Morgan Advanced Materials is a $1.5 billion company based in the UK and traded on the London stock exchange that services many industries as an engineered materials manufacturer. One of those industries is the medical market.
Christien Vaillancourt is the Business Development Manager out of the New Bedford, MA facility where the company makes ceramic-to-metal assemblies, specifically for the active implant market: pacemakers, defibrillators, implantable impulse generators, implantable drug delivery pumps, and other types of implantable devices. While this is Vaillancourt’s area of expertise, other medical assemblies are also manufactured in New Bedford, such as cathode and anode assemblies for medical imaging.
“In my area, we specialize in custom, hermetic, ceramic-to-metal assemblies, typically, used for feedthroughs. If you have a device such as an implantable pulse generator (IPG), you typically have a titanium can that houses the electronics which are the brains of the device. Then you have leads that go to the target therapy site,” explained Vaillancourt.
All signals must be isolated as they go out of and into the device. They need to be both hermetically sealed and electronically isolated. This prevents signal crossing and shorts. “Our products enable the device to get a clean signal both in and out while maintain the hermaticity of the device,” said Vaillancourt.
Typically, a customer will approach Morgan with a preliminary device concept, and they will let them know how many leads are required to provide therapy to the specific area of the body that they are trying to stimulate.
Morgan will then provide them with a hermetic feed-through that will get the signal in and out of the device. Morgan’s experienced Applications Engineers always work with customers to improve on the proposed design by recommending space and cost savings initiatives.
“Over the years we have developed tighter and tighter pin pitches to allow our customers to make smaller implantable devices,” said Vaillancourt. “A typical feedthrough would be a titanium flange, a ceramic insulator, typically a 94% min alumina, platinum or platinum/iridium leads and 99.99% pure gold braze. We use only all biocompatible components.”
While the company has been developing these types of products since the mid-70s, the big push into ever smaller implantable devices really started to surge in recent years. Along with size reduction, Vaillancourt says that they are also seeing a lot of innovations and need for their products in the neuromodulation space. “The cardiac market has become rather stable but requests for unique neuromodulation devices are growing rapidly,” he said. “At the moment, there is a lot of really interesting development going on in the deep brain, retinal, hearing and sensing space. In the past, a typical device might need only a 2 or 4 pin feedthrough, today we are seeing that it is rare to see any device that requires less than 16 pins.
We are actually working on projects right now that have 20 pins, 25 pins, even 45 pins. So as the neuromodulation market evolves, our customers are finding ever more unique applications for their devices. They are requiring us to provide ever more inputs and outputs through our feedthrough to get different therapies to different parts of the body.”
As neuromodulation device technology advances, and its customers add more and more features to their products, Morgan Advanced Materials is constantly pushing the limits with regards to number of pins and the pitch between the pins. Products that may have only required 8 pins in the past may now require 2 or 3 times that many today, but in the same, or smaller area.
While the materials and processes used in manufacturing these feedthroughs remain relatively consistent, each customer has a specific and unique application that needs special attention. Regardless, Vaillancourt says that all feedthroughs manufactured at Morgan New Bedford will undergo 100% visual inspection, a 100% MIL spec thermal shock, 100% electrical testing for insulation resistance between pins and between the pins and flange and 100% hermaticity test to ensure there are no leaks when they are in vitro. All of this is done on every product for every project before it is integrated into the proprietary design as designated by the customer.
Leading into the Future
On the leading edge, Morgan has developed what they call a high density feed-through. Vaillancourt explained, “The High Density Feedthrough (HDFT) is a shift in technology for us. In this instance, we are not using our typical gold braze technology, but we are actually direct-bonding the pins into the ceramic. This allows a tighter pin pitch than has ever been achieved in the past. It’s something we recognize there will be a need for with the new devices that are coming out and we are always trying to stay ahead of the development curve.”
Morgan’s area of expertise has traditionally been in custom feedthroughs so when a customer needs something unique, this is where they excel. But recently, the company has also found that, due to the long development time required to produce an implantable device, some customers may not need the true end-customized devices at the onset. For long duration and multi-stage medical device projects, a customer may want to work in-house with more simple feedthroughs until they reach the point where they need true customization.
“To meet this need, we plan to launch a line of standard feedthroughs for these types of applications. We will offer standard feedthroughs from 2 to 8 pin models. Customers will be able to use these feedthroughs in whatever configuration and pin count their application dictates,” said Vaillancourt. “From the initial stages of these innovative active implantable devices to the final product, we get the opportunity to work with the very leading edge companies. It is a highly rewarding job.”