Beyond the Product: The Importance of Packaging Design

As we come out of the busiest season for every postal worker and mailman, we are reminded of how little thought often goes into the shipping and packaging of all the gifts and products being transported. It can be hard enough for the manufacturer to ship your online order to meet the gift’s deadline for arrival, so considering how the packaging affects the final result might be an unaffordable luxury. A set of fine china placed into a cardboard box with no bubble wrap might result in a pile of fine chips when thrown onto a delivery vehicle. Your family’s secret fruitcake recipe might arrive as a fruit-pancake after having your neighbor’s new weight set stacked on top of it at the warehouse while awaiting delivery.

When we take the same look at the medical device field, many of the same concerns apply. Your newly developed medical device, sure to make a big market splash as the ideal blend of form and function, is only as good as the condition it arrives in to the end user. Additional design work is required to ensure that the form isn’t crushed and the function isn’t lost from poor transport conditions. Just like the piece of delicate china, care must be taken to ensure compressive forces, drops, constant vibrations, temperature fluctuations, and pressurized chambers don’t tamper with your perfect design in transit.

When it comes to medical devices, several other considerations must take place. Most notably, shipping offers the ultimate test to the sterile barrier of your device. Even when the device itself is sturdy and resilient, a puncture to the packaging or a leak in a seal could render the device just as useless and more dangerous to the end user than a shattered component. Unlike opening a squished fruitcake, defects to sterile barriers might not be as obvious.

At Poly-Med, our devices, components, and materials offer an additional packaging challenge. We produce a wide variety of biodegradable polymers which break down by bulk hydrolytic degradation. The very sensitivity to moisture that allows for novel applications such as timed pharmaceutical release, temporary structural strength, and reductions in device removal surgeries also requires that we consider packaging a main concern. When designing the packaging for our products, we must utilize materials which offer moisture, bioburden, and UV barriers in addition to the structural support required by other device types. Most often, this requires our packaging and materials to be thoroughly dried prior to shipment in order to extend the product shelf-life to its maximum potential. We also run extensive validation efforts on every aspect of the packaging design, where a small channel in the seal or puncture in a pouch is unacceptable. With the added design work and validation runs, we take the extra forethought and effort to ensure that products arrive just as they were designed, no matter how loaded the delivery truck is.

If you are working on a medical device application and are interested in learning more about degradable polymers and how to successfully package them, Contact US to learn how we can advance your idea.

Andrew Hargett, M.S.

2018 marks 25th Anniversary at Poly-Med

In 2018, Poly-Med will celebrate its 25th anniversary. My father, our founder, Dr. Shalaby Shalaby is considered one of the forefathers in the bioresorbable polymer industry. In the late 1970’s he led an exploratory group on polymers for biomedical applications at a large medical device company. During that time, he was one the lead inventors for several bioresorbable products including the Vicryl® suture.

In 1990, his love for research and education brought him to Clemson University in South Carolina. In the summer of 1993, Dr. Shalaby founded the company as a means to continue unfettered research in the bioresorbable polymer industry and to teach and sponsor students. He and a handful of PhD students started working out of a Clemson incubator building. This was a time for a lot of personal and professional growth as everyone was learning new things and pitching in to help where needed. During these early years, the focus was on research and education.

From the very beginning, Dr. Shalaby encouraged his employees to continue education in pursuit of creativity. We continue this emphasis with over 30 graduate thesis earned through a partnership with Clemson University and Poly-Med. Today, Poly-Med’s influence reaches beyond the classroom. We’ve grown to over 85 employees and work with some of the largest medical device companies in the world.

As we evolve as a company, my father’s work is at the heart of what we do. His hundreds of patents allow us to provide creative solutions to medical device companies as they work on novel devices to improve patient lives. Through continual improvement by personal and professional growth, our employees are excited to make an impact on the medtech industry. I’d like to think my father would be proud to see how far we’ve come as a company and that the foundation he built continues to support us 25 years later and beyond.

Dave Shalaby
President, Poly-Med, Inc.

Bioresorbable Polymers: How do they Degrade?

Poly-Med’s bioresorbable polymers offer customized product solutions when an implant does not need to permanently remain in the body. The key trait for our materials is that they degrade within a physiological environment. Often times, this can be misconstrued to be a variety of degradation mechanisms including surface erosion, bulk erosion, among others.

Surface erosion takes place when mass loss for a device occurs at the water/implant interface, causing the implant to resorb from its outer surface toward its center while maintaining its bulk integrity. This is sometimes referred to as ‘device thinning’.

The majority of Poly-Med’s polymers degrade by a process known as bulk erosion. Bulk erosion occurs when the main mechanism for degradation is by the diffusion of water into the device or polymer structure, leading to hydrolysis. For bulk degradation, polymer properties are generally affected first by a decrease in molecular weight, followed by a decrease in strength, and finally, a decrease in mass.

By having a staggered rate of degradation for different polymer properties, it is extremely important to perform in vitro characterization of your product to truly understand the time scale for degradation and the appreciable loss of properties.
If you are working on a medical device application, and are interested in learning more about our bulk eroding polymers, Contact Me to learn how we can advance your idea.

Seth McCullen, Ph.D. Manager, Business Development

Join us for our Upcoming Webinar: Adding Value to Additive Manufacturing

Poly-Med is looking forward to presenting, “Adding Value to Additive Manufacturing, Creative Solutions for Bioresorbable Polymers” to a screen near you. Poly-Med CTO, M. Scott Taylor, Ph.D. continues to lead our innovative work in this space and will be sharing new information the Poly-Med team is learning in this continually evolving field of 3-D printing for medical devices.

We are working with our partners at Media Design Briefs to bring this webinar to you on December 12th at 2pm. Here are more details for registration.

