What Medical Device Regulation Might Mean for 3D Printed Patient-Specific Implants

You would be hard pressed to find a sane member of society who would advocate for a removal of all oversight in the field of medicine. However, that doesn’t mean there is common consent regarding the who, what, when, where, why and how of regulation. A parent of a child who could benefit from an experimental intervention may advocate for less regulation, while a doctor having seen the results of unforeseen consequences could heartily back increased hurdles before allowing interventions to be released for patients. Both would be working to secure what they see as the best interests of medical practice. In addition to these opinions and expertise, there is an enormous amount of money in play as companies strive to introduce their products into the medical marketplace and an incredibly powerful lobby working to help grease the wheels.

Any effort to address issues this complex are bound to be fraught with difficulties; whether they are failures or victories depends on the point of view of the person or entity evaluating the regulations, and the likelihood that any piece of regulation will be completely satisfactory to even one of the many stakeholders is nearly non-existent. It was into such complexity and contradiction that was born the European Union’s new Medical Device Regulation (MDR). Created in 2017, the regulations were given a three-year phase-in window to come into full effect in 2020, and producers and medical professionals alike are scrambling to understand how these regulations will affect them.

One particular group that is concerned about these new regulations are manufacturers of patient-specific implants (PSI), a development in the practice of medicine that has been made possible because of the capabilities of 3D printing to create custom devices, but on an industrial scale. The concern voiced in a myriad of ways by those who produce PSIs is that they will find themselves beholden to new restrictions meant to apply only to those companies who produce a single device on an industrial scale, not those that produce a multitude of individual devices, and they will find their operations greatly hampered by the new regulations in ways that were not intended.

The new regulations remove the exemptions for custom made for any devices that are manufactured on an industrial scale and therefore require that they have their own clinical data to demonstrate their sustainability. This could greatly impede their production, despite the fact that they have repeatedly been demonstrated to have positive impacts on surgical outcomes. As Bryan Austin, General Manager, Renishaw,  Medical and Dental Products Division explained:

“Traditionally, if a patient had a particular cranial tumour, a surgeon would first have to remove the tumour and close the wound. The patient would then require further CT scans to determine the size of the cranial plate needed, dependent on the size of the wound from the previous surgery. The surgeon would then perform a second procedure to insert the implant. Additive manufacturing removes the need for a second procedure by enabling pre-planning and the production of patient specific surgical tools, that define exactly the size of the wound that will be left. Having fewer procedures needed for the same result improves the process for both patient and surgeon.”

It is clear that Renishaw has a dog in this fight, but it appears that patients and medical practitioners do as well. The question is whether the regulation, which has already been passed and therefore must be addressed rather than lobbied against, will be executed in such a way that it hinders the great advances made in individual medical interventions that utilize advanced manufacturing technology. What Renishaw, and other manufacturers, are hoping is for the opportunity to influence the guidance documents that dictate the ways in which this new regulation is to be carried out.

There will be no resolution to this that will leave all parties satisfied; unfortunately, what is good for the group may not be good for the individual and vice versa. In addition, no any one interested party has an unfiltered ability to see what is best and disinterested parties are like unicorns, wonderful to consider but most likely non-existent. The key is to not throw the baby out with the bathwater, but to find some method for allowing the great benefits provided through the customization capabilities of 3D printing to continue without assuming that all industrially produced patient specific implants should be allowed to develop free of any type of oversight. The question is whether the regulations, and their application, will indeed be nimble enough to get out of the way and allow good things to happen or whether they will exist more as a cudgel to quash innovation.

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