk, ‘why does a cauterizing pen with $3 of materials cost $25?’ At least part of the answer lies in the cost required to get these products to market. Quite simply, it takes significant time, resources and a great deal of expertise to follow a systematic development process that considers a wide range of users, behaviours, usage scenarios, and environments, to create a safe device design that avoids others intellectual property and to develop and control the manufacturing process to ensure that the every device produced meets the same standards as the first.

So yes, it’s certainly possible to get a lot closer to this $3 price tag if the rigour is removed from the process, but is this genuinely desirable, or in fact, something more of a retrograde step? The exact balance between development cost, thoroughness and safety is never going to be easy to define, particularly when cost becomes a barrier to purchase; however, it is contended that this would be better addressed by evolving the regulatory process rather than side-stepping it completely and failing to put anything in its place. It could, of course, be argued that the risks associated with some products are low, and thus a DIY approach could be more acceptable. However, in these scenarios, if a rigorous development approach is followed and low risks are identified, then the development of a safe product will be relatively quick and simple anyway.

So what is the alternative? Well arguably, one alternative is already a reality for many medical devices manufacturers. Many manufactures have in-house human factors teams, or partnerships with consultancies, and are doing research at the point of use. These teams are already mapping stakeholder needs and values (not just clinicians, but patients, and those involved in manufacture, cleaning and servicing) and ensuring that these needs and values are considered throughout the design and manufacture process. What’s more, they are involving these stakeholders in participatory design, ensuring that current workarounds are explored, unmet needs identified, and that product prototypes are evaluated and iterated throughout the design process.

That said, we of course shouldn’t be complacent, there are also device manufacturers that require further change to get to this point. Better channels of communication between stakeholders and end-users should be encouraged so that new product ideas and existing product improvements can be ‘pushed’ to manufactures rather than ‘pulled’ from the market to fit with the manufacturers development cycles. A version of maker spaces that allows insights to be shared and co-creation to take place may serve as an excellent conduit for this; however, it is proposed that a very clear line is drawn between what is experimentation and exploration of design problems, and what is the final definition and controlled manufacture of medical devices which can be highly safety critical.