PEEK leads the way for the future of active implantable medical devices

We sat down with Thomas Billings Senior Application Engineer and Marcus Jarman-Smith Market Strategist, to dig deeper into why Invibio are championing PEEK as an efficient, innovative material for use in implantable medical devices, and what its adoption could mean for the promising future of the MedTech space. 

Implantable medical devices, such as pacemakers, are not a new construction by any means, however the technology that drives them is constantly evolving. From build quality and bioavailability, through to technological features such as remote operation programming and battery life, the systems that run these medical devices  are devices are in constant development.

Polyether ether ketone (PEEK), is a thermoplastic polymer, and part of the polyaryletherketone (PAEK) family. PEEK’s heat and chemical resistance, specialised electrical properties and general robustness, means it’s modern usage spans across the aerospace, automotive, and chemical process industries.

Challenges driving innovation for active implantable medical devices

Cost reduction, miniaturization and a longer lifespan are all key for active implantable medical device development across the MedTech industry, to produce less invasive medical procedures. Marcus provided us with an insight on the real-world challenges that drove this need for product and material innovation.

He explained: “The challenges were raised or highlighted by COVID-19 and the pandemic. We saw this during the lockdowns that we had. Things like restricted access to healthcare highlighted the need and benefits of remote patient monitoring, and things like connectivity and the importance that could bring.

“There was also a shift from providing decentralised healthcare, so not as an inpatient, but different points of care as outpatients or as a remote patient. 

“Product innovation can allow those challenges to be more readily overcome. It allows you to incorporate data acquisition, remote adjustment of the devices and I guess as we're asking new things of these devices, demanding connectivity. Then the key end user requirements have changed and this often has implications.”

A shift towards new materials is happening right now

This shift towards utilising new materials, according to Marcus, was as much of a cultural shift as it was a technological change, we now lived vastly different lives to how we did just five years ago, let alone 10. 

The Internet of Things (IoT) has highlighted the demand for remote connectivity, a pandemic temporarily changed our ability to access traditional healthcare services, unexpectedly revolutionising digital processes, and so what we ask of our implantable devices must follow an entirely new narrative.

We want connectivity, 24/7

Tom Billings further explains how the need for change has been driven in such a short space of time.

He said: “The materials that might have been fine before, when you were asking a device to do something, suddenly you're asking it to be in a different patient, to be connected  24/7 and to acquire information whilst being implanted for longer.

“So that's where we've seen more product innovation and more requests for our material. The PEEK-OPTIMA material was developed to deal with more key end user requirements.”

Minimizing risk in the operating theatre and beyond

It’s not just the societal pressures and changes that have formed the need for rapidly-evolving MedTech devices, as naturally, a lot of change is driven from within the industry, as Tom adds.

“The driving force is the Original Equipment Manufacturer (OEM) as well, they are key,” he says. “What they're driving to do is make the device more friendly and more connected.”

“They can monitor usage of the device remotely, to understand what settings they need to use based on individual patient needs and track that data. From a surgeon’s perspective, a smaller device is going to be a smaller incision. It's going to be less invasive for the patient and just better outcomes overall for their surgeries.”

From a technological standpoint, Tom shared some of the aims that innovation of technology hopes to bring to healthcare professionals. 

He said: “The key aims of new technology for the Med tech industry are driven from OEM's considerations, so when designing technology such as pacemakers and neurostimulation devices, they're taking input from surgeons. they're taking input from the patients, and they're trying to be more patient-centred.” 

“I would say miniaturisation has been key with every person we talked to - they're always trying to make these devices smaller. It's just the natural outcome of having something implanted and it being surgical.”

It is this nature of implanting a device through surgery that led to PEEK being one of the few compatible choices.

Tom added: “With the selection of materials, they're very limited because they need to be bio compatible, they have to be more selective with what they do and the long lead times to market affect decision making as well.” 

Design challenges for active implantable medical devices

Continuing on our discussion, Tom highlighted that having something implanted inside your body brings a whole host of considerations, and smaller incisions, made possible by miniaturization are key from a less invasive point of view.

He said: “Yes, and more connected, meaning more ability for Bluetooth and RF transmission, the ability to recharge for some devices is also very helpful because of battery life. Battery life a huge driver for a lot of these considerations because they can limit the device time.” 

Limited material options because of biocompatibility helped to accelerate PEEK’s adoption, and during the process of looking at other materials, PEEK came out on top because of multiple driving factors.

Tom added: “That's the challenge in itself. When you look at the short list of tools or materials that you can use to do that job, it makes it even more challenging. PEEK has been evidenced through being used in other medical implant applications. Through industry and applications, it can be tailored to have different types of properties, providing a real versatility. The ultimate goal is we’re trying to improve the status of where we are today.” 