Poly-Med a part of MADE in South Carolina

We’ve included a portion of the press release from Clemson University about a recent announcement featuring a new initiative: Materials Assembly and Design Excellence (MADE) in South Carolina. Poly-Med is proud to be a partner in this statewide initiative.

CLEMSON, South Carolina — South Carolina’s position as a national leader in advanced materials just got a giant boost.

A team of researchers from 10 universities across the state has received a $20 million, five-year grant from the National Science Foundation’s Established Program to Stimulate Competitive Research (EPSCoR) to establish a new initiative: Materials Assembly and Design Excellence in South Carolina, or MADE in SC.

“The vision of MADE in SC is to discover and establish new and sustainable approaches for the design and assembly of advanced materials that serve South Carolina’s STEM research, education and workforce needs, and to invigorate economic development,” said Rajendra Bordia, professor and chair of the materials science and engineering department at Clemson University and the co-principal investigator and scientific director for the statewide program.

Other collaborating colleges and universities are the University of South Carolina (USC), the Medical University of South Carolina, the College of Charleston, Furman University, USC Beaufort, Winthrop University, Claflin University, South Carolina State University and Florence-Darlington Technical College.

With the EPSCoR grant, MADE in SC is committed to hiring 17 new researchers over five years at five institutions. The universities will also invest in training postdoctoral fellows, graduate and undergraduate students; outreach to K-12 schools and the public; and developing new facilities.

Clemson will receive $5.9 million of the grant and will hire five new faculty members, support 12 new doctoral students to work with 17 faculty members from six departments, and invest in new equipment for materials research.

MADE in SC underscores how important academic research is to economic development, said James P. Clements, president of Clemson University.

“Universities are hotbeds of innovation and as Clemson’s research enterprise grows, so grows the South Carolina economy,” Clements said. “Our incredibly talented faculty, staff and students allow us to conduct valuable research that our partners in industry can build upon and which will continue to benefit the residents of South Carolina for decades to come.”

Among the current corporations in South Carolina for which MADE in SC will provide support and future employees are AVX, BMW, Boeing, CuRE Innovations, GE, IBM, Michelin, Milliken, Poly-Med, Savannah River National Laboratory and Tetramer, Bordia said.

To access the full press release

Video from: “Printing the Future: 3-D printed today, tomorrow & beyond”

Poly-Med’s Dr. Scott Taylor presenting at the Annual Advanced Medical Technology Association’s MedTech Conference Session.

Medical Device Daily Article: 3D Printing Perspective at MedTech

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.

ASTM Standards & Med Device Development

ASTM International standards are widely recognized for industry-leading work on creating consistency and supporting traceability for medical device development. The tagline “Helping Our World Work Better” is an excellent description of purpose. In reality, ASTM International is a volunteer organization where industry and academic collaborators develop standards to guide users in the selection, use, and analysis of materials, including critical evaluation parameters for products in development. The FDA medical device regulatory process also references the use of ASTM standards in guidance documents to support new product applications.

At Poly-Med, we apply ASTM standards on a daily basis, both to create consistency in our work but also to educate our employees and companies we work with. Making sure we are all “speaking the same language” is crucial to our success. Some key ASTM standards that guide the use of our materials include:

    • ASTM F1925-09: Standard Specification for Semi-Crystalline Poly(lactide) Polymer and Copolymer Resins for Surgical Implants
    • ASTM F2313-10: Standard Specification for Poly(glycolide) and Poly(glycolide-co-lactide) Resins for Surgical Implants with Mole Fractions Greater Than or Equal to 70 % Glycolide
    • ASTM F2579-11: Standard Specification for Amorphous Poly(lactide) and Poly(lactide-co-glycolide) Resins for Surgical Implants
    • F2902-16e1: Standard Guide for Assessment of Absorbable Polymeric Implants

    It is also important to note that ASTM is continuously evaluating standards for improvement and to adapt to new technologies. This is a reason that we are involved with ASTM, in particular the F04: Medical and Surgical Materials and Devices and F42: Additive Manufacturing committees, and we uphold active status through the maintenance of existing and development of new standards.

    In a recent example, we are working in the F04.11 group to develop a new standard for Polydioxanone resin. Over the past several years, we have seen interest in polydioxanone increase as it has an intermediate degradation life (6 – 8 week strength retention typical), excellent flexibility, and processing through fiber extrusion and injection molding, for example.

    To support the broader adoption of this polymer, this standard compiles and addresses specific keys for identifying quality resin to give products the best chance for success. Through these efforts we expect this new standard to become approved in 2018. By working with ASTM International, we all work together towards improving products and helping those that use them.

    M. Scott Taylor, Ph.D.
    CTO, Poly-Med, Inc.

    Contact Us if you would like more information about Poly-Med and our work with ASTM.

Poly-Med CTO speaking alongside the best in MedTech

Poly-Med CTO, Scott Taylor, Ph.D. will be a featured panelist at the upcoming MedTech Conference. He will be joining industry leaders as a speaker on a panel titled, “Printing the Future: 3D Printing Today, Tomorrow and Beyond.” As Poly-Med continues to be at the forefront of this field in the bioresorbable polymer space, Dr. Taylor will be offering his thoughts and expertise on this subject.

The Poly-Med business development team will also be in attendance and look forward to meeting industry executives interested in the 3D printing industry with bioresorbable polymers. Here are the details for the panel.

Date: Monday, September 25, 2017

Time: 2:30 PM-3:45 PM

Track: MedTech (R)evolution

For more information about the conference, visit TheMedTechConference

Contact Us if you would like more information about our polymers and 3D printing.

Poly-Med team travels to The SiMT to tour 3D Printing facilities

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.

SiMT Tour

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.