中国国际医疗器械设计与制造技术展览会(Medtec China)2018

Dedicated to design & manufacturing for medical device

25-27 September 2019 | Shanghai,China

Entering a Golden Age of Medical Materials

2018-04-20

Materials science is a field that is constantly evolving as technologies advance around us at lightning pace. New trends and developments continue to drive device innovation, but they also push new materials to the forefront as well. Device makers and engineers have made great strides in using these new materials to create exciting new technologies, with recent discoveries made from advances in medical electronics, biomaterials, plastics, and soft materials.



Monicore/Pixabay.com

Jacqueline Anim is the principal material engineer for Ethicon, a subsidiary of Johnson & Johnson that manufactures surgical systems and instruments. She currently serves as a subject matter expert for the company as it aims to leverage various blends of polymer technologies to innovate in the design and manufacturing of digital and non-digital devices and instruments.

Anim has garnered more than 24 years of experience in materials science and material application engineering, and she will be part of a panel discussion in June at the Medical Design & Manufacturing East conference in New York—a session that will explore what’s new in medical materials.

Anim recently sat down with MD+DI to preview her panel discussion and talk about what’s new in medical materials these days. In the following Q&A, she talks about some of the trends in medical materials, and explores how recent advancements in materials and technologies will shape new technologies in the years to come.

MD+DI: The field of materials science is constantly evolving as technologies advance each year. How much of a challenge is it for you to stay on top of emerging trends and new developments as you work toward sustaining and developing new devices and technologies?

Anim: There are so many avenues to keep you connected to emerging trends and pipeline innovations when it comes to materials in general. I have learned over the past 20 years that it is actually a two-way street, noting that “device innovation drives new material development” and “advancement in materials also innovates medical device development” when an unmet need associated with materials is addressed. Most manufacturers and toll compounders will work closely with you to develop or modify an existing material chemistry if the off-the-shelf alternative doesn’t meet your design requirement. They are also receptive to making site visits to come and discuss new products and future innovations targeted for research and development.

Avenues such as attending conferences and around-the-clock networking can sharpen your knowledge about new trends. Another area includes working with other subject matter experts both within and outside your field of specialization to give you some perspective relative to the adaptation of alternative technology solutions from other markets. I have seen this approach to be very effective when it comes to addressing unmet need in medical device manufacturing. Trade shows are a fertile ground to experience the applications of new technologies from other industries (e.g., consumer electronics). Trade magazines are also a good source of fast-paced technology advancement information for all industries, including medical.

MD+DI: You work specifically with polymers and plastics—what are some of the trends you’re seeing, and are there any new developments on the horizon that you’re particularly excited about?

Anim: Most of the attention has been on 3D-printable material developments and the creation of the associated test methods, just like the ASTM’s for moldable plastics. I am personally excited about printable biomaterials. The work that is being done around the optimization of environmentally sustainable materials, organic-derived materials to reduce carbon footprint is very refreshing. Materials that have direct electric circuit printing capability for miniaturization and combination product developments is also one to be noted. The segregation of medical-grade polymers from their industrial grade alternatives, from my vantage point, is business critical, as this global trend will make it possible to lock down and control material formulations enabling compliance to ISO 10993 and USP Class VI.

There are also some unprecedented efforts being put into the development and commercialization of sensitive and smart polymers to make them more cost-effective and more attractive to be incorporated into the next generation of medical device designs. These smart polymers will play a major role in the next generation of wearables, with their thermo, photo, aqua etc. sensitivity characteristics, just to mention a few. Lastly, the recent introduction of e-commerce for biocompatible 3D printing materials from original material manufacturers (e.g., Solvay Advanced Polymers) is another positive trend, since this will bring other added benefits such as OEM support.

MD+DI: What do you think are some of the key factors that drive innovation forward when it comes to not only finding new materials to work with, but maximizing their potential when it comes to using these materials to develop new technologies?

Anim: One key element is that when it comes to materials, one size does not fit all. Each material is developed to offer a solution to a preconceived problem or to address an existent unmet need. Hence, during new product development, it is critical to consult or have a materials expert on your team to provide guidance on material selection and design optimization. Additionally, collaboration with the fabricating house—for example, the injection molder—earlier in the process could be very beneficial. Design for Manufacturability (DFM) and Design for Quality (DFQ) go hand in hand, since a substandard design could have long-term quality implications and cost impact. Optimizing the design around the material allows the material’s maximum potential to be realized.

Some materials are designed purposely for thin-wall molding with ultra-high melt flows (e.g., 55 melt), and others may be designed for micro-molding with micro pellet sizes. Apart from material selection optimization, there are lots of other primary factors and avenues that can drive innovation. For example, 3D printing of low volume complex parts, combination molding to reduce components counts in a medical device, co-injection molding of a single part versus multiple pieces, direct circuit printing, one-shot overmolding, and the potential elimination of redundant secondary operations. I would also like to add that when the “end user” and the “end use” benefit becomes the focus of your design, innovation is activated during new technology development.

MD+DI: How would you characterize the role of materials in the medical device life cycle? Do you think it will become even more crucial as technologies advance?

