ODC Industries, a subsidiary of Contamac Ltd, are a medical device manufacturer based in France who produce a variety of products for the ophthalmic industry. We interview Martina Clifford, ODC Industries’ Quality Director to get an overview of her role and the significance of quality assurance in the Medical Device industry.
Please describe your role
I am the Quality Director at ODC Industries responsible for maintaining ISO 13485 and CE mark certification under MDD 93/42 EEC and leading the (EU) MDR conformity assessment process. I’ve been a part of ODC from its founding, contributing to the establishment of the company as a member of the management team. Additionally, I collaborate closely with the R&D team to develop new products and implement improvements for our customers.
What is your professional history?
After completing my degree in Business Information Systems at university, I participated in a Knowledge Transfer Partnership (KTP) Project. Since 2008, I have been involved in the contact lens and intraocular lens industry, taking on various roles in operations, quality, and management. Since 2017, I have served as a board member of EFCLIN (European Federation of the Contact Lens and IOL Industries), leading the quality and regulatory group. Additionally, I represent EFCLIN in the regulatory affairs group at EUROMCONTACT.
What do you enjoy most about working at ODC Industries and in the medical device industry?
I really appreciate working alongside the fantastic team at ODC Industries and Contamac. I find it rewarding to collaborate with individuals in various roles, including engineers, surgeons, and regulatory specialists. While many companies in the medical device industry are encountering challenges, I observe that within our industry, there is a strong desire to collaborate, understand, and navigate the regulatory landscape, supporting one another in the process. Most importantly, I am grateful that our efforts contribute to enhancing patients’ quality of life.
In your words, what is the significance of quality assurance in the medical device industry?
Quality assurance (QA) is critically important in the medical device industry for several reasons, the primary one being patient safety, ensuring that medical devices are safe for use. By implementing QA processes and complying with regulatory standards manufacturers can help maintain consistent quality of products. A proactive approach to QA can also save time and resources by identifying issues early. It also serves as a culture for continuous improvement; by regularly analysing processes and outcomes we can improve manufacturing resulting in a safer device.
In the intraocular/ injector arena, what are some of the key areas affected by MDR?
The MDR has considerably affected our industry across many areas, including clinical evaluation, technical documentation, post-market surveillance, vigilance, traceability, and quality management systems (QMS). Manufacturers are now required to comply with strict clinical evaluation processes and submit detailed documentation, requiring substantial evidence of the safety and efficacy of their lenses and injectors. Additionally, the MDR’s increased regulatory requirements, and associated costs are influencing research and development as well as new product development, potentially affecting competitiveness and innovation within the industry. However, we are still dedicated to advancing our industry and creating new products.
Based on this, what core quality measures have been implemented at ODC Industries?
ODC Industries has revised all technical documentation to comply with MDR requirements and has established a proactive risk management and post-market surveillance system to monitor the performance and safety of our devices. Our Quality Management System (QMS) has also been updated and successfully passed the MDR QMS audit conducted by the notified body.
ODC Industries promotes a culture of continuous improvement by investing in employee training, conducting audits, and implementing feedback systems to identify potential issues early and enhance quality performance and innovation across the manufacturing process. By prioritising our core quality measures, ODC Industries can guarantee product quality, ensure patient safety, and maintain regulatory compliance.
How do you and your team support ODC Industries’ customers?
At ODC Industries, we assist our customers in various ways, including offering training, prompt customer service, and support whenever required. We supply technical documentation, product information, and training sessions to guarantee the safe use of our devices and instill confidence in our users. Additionally, we collaborate closely with our customers to gather feedback, which allows us to focus on product improvements and the development of new products.
What do you like doing outside of work?
I love spending time with my son, my partner, family & friends! I also like walking and exercise, which is essential since I have a passion for good food and wine!
If you were shipwrecked on a deserted island, but all your human needs - such as food and water - were taken care of, what two items would you want to have with you?
I won’t mention people as they may be offended being called items! A phone or laptop with internet access and a solar powered portable charger to stay connected with my loved ones and listen to music.
If you could eat one meal for the rest of your life, what would it be?
Pasta! I love truffle pasta or really spicy pasta, especially with a nice glass of wine, of course! 😊