How the FDA is wrestling with bio-medical 3D-printing.

In a science-fictional universe way ahead of us in the future, there is no industrial complex as we know it today. No sprawling manufacturing campuses or security-patrolled warehouses crammed with shelved inventory. Everything we use on a day-to-day basis is created on demand, at the very moment it is required. All of our homes are equipped with a device that creates material objects from digitized plans for immediate use and easy recycling. It is a world where anyone can create anything, from a thumbtack to a prosthetic limb.

It is a world where anyone can create anything, from a thumbtack to a prosthetic limb.

But wait. This projection is actually not so far ahead. In fact, some of the technology necessary for this possible future already exists and is closer to hand than you might think. Additive Manufactured (AM) devices – also known as 3D-printed devices – are already working their way into the national discourse, our homes, and even our bodies. But what exactly is this cutting-edge design process and how will it impact our industry and our lives?

Put in the simplest of terms, additive manufacturing is essentially the process of creating solid, three-dimensional objects from a digital ‘blueprint’ created from a Computer Aided Design (CAD) file. In what’s known as an ‘additive process,’ horizontal layers of material are laid down one upon the other and blended to fashion the object, slowly building up to a completed piece.

Depending on the item being produced, one of several processes is used to construct these layers. One of the more common is selective laser sintering (SLS) which uses a laser to form powdered metal, plastic, ceramic or glass into a solid mass using heat or pressure. This is a process termed sintering. Fused deposition modeling (FDM) is a second technique, one that uses a solid coil of metal wire or plastic filament to create the final product. And stereolithography (SLA) focuses an ultraviolet laser on a vat of liquid photopolymer resin to solidify and form a single layer of the final object.

But whatever the technique deployed to create these additive manufactured devices, when it comes to their final use – especially within the bio-medical field – one aspect is common: the need for effective cleaning and sanitation. And this is where it gets interesting because, until comparatively recently, little to no regulation existed to ensure patient safety in this swiftly changing industry.

“one aspect is common: the need for effective cleaning and sanitation.”

By 2015, the Federal Drug Administration (FDA) had already approved at least 85 devices through what’s known as its 510(k) approval pathway, with other devices gaining traction through custom device exceptions, pre-market approvals (PMA), and human device exceptions. And perhaps given the relatively small number of products, the FDA has been slow to issue guidance on regulation and approval processes. As recently as 2014, the agency held an open workshop for device manufacturers in which it solicited industry feedback. Insiders justifiably assumed that FDA regulation was in the pipeline but, to date, this has not appeared. In fact, in a 2016 Guidance Agenda, the FDA went as far as to drop the field from its report altogether.

And why is this? Perhaps a reasonable explanation for the apparent lack of FDA interest is recognizing that the agency’s traditional regulatory framework is outmoded when it comes to 3D-printed devices. The traditional 510(k) pathway for device approval was crafted for use with mass-produced items with little or no customization. By their very nature, 3D-printed items are highly customized and their strength lies in the way they can be created as ‘one off,’ single items with the specific individual end user in mind. And furthermore FDA regulation relies in some measure upon clinic trials. When the intended recipient of a device or a treatment is a single patient, a clinical trial – in the traditional sense – is not possible.

So where can – and does – the FDA seek to regulate this technology?

So where can – and does – the FDA seek to regulate this technology? One aspect is in the creation of standards for sanitation and sterilization. And indeed this is perhaps where the agency is focusing its greatest attention. Additive manufacturing in the bio-medical field seeks to craft products that may end up becoming part of the recipient for the duration of their life. 3D-printed prosthetics and implants such as hip or knee joints are already becoming increasingly common, but these may be only the tip of the clinical iceberg. In a Med Device Online article, 3D-Printed Medical Devices: Which Regulatory Strategy is Appropriate? (And Why), Michael Drues suggests that based on our current pace of technological acceleration the future holds the promise of 3D-printed human organs and living tissues. Clearly, within this context, a discussion of cleaning and sterilization merits serious and careful consideration.

Last month (May 2016), the FDA finally issued a draft guidance entitled Technical Considerations for Additive Manufactured (AM) Devices, which seeks to cover not only devices entirely created by an additive process, but also any item whose manufacture includes “at least one AM fabrication step.” This is a huge step forward, especially as Section E – Cleaning and Sterilization – clarifies some of the manufacturers’ responsibilities in the post-production process prior to the device being provided to the end user. As leaders within the contamination-control industry, Berkshire Corp welcomes the FDAs inclusion of this crucial factor in the draft guidance, observing its incorporation as a path to mitigating potential problems as the technology matures. Berkshire also looks forward to reading what specific SOPs the FDA will recommend in ensuring the cleaning of manufacturing materials from devices before they are used with actual patients.

Do you have thoughts or comments on the role of the FDA and additive manufacturing in the bio-med world? We would love to read them!

References:

http://www.insidecounsel.com/2016/03/09/how-will-the-fda-regulate-3d-printing

http://www.meddeviceonline.com/doc/3d-printed-medical-devices-which-regulatory-strategy-is-appropriate-and-why-0001

http://www.lexology.com/library/detail.aspx?g=201567a5-f5cf-4e7a-a5e3-20f9ea1d1649&utm_source=Lexology+Daily+Newsfeed&utm_medium=HTML+email+-+Body+-+General+section&utm_campaign=Lexology+subscriber+daily+feed&utm_content=Lexology+Daily+Newsfeed+2016-05-19&utm_term=

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM499809.pdf

http://www.btlaw.com/food-drug-and-device-law-alert—fda-issues-draft-guidance-on-additive-manufacturing-including-3d-printing-05-16-2016/