“There is a growing awareness that if you bring in Regulatory at the beginning of designing a product, you will end up with a more robust product.
In this Let’s Talk Risk! conversation, Christine Zomorodian highlights some of the barriers that have traditionally hindered good communication and collaboration between QA/RA and Engineering functions in MedTech. However, she also points out that there is reason to be optimistic about the future.
Gender roles are changing, with more women entering Engineering and an increasing number of men choosing the QA/RA profession due to availability of graduate level academic programs. Company cultures are also adapting to big advances in compliance infrastructure technologies and the rapidly changing regulatory landscape. Together, these really underscore the importance of open communication and cross-functional collaboration.
A good tool to foster collaboration is a Quality Plan, which continues to be under-utilized in our industry. But a Quality Plan can help your entire team come together to figure out how you could efficiently achieve a desired goal, whether it is a remediation project or developing a suitable quality system in a startup environment.
Listen to this Let’s Talk Risk! conversation with Christine Zomorodian, which also includes an open discussion with a live audience. Jump to a section of interest using these timestamps.
00:01:59 Introduction
00:05:06 An example of impact of poor cross-functional collaboration
00:08:36 Traditional barriers to cross-functional collaboration in MedTech
00:12:05 Optimistic trends helping to improve communication and collaboration
00:14:00 Audience Q&A and general discussion
00:29:00 Closing comments and key takeaways
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Suggested links:
Tips for improving collaboration in risk management
Collaboration is the secret sauce for success in risk management
About Christine Zomorodian
Christine Zomorodian is the Founder and Managing Consultant at Gish Consulting, LLC, advising MedTech companies in regulatory strategy, quality assurance, regulatory affairs and engineering process improvement. She also serves as a Person Responsible for Regulatory Compliance (PRRC) for EU-MDR compliance, and a guest lecturer at University of Washington. She has over 25 years of industry experience in various QA/RA roles at multiple global medical device companies. She holds a B.A. degree in International Affairs with concentration in Biology and Communication, and a M.S. degree in Biomedical Regulatory Affairs.
Let’s Talk Risk! with Dr. Naveen Agarwal is a weekly live audio event on LinkedIn, where we talk about risk management related topics in a casual, informal way. Join us at 11:00 am EST every Friday on LinkedIn.
Disclaimer
Information and insights presented in this podcast are for educational purposes only. Views expressed by all speakers are their own and do not reflect those of their respective organizations.
LTR 62: Overcoming barriers to cross-functional communication and collaboration