How Eastman's technology collaborations succeed
Eastman is far more than a raw material supplier. It is also a partner in the entire development process. The company explains how its technology collaborations begin and succeed.
Medical device manufacturers are continually challenged to be innovative while operating in a highly regulated environment.
When regulations or market conditions demand a change or create a new opportunity to improve patient safety, a manufacturer often needs to step outside its own comfort zone. Starting early in a new product development process—can reduce risk, eliminate false starts and avoid costly delays in bringing effective products to market.
Technology collaboration is vital! Two companies explain how collaborating early in the development process is expanding opportunities for technical innovation and commercial success.
Two collaborators with a plan
Insight and long-term vision have fuelled the successes of Elcam Medical and Eastman Chemical Company. Through years of experience working with hospital and government regulations, both are better prepared to anticipate future needs—then plan ahead for success.
Elcam Medical is manufacturer of disposable medical devices for the OEM market. Its validation and verification process helps it collaborate effectively with OEM customers.
Eastman Chemical is a key player in medical grade polymer solutions. For more than 65 years the company has worked with customers to deliver innovative products and solutions while maintaining a commitment to safety, confidentiality and sustainability.
Its ‘total solutions’ approach to the medical industry now offers world-class technology platforms and even greater insights into technical support in design, processing and secondary operations.
Working together the companies discovered many shared values that work in harmony with their specific technical capabilities. Their ongoing collaborations have resulted in chemical- and lipid-resistant connectors designed to meet ISO 80369 standards—both made with Eastman Tritan copolyester.
Opportunities to collaborate
Elcam understands how to design robust and reliable medical devices. Eastman has specialised and proprietary expertise about its materials. Together, they’ve been able to innovate and bring safe products to market more quickly.
“Our two companies have been successful at combining medical science and material science,” according to Eldad Ohayon, marketing director from Elcam: “Based on our individual expertise and shared trust, we engage early in the development process to save time later in the process.”
CONCEPT
Early in the concept phase, Elcam considers regulatory issues and fitness for use (FFU) of candidate materials. How will the product be used? What stresses will be applied? What chemicals will it contact? Are there minimum rigidity or toughness requirements? Answers to these questions help inform material selection and avoid costly false starts.
MATERIAL SELECTION
Meanwhile, Eastman refines data regarding its polymers, such as
biocompatibility or compliance with other regulations. Eastman shares data with Elcam and can provide Product Regulatory Information Sheets and other documents required for premarket 510(k) submissions. Knowledge of material properties also can make processing more efficient— and can help provide consistent quality and reproducibility.
DESIGN
At this critical design stage, it is common for Elcam to also talk to other stakeholders—including mould designers and toolmakers—as part of its validation and verification process.
TRIALING
Trial support validates the material and design choices and helps make any needed adjustments. Eastman uses infrared cameras as a specialised technology to monitor the mould performance and the cooling of the mould and parts. Also the drying capabilities are checked during the trial phase; the dew point was monitored under Statical Process Control (SPC) methodology.
MANUFACTURING
Early collaboration often eliminates any manufacturing issues before the first piece is produced. Unfortunately, many companies wait for the trialing and manufacturing stages to identify problems. Then, they are under a time and budget crunch to troubleshoot and find someone to fix the problem.
TESTING
Eastman continually tests properties of Tritan and other medical-grade polymers using equipment that gives Elcam specialised analyses they may not find on their own. Throughout this technology collaboration, the companies apply this information to confirm the material’s fit for the specific applications. For example:
• They test how a part will withstand gamma radiation sterilisation.
• They reproduce exposure to different chemicals and stresses that can reduce functionality.
• They expedite accelerated aging and other tests required for regulatory compliance and retention of product performance.