“Ultimately, you want to deliver a better patient experience and have better clinical outcomes. PEEK helps with that. New technology in this space helps us to be more data-driven, remote-capable and it's allowing us to develop more intelligent devices and services as well. These kinds of super polymers are very digital friendly, in terms of transmissibility and electrical compatibility. “

“It allows us healthcare professionals to understand, diagnose, and treat in a different way, a more efficient way, and it allows a more patient-centric kind of treatment also.” Marcus explains.

Tom then provided us with more detail on PEEK’s benefits within the human body, as far as bio-compatibility and technologies are concerned.

He explained: “When you're at the hospital with a pacemaker, there's a tech that will come in and set the parameters by which electrical signals are going to pace the heart and the boundaries in which is going to do so. That happens once it's already in your body and the only reason it can happen right now is because an antenna that's sticking out of the cannon, making the device a lot larger. With PEEK that wouldn't be needed because it is RF transmissible” 

The main challenges of designing the specific active implantable medical devices were able to be overcome, but the process wasn’t straightforward. Tom highlights the expertise and technology at Invibio that has helped to innovate and break through some of those barriers to change. 

“One of the biggest challenges with choosing PEEK is around the hermetic nature of these devices,” he says. "For pacemakers, LCDs or anything in the body, they can't have moisture ingress because the basic function of these devices is to have electronics inside of them and water ingress will destroy those boards and it will eat away. It can cause rust and all kinds of things that affect the longevity of the device.”

“Some of the ways that we've looked to overcome this is through welding techniques for PEEK. Even though some people do not think that it's easy to weld, it absolutely can be welded with laser welding and with ultrasonic welding, then hermetic sealing. There's been a lot of advancements on the electronic side too. To reduce free ions and the sort of things that cause rust to occur.”

Tom continued on to say that it’s not just the hermetic nature of PEEK that has allowed it to excel in the sector, the material’s uptake has also been driven by its relation to heat and battery function.

He said: “If you're recharging the device or adding any step of heat, it really limits the available materials that you can choose that are going to be able to withstand that type of temperature in the body.

“With film selection, PEEK makes a lot of sense, but it just needs those performance key engineering requirements to be high enough where you know some of these other materials just aren't going to line up.” Marcus added that: “PEEK also has a lot of transferable applications. For example, it's in billions of smartphones.”

"Ultimately, you want to deliver a better patient experience and have better clinical outcomes. PEEK helps with that. New technology in this space helps us to be more data-driven, remote-capable and it's allowing us to develop more intelligent devices and services as well. These kinds of super polymers are very digital friendly, in terms of transmissibility and electrical compatibility."
Thomas Billings
Senior Application Engineer
Invibio

Market Trends in MedTech, led by PEEK

Looking at the trends and mega-trends in the MedTech space, Marcus was able to forecast and shed some light on the developments in the active implantable medical device market and how they could solve ongoing problems. 

He said: “The trends are moving towards acquiring real-world evidences and data-driven treatments. Implants are particularly targeted to an incorporating digital solution. The device development will allow us to evolve and create better solutions that are more efficient, patient-friendly, and sustainable.”

Final Thoughts

With this in mind, we can expect to see evolution across the industry as a result of uptake and usage of modern active implantable medical devices - whether it’s a certain way of thinking or new practices that evolve. Marcus had some final thoughts.

He stated: “I think most people look at PEEK in a very analogous way,” he says. If I switch metal titanium's for example with PEEK, this super polymer costs a lot more and that’s a traditional way of thinking. Most of the applications that really benefit from PEEK look at the total cost of the solution.” 

“With PEEK being a different material, it enables something completely different, so a new design to solve the problem that might be more efficient. It might be a way to consolidate parts. It might be ways to assemble parts more efficiently. Or it might be things like shifting away from milling metal to moulding polymer so that you can mass produce it more efficiently.”

“It's important to consider the total cost of the solution and to consider the fact that a new material can bring you a lot of new capabilities that may trigger off completely new product lines or completely new generations of devices. It's important to consider those factors with the cost analysis.”

“If you want particularly complex designs, or to be able to do something that you just can't do with the other kind of manufacturing technologies, then it's probably time to start thinking about the benefits of PEEK.”

So, there you have it, miniaturisation, less-invasive procedures, the rising need to connect and maintain devices remotely, all while being manufactured to an ultra-high standard of hermetically-sealed, bio-compatible, battery-friendly construction. PEEK’s entrance and subsequent position as a mainstay in the MedTech industry is through no fluke or stroke of luck, but a carefully considered antidote to a fast-evolving space in a sector experiencing immense change and disruption.

Marcus signed off with: “PEEK is a real advantage, and I mean so much to the point that we have over invested heavily in this kind of area because we see it as part of the future. Invibio has capability in this space.” 

Do you want to learn more about implantable PEEK and what it could do for your MedTech business? Get in touch and we can provide you a quote in two business days.

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