The medical device industry is at the peak of innovation, believes Asmita Khanolkar, head of manufacturing engineering, CeQur. To meet the demands of today’s complex devices, new materials are needed, she said. The main areas of research include advancements in biomaterials, medical electronics, flexible materials and new raw materials for rapid prototyping and additive and subtractive manufacturing, she said. MD + DI.
Khanolkar will explore emerging materials at the upcoming BIOMEDevice Boston session on April 18, “What’s New and Exciting in Medical Materials”. She will examine 5 and 10 year trends in biomaterials, medical electronics, plastics and flexible materials, and explore the cutting edge applications used by today’s medical device engineers.
Khanolkar has over 22 years of specialized medical device manufacturing experience, 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 regeneration. surgery, blood collection, pharmaceuticals, diagnostics, needle protection, and respiratory products.
MD + DI asked Khanolkar a few questions to better understand some of these emerging materials and how they might enable the medical device innovations of tomorrow.
MD + DI: Why do we need new materials?
Khanolkar: The evolution of science, technology and manufacturing and the convergence of these technologies are the main driving factors for new materials in the market. Scientific developments in the fields of microfluidics, tissue regeneration, gene therapy, miniaturization and bioMEMs, and nanomaterials require the use of new materials in medical devices, where previously some synthetic inert plastics and metals were used. Today, there is an explosion in many new categories of biomaterials, including natural materials, hybrid materials, bioactive, biomimetic and combination materials, including combination drug and biologic devices.
The technological convergence of embedded chips, interoperability, connectivity, flexible sensors, electronics, electrical wiring, microprocessors and artificial intelligence in medical devices has revolutionized the selection of materials for medical electronics. The electronics industry, although also regulated, lacked regulatory standards for medical devices. As this learning curve is integrated, new materials have been tested, standardized and packaged so that they are available today for integration into medical devices.
Finally, the evolution of manufacturing rapid prototyping, 3D printing, multiple additive and subtractive manufacturing, automation and assembly methods has been a key driver for the search for new materials and applications for correspond to 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 limited to performance characteristics, but also include other considerations for biocompatibility, sterilization, sustained use in harsh environments, aging, and regulatory and statutory requirements. The development of materials for medical devices is a long cycle and requires rigorous clinical trials and studies, especially for short and long term implantable applications. However, as research and material choices expand, they help bring new and improved devices to market for patients.
MD + DI: What are the new materials that could meet such challenges?
Khanolkar: There is considerable development in the field of materials for new flexible sensors, bioelectronics and biomarkers, which can be used in medical devices to detect, monitor and transmit data, thus enabling tomorrow’s technologies for personalized medicine, artificial intelligence, human augmentation, biochips and brain-machine interfaces.
MD + DI: Are there any obstacles to the use of new materials?
Khanolkar: There are many challenges related to the speed of development and getting materials to market in a timely manner. Scalability is another challenge, and reducing the risk of scaling plans early on so that hardware availability is not an issue. Company costs and marketing guidelines also determine whether the equipment will be marketed. Consolidation and mergers of suppliers affect the materials, grades or quantities that will be available. Other risks include unknowns in testing and long-term biocompatibility issues. Regulatory and statutory standards are constantly updated and materials must comply with all regulations.
MD + DI: What materials still need to be developed?
Khanolkar: As new applications are developed, there will be a continuing need for new materials, and it is inevitable. However, standardizing some of the development processes and regulations can help bring new medical device materials to market faster.
MD + DI: What do you hope participants will do differently after attending your session?
Khanolkar: In this session, we will take a look at the main drivers, trends and materials of the future. We will also review advanced applications using new materials as well as traditional materials used in new ways.
MD + DI: What has been the traditional material selection process for medical devices, and how might this process evolve?
Khanolkar: A material selection approach is best implemented when considered early in design development and with a holistic approach to selection. I recommend considering three areas when selecting materials: first, device requirements and regulations; second, application and performance; and third, manufacturing and costs. Within these categories are many important selection criteria that help decide not only the material, but also decisions to innovate in relation to the use of available choices and build vs. buy decisions. Most devices today use several materials; some come into contact with the body and fluids, some are external and some are semi-contact. A good device needs analysis helps identify risks or concerns early on and helps mitigate them. Finally, cleanliness requirements, material controls, supplier controls and business continuity are also important and equally important considerations given the global supply chain.
In addition to serving as the Director of Manufacturing Engineering for CeQur, Khanolkar volunteers as a mentor for the FIRST Robotics Team, Girls in STEM and Women in Engineering. She was a finalist for the 2017 INE Woman of the Year award for promoting STEM and women in engineering.
Please click here to register and attend “What’s New and Exciting in Medical Equipment” on Wednesday, April 18 at 8:30 am.