Poly-Med CTO, Scott Taylor, recently contributed to a panel discussion at the MedTech Conference. The article below summarizes the panel discussion.

Panel says 3-D printing opens many possibilities in med-tech production

Medical Device Daily – 10/2/17

by Katie Pfaff

SAN JOSE, Calif. – 3-D printing is a much lauded technology, but does it offer real benefits in med tech? Panelists at the Advanced Medical Technology Association’s MedTech Conference session “Printing the future: 3-D printed today, tomorrow and beyond” discussed implications of printing with 3-D in medical device manufacturing.

Framed as a follow-on session from a discussion the prior year of regulation and 3-D printing, moderator Allison Shuren, partner, Arnold and Porter Kaye Scholer LLP, spoke with industry panelists about the promise of 3-D in creating medical devices, and what may be on the horizon. Shuren discussed a general example of 3-D printing in which a Hornbill bird at the National Zoo in Washington, D.C., was provided a printed beak so that it was able to feed and survive. The beak was created through a collaboration between the Smithsonian Institute and the Museum of Natural History, the latter of which provided the skeleton of a Hornbill from its archives to provide basis material for 3-D printing.

Elle Meyer, director, life sciences, Carbon, then discussed the benefits of additive manufacturing compared to traditional manufacturing, which she saw as three-fold.

“The first reason, which may be obvious, is that it creates opportunities not available in traditional manufacturing, or that would be prohibitively expensive,” she said.

Additive manufacturing introduces possibilities such as lattices which could not be produced otherwise, as well as patient-matched items which improve comfort and effectiveness like orthodontic appliances, hearing aids or CPAP masks, she said. Secondly, additive manufacturing allows for smaller manufacturing opportunities when a device is needed. Third, additive manufacturing can lead to cost reduction through cost-effective low-volume production, improving processes, time-reduction and removing complex steps.

Regulatory perspective

Dennis Hahn, director, regulatory policy innovation, Ethicon and vision care, Johnson and Johnson, noted that regulators are addressing the uptick in what may be referred to as “customized devices,” and the FDA does already address such med tech.

“We are very fortunate in the U.S. to have a very specific definition for a custom device,” said Hahn.

Customized devices are defined as those manufactured for individuals, created by prescription and used or distributed through a health care practitioner, and are limited to no more than five per year, he said. However, items like 3-D printed devices or devices with 3-D components, would more likely be handled differently.

“Really what we are looking at in customized device – patient specific device, patient matched device, personalized device are all same. In the U.S. these are not customized devices, they’re different, and our regulatory approval pathway is determined by how you define those fixed dimensions and parts that are customized,” said Hahn.

Manufacturers would seek an approval based on fixed aspects of the device and a range for customization in a similar manner that contact lenses are approved with a set diameter of the lens and a range of prescriptions or powers depending on patients’ sight needs. Europe is more complex with rules that customized devices cannot be mass-produced while Australia, Brazil and other markets have no definition for customized devices.

Devices to improve response

Scott Taylor, CTO, Poly-med Inc. talked about applications for 3-D printing which allow for enhanced capabilities in medical devices.

“What we’re seeing is the body is filled with these tailored structures that are not necessarily patient specific. Bone, other tissues, they have all these extracellular components that are far beyond the capabilities of what we can do,” said Taylor.

Instead of building patient-specific devices, 3-D printing can be used to build “tiny structures to encourage a specific response” like healing or tissue growth.

“We have a much better understanding behind the biologics of these injuries [hernias, for one] and to reconstruct them,” said Taylor. “And now we finally have this microscopic ability to create structures and create surfaces that can elicit that type of response. That’s ultimately where we want to be.”

He pointed to hernia mesh to promote healing or orthopedic devices that initiate bone growth in addition to surgical placement of a plate and screw. Additive manufacturing also presents an opportunity to streamline processes, he said, reducing multistep processes to one that can incorporate a high-level of complexity.

Metal manufacturing and 3-D

Jonah Meyerberg, co-founder and CTO, Desktop Metal, moved the conversation to how additive manufacturing applies in metal medical devices.

“The medical sector is very well positioned for additive manufacturing in general and additive manufacturing of metal is not an exception,” said Meyerberg. “The complex shapes you are able to create and the properties of metal really allow additive manufacturing to apply geometries that are modeled after biological geometries and environments like never before. And the relatively small production volumes and custom parts, additive makes it economical in a way it was not before.”

3-D printing can accommodate custom shapes and greater complexity.

He also added medical devices had lead an entry into 3-D printing with polymer usage in hearing aids to customize shapes into the ear canal, and in orthodontic appliances like custom-made trays. Meyerberg said 3-D applications in metal devices have not yet been fully realized, highlighting as an example orthopedic implants with porous areas encouraging tissue to grow into the device.

When asked if the new methods introduced problems for regulatory bodies, Meyer commented industry was steadily validating the materials or additive manufacturing methods, and that FDA would evaluate using their “same toolkit.” As with any medical device, those made using 3-D printing would be evaluated to determine if the process is replicable, the device is biologically compatible, manufacturing methods meet quality standards, and ultimately that the device is effective and safe in its intended use.

The Poly-Med 3D printing team traveled to Florence, SC to visit with leadership at The Southeastern Institute of Manufacturing & Technology, The SiMT. We were impressed from the moment we drove up as our Poly-Med logo was shining big and bright on the large welcome screen.

We toured the remarkable conference facility, advanced machining center, the listening center, and of course the additive manufacturing center. The potential to have partners like those at The SiMT experiment with our materials is exciting to us. We are learning something new everyday in this continually changing field of 3D printing as we are actively working with clients including Universities.

