Medical devices drive incredible advancements in patient care. Achieving that kind of innovation begins with the building blocks of these devices: the materials. Medical-grade polymers are used in the design and manufacture of implantable and non-implantable devices for myriad applications.
Today, plenty of off-the-shelf polymers are available to create all kinds of devices. But there is always the need for solutions that cannot be made from readily available polymers.
How can devices be made more biocompatible? How can their long-term stability be improved? The answer lies in the materials. Polymers can be tailored to solve specific challenges and create new, pioneering devices.
Large OEMs, startups and universities are among the organizations invested in developing newer, better medical devices. In the reality of today’s medical industry, companies want and need to innovate, but they are faced with ongoing cost pressure and a complex regulatory environment. They don’t have endless budgets to pour into R&D when they need a custom polymer.
Why is customization so important in the world of medical devices? Adjusting the base chemistry of a material imbues it with characteristics that solve a specific challenge. And each of these characteristics must be carefully calibrated and balanced to deliver an effective polymer.
Hardness is an essential characteristic of material used to make medical devices. How soft or hard does the polymer need to be? How does it balance softness with kink-resistance in something like a catheter? The answer to these questions is specific to the device application. A catheter used in neurovascular surgery, for example, will need to be much softer than a catheter used for urinary intervention.
Some devices may need radiopacity; clinicians need to be able to see that device in radiographic images. So, a polymer can be finetuned with the addition of radiopacifiers. Physicians will be able to see the device while placing it in the body.
Device manufacturers may seek antimicrobial properties, and polymers can be tailored to deliver.
Lubricity is an essential attribute in some devices. Device manufacturers may want a polymer that can reduce friction.
Ultimately, biocompatibility is of the utmost importance. As a material’s base chemistry is adjusted to reflect distinct characteristics, those changes must be balanced with the long-term stability and safety of the device.
“When you put all that into the customer wish list, that’s a product that’s not available off shelves as of today,” says Benjamin Fadda, a key account manager with Mitsubishi Chemical America.
While many medical-grade materials are available in the market today, right off the shelf, there is a niche for customized materials. It is here that device manufacturers can find the space to innovate.
“They come to us for innovations that would not be possible with off-the-shelf polymers,” says Fadda.
How do these tailored materials lead to tailored solutions? At Mitsubishi Chemical America, it begins with the customer’s idea. Technical experts work with the customer to understand their needs, and then they begin to explore how to develop a material that meets those needs.
“It’s all about aligning the material design with their specific requirements,” Fadda explains.
Once the Mitsubishi Chemical America team has developed a customized polymer, it undergoes rigorous testing to understand how customization delivers on the customer’s idea. For example, the team conducts the softest and hardest versions of a polymer. The customer then has the data to determine exactly which version meets their needs.
“They want assurance that the material has already been tested and validated,” says Fadda.
Synthesizing customized materials are one step in the process of bringing an idea for a medical device to fruition. Manufacturers often need to produce small batches for prototyping. A partner, like Mitsubishi Chemical America, can deliver small volumes of tailored materials to support this process.
“Medical devices are really small,” Fadda explains. “If customers want to try different materials, it’s definitely not large volume.”
With different versions of customized polymers at their disposal, technical experts can help guide customers through the product design process.
That support helps customers move faster in an environment that demands speed alongside rigorous regulatory compliance.
Customized materials have a broad range of applications across specialties. “We are seeing projects all over the scale everywhere in all medical applications,” says Fadda.
A tailored polymer can solve a unique problem, down to specific properties designed for different patients. These customized materials can also open the door to long-term R&D projects that build the foundation for future innovation.
Tailored materials and tailored solutions give device manufacturers a leg up in a crowded industry. “Tailoring helps customers to differentiate their medical devices from competitors’ devices,” Fadda points out.
Once finding a polymer that meets their specific needs, customers may sharpen their competitive edge in the world of tailored materials “We have projects where we develop a polymer together with the customer and the customer signs an exclusivity agreement with us to keep that polymer exclusive to them,” Fadda explains.
Designing and bringing to market a medical device requires partnership. Any polymers used in these products must deliver as promised to ensure regulatory compliance and patient safety. How can medical device manufacturers develop a trusted relationship with a customized materials solutions provider?
Mitsubishi Chemical America works with its customers on a multitude of different projects. Some are short-term; a customer may simply want to tweak the characteristics of an existing product. Other projects span years. Transparency is at the heart of these successful relationships. Clients need to be able to share their vision with a partner that communicates openly.
“How can we develop a material that would fit those customer’s needs and is it possible at all?” says Fadda.
If a customer’s vision is possible, a trusted partner is instrumental in bringing it fruition and overcoming hurdles along the way. Fadda shares the access to raw materials as a common pain point for customers. “Customers often struggle with the reliable supply chain, especially for customized materials,” he elaborates.
With an established supply chain, a customized materials solutions company can synthesize polymers for customers. Customers do not have to shoulder the risk of material unavailability that they might face if attempting to customize their own polymers.
Trust is further developed through consistency and reliability. Consistency can be a challenge for device manufacturers dealing with different parts and manufacturing sites around the world. A trusted partner can deliver material consistency over a large number of different polymer batches. And that partner tests those batches to ensure the polymers meet the customers’ goals. All of this work being done at the materials level must be done efficiently and reliably to maintain that trust.
“Reliability comes from collaboration, from supporting the small-scale batches, supporting R&D projects and then being able to scale that into industrial production,” says Fadda.
So much more innovation is possible in the world of customized materials. What can the next wave of smart devices look like? How can device biocompatibility be improved? Can long-term, implantable lubricious materials be developed?
Not every stakeholder in the medical materials space has the time and budget to pursue answer to those questions, but the R&D team at Mitsubishi Chemical America team has experts dedicated to exploring new materials and future formulations. New discoveries could open the door to more customizable materials and more medical innovation.