Ranica Arrowsmith, Associate Editor03.22.16
Jens Troetzschel, vice president of Advanced Technologies for St. Paul, Minn.-based Heraeus Medical Components (Heraeus Deutschland GmbH & Co. KG), discussed materials science with MPO for the March issue. Here is his extended interview.
Ranica Arrowsmith: What about medical device-related materials science is exciting you today?
Jens Troetzschel: The healthcare profession is recognizing that technology and innovation can produce better treatment outcomes and help put the brakes on costs. Driven by the Affordable Care Act, healthcare is going in the direction of result oriented selection of therapy and device. Direct and sometimes an immediate positive outcome is becoming more and more important. In the future and in some cases already today, the “payers” will not pay if there is no positive result of a therapy. As a consequence, hospitals and medical device manufacturers strive to apply the most efficient therapy. That means safe, effective and cost efficient for everyone including the patient.
From a material selection perspective, it becomes more and more important to use and/or to develop materials that provide superior biocompatibility and bio-stability, durability and mechanical integrity, multi-functionality and smart materials. From a manufacturing perspective these trends drive the need for:
Arrowsmith: What challenges in R&D, testing, sterilization, packaging, etc. do the different materials you work with pose?
Troetzschel: It is no secret that the regulatory hurdle to develop a “new” material or to customize it for a medical application is very high. It takes time, effort and financial resources. More complex materials systems require an increasingly interdisciplinary approach. The time to market is long (for implants) and the return of investment carries risk due to the long timespan required. Historically, regulations require more and more testing today and it is hard to introduce new materials.
But our philosophy at Heraeus Medical Components is simple: we do not see obstacles, we see opportunities. Yes, the reality is we all work in a highly-regulated industry, but that should never be an excuse for taking our foot off the gas pedal when it comes to R&D. It may take time for an idea to go from the “research lab” to become a “real world” treatment, but there’s too much at stake not to strive forward to the future. Healthcare is a truly noble profession; the well-being of patients is at stake every day. We recognize that our work makes a difference, and that’s why we take on that challenge every day.
Arrowsmith: What advancements in recent years have occurred in materials science in the medical device industry? What do you see coming down the pipeline?
Troetzschel: When you optimize the right material or composite materials you can significantly improve the performance and reliability of the finished device. And we are seeing some impressive breakthroughs in unlocking the potential of materials. There have been huge steps made in manufacturing technology to produce greater precision and accuracy, for example. Improving materials also enables the industry to raise quality standards, which is a critical requirement for the industry. All of these developments are encouraging, but we aren’t there yet as an industry. But I am confident that we will see continued progress in these areas.
One example is the FT (feedthrough) technology for implantable active medical devices.
These devices should be smaller and more advanced. If you can increase the number of channels the device has to communicate with the human body, the result is a better, more targeted therapy of the patient. It’s a bit like our digital camera or your smartphone screen–the more pixels, the better the picture.
But there is a serious bottleneck right now. Feedthroughs are an old technology developed in the 1950’s. They integrate wires in a ceramic, which is a cumbersome, manual and expensive process. It limits the ability to miniaturize the whole device and you cannot significantly increase the number of channels.
We’ve solved this problem through our CerMet technology, which uses a novel biocompatible platinum-ceramic paste. We apply a simple but efficient multilayer technology that allows for direct implementation of conductive, even 3-dimensional shaped channels into ceramic. After printing, the paste is co-fired together with the ceramic to yield a new functional, hermetically tight and mechanically robust composite material.
This innovation will allow device companies to break free from the chains and limitations of a 1950’s technology and re-think the design of their devices. They will be able to produce smaller devices, and the ability to miniaturize will produce new treatment options for infants and children. From a patient safety perspective, as implantation becomes smaller, the risk of complications is significantly decreased. Additionally, our technology allows for an almost infinitive number of channels for sensing and stimulation, which will provide more reliable, more accurate, more to the point high resolution therapy.
Arrowsmith: Are there any new categories of devices that have posed interesting or exciting materials challenges for you? How about old devices that are being updated?
Troetzschel: High-resolution treatment therapies will play an increasingly important role in the healthcare profession, and they will become a bigger focus in the medical device industry. The fast growing field of neurostimulation devices introduces a new challenge related to the feedthrough technology. In previous situations, a pacemaker with 4 to 10 channels were sufficient for pacing and sensing; today’s latest neurostimulation devices are equipped with 16 or 32 channels and the trend to increase the number of channels is obvious for better results of the patient.
High-resolution therapies can notably increase the life quality of patients. Here is an example of retinal implants:
High-resolution therapies are not restricted to vision, but extend to hearing, brain and neurostimulation, or brain readers. All of their treatment therapies could benefit from more channels.
Arrowsmith: What is your view on 3D printed materials and their effect on the industry?
Troetzschel: 3D shows lots of promise and potential, but it’s still in its infancy as an emerging process. Additive manufacturing has a huge potential to revolutionize every industry and the medical field is no exception. Noteworthy are especially orthopedic implants that could potentially be tailored and custom-made for a patient–something that would be otherwise hard to achieve by conventional methods. The potential of 3D printing for the field of active implantable medical devices is yet to be revealed.
Heraeus is highly active in the field of 3D printing materials, and we have formed a global team focused on “additive manufacturing.” 3D printing and manufacturing has a lot of opportunities within medical/healthcare even if it is still in its early stages. Our scientists, engineers and researchers are taking on this opportunity whether by the use of own 3D manufacturing facilities or by research into novel materials for this technology.
