Mark Hendriks: Biomaterials technology will help the industry and the medical community successfully address some of the most significant issues and trends in healthcare delivery today and in the future, including:

On Costs. The pace of growth in healthcare expenditures is not sustainable and reimbursement of medical device products is under increasing cost-pressure. Obviously, such pressures will trickle down to the level of biomaterials technology suppliers and solutions providers. As a biomaterials solutions provider this is a concern; however, it can also be seen as an opportunity for innovation.

For example, [at DSM,] we have embedded innovation in the way we develop and market our novel medical coatings technologies. We focus on developing best-in-class coating chemistry, as well as developing a robust coating process for application of that chemistry. Moreover, we help transfer this coating process to our customer through an on-site process validation. This creates a comprehensive solution for our customers, which helps keep the total cost of ownership very competitive.

Another example relates to our novel implant-grade polyurethanes. Through careful design of the chemistry of this class of medical polymers we can provide a material with desirable characteristics – such as hydrophilicity, or antimicrobial activity —which may allow developers to omit a final coating step altogether. In other words, a surface-modified medical device can be designed immediately from the raw material, which also helps to keep costs competitive.

On Minimization. Medical devices are getting smaller and smaller. We have seen the various clinical fields increasingly turn to percutaneous therapies or minimally invasive procedures. The reasons are obvious: Smaller devices help to reduce trauma, speed recovery time, and shorten hospital stays; all which reduce the burden on our healthcare system and patients as well as increase cost effectiveness.

Needless to say, reducing the size of medical devices raises the bar on what can be expected from traditional biomaterials in regards to meeting design specifications. One cannot keep decreasing the wall thickness of a polymer tubing made from traditional materials, for instance, and expect the same mechanical performance and endurance as before.

From the perspective of medical device designers, this means that they will need biomaterials that can enable decreasing device size without compromising on strength and durability.

On Infection Prevention. It is well known that reimbursement agencies have said that the cost of treating hospital-acquired infections will no longer be reimbursed by CMS. The consequences of a device-associated infection can be dramatic. It typically means surgery to remove the infected device and concomitant intense treatment with antibiotics to eradicate the infection. Depending on the clinical indication, after the infection has been eradicated, another intervention may be necessary to replace the medical device. Costs associated with a device-associated infection can be dramatic. Literature has reported that treatment of a device-infection can easily cost six times the price of the original device placement.

Therefore, it is no surprise that the change in reimbursement policy has created greater demand for antimicrobial materials technologies. To meet that demand, biomaterial technology developers are focusing on the development of innovative materials including non-biofouling coatings, “contact-killing” surfaces and antibiotic-releasing materials.

In the future, biomaterials technology will continue to provide solutions to improve clinical success in both drug delivery—notably delivery of protein therapeutics—and regenerative medicine.

Though controlled and sustained delivery of protein therapeutics meets a clear clinical need, at present, there are few tangible solutions where active therapeutic protein can be delivered for more than one month. The biodegradable polyester-based materials that are currently used are not fully suitable because of their bulk degradation and local acidity problems. Biostable polymer delivery systems are generally not suitable for protein delivery as the molecules are too large to be released by diffusion. As a result, there is a clear and growing need for materials that can protect the protein payload from the degradation mechanism of the body, yet allow for it to be released in a fully functional and non-aggregated form.

As professor Tony Mikos of Rice University once told me: “There are no purpose-designed materials for tissue engineering and regenerative medicine.” For example, instant hydrogels for cell delivery; materials for tissue engineering scaffolds; and, as mentioned before, materials for controlled delivery of protein therapeutics, such as growth factors. The promise of regenerative medicine will be advanced as more developers focus their efforts on the design and development of biomaterials that are fit for that purpose.