The medical device industry is at the peak of innovation, believes Asmita Khanolkar, manager, manufacturing engineering, CeQur. To meet the requirements of today’s complex devices, new materials are needed, she said. Key areas of research include advances in biomaterials, medical electronics, soft materials, and new raw materials for rapid prototyping and additive and subtractive manufacturing, she told MD+DI.

Khanolkar will be exploring emerging materials in the upcoming BIOMEDevice Boston April 18 session, “What’s New & Exciting in Medical Materials.” She’ll look at 5- and 10-year trends in biomaterials, medical electronics, plastics, and soft materials, and explore cutting-edge applications being used by today’s medical device engineers.

Khanolkar has more than 22 years of manufacturing experience specializing in medical devices, working on projects in diabetes management, surgical devices, orthopedics, respiratory products, cardio products, patient safety and health monitoring devices, biomedical and cell regeneration devices, drug delivery, sports regenerative surgery, blood collection, pharmaceuticals, diagnostics, needle protection, and airway products.

MD+DI asked Khanolkar a few questions to better understand some of these emerging materials and how they could enable tomorrow’s medical device innovations.

MD+DI: Why are new materials needed?

Khanolkar: Evolution in science, technology, and manufacturing and the convergence of these technologies are the key driving factors for new materials in the market. Scientific developments in microfluidics, tissue regeneration, gene therapy, miniaturization and bioMEMs, and nanomaterials demand use of new materials in medical devices, where previously a few synthetic inert plastics and metals were being used. Today there is an explosion in many new categories in biomaterials including natural materials, hybrid materials, bioactive, biomimetic, and combination materials including drug and biologic combination devices.

Technology convergence of integrated chips, interoperability, connectivity, flexible sensors, electronics, power harnessing, microprocessors, and artificial intelligence in medical devices has revolutionized medical electronics material selection. The electronics industry, although also regulated, did not have the regulatory standards of medical devices. As this learning curve was integrated, new materials were tested, standardized, and packaged so that today these are available for integrating in medical devices.

Finally, the manufacturing evolution of fast prototyping, 3D printing, multiple additive and subtractive manufacturing, automation, and assembly methods has been a key driver for research in new materials and applications to match human organs.

MD+DI: Are there any challenges or limitations with traditionally selected materials, and if so what are they?

Khanolkar: The challenges for medical device materials are not just limited to the performance characteristics, but also include other considerations for biocompatibility, sterilization, sustained use in harsh environments, aging, and regulatory and statutory requirements. Development of materials for medical devices is a long cycle and requires stringent testing and clinical studies, especially for short- and long-term implantable applications. However, as the material research and choices broaden, they help bring new and improved devices to the market for the patients.

MD+DI: What are some new materials that could address such challenges?

Khanolkar: There is tremendous development in the area of materials for new flexible sensors, bioelectronics, and biomarkers, which can be used in medical devices to sense, monitor, and transmit data, thus enabling the technologies of tomorrow for personalized medicine, artificial intelligence, human augmentation, biochips, and brain machine interfaces.

MD+DI: Are there obstacles to using new materials?

Khanolkar: There are many challenges related to speed of development and getting the materials in the market in a timely manner. Scalability is another challenge, and de-risking scale-up plans early on so material availability is not an issue. Costs and company business directives also drive the decisions if the material will be commercialized. Consolidation and mergers of suppliers affect what materials, grades, or quantities will be available. Other risks include the unknowns of testing and biocompatibility issues over a long time. Regulatory and statutory standards are constantly updated, and the materials need to be compliant with all regulations.

MD+DI: What materials still need to be developed?

Khanolkar: As new applications are developed, there will be a continuous need for new materials, and that is inevitable. However, standardization of some of the processes and regulations for development may help bring new materials to market sooner for medical devices.

MD+DI: What do you hope attendees will do differently after attending your session?

Khanolkar: In this session, we will look into the key drivers, trends, and materials of the future. We will also review cutting-edge applications using novel materials as well as traditional materials used in a novel way.

MD+DI: What has been the traditional process for selecting materials for medical devices, and how might that process be changing?

Khanolkar: A material-selection approach is best implemented when looked at early on in design development and with a holistic approach to selection. I recommend considering three areas when selecting materials: first, device needs and regulations; second, application and performance; and third, manufacturing and costs. Under these categories fall many important selection criteria that help decide not only the material, but also decisions to innovate versus using available choices and build-versus-buy decisions. Most devices today use multiple materials; some come in contact with the body and fluids, some are external, and some are semi-contact. A good analysis of the device needs helps identify any risks or concerns early on and allows mitigation. Finally, cleanliness requirements, material controls, supplier controls, and business continuity are also important considerations and equally important given the global supply chain.

In addition to serving as manager, manufacturing engineering, for CeQur, Khanolkar volunteers as a mentor for FIRST Robotics Team, Girls in STEM, and Women in Engineering. She was a finalist for the INE Woman of the Year 2017 award for promoting STEM and women in engineering.

From:MDDI