Meet The Team: Q&A with Director of Technology, Polymers- Shane Wood

Shane Wood is the Director of Technology for polymers (filmcast, extrusion, complex catheter manufacturing, and balloons) for Confluent Medical Technologies. She has approximately 19 years of experience in medical device manufacturing, and, in that time, has led production and new product introduction engineering teams utilizing filmcast, extrusion, and catheter assembly technologies. Prior to medical device manufacturing, she held engineering positions in the semiconductor and optical fiber industries. Shane holds undergraduate degrees in chemistry/math and chemical engineering from Agnes Scott College and the Georgia Institute of Technology.  She has a Master of Engineering Degree from North Carolina State and a Master of Biomedical Engineering from Colorado State University.  Shane also holds a graduate certificate in Regulatory Affairs from the University of Georgia and is a Certified Six Sigma Blackbelt.

• What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

I was originally interested in the medtech/pharmaceutical industry because I wanted the opportunity to build a long-term career in a stable manufacturing engineering environment.  At that time, I had seen, firsthand, the impact of sustained volatility in the semiconductor and optical fiber markets.  Thankfully, over the last 19 years, the medtech industry has given me the opportunity to build a career while improving lives and doing work that matters.

• In your opinion, what applications within delivery devices have the greatest potential for growth and innovation? 

Advances in stroke treatment have been, and will likely continue to be, a significant area of growth and innovation in medtech. This will be an area of focus because of the sheer number of patients impacted and the potential for innovation (aspiration, robotic-assisted procedures, performance improvement of catheters, pharmacological treatments, etc).  Treating irregular heart rhythms using safer and more efficient ablation methods like Pulsed-Field Ablation (PFA) will also be a big focus in the upcoming years.

• What is one of the biggest challenges within the Polymer industry right now? 

One of the biggest challenges within the Polymer industry right now is the risk to the supply chain. N-Methyl-2-pyrrolidone (NMP), molecular formula is C₅H₉NO, is an organic solvent consisting of a five-membered ring with an attached methyl group.  Due to its unique properties, including high boiling point, low volatility, and high chemical solubility, it is an ideal solvent for a variety of compounds.  Due to these properties, NMP is used in numerous industrial applications, including polymer processing.

In a recent finding that could have ramifications in the industry, the EPA has found that NMP, as a whole chemical substance, presents “an unreasonable risk of injury to human health when evaluated under its conditions of use.”  It was found to pose risks from both Acute and Chronic exposures through inhalation and dermal contact, including developmental and reproductive toxicity.  In addition to the reproductive hazards posed, additional risks included liver and kidney toxicity, immunotoxicity, and neurotoxicity.  This finding determined that NMP posed an unreasonable risk to health in 29 of 37 use cases, which include domestic manufacturing, import, processing in plastics manufacturing, various other industrial uses, as well as disposal. The EPA is expected to propose a set of risk management actions, which will then be followed

by a public comment period. There is still substantial uncertainty as to the final restrictions, which puts the established filmcast polyimide supply chain in question.

• Depending upon the agency’s decision, what might this mean for the supply chain for medical device manufacturers using this material? And are there alternative options that device manufacturers should consider?

The outcome could range from more stringent Personal Protective Equipment (PPE) requirements to targeted restrictions in specific applications, up to a ban on manufacture, import, and use.  The proposed regulations are anticipated to be released in 2024 followed by a public comment period. 

NMP is already subject to certain restrictions under the European Union’s REACH regulation (Registration, Evaluation, Authorization, and Restriction of Chemicals). REACH is a comprehensive regulation aimed at ensuring the safe use of chemicals within the EU with the objective of protecting human health and the environment. Companies utilizing medical device components that contain NMP are responsible for ensuring compliance with REACH restrictions. There are two possible pathways to ensure REACH compliance. One pathway is to ensure that sufficient residual NMP is removed during processing. This pathway can be expensive, time-consuming, and somewhat unpredictable due to material and process variation. Another pathway, and the direction we have chosen at Confluent Medical, is to utilize raw materials with solvent systems that are not REACH-restricted. This minimizes the burden on the device manufacturer to ensure compliance. If additional NMP supply chain restrictions are imposed by the EPA, this becomes an even more critical challenge for medical device manufacturers. While there is still substantial uncertainty as to the final restrictions, NMP is the primary solvent used in the vast majority of filmcast manufacturing today.  Migrating to a filmcast polyimide solution that does not contain NMP will serve to mitigate any potential issues due to these restrictions.

• Besides the concerns with the material supply chain, what is a major trend in the Polymer market right now? 

A major trend in delivery systems right now is stent delivery devices that require Polyimide with exceptional tensile strength but without compromising wall thickness to allow for more real estate inside the catheter itself. Confluent has invested in an innovative solution to this problem with Ultra Polyimide. This new material offers almost 2x the strength of traditional Polyimide. This allows manufacturers to achieve exceptional tensile strength while allowing for more room inside the catheter.

• Can you explain more about this new Ultra Polyimide?

Although traditional polyimide is known for its strength, with the constant evolution of medical device designs, there is a strong demand for a tubing solution with decreased wall thickness without compromising strength. Conlfuent’s Ultra Polyimide is manufactured without the use of any REACH and/or EU MDR-restricted solvents and offers about double the strength of traditional polyimide without limiting the real estate inside the tube. Ultra Polyimide will allow design teams to reduce the amount of material needed in a new medical device to provide the same column and/or tensile strength required for the application. Therefore, offering customers greater flexibility to address other design constraints by freeing additional cross-sectional areas within the device.

• Do you have any additional comments or insights into where the future of Polymer tubing is headed? 

The demand for minimally invasive procedures means these devices continue to get smaller and are indicated for increasingly challenging anatomy. The development of Ultra Polyimide and a REACH Compliant supply chain allows Confluent to offer customers the latest advancements in polymer tubing without disruption to the supply chain. With the fastest lead times in the industry, Confluent is committed to empowering their customers to create life-saving devices through innovation, exceptional quality, and operational excellence.