Summary

“Risk management should not be a compliance checkbox. It must actively govern design decisions and feedback loops across the product lifecycle.”

In this Let’s Talk Risk! conversation, host Naveen Agarwal sits down with Pujitha Gourabathini, Quality Assurance and Risk Management leader at Becton Dickinson, to explore one of the most persistent challenges in MedTech: effectively integrating risk management with design controls.

Pujitha shares practical, experience-based insights on why risk files often become disconnected from design inputs, verification strategies, and sustaining engineering changes. Drawing on real-world examples, she explains how “like-for-like” assumptions, tight timelines, and limited cross-functional engagement can quietly erode patient safety if risk is not continuously reassessed.

The conversation goes beyond procedures to focus on culture, highlighting the importance of collaboration, early engagement, and continuous improvement to ensure risk truly governs design decisions. As QMSR approaches, this episode offers timely guidance for QA/RA and engineering leaders looking to move from checkbox compliance to lifecycle risk assurance.

Listen to the full 30-minute podcast or jump to a section of interest listed below.

Chapters

00:00 Welcome and introduction01:00 Pujitha’s path into quality and risk management03:40 Where risk and design controls disconnect in practice05:20 Sustaining engineering: the most overlooked risk blind spot06:40 “Like-for-like” changes and dangerous hidden assumptions09:00 Proactive risk reassessment through continuous improvement11:10 Organizational barriers: timelines, awareness, and ownership25:05 Closing takeaways: culture, collaboration, and QMSR readiness

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Suggested links:

LTR: Managing Post-Market Design Changes.

LTR: Building Safety by Design.

LTR: Beyond Compliance - Building Good Practices Under QMSR.

Key Takeaways

* Risk management must actively inform design inputs, outputs, and verification, not exist as a standalone file

* Sample sizes and verification strategies should be scaled to patient impact, not convenience

* Sustaining engineering changes often carry hidden risk and deserve the same rigor as new product development

* “Like-for-like” component changes can invalidate prior risk analyses if assumptions go unchallenged

* Continuous improvement programs work best when risk awareness extends beyond Quality into engineering and project management

* Early collaboration reduces rework, delays, and late-stage risk discoveries

* QMSR raises expectations for closed-loop feedback between design, risk, and post-market data

Keywords

Risk management, design controls, QMSR, sustaining engineering, ISO 14971, patient safety, verification strategy, continuous improvement, safety culture, lifecycle risk

About Pujitha Gourabathini

Pujitha Gourabathini is a Quality Assurance and Risk Management leader in the medical device industry with deep expertise in lifecycle risk integration, design controls, and post-market safety. She currently serves as a Quality Assurance Manager focused on risk management, where she leads cross-functional efforts to embed patient safety into both new product development and sustaining engineering activities.

With hands-on experience across ISO 14971, FDA QSR/QMSR, EU MDR, and safety assurance practices, Pujitha is passionate about moving risk management beyond documentation toward practical, decision-driven application. She is an active contributor to industry discussions through writing, mentoring, and knowledge sharing—advocating for stronger safety culture, continuous improvement, and proactive risk ownership across organizations.

Let’s Talk Risk! with Dr. Naveen Agarwal is a bi-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, and not as legal advice. Views expressed by all speakers are their own and do not reflect those of their respective organizations.

Parts of this article were created using AI-generated content, which was subsequently reviewed, edited, and fact-checked by the author to ensure accuracy and alignment with our standards.

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