Orthopedic Medical Devices
5 min

Q&A with Sandeep Ramineni, Ph.D.: Navigating Orthopedics and Medical Device Regulations

Explore Orthopedics and Medical Device Regulations with Dr. Sandeep Ramineni. Insights into biomaterials, compliance, and manufacturing intricacies.

Date: 22 Sep 2023

QA with Sandeep Ramineni, Ph.D.: Navigating Orthopedics and Medical Device RegulationsWelcome to our Q&A blog post featuring Dr. Sandeep Ramineni, Product Expert - Orthopedics at TÜV SÜD. With his extensive expertise and experience, Dr. Ramineni provides us with insights into orthopedic innovations and the intricate world of medical device regulations.

 

 Q: Can you share your journey and how your background in research has influenced your career in the medical device industry?

A: Certainly! My journey has been an exciting blend of research and practical application. I earned my Doctor of Philosophy (PhD) in Biomedical/Medical Engineering from the University of Kentucky. During my time there, I focused on developing combination devices for treating oral disorders. This research instilled in me a deep understanding of biomaterials, material interactions with body, influence of design and manufacturing on the performance of devices. I've translated this knowledge and mainly experience into my roles, where I've contributed to process development, validations, and compliance with industry standards.

Q: Could you elaborate on your involvement with industry regulations such as ISO 13485 and MDSAP?

A: Of course. ISO 13485 is a critical standard that outlines quality management system requirements for medical device manufacturers. Adhering to ISO 13485 ensures that processes are in place to maintain product quality, safety, and regulatory compliance. Additionally, the Medical Device Single Audit Program (MDSAP) is gaining prominence. It allows medical device manufacturers to undergo a single audit that satisfies the requirements of multiple regulatory authorities. While working at different esteemed medical device organizations, I specifically worked on projects that addressed gaps and noncompliance to these standards. This experience provided me valuable insights into different interpretations of the standard, and fine lines between compliance and non-compliance. Now, being in a notified body, I am happy to identify such gaps and ensure medical devices of only highest quality are reaching to patients worldwide.

Q: How does the new Medical Device Regulation (MDR) impact the orthopedics field, and how are you navigating these changes?

A: The new Medical Device Regulation (MDR) represents a significant shift in the European regulatory landscape. It places heightened emphasis on patient safety, clinical evidence, and post-market surveillance. In the orthopedics field, this translates to more rigorous assessment of implantable devices, stricter clinical evaluations, and enhanced traceability throughout the supply chain. This includes but not limited to revisiting old test results and challenging decades old notions/assumptions in favor of objective evidence, compliance to latest standards, up-classifications, and additional testing such as MRI. To navigate these changes, we've been proactive in revisiting our processes, documentation, and interactions with other notified bodies. Adapting to MDR ensures that our products meet the highest standards of safety and efficacy.

Q: Could you share a challenging project you've worked on and how you overcame it?

A: Certainly. One challenging project was during a crisis response aimed at resuming manufacturing at a global location. This involved addressing systemic issues and improving compliance with industry standards, particularly those outlined in 21 CFR part 820.70 Production and Process controls. The key to success of this project is going to the basics of QMS standards and 21 CFR 820 regulation, and address issues from QMS side and then finishing it with technological improvements. By leading a team of 10, we not only resolved the crisis but also improved lead times by 20%. This experience highlighted the importance of effective project management, collaboration, and QMS compliance in the face of challenges.

Q: How do you stay updated with the latest advancements in orthopedics and medical device regulations?

A: Staying informed is a continuous effort. I actively participate in conferences, webinars, and industry publications to stay abreast of the latest developments. Networking with professionals and attending workshops provide valuable insights into emerging trends. Additionally, I regularly engage with ISO 13485 and MDSAP updates to ensure our processes align with the evolving regulatory landscape.

Q: What advice would you give to those aspiring to enter the medical device industry, considering the evolving regulations and advancements?

A: A solid educational foundation is key, whether in engineering, life sciences, or related fields. Seek internships, co-op programs, or research opportunities to gain hands-on experience. Be curious and question the reasoning behind a specific process/specification. This helps one to understand the regulations/QMS standards that drive the process. Young professionals are rarely aware of regulations and standards during R&D phase and new process development phase of a device. As you spend time and be curious to understand the regulations it saves lot of time down the line in process improvements troubleshooting and in developing future generations of a device. Embrace continuous learning to stay informed about advancements in technology, regulations, and industry best practices. Flexibility and adaptability will be your allies in this dynamic and rewarding field.

Q: Lastly, could you recommend a book or resource that has significantly impacted your career journey?

A: Certainly. "Artificial Intelligence Foundations: Machine Learning" by Doug Rose has been influential. It underscores the potential of AI and machine learning in healthcare and medical device development. As technology becomes increasingly integral to our industry, understanding these advancements can reshape how we approach patient care and innovation.


Thank you again to Dr. Sandeep Ramineni for sharing his invaluable insights into the orthopedics and medical device arena, as well as his experiences with regulations including ISO 13485, MDR, and MDSAP. His journey exemplifies the synergy between research and practical application, essential for shaping the future of medical devices. Thank you, Dr. Ramineni, for your time and expertise!


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