Quality is Everyone’s Responsibility – Lessons from the Lens of an R&D Engineer

Introduction

When most people hear “Research and Development”, the picture their minds draw would be scientists in lab coats running experiments or engineers making sketches and researchers fussing over how they could squeeze another micrometre of performance out of a catheter tip. Well, this picture isn’t particularly wrong, but in a regulated , typical medical device space, it is for the most part incomplete.

Twelve months into my internship in the R&D department of a medical device company, the lesson that has been of the biggest surprise to me is this: the hardest part of R&D isn’t the research nor the development. It is the discipline and quality with which you carry them both out.

What Does R&D Really Mean in Medical Device Development?

The first few weeks were an eye-opening learning curve. My work involved troubleshooting, digging into root causes, asking question after question until I could trace a failure back to its birthplace. I contributed to design iterations, flagged potential improvement and took part in cross departmental meetings where quality , R&D, production and overall operational perspectives blended in one room. It felt exactly like how I imagined R&D to be.

This is when I was introduced to the document control system and everything I had understood thus far about what R&D comprised of, expanded considerably. Every test that was run, every design proposed, every material change suggested had to exist not just in my head and out as words, or even as a document on my system, but as a controlled, classified and a traceable artefact within the QMS (Quality Management System). I quickly came to realise that the actual R&D work was only valid if it was documented correctly.

How Document Control and QMS Structure R&D in MedTech

In a regulated med-device company, each document resides in a structured hierarchy and the precise understanding of that hierarchy becomes non-negotiable to maintain quality. Technical notes , test protocols, fabrication files, design and product specifications , each of these belong under a specific category of document type. Each artefact is assigned it’s own document number depending on the type of document it falls under, and each revision change is released as a separate change order. Understanding the difference between verification protocols and validation protocols became significant. These distinctions mattered because the regulatory bodies such as the U.S FDA (United States Food and Drug Administration) under 21 CFR Part 820 (Quality System Regulation) or other regulators and notified bodies that assess conformity with ISO 13485 will look at exactly this architecture and structure when auditing a Design History File (DHF).

In R&D change is constant, and in many ways, it is the whole point. A dimension is altered by a couple millimetres, a new usage recommendation is proposed, a test method is refined, a new work instruction is released. Each of these events, however minor they might sound, requires to be documented though a formal change order. Document Change Orders (DCOs) are responsible for changes made to existing controlled document, and Engineering Change Orders (ECOs) track top level modifications. Each order needs to be signed off by relevant corresponding stakeholders, must be cross-referenced against related documents, and released through the QMS before the change is considered live.

On busy weeks, when five or six changes run in parallel, keeping track of the status of every sign-off, chasing approvals, and ensuring that no revision is out of sync with the documents that reference it becomes a whole project in itself.

Why Quality Starts in R&D and Not Quality Assurance

One of the most significant mindset shifts that I underwent during the course of my internship was when I understood where quality actually begins. It is tempting , especially as a newcomer to think that the Quality Assurance department guards and maintains compliance. A team that reviews document before release and raises Nonconformances and liaises with regulatory bodies, don’t get me wrong , QA most definitely fills that role but treating it as the first line of defence is a major misunderstanding of how a good quality culture is practiced.

In a high functioning R&D department end, quality duties aren’t something you just hand over to the QA department at the end of a project. It is something you consciously build from the beginning. For example, when I write a test protocol , as I begin the first line I am already thinking if every objective links back to a design requirement. When I update a fabrication file, I am thinking about version control- does every downstream document that references this file know that a new revision exists? When I log an anomalous result, I am thinking if it requires deviation management or if it falls within the defined acceptance criteria. These questions as I came to realise, are not QA questions. They fall within the R&D mindset.

The Overlooked Skills in R&D: Communication, Traceability and Compliance

No one told me during the entire span of my extensive bachelor’s and master’s degree, that a significant portion of my engineering career would involve chasing approvals and managing signoffs for Change Order releases. But that coordination and communication, following up with department heads, making sure that the right people have signed the right documents, maintaining a clear trail of who approved what and when is extremely critical. Traceability isn’t just a regulatory buzzword. I came to understand that it is the difference between a company that can answer an FDA auditor’s question in five minutes and one that scrambles for the next couple of days. The communication skills needed to navigate such an environment with clarity, persistence and diplomacy are as important as any technical skill.

Attention to detail, too, takes on a new meaning in a regulated context. In academic settings, a missed reference or an inconsistent table would be considered a formatting error. On the other hand, in a medical device DHF, it is a potential audit finding. The standard I now hold my own work to has changed for the better permanently and I think that is one of the most valuable learnings that my experience in a med-device company has imparted to me.

Redefining Medical Device R&D: From Innovation to Traceability

Looking back across the past year, I would define R&D in a med-device space differently from how I would have defined it when I first arrived. It is a place where innovation is made defensible, and where every creative decision is documented, controlled, and traceable in a way that can ultimately stand up
to regulatory scrutiny and, more importantly, protect the patient or the end user. For any aspiring biomedical engineer entering this industry, here are my 2 cents: do not underestimate the document. Learn and understand the QMS early. Ask why a document is classified the way it is. Because the technical work you are most excited about, be it the testing, the designing, the problem-solving, is only as strong as the paper trail that’s built around it.

Quality is a mindset that is absolutely essential to nurture a robust medical device environment.

Disclaimer. The views and opinions expressed in this article are solely those of the author and do not necessarily reflect the official policy or position of Test Labs Limited. The content provided is for informational purposes only and is not intended to constitute legal or professional advice. Test Labs assumes no responsibility for any errors or omissions in the content of this article, nor for any actions taken in reliance thereon.