When it comes to designing new medical devices, Gavin Braithwaite, CEO at Cambridge Polymer Group, said it is never too early to be thinking about things like material choices and how the sourcing of their chosen materials could evolve over time. He also said that designers should be looking at possible future regulatory and reimbursement trends that could adversely affect the clearance and usage of their product.

“It’s kind of a next-generation mindset, thinking about the implications of choices that [designers are] making now,” he said, in an interview with MD+DI. “In a sense, this philosophy attempts to consider the demands that are going to be on the device beyond just the functional needs, to avoid getting trapped into dead-end design decisions that are going to cause problems in the future.”

Braithwaite will discuss this mindset in detail at MEDevice Boston in his presentation, “Don’t Develop Your Device Twice: Planning for the Next Generation, and the Next, and the Next…”

“At a high level, I want to present the medical device design perspective from a material science perspective, with particular emphasis on the ‘gotchas,’ the things outside the engineering solution that they should be aware of as they develop a device,” Braithwaite said.

MD+DI spoke with Braithwaite recently, and what follows is a little preview of what he hopes attendees will take away from his session.

What steps would you suggest companies take to have a next-generation mindset when they’re still in the planning and design phase of a new device?

Braithwaite: It’s thinking about, ‘are the choices I make now, which may work for the current design or the current regulatory requirements, going to cause me a problem when I come to the next-generation device?’

For example, there’s a lot of press at the moment around the problems with ethylene oxide sterilization. Clearly, it’s a ubiquitous sterilization process. From a polymer perspective, it doesn’t have a great deal of impact on materials. But there’s a lot of chatter about ‘is the usage of EtO going to be curtailed or reduced because of potential FDA or EPA changes?’

So, thinking ahead, am I selecting materials that may end up having to be sterilized through another method, the choice of which is going to burn me when I get to making generation two? It might be fine for now, but if it’s radiation sensitive, it’s not going to be sterilizable using gamma or e-beam, and that simple choice early on has boxed the manufacturer into a difficult and costly position. In this case, at best there will be costly mitigation activities, and at worst, the device will have to be torn up and new materials implemented.

So, knowing now what regulations may be coming down in the pipeline is helpful. What about the ability to source materials in the future?

Braithwaite: Yes. Obviously coming out of the COVID pandemic there is a lot of discussion about sourcing materials or onshoring materials. There are a lot of pressures on U.S. companies to think about secondary sources and alternative vendors within the United States, and the impact that has on performance changes and quality. So, thinking ahead for that sort of thing. But more broadly, and you touched on this, manufacturers must be aware of potential regulatory changes being considered. It’s approaching the material and device design with a broader perspective than just the mechanical properties of the device that you’re trying to resolve at that moment in time.

And that’s where small companies in particular struggle because they don’t have that expertise or the broader experience. But even the bigger companies, where the expertise can be siloed, don’t necessarily have the folks who are aware of what’s happening in those peripherals, but related, areas.

Without a crystal ball, how can companies plan? How would you advise let’s say a start-up or somebody that didn’t have any experience at all?  What steps should they take?

Braithwaite: First, for start-ups, I think it’s the hardest question because any decision they make has profound impact on their cash flow. Essentially the easy path is for a start-up to say ‘Well, I need to fix this mechanical problem. I’ll pick a material that meets my immediate performance specifications and I’m good to go. I’ll make a prototype and it seems to be working.’

Our advice would be – that can be short-sighted and that it’s actually more cost-effective in the long run to spend money on finding the resource to give you advice early as to both choices. Obviously, that can be challenging for a startup, but that support does not need to be hugely burdensome, and can save substantial time and effort, even at the early stages of development.

If you’re talking to someone like us or regulatory consultants, bringing them in earlier to have those conversations and asking, ‘Is that going to cause me problems down the track?’  You can cover this by bringing in individual resources, regulatory consultants, and toxological consultants. Or you can cover it by bringing in expertise that’s been exposed to a lot of different systems, different products.

Before you even start the design or knowing what materials you might want to use? Very early on?

Braithwaite: Sometimes, it’s so early you might look at it go, ‘why am I talking to these people now?’ But we’ve seen situations where a choice is made for totally pragmatic reasons in the prototyping phase, which becomes set in stone because that’s the material they’ve been working with. And then you arrive at a point and go ‘wait a second, we can’t source this in a medical-grade material,’ or it’s not going to survive the sterilization process or the cleaning processes it has to go through. And then you have to stop and rewind. So, you’re basically doing two development tracks there. And that’s where the cost burden comes in.

How far out should they plan? The title of your session says next generation and the next, and the next…

Braithwaite: Obviously, the company’s strategic goals play into that. If they’ve got a planned pipeline obsolescence of two or three generations, then they probably want to be thinking about if they can make the transition from generation one to generation two as smooth as possible, so they need to be thinking about that process early.

But if they are a start-up and they’re aiming for their first device and that’s the thing that they really need to get their value to get the company sold, then that’s probably as far ahead as they really need to look.

So, it’s stages of maturity. There’s no one-size-fits-all answer to that.

What are some of the mistakes that you commonly see companies making when they’re not planning with this mindset?

Braithwaite: I think some of the mistakes we’ve seen are prototyping with the wrong materials. Then you end up having to make patch fixes rather than picking the right material to begin with, or you end up having to rewind and start again and then go through whatever testing you’ve already done.

We’ve also seen, and this is more common for startups, companies with a small number of staff that don’t have a lot of experience outside of their experience, in the area of sterilization and cleaning, for example. It’s not thinking through what the end patient-facing device is going to look like or what regulatory hurdles it has to go through. The mistake that they often make is ‘I’ve got this great idea. We’ve got an animal study that proves that it works,’ but what they’re designing is a prototype that gets into the animal study and the demands for going over the regulatory hurdles in the next phase are much higher. And sterilization is a great example. If you’ve not taken into account that you’re going to need to e-beam this, for example, and we’ve seen this certainly with crosslinking and polymeric materials in particular, which is our core specialty, you can end up changing the material properties substantially and you never expected that when you’re the engineer.

Who would you like to see attend your session?

Braithwaite: CTOs, founders, startup people. I think they’d get a lot out of this because they’re exactly the area where we see a lot of these mistakes. They’re not thinking about the cost benefits of investing, or they feel constrained in the early development stage and also are not aware of the things they’re going to encounter as they move down the path.

But, at the same time, R&D groups within some of the big companies, so the lead of an R&D group where they’ve got a tightly defined focus, but they might not have the peripheral skills and expertise in-group. They might exist in the rest of the company, but as part of that collaborative group, they might not have those skills. So, being able to look outside their immediate development paths.

Last, what do you hope your attendees will take away take away from your session?

Braithwaite: The importance of thinking outside of the immediate engineering problem you’re trying to solve. That’s probably the big bullet point. Being aware of the pressures that have nothing to do with material science that are going to play on your device as you get closer and closer to launch, particularly when you are thinking ahead to the next generation of the device.

Braithwaite will present “Don’t Develop Your Device Twice: Planning for the Next Generation, and the Next, and the Next….” on Thursday, September 26, from 11 to 11:45 a.m., in Conference Room 52B, at MEDevice Boston.

article source: MDDI