Blog

California, known for its progressive stance on environmental and health issues, is once again at the forefront of regulatory change. On September 25, 2024, California Governor Gavin Newsom signed the Toxic-Free Medical Devices Act (AB 2300) into law. The legislation prohibits the use of certain ortho-phthalates, specifically di-(2-ethylhexyl) phthalate (DEHP), in intravenous (IV) solution containers and tubing products. 

What Are Phthalates? 

Phthalates are a group of chemicals used to make plastics, primarily polyvinyl chloride (PVC),more flexible and durable. These additives are commonly found in various medical products, including medical devices such as IV bags, tubing, and catheters. They have also been used more broadly in industries ranging from toys to tools, although legislation is generally already in place outside of medical devices. In some cases, these compounds can be present at greater than 30% of the mass of the material.  

Toxic Free Medical Devices Act – California AB 2300  

Implications for the Medical Device Industry 

Regulatory Compliance 

We are thrilled to announce a new operating model at Cambridge Polymer Group (CPG) designed to meet the demand for customized material optimization across the product lifecycle.  

Addressing the Evolving Materials Landscape

Increasingly, manufacturers and product designers across all industries are using new materials in novel applications and pushing existing materials into new uses that stretch their performance to the limit. These materials do not always behave as expected, and conventional material specification sheets and standard testing methods are no longer enough.

Today's successful products can only be obtained through a multi-disciplinary approach, with an emphasis on safety. Developers need deep expertise in materials across industries, along with a thorough understanding of polymer science. This includes the impact of additives, manufacturability (encompassing cleaning and sterilization), biocompatibility, and the intended use of the device or product.

Enhanced Client Collaboration through SME Leadership

To address this growing need for materials expertise, Cambridge Polymer Group is implementing a new five-position management structure. This structure empowers senior Subject Matter Experts to remain at the forefront of client collaboration – a cornerstone of CPG’s successful partnerships. This strategic shift ensures dedicated resources for complex projects, delivering the hands-on materials support clients increasingly require.

Leadership Team Focused on Client Success

Vice President of Research, Dr. Gavin Braithwaite, will step into the newly created position of Chief Executive Officer.  

“By staffing our newly designed senior management structure with seasoned scientists, we can ensure the continued delivery of high-quality science to our clients, while placing a stronger emphasis on product development and challenging testing projects,” said Braithwaite. “I am excited to grow the development aspect of our work and build a deeper relationship with our clients, helping them decrease risk, expand into new markets, and increase profitability.”

After 27 years as Cambridge Polymer Group’s President, Dr. Stephen Spiegelberg is moving into the new role of Chief Scientific Officer (CSO).

This transition will enable Dr. Spiegelberg to spend more time collaborating with clients and working on large-scale projects in his subject matter expertise, such as biocompatibility, root cause analysis, product development, and medical device cleaning.

“I am personally looking forward to having more scientific interactions with our clients, spending more time on ASTM and AAMI standards development, and studying industry trends to help assist in product development,” said Spiegelberg.

Jaimee Robertson will oversee research operations in the newly created role of Director of Consulting Services.

Robertson will work with CEO Gavin Braithwaite and CSO Stephen Spiegelberg to develop and implement CPG’s research strategy and assist clients in their development projects and root cause analysis work.

Norma Turner will manage lab operations and testing services as Director of Analytical Services.

Turner will ensure CPG’s full-service laboratory provides essential support for R&D and consulting projects, as well as value-add to routine analytical testing clients. Norma will be leveraging her extensive experience in ASTM and ISO standards testing to help with both routine and non-routine testing, including residue analysis and extractables and leachables testing.

Dr. Rebecca Bader, Associate Director of Chromatography, will oversee the direction of this critical department and lead CPG’s biocompatibility and risk assessment group.

Bader’s material science and analytical chemistry expertise combined with her biocompatibility experience will help clients navigate the challenging regulatory landscape.  

Benefits for Our Clients

• Deeper Collaboration with Material Experts: Our clients will continue to benefit from close collaboration with CPG's SMEs.
• Enhanced Support for Complex Projects: The new structure ensures dedicated resources for even the most demanding R&D initiatives.
• Future-Proofed Innovation: CPG is positioned to deliver the advanced materials expertise needed to bring groundbreaking products to market.

We are confident that this new operating model will allow us to further strengthen our partnerships and empower our clients to achieve their innovation goals. 

Together, let's turn groundbreaking ideas into reality.