We’ve successfully launched three 3D printing bioresorbable filaments earlier this summer and are working towards launching our next material options. Contact Us if you would like more information about our filaments.

“If we can expand the number of biomaterials used in additive manufacturing, we can tackle a tremendous number of problems in all fields of reconstructive surgery and make enormous strides for the benefit of patients.”
– Dr. Scott Hollister, University of Michigan¹

3D-Printing. Additive manufacturing. Rapid prototyping. These buzz-phrases are always sure to attract attention at talks, conferences, on posters; you name it. Up until recently, the world of additive manufacturing was considered more niche, and some speculated the field would never realize the potential many industry leaders were suggesting. In fact, additive manufacturing has grown to become a $5.2 billion industry as of 2015, and some say total revenue could reach upwards of $20 billion by 2020 and beyond.² Undoubtedly, 3D-printing is a disruptive technology that is still growing at an exponential rate, as more companies are beginning to adopt and reap its benefits.

While the medical field only accounts for a small fraction of the overall additive manufacturing industry, it too is finding new uses for the technology at an ever-increasing rate. Already, patients are receiving customized, 3D-printed implants and prosthetics. 3D-printing has saved the lives of numerous infants born with rare tracheal defects. Joint replacements and bone reconstruction therapies are becoming more effective due to a level of customization that simply did not exist before additive manufacturing methods. These are only a few of many medical applications developed to date.

Despite all of the medical advances employing the use of 3D-printing, medical grade materials suitable for 3D-printing are very difficult to procure. Stock polylactic acid (PLA), polycaprolactone (PCL), and acrylonitrile butadiene styrene (ABS) have been around for many years, though companies looking for medical grade 3D-printing filaments are generally out of luck. Additionally, if the goal is to develop a bioresorbable 3D-printed medical device submitted for FDA review, device manufactures have a difficult time identifying reliable, ISO-certified suppliers to pursue.

Poly-Med, a world leader in bioresorbable polymers, has taken note of the lack of materials available and will be providing medical-grade material options to the 3D-printing filament market. Our extensive polymer catalogue translates easily into the additive manufacturing materials space. And, Poly-Med’s materials are supported by an ISO 13485 certified quality system.

Poly-Med is launching its new line of 3D-printing filaments later this year. This innovative product line is set to include Lactoprene® 100M, Dioxaprene® 100M, and Maxprene® 955 as the flagship filaments, with many additional polymers set to follow in late 2017 and into 2018. These three initial filament offerings provide unique features.

Lactoprene® 100M is analogous to many standard 100% PLA filament offerings widely available, except that Lactoprene® 100M is medical grade and fully traceable. It is tailor made for 3D-printing applications involving orthopedics or for any device that requires a long-lasting, high strength material. Where faster resorption times are a design criteria, Maxprene® 955 is a good option. Maxprene® 955 is a custom 95/5 poly(glycolide-co-lactide) copolymer, boasting a high tensile modulus coupled with a shorter timeframe for strength and mass loss. Dioxaprene® 100M is a 100% polydioxanone material that has extended strength retention and also carries a degree of softness and flexibility. Dioxaprene® 100M may be appropriate when moderate degradation time is required.

Beyond these three initial offerings, Poly-Med is also evaluating translation of other bioresorbable polymers in its catalogue to 3D-printing filaments. Lactoprene® 7415, Strataprene® 3534, Caproprene® 100M, and Glycoprene® 7027 are just a few of the polymers in the 3D-printing filaments pipeline. Poly-Med is excited to be on the forefront of additive manufacturing materials and is poised to be the industry leader for bioresorbable, medical grade 3D-printing filaments. Please contact us with any questions about our 3D-printing materials or additive manufacturing developmental capabilities.

¹EOS. University of Michigan reference

²Keeney, Tasha. ”3D Printing: A Disruptive Innovation Still In Its Infancy”. Ark Invest. October 2016

This month we welcome David Gravett to Poly-Med as Vice President of Strategy. He brings over 20 years of experience working with small to mid-sized companies in the medical device, combination product and drug delivery fields. An inventor on 18 issued US patents and over 130 US patent applications, he’s developed numerous drug and combination devices that utilize a range of biomaterials and pharmaceuticals.

Before joining Poly-Med, David was Vice President, Research and Development at Carbylan Therapeutics located in the Bay area in California. Carbylan was focused on developing a novel injectable hyaluronic acid based product for the treatment of pain associated with osteoarthritis. During this time David led the development of the product, the preclinical safety studies and the development of the clinical manufacturing process, taking the product from concept through to the completion of a Phase III clinical study. David first partnered with Poly-Med in 1998 when he was developing drug-device combination products at Angiotech Pharmaceuticals as the Vice President, Formulations and Polymer Chemistry.

A native of South Africa, David completed his undergraduate degree and MSc at the University of Natal in South Africa. He received his PhD in physical chemistry at the University of Toronto under Prof. Guillet. His thesis involved the investigation of controlling the selectivity of photochemical reactions with the use of polymers that were capable of transferring light energy to a spatially defined cavity. It was during this time that he was introduced to the field of biomaterials and drug delivery. David then completed a NSERC industrial Post-doc at Pasteur-Merieux-Connaught (Toronto, Canada) where he investigated the targeted delivery of DNA vaccines via liposomes as well as the use of PLGA microspheres as delivery vehicles for vaccines.

Poly-Med is pleased to welcome someone of David’s caliber join to the ranks here at Poly-Med.