New Horizons: How to Navigate Changes in Medical Device Regulatory Compliance

To explore how companies can approach excellence in the medical device industry, we held an exclusive interview with Geoff Foster, CEO and President of Core Technology Molding Corp. Geoff explores the transformative journey of his company from a predominantly automotive focus to a thriving presence in the biological pharmaceutical and medical device sectors. The company’s bold move to pursue ISO 13485 certification not only paved the way for rapid growth but also redefined internal processes and team collaboration.

In the following interview, Geoff explains how embracing rigorous medical device regulatory compliance standards has reoriented the company's strategic priorities. He addresses key topics such as the tangible benefits of ISO 13485 certification, the operational challenges overcome during its implementation, and the role this compliance plays in driving continuous internal improvement and market expansion.

Q: Geoff, why did you decide to pursue ISO 13485 certification?

A: Prior to Covid-19, we were 65% Automotive and only 5% Biological Pharmaceuticals and Medical Device. We have a certified Class 10,000 ISO7 Clean Room for injection molding but were getting opportunities for Class 1,000 ISO6 for HPV assemblies. To grow in that space, it was identified in a SWOT (Strengths, Weaknesses, Threats and Opportunities) analysis that the next certification we needed would be ISO 13485.

DQS had already certified us with IATF 16949 for Automotive and ISO 14001 as a for Environmental as this was required as a Tier I supplier. We were very comfortable with their guidance and partnership throughout the process.

Q: What challenges did you face when implementing the quality management system?

A: DQS helped with the learning curve going from Automotive to Medical Device with a Gap Analysis. This identified the areas that we needed to focus on and helped our Quality Manager, George (Jimmy) Kirk put a plan of action together. He brought in outside 3rd party instructors from NC State IES to provide training for ISO 13485 Medical Devices.

Kirk was able to hire a Quality Analyst, Quality Technicians and a Quality Inspector to strengthen his Quality Department. All of these moves changed the culture in our organization and the team was able to raise the expectations in the facility, providing a more robust QMS.

Q: How has the ISO 13485 certification impacted your internal processes and team collaboration?

A: The ISO 13485 certification made internal processes that much better, as it has engaged talented people not only in the Quality Department, but the entire company. Operators that were top performers in the manufacturing facility, were given the opportunity to get promoted to working in the Clean Room.

This brought wage increases internally and we were able to hire form within the organization. This also motivated the employees to see that there were opportunities to get promoted and get paid more with our Clean Room training matrix that was developed.

Q: Have you received feedback from customers or partners that you can attribute to the ISO 13485 certification?

A: Our customers in the Medical Device space are amazed with the transformation since the ISO 13485 certification and are looking for more opportunities to support our growth.

Undoubtedly, it has lifted the level of knowledge in the entire facility and we are shipping parts to over 150 countries, driving down PPMs and scrap rates while improving yields. Our customers have supported our growth by providing Six Sigma training and the methodology is being utilized by our Engineering Manager who is a Black Belt. This White Belt and Green Belt training will help the Operators with troubleshooting and we are all speaking the same language when problem solving.

Q: How do you ensure that the requirements of the ISO 13485 are continuously met and further developed?

A: Our Quality Manager is constantly providing cross-training in the clean room and Quality Department. The Operators now understand the importanace of documentation and they are training other employees, who have been identified as having growth potential, for the Clean Room. This has created an internal talent pipeline, and we are able to “mold“ our employees following the ISO 13485 certification and our QMS.

Core Technology Molding Corp.’s successful transition and exponential growth underscore the vital importance of robust medical device regulatory compliance. The ISO 13485 certification has not only unlocked new market opportunities but also enhanced internal processes, ensuring that every aspect of production adheres to the highest standards of quality and safety.

As the company continues to expand, its commitment to regulatory excellence will remain a cornerstone of its operational success and competitive advantage.