Contact Us

If you have any questions or are interested in learning more about how CPG's materials science expertise can benefit your business, please email or call us at 617-629-4400 today.

Thirsty the Hydrogel
Was a sodium polyacrylate soul
With a Bakelite pipe and a resin nose
And two eyes made by injection mold

Oh, Thirsty the Hydrogel
Is a feat of science, so they say
He was made of fake snow
And the lab techs know
How he wicked moisture away

There must have been some water in
That plastic hat they found
For when they placed it on his head
He began to swell around

Oh, Thirsty the Hydrogel
Was absorbent as he could be
He could hydrate
to 300 times his weight
Not the same as you and me

Oh, Thirsty the Hydrogel
Knew the temp was warm that day
But he said, "Let's play and perform TGA
Because I won’t melt away"

Down to the laboratory
With a pipette in his hand
Running here and there
Volumizing scientists’ hair
Saying, "Deform me if you can"

They chased him through the lab benches
Right past a Research Scientist II
And Thirsty only stopped a moment
When she yelled, “You’re not wearing shoes!!!!"

Hmm, Thirsty the Hydrogel
Had to apply his linking agent spray
No need to wave goodbye, he said, "Don't you cry
Because crosslinks save the day!"

Slurpity, slurp, slurp, slurpity, slurp slurp
Look at Thirsty grow!
Slurpity, slurp slurp, slurpity, slurp slurp
Over streams of aqueous flow!

CPG Holiday Hours

In observance of the holidays, Cambridge Polymer Group will be closed on Friday, December 22nd, and Monday, December 25th. We will be open Tuesday, December 26th, to Thursday, December 28th, closing again on Friday, December 29th, and Monday, January 1st. We will return to regular business hours on Tuesday, January 2nd.

Figure 1: Compilation of bullet hole damage found on planes that returned from battle.

In analysis of data, bias can lead to an incorrect interpretation of the data if the analyst has a firmly-held preconceived notion of the study outcome, or if a complete dataset is not considered. The analyst may not be aware that they are biasing their data interpretation. A careful analyst will always question their study interpretations to make sure that bias has not crept in.

Mathematician's Insight Led to Critical Breakthrough in World War II

An example of bias can be found in World War II. The Navy wanted to reduce airplane loss during battles. They thought more armor reinforcement would help protect the planes, but they needed to be strategic in where to place the armor; heavier planes used more fuel and were less maneuverable. They collected data on the accumulated bullet holes on planes returning from battle in Europe, and compiled it into an image like that shown in Figure 1. They noted that the bullet damage was largely segregated to the wings and fuselage, and there was little damage to the engines. Based on this analysis, they initially concluded that more armor was needed on the wings and fuselage.

A statistician in their group, Abraham Wald, looked at the data and had a different interpretation after considering the larger picture. He realized that a dataset was missing from the analysis, namely the planes that did not return from battle. All the planes that led to the data set in Figure 1 were able to return to base and, hence, did not have critical damage.

Wald initially speculated that bullets holes should be randomly distributed over the plane and that the dataset in Figure 1 was biased by considering only the planes without critical damage. He further speculated that planes that took hits to the engines were unable to return to base, suffering critical damage and, hence, were not part of the dataset. In consideration of the entire dataset, the conclusion would be to armor the engines, and that the wings and fuselage could withstand damage without crashing. Wald therefore looked for where there were no bullets to arrive at his conclusion.

Overcoming Bias in Medical Device Materials Analysis

Cambridge Polymer Group considers this approach when conducting analysis projects for clients. For instance, in extraction studies for ISO 10993-18, if we do not see potentially toxic compounds in an extract using one detector, we use another detector on the same extract to see if compounds are identified with a different detection mode. This approach is particularly necessary when we are looking at the bill of materials for a medical device to identify what detector will reliably pick up potential extractable materials. Just because one detector does not pick up a compound does not mean the compound is not there.

Cambridge Polymer Group is helping to organize a workshop on Best Practices for Precision and Bias for Medical Device Standardization, to be held in May of 2024 in Philadelphia. This workshop will discuss how to conduct interlaboratory studies on test methods to generate statistical information relevant for a precision and bias (P&B) statement in an ASTM test method, how to use P&B information, and when a P&B study is not appropriate.

A call for abstract submission will be going out later this year. Please contact Cambridge Polymer Group if you would like to present or attend the workshop.

