Examples of implantable fabrics. Image courtesy of Secant Group.
The medtech industry is mostly still using the same polymers and metallic materials used 60 years ago, says Jeremy J. Harris, Ph.D., director, research, for Secant Group. “There’s been little introduction of new materials,” with the exception of resorbables, he told MD+DI. But “as medical technology advances, such as it is in regenerative medicine and tissue engineering, there’s a greater demand for new materials.”
Such insufficiency can result in a “compliance mismatch” between devices and tissue, he said. “There’s a difference in the physical properties of devices versus those of tissues. We’ve come a long way in understanding tissue response, so now there’s a need to best match the physical properties of the device to that of the tissue.”
For instance, when the industry first started using certain materials years ago, “it looked at whether they were inert or resulted in a minimal inflammatory response or whether they matched the tensile strength of bone, for instance,” Harris said. “As we move into new therapies, it’s not just the physical properties that are important—it’s now also understanding the biological interactions between the material and tissue. Materials are needed that can participate in the healing process.”
Collaboration between medical device manufacturers and academia could bring about the emergence of such “active” materials, said Harris. “There needs to be a marriage between academics and commercial activity,” he said. “Academia has access to science and cutting-edge research, and it takes a high-level of risk to be able to do this research.
“But academia can be stuck in research mode and often don’t consider commercial or regulatory requirements needed to market a new technology,” he continued, so the medical device industry can help academics think about scale-up, shipping, storage, shelf-life, sterilization, packaging, quality assurance, regulatory, and other considerations for readying products for market. “Commercial companies have all this in mind during all stages of development,” he added.
Harris said that Secant has been collaborating with academic institutions. “We recognize the need, and we are still in the early stages, but we are reaching out for our own development,” he said. The company develops implantable structures for medical devices and offers contract manufacturing support.
For instance, Secant previously licensed poly(glycerol) sebacate (PGS) from MIT for use in developing cardiovascular devices. “In terms of physical properties, it is a true elastomer,” Harris said. “Many of today’s medical polymers are thermoplastics, so they have very little elasticity. Tissue, especially cardiovascular, is elastic so an elastic material is needed to successfully match the compliances. In addition, PGS is bioresorbable and experiences surface erosion, opposed to bulk erosion, which allows better control of the degradation process.”
Secant would like to pursue off-the-shelf materials for medical devices. “Our business plan is to take development as far as we can and partner with medical device companies so they can take it further,” he said. One example is the Regenerez bioresorbable resin platform.
There are some challenges in bringing new materials to market. In terms of testing, “as we change the paradigm about what we want materials to do, testing changes—it is no longer just measuring the physical properties,” he said. For instance, there’s a “need to develop test methods to determine how a material is interacting with surrounding tissue. It is new ground for medical device companies and FDA. There is some guidance, but it is lagging behind rapidly evolving technologies.”
When asked whether academia could help with new test methods development, Harris said they could. "Since they typically have a deeper understanding of the science, they could develop new testing procedures," he explained.
Another challenge involves helping end-users cope with product changes. “Clinicians and surgeons don’t like change or anything that disrupts their workflow or takes longer,” he said. “It can be a challenge to get their input, so find clinicians who are open to change and can generate data [demonstrating] a clinical advantage. Get practicing clinicians involved early in the development process. In academia, there are research-centric surgeons open to new ideas, and they can help generate data to convince everyday clinicians.”
Ultimately, medtech companies need to keep an eye on “where technology is going if they want to be in the forefront, and they have to take on a higher degree of risk in developing materials and processes,” Harris said. “Find a partner, academic or commercial, to help spread the risk, or be willing fund your own internal research.”