Anim: Materials have and will continue to play a major role in the medical device life cycle, and even more so with the introduction of digital surgery, the expectation of this role will increase exponentially. Just to cite a few examples, the miniaturization of med capital equipment (e.g., medical robots and consoles) and making it affordable to all types of medical solutions around the world is driving the advancement in additive manufacturing and use of antimicrobials. Even though antimicrobials have been around for years, their inclusion in advanced material development has been relatively slow.

Another case in point is the push for more aggressive chemical-resistant materials, including quaternary ammonium compounds containing cleaners used in some of the hospitals, such as sani wipes. Whiles such requirements used to be out of scope a decade ago, now it’s becoming part of most product development requirements.

Additionally, as customer expectations of medical devices change, so will the bill of materials that make up the device. Material technologies will be expected to be available in all colors, including thermochromics, as entry levels with no extra charge to the consumer. Wearables will be expected to look fashionable and high-end, with a fine to no line between medical wearables and the runway options.

MD+DI: Some of the biggest trends in materials science have come from biomaterials, medical electronics, soft materials, and plastics. Which of these do you see having the biggest impact on device development in the next five to 10 years?

Anim: From my vantage point, medical electronics might have the largest impact, as we currently can collect data. This new capability will allow the medical device industry to track patients before surgery, during, and after the procedure through the use of internal implants and external communicating devices (wearables). With new advancements in smart polymers and the evolution around implantable silicones, ultra-high-molecular-weight polyethylene (UHMWPE), polyphenylsulfone (PPSU), thermoplastic urethane (TPU), polylactic acid (PLA), glycolic acid and lactic acid (PGLA), and polyetheretherketone (PEEK), just to name a few, medical electronic execution will have no limits. The redesign of digital surgery infrastructure (e.g., the da Vinci surgical robot and instrument) is also paving the way for use of unique material chemistries with conductive properties, built-in insulation capabilities, and coatings with variable insulated areas and tight tolerance controls.

Most certainly, advancement in medical electronic systems will be the main fuel to drive cutting-edge developments in BioCompatic materials, soft and flexible materials, silicones, and plastics. Long-term applications and offerings will be centered on various combinations of the above and permutations in an ecosystem with codependency. During the next five to 10 years, we should see an elevation in the application of materials science in medical device products through the adaptation of engineering solutions from other industries.

MD+DI: With recent developments in all of these materials, do you think we’re in sort of a golden age for materials science? The medical device market is booming with innovation, do you think the advancement of medical materials is one of the driving forces behind that?

Anim: Looking at the data that we currently have, I strongly believe we are currently in an upward incline. It may seem like we are in a golden age, but we are actually in an ascent mode. Some of the immediate observation points to the fact that customer expectations have changed drastically within the last few years, and that is the driving force behind the boom. Currently, advancement in other industries, such as consumer electronics, and seamless integration of complex logistics (e.g., Amazon, Alibaba) is also enhancing the sense of optimism in medical device innovation. The good news is that with the floodgate wide open, people can now innovate with little to no restrictions. Furthermore, progress in computer-aided design and high-speed internet is influencing 3D printing more than ever before. Interpersonal capability to scan site or any object and transfer large files with speed and accuracy has contributed to advancements in additive manufacturing and 3D printing. Large and complex 3D models can now be made to a part print and sent to be printed at the point of use (virtual manufacturing), eliminating centralized manufacturing with initial huge infrastructure investment requirements.

Without minimizing and/or losing sight of technologies that have come along to make 3D printing flourish, there are more materials yet to be developed to support even the current innovation level. A few example include the development of a biosafe bill of materials for internal wearable applications that will communicate with an external wearable for data collections, the development of materials to use as encasements or encapsulants to implant electronic devices with connectivity on each side, materials with direct electrical circuitry printing capabilities, as well as the development of a universal 3D printable material database and test methods will help us expand beyond our current capability.

MD+DI: Finally, as we look toward the future of materials science, what advice would you give to medical device engineers when it comes to staying on top of emerging trends to successfully blend new materials into device development?

Anim: As our customer base, the patient expectations of medicine are changing from “absence of disease” to “total wellbeing” of the person. The need to blend new material technologies into our design platform is becoming mandatory. Additionally, as some of the operating room (OR) procedures are now being pushed outside the OR, material selection will have to be dynamic and not static. Case in point, a patient wearing prosthesis does not want it to look “plastic and shiny” but wants to have the ability to walk and also make a fashion statement. An asthmatic patient who depends on an inhalation machine at home would like the device to blend into the home décor and not stick out or look out of place.

Now, when it comes to medical devices, my advice is don’t close your mind and don’t let it impede your ability to try new materials because we are in a regulatory environment, but look at what it will take to imprint new materials into your design since most of the new technologies do meet current environmental regulations (i.e., REACH, RoHS, MDR). This recommendation is also applicable to revisions to existent designs, as some new materials could be added to address unmet needs. Finally, always rely on subject matter experts to help you incorporate new materials into your design as regulations continue to change.


From:https://www.mddionline.com/entering-golden-age-medical-materials?ADTRK=UBM&elq_mid=3982&elq_cid=4441584