ABHI Update: The Potential of Additive Manufacturing
Additive manufacturing is a hot topic right now.
From food and clothing, to home and building materials, the potential of the field is vast, with many companies across the globe investing heavily in its future.
And when it comes to adopting such approaches to manufacturing, there is, arguably, no other industry more suitable than healthcare. From medicines to implants, to surgical instruments, prosthetics and training aids, surgeons, and the patients they support, stand to benefit significantly through its use.
The beauty of this method is in its name. Objects are created by adding material, layer-by-layer, to make something from a 3D model, as opposed to the traditional method of subtractive manufacturing, which removes matter from a solid material. The process is ideal for complex procedures that require accuracy for tailor-made products that are bespoke to a patient, in turn supporting better clinical outcomes and patient recovery time.
With the UK’s strong engineering pedigree, world-leading universities, a vibrant community of innovative small businesses, and of course, the NHS, our country is well positioned to lead the way in this exciting field. The challenge right now, is finding an appropriate and proportionate regulatory system that ensures a robust system of patient safety, but that also allows for rapid development of products made through additive manufacturing methods.
As things stand, the new Medical Device Regulation (MDR), in addition to Annex XIII which covers 'Custom Made Products', potentially requires each unique Class III implantable product made via additive manufacturing to have a corresponding technical file, akin to any traditional medical device. This includes the corresponding NB interactions and issue of type examination certificates, which is likely to be prohibitive to the technology and manufacturers, and severely restrict access to patients.
With these issues notwithstanding, the definitions for ‘Custom Made’ and ‘Mass Produced’ in the MDR are confusing at best, making it difficult to ensure consistency across any future review and auditing by Notified Bodies.
Finally, we have to be cognizant of access to these technologies. The medical technology industry will be utilising these new processes under strict controls of Quality, Safety and Performance, whilst the possibility for in-house manufacturing may spawn many less controlled instances of implant manufacture. Regulation is put in place to ensure patient safety, which is paramount, so we have to make sure that consistent standards of manufacture are maintained across the whole system.
That being said, the ability of hospitals to manufacture bespoke implants in extremely short timescales, will undoubtedly save lives. In those instances, do these institutions have the regulatory and quality capacity to handle preparation of suitable Technical Files and maintain Quality Systems as manufacturers according to the MDR?
So where does this leave us?
We have an exciting and disruptive technology, which in itself is improving year-on-year, but a current set of regulations that does not quite fit this process – a round peg in a square hole.
The possible solution, therefore, is too look further afield than the MDR for definitions and regulatory practice. Both IMDRF and FDA guidances provide valuable insights into alternative systems, that we as a collective industry, can consider as potential future best practice.
It is clear from discussions at the recent London conference on Additive Manufacturing, that the regulators and notified bodies are ready for this discussion.
A number of our members are already involved in additive manufacturing, and many more will be entering the market over the coming years. If the system can find the right balance between safety and timely production, then the benefits to patients and the wider healthcare system are tantalising.
