The medical industry as a whole has galvanized its entire workforce toward developing a cure and relief for the ongoing COVID-19 pandemic. One facet of the industry now experiencing an uptick in attention and recognition due to the growing shortage of required raw materials and components for the production of medical equipment is the medical materials industry. When it comes to the manufacturing of medical devices itself, this is a very complicated production process due to the many parts and components involved. The onset of the pandemic has led to a disastrous decrease or even complete stop in production of medical equipment domestically and abroad with several medical device supply chains scrambling to resume their work. Currently, medical device manufacturers are searching for alternative manufacturers and locations.

In this Q&A, Asmita Khanolkar, senior director at Cambridge Pharma, SMC, talks about the surprising and novel uses for new medical materials. She explores why thinking about materials should not be an afterthought and what she sees for the future of the medical materials industry moving forward, post-COVID. Khanolkar presented “Material Selection for Medical Devices” at Virtual Engineering Week, which took place Nov. 30–Dec. 4, 2000.

MDB: Asmita, you spoke at Virtual Engineering Week on the topic of material selection for medical devices, can you share what attendees learned from your presentation?

Asmita Khanolkar: Today’s medical devices are complex and span over multiple emerging technologies. Selecting the right materials and developing a robust material strategy is not only crucial to the device design and function but can also help streamline and accelerate the development process. The talk explored the industry trends, factors driving innovation in materials, and selection criteria considerations for various market sectors including medical devices, diagnostics, and pharmaceuticals.

This is the era of convergence of technologies, collaboration of sciences and combination of drug-device. Some of the trends driving innovation in materials can be discussed under five major categories, hospital to home, smart devices, personalized medicine, nanotechnology, and regenerative medicine. Strengthened by the impact of COVID-19 pandemic, the hospital-to-home trends have further reinforced the focus on patient use drug-delivery devices, home diagnostics, mobile imaging, telehealth, and remote monitoring. Patient centric autoinjectors that can be used at home by the patient is important in the COVID times to save hospital visits.

ArQ-Bios and ArQ patient-centric subcutaneous autoinjector designs. (Credit: Oval Medical Technologies, an SMC Ltd. Company)

The movement of chemotherapy from hospital to home is leading to the requirement for subcutaneous delivery of cancer treatments as opposed to intravenous delivery in a hospital setting. This trend is leading to a need for devices for self-administration that can deliver large volumes of formulation. Material selection for primary drug containers that can withstand high pressures leading to acceptable delivery times will determine the success of this important transition from hospital to home.

The advent and expansion of biologics drives the need for materials for drug delivery that avoid the known issues of legacy glass materials and provide better stability. Smart devices continue to challenge innovation in the field of medical electronics, soft electronic materials, sensors, biomarkers, and sterilizable power sources. Additive manufacturing brings new life to personalized and customized medicine and moving away from this notion of one solution fits all. Bioprinting, new biomaterials, and implantable material solutions are some examples in this field of innovation. Nanotechnology trends surrounding injectable bioadsorbables, microelectromechanical systems (MEMS), and nanogels have been launched. And finally, regenerative medicine, cell/tissue materials, and organs on a chip are some of the examples of new developments in the field.

The material selection matrix comprises three major areas of focus starting first with understanding the device classification, regulatory, and stipulatory requirements. This encompasses evaluating materials based on patient contact, biochemistry, biological, and toxicology evaluation. The second area focuses on functional requirements and service use over time. Finally, the third area of focus is on manufacturing and costs. This systematic tiered approach promotes a robust selection strategy.

MDB: The COVID-19 pandemic has disrupted many industries, notably medical devices. Can selecting the right materials help combat this ongoing crisis?

AK: COVID-19 is a brutal reminder of the disruption that can affect any product life cycle management and the need for risk planning and contingency strategies. In terms of material selection and strategy, it is often an afterthought, and yet it is the most important consideration that makes the difference between completing a product design versus converting it into a commercially viable medical product. A systematic material selection approach along with considerations for manufacturing and assembly can reduce threats to the product launch. Today’s complex medical devices have multiple platforms, configurations, components, subsystem assemblies, system-level assemblies, and packaging and labeling components. The solution is to incorporate good strategies, practices, and business continuity evaluations early on in the concept phase and avoid potential crises later on.

MDB: What excites you most about your field?

AK: In my current role at SMC Ltd., my responsibilities include device and pharmaceutical services strategy and commercialization of innovative technology platforms for drug-delivery and fill-finish combination products. As science and technology continue to advance bringing many novel therapies to the forefront, I see material selection play an increasingly important role.

The drug-delivery industry is seeing tremendous growth in new formulations, delivery technologies, and delivery platforms. There are various market segments that support the drug-delivery growth. Indications in the field of oncology, CNS, infectious diseases, cardiovascular, and metabolic disorders are driving some of the trends mentioned above.

The delivery device market trends are evolving in single-use, wearable, and implantable areas to support the global trends of hospital to home. In addition to handling the delivery of challenging new drugs and formulations, other developments are focused on patient centricity requirements, evolving regulations, and the path toward smart devices. Digitization, interoperability, connectivity, big data, data security, and analytics are other focus areas key to telemedicine and remote care. With all the activity in this space, there is rarely a dull moment.

MDB: Anything else you would like to add?

AK: An important aspect of accelerating drug-device development includes the integrated approach of development, manufacturing, and analytical testing services. Combining development, manufacturing and sterile fillfinish packaging for clinical and commercial use provides a complete end-to-end solution. As a single source provider with a global supply chain, the development process is accelerated and the path to commercialization is de-risked with a knowledgeable partner.

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Medical Design Briefs Magazine

This article first appeared in the January, 2021 issue of Medical Design Briefs Magazine.

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