Ranica Arrowsmith: What about medical device-related materials science is exciting you today?
Jens Troetzschel: The healthcare profession is recognizing that technology and innovation can produce better treatment outcomes and help put the brakes on costs. Driven by the Affordable Care Act, healthcare is going in the direction of result oriented selection of therapy and device. Direct and sometimes an immediate positive outcome is becoming more and more important. In the future and in some cases already today, the “payers” will not pay if there is no positive result of a therapy. As a consequence, hospitals and medical device manufacturers strive to apply the most efficient therapy. That means safe, effective and cost efficient for everyone including the patient.
From a material selection perspective, it becomes more and more important to use and/or to develop materials that provide superior biocompatibility and bio-stability, durability and mechanical integrity, multi-functionality and smart materials. From a manufacturing perspective these trends drive the need for:
- Highest standards of the production system and quality standards;
- Zero failure production;
- Ability to automate and to drive out the manual work;
- Surface technology; and
- Integration platform technology.
Arrowsmith: What challenges in R&D, testing, sterilization, packaging, etc. do the different materials you work with pose?
Troetzschel: It is no secret that the regulatory hurdle to develop a “new” material or to customize it for a medical application is very high. It takes time, effort and financial resources. More complex materials systems require an increasingly interdisciplinary approach. The time to market is long (for implants) and the return of investment carries risk due to the long timespan required. Historically, regulations require more and more testing today and it is hard to introduce new materials.
But our philosophy at Heraeus Medical Components is simple: we do not see obstacles, we see opportunities. Yes, the reality is we all work in a highly-regulated industry, but that should never be an excuse for taking our foot off the gas pedal when it comes to R&D. It may take time for an idea to go from the “research lab” to become a “real world” treatment, but there’s too much at stake not to strive forward to the future. Healthcare is a truly noble profession; the well-being of patients is at stake every day. We recognize that our work makes a difference, and that’s why we take on that challenge every day.
Arrowsmith: What advancements in recent years have occurred in materials science in the medical device industry? What do you see coming down the pipeline?
Troetzschel: When you optimize the right material or composite materials you can significantly improve the performance and reliability of the finished device. And we are seeing some impressive breakthroughs in unlocking the potential of materials. There have been huge steps made in manufacturing technology to produce greater precision and accuracy, for example. Improving materials also enables the industry to raise quality standards, which is a critical requirement for the industry. All of these developments are encouraging, but we aren’t there yet as an industry. But I am confident that we will see continued progress in these areas.
One example is the FT (feedthrough) technology for implantable active medical devices.
These devices should be smaller and more advanced. If you can increase the number of channels the device has to communicate with the human body, the result is a better, more targeted therapy of the patient. It’s a bit like our digital camera or your smartphone screen–the more pixels, the better the picture.
But there is a serious bottleneck right now. Feedthroughs are an old technology developed in the 1950’s. They integrate wires in a ceramic, which is a cumbersome, manual and expensive process. It limits the ability to miniaturize the whole device and you cannot significantly increase the number of channels.
We’ve solved this problem through our CerMet technology, which uses a novel biocompatible platinum-ceramic paste. We apply a simple but efficient multilayer technology that allows for direct implementation of conductive, even 3-dimensional shaped channels into ceramic. After printing, the paste is co-fired together with the ceramic to yield a new functional, hermetically tight and mechanically robust composite material.
This innovation will allow device companies to break free from the chains and limitations of a 1950’s technology and re-think the design of their devices. They will be able to produce smaller devices, and the ability to miniaturize will produce new treatment options for infants and children. From a patient safety perspective, as implantation becomes smaller, the risk of complications is significantly decreased. Additionally, our technology allows for an almost infinitive number of channels for sensing and stimulation, which will provide more reliable, more accurate, more to the point high resolution therapy.
Arrowsmith: Are there any new categories of devices that have posed interesting or exciting materials challenges for you? How about old devices that are being updated?
Troetzschel: High-resolution treatment therapies will play an increasingly important role in the healthcare profession, and they will become a bigger focus in the medical device industry. The fast growing field of neurostimulation devices introduces a new challenge related to the feedthrough technology. In previous situations, a pacemaker with 4 to 10 channels were sufficient for pacing and sensing; today’s latest neurostimulation devices are equipped with 16 or 32 channels and the trend to increase the number of channels is obvious for better results of the patient.
High-resolution therapies can notably increase the life quality of patients. Here is an example of retinal implants:
High-resolution therapies are not restricted to vision, but extend to hearing, brain and neurostimulation, or brain readers. All of their treatment therapies could benefit from more channels.
Arrowsmith: What is your view on 3D printed materials and their effect on the industry?
Troetzschel: 3D shows lots of promise and potential, but it’s still in its infancy as an emerging process. Additive manufacturing has a huge potential to revolutionize every industry and the medical field is no exception. Noteworthy are especially orthopedic implants that could potentially be tailored and custom-made for a patient–something that would be otherwise hard to achieve by conventional methods. The potential of 3D printing for the field of active implantable medical devices is yet to be revealed.
Heraeus is highly active in the field of 3D printing materials, and we have formed a global team focused on “additive manufacturing.” 3D printing and manufacturing has a lot of opportunities within medical/healthcare even if it is still in its early stages. Our scientists, engineers and researchers are taking on this opportunity whether by the use of own 3D manufacturing facilities or by research into novel materials for this technology.