Although this title manages to capture three yawn-inducing groups of words[1] (“non-volatile residue,” “standardization”, and “ASTM”), when these groups are combined, they represent an important subject for manufacturers of medical devices. Non-volatile residues (NVR) are those residues that can be removed from a medical device that are not intended to be part of the device, and are of sufficiently low volatility that they do not evaporate upon removal of extraction solvent. NVRs are often used to assess how clean a device is, or how effective a manufacturing process is.

The American Society for Testing and Materials (ASTM), the United States Pharmacopeia (USP), and the International Standards Organization (ISO) employs the concept NVR in several of their standards. For example, in extraction and leaching studies of medical devices used for chemical risk assessment per ISO 10993-18 and USP, NVR measurements of components that can be extracted from finished medical devices are used to established both the total mass of extractable residue as well as an indication of whether exhaustive extraction conditions have been achieved.

NVR Standards for Medical Devices

Scientists at Cambridge Polymer Group are involved in drafting several new standards involving NVR assessment. In ASTM committee F42.07.03 for additive manufacturing of medical devices, a new standard is being developed to quantitatively measure residual powder bed feedstock on additive-manufactured medical devices, with one required test using NVR measurements. This draft standard is currently titled Standard Test Method for Additive Manufacturing for Medical – Powder Bed Fusion – Assessment of Residual Powder (WK82776).

Another standard that involves NVR measurements is ASTM F2459 Standard Test Method for Extracting Residue from Metallic Medical Components and Quantifying via Gravimetric Analysis, which is primarily used as a measurement of how clean medical devices are. This standard, which originated at Cambridge Polymer Group, is currently being modified to include plastic and ceramic medical devices.

At Cambridge Polymer Group, we are regularly involved with measuring NVR in medical devices to help ensure safety and compliance to standards. Contact us to have us help you with your NVR measurements.

CPG Employee Spotlight: Dr. Rebecca Bader

Dr. Rebecca Bader is Cambridge Polymer Group's Associate Director of Chromatography and our biocompatibility specialist. She has a PhD in Materials Science from Oregon State, a master’s in chemistry from Princeton, and has taught biomedical engineering at Syracuse University. Becky worked for CPG for four years until 2019 when she moved to the West Coast. We are thrilled that she has returned, both to the East Coast and to CPG.

How did your time away from Cambridge Polymer Group help you in your current role?

“I worked with a pharma company, doing contract research for formulations and drug delivery. I picked up some GMP skills. I decided though that I wanted to work in medical device because I really missed contract research in material science. I very much missed materials, so I took a series of NAMSA classes on 10993-18 and biocompatibility to get into the industry. I leveraged that certificate along with my previous CPG experience to apply for biocompatibility expert roles, which focused on my material science expertise combined with my knowledge of the ISO standard.

I was hired by a medical device company as a biocompatibility engineer in their Regulatory Affairs department. I was able to pick up on FDA and EU regulatory expectations, beyond just biocompatibility.

Over the past two years, I also completed some women’s leadership courses from Cornell University."

Now that you’re back on our team, how do CPG clients benefit from your experience?

“I can now provide more regulatory input as well as biological risk assessments that are tailored to the appropriate market.”

Do you have any advice for women trying to advance in science?

“It’s OK to stand your ground and to ask for what you think you deserve. Those are both things that women struggle with inherently, a little bit. Women tend to be less confrontational. I also think it’s OK to be emotional sometimes.”

What is your favorite part of your job?

“I get to work with brilliant people who care about science and are ethical and above board. Also, I love bringing in new business related to medical device and biocomp.”

What are your favorite activities outside of the office?

"Triathlon. My gift to being an athlete is endurance. I can hold the same effort level indefinitely. I used to be a competitive marathon runner but I’ve switched to only racing Ironman where the marathons are a little slower.

I’ve been to the world championships four times now, and I’m not satisfied with how I’ve done, so I keep going back to race. This past year I had heat stroke and Covid, it was the slowest race I’ve ever done.

Running is my favorite thing in the whole world; it’s my stress release. I love training with my dogs and my person, Adam. I have springer spaniels because they’re the most hyper dogs, and they suit my personality. They run with me, they swim, they’re very Becky-like. Adam shares my love for exercise and my passion for material science.”

Becky is racing Ironman in Lake Placid this week, but she'll be back next week, ready to apply her winning combination of expertise and endurance to your material science challenges. Feel free to reach out about your ISO 10993 needs.