Ranica Arrowsmith, Associate Editor03.21.16
Gemma Budd, business manager of Healthcare for Lucideon Ltd., a materials technology company based in Staffordshire, United Kingdom, and Raleigh, N.C., discussed materials science with MPO for the March issue. Here is her extended interview.
Ranica Arrowsmith: What about medical device-related materials science is exciting you today?
Gemma Budd: What’s exciting today is that there is much more of a focus on trying to better mimic the behavior of natural biological systems and materials For example, self healing polymers, bioresorbable composites, cellular scaffolds, etc. which often also have a therapeutic effect—they are not just inert physical structures that simply sit in the body. They are bioactive, either inherently, e.g. via release of ionic species that trigger cellular pathways or having surface functionality that attracts cellular attachment or stimulates behaviors; or by acting as carriers for drugs, whether that is small molecules or larger protein based therapies. Many existing materials can’t offer the right balance between physical integrity and biological activity, so there is a lot of work being done to try and develop new ones or to combine the best of multiple materials by engineering new processing technologies as well as exploiting natural processes.
Arrowsmith: What challenges in R&D, testing, sterilization, packaging, etc. do the different materials you work with pose?
Budd: The big issue with testing these materials is that the standards that are available serve the lowest common denominator. They haven’t kept up with the pace of innovation and fail to demonstrate and validate the features our customers are trying to put into the materials. It might be easy enough for people to “pass the test”, but to really showcase what their products and materials are doing–and to make sure they are safe - they need to develop new methods and engineer new test configurations, and this is what we are being asked to do a lot at the moment. Similarly, speed to market is important, and whilst it is important for our customers to show their products will last a lifetime, they can’t wait a lifetime to prove it–so developing accelerated ageing that are aggressive enough to truly challenge the product is another area we are active in.
Arrowsmith: What advancements in recent years have occurred in materials science in the medical device industry? What do you see coming down the pipeline?
Budd: Inherently responsive materials are really exciting. For example, using the physics of materials to trigger a change in form, or to release an encapsulated active, when there is a change in the environment, is where the industry is going. For example, there is some great work being done developing smart insulin delivery systems that absorb and release insulin based on local glucose levels–no need for an external pump or injections. This is where materials can be so important–this isn’t about a fancy implant design–it’s about understanding the fundamental properties of each material and knowing how to influence it to give you the outcome you need.
Arrowsmith: What is your view on 3D printed materials and their effect on the industry (if you have any experience/insight into this area).
Budd: 3D printing is potentially turning into a Pandora’s box at the moment. There is undoubtedly a lot it can offer, but it is being dubbed the answer to the world’s problems… But the truth is, it is causing a lot of problems as well! We are spending a lot of time working with medical device manufacturers using metal and even ceramics for 3D printing–because they are realizing that they are gaining some features at the expense of others. What they don’t know yet, is whether the “lost” features are critical to performance or whether they have been previously over-engineered. Using our expertise in materials science and engineering, we look at the fundamental properties e.g. microstructure of the 3D printed materials vs. traditional processing routes, and give more informed insight into whether they do need to be concerned–and how to overcome some of those concerns by modifying the process/materials. For example, a key issue is that 3D printing relies on the joining of lots of discrete particles–which means there are lots of potential defect points vis-à-vis normal processes–and ensuring those potential defects don’t lead to actual defects is a challenge that spreads from medical devices through to aerospace. Customers are now starting to look at post-processing as well as taking more control over their raw materials, to limit these risks moving forward–and we are helping to design and validate these processes.
Ranica Arrowsmith: What about medical device-related materials science is exciting you today?
Gemma Budd: What’s exciting today is that there is much more of a focus on trying to better mimic the behavior of natural biological systems and materials For example, self healing polymers, bioresorbable composites, cellular scaffolds, etc. which often also have a therapeutic effect—they are not just inert physical structures that simply sit in the body. They are bioactive, either inherently, e.g. via release of ionic species that trigger cellular pathways or having surface functionality that attracts cellular attachment or stimulates behaviors; or by acting as carriers for drugs, whether that is small molecules or larger protein based therapies. Many existing materials can’t offer the right balance between physical integrity and biological activity, so there is a lot of work being done to try and develop new ones or to combine the best of multiple materials by engineering new processing technologies as well as exploiting natural processes.
Arrowsmith: What challenges in R&D, testing, sterilization, packaging, etc. do the different materials you work with pose?
Budd: The big issue with testing these materials is that the standards that are available serve the lowest common denominator. They haven’t kept up with the pace of innovation and fail to demonstrate and validate the features our customers are trying to put into the materials. It might be easy enough for people to “pass the test”, but to really showcase what their products and materials are doing–and to make sure they are safe - they need to develop new methods and engineer new test configurations, and this is what we are being asked to do a lot at the moment. Similarly, speed to market is important, and whilst it is important for our customers to show their products will last a lifetime, they can’t wait a lifetime to prove it–so developing accelerated ageing that are aggressive enough to truly challenge the product is another area we are active in.
Arrowsmith: What advancements in recent years have occurred in materials science in the medical device industry? What do you see coming down the pipeline?
Budd: Inherently responsive materials are really exciting. For example, using the physics of materials to trigger a change in form, or to release an encapsulated active, when there is a change in the environment, is where the industry is going. For example, there is some great work being done developing smart insulin delivery systems that absorb and release insulin based on local glucose levels–no need for an external pump or injections. This is where materials can be so important–this isn’t about a fancy implant design–it’s about understanding the fundamental properties of each material and knowing how to influence it to give you the outcome you need.
Arrowsmith: What is your view on 3D printed materials and their effect on the industry (if you have any experience/insight into this area).
Budd: 3D printing is potentially turning into a Pandora’s box at the moment. There is undoubtedly a lot it can offer, but it is being dubbed the answer to the world’s problems… But the truth is, it is causing a lot of problems as well! We are spending a lot of time working with medical device manufacturers using metal and even ceramics for 3D printing–because they are realizing that they are gaining some features at the expense of others. What they don’t know yet, is whether the “lost” features are critical to performance or whether they have been previously over-engineered. Using our expertise in materials science and engineering, we look at the fundamental properties e.g. microstructure of the 3D printed materials vs. traditional processing routes, and give more informed insight into whether they do need to be concerned–and how to overcome some of those concerns by modifying the process/materials. For example, a key issue is that 3D printing relies on the joining of lots of discrete particles–which means there are lots of potential defect points vis-à-vis normal processes–and ensuring those potential defects don’t lead to actual defects is a challenge that spreads from medical devices through to aerospace. Customers are now starting to look at post-processing as well as taking more control over their raw materials, to limit these risks moving forward–and we are helping to design and validate these processes.