Issue 4: Why did I start this newsletter?

I’ve been thinking about starting a newsletter for a while. The goal was simple: publish consistently and share something useful people actually want to read.

Most advice says to pick a narrow niche. That never felt like me. I’m curious about many aspects of RA and passionate about helping people with their careers.

On LinkedIn, career transitions, especially from academia into RA, kept coming up. I tried answering as many questions as I could, but balancing a full-time role and content creation made it tough.

The newsletter solves that: a structured, scalable way to share insights. my own and those from people who’ve successfully navigated RA careers.

Have questions? Reach out on Substack or LinkedIn. I may not reply all messages individually, but I always try to turn your questions into guidance for everyone.

This week, I write about;

• a recall worth learning from

• news worth reading

• career advice worth exploring

Enjoy the read!

A recall worth learning from

This week, I’m looking at two IVD recalls where the assays themselves worked, but patient results were misleading.

In one case, CD4 cell enumeration kits (for flow cytomety) by Sysmex Partec were recalled because certain lots may overcount CD4 cells by 10–30 cells/μL.

In another case, Cortisol RIA kits by Beckman Coulter may overestimate cortisol levels by ~19%, up to +35%.

In both cases, the assay ran as intended.

The problem was analytical bias.

Without correct results:

• Clinical decisions can be delayed

• Patient management may be affected

• Risk is subtle but real

What makes this tricky is that these deviations are not obvious to the user.

For regulatory and quality teams, this reinforces a few key points:

• Analytical performance must be continuously monitored post-market

• Small deviations can have clinical consequences

• Traceability and rapid communication are essential in field actions

Take away:

Even a “functioning” test can mislead treatment decisions.

Post-market vigilance is as critical as pre-market validation.

News worth reading

The Future Is Here: Smart Contact Lenses

A Dubai- based start up, XPANCEO, is developing smart contact lenses that do more than correct vision are arriving sooner than expected. Prototypes combined on-lens displays, round-the-clock health monitoring, and even the potential to spot early signs of disease, all in a lens smaller than a fingertip.

With consumer versions possibly by 2027, they could redefine wearables and health tracking.

But here’s my regulatory question:

How will regulators handle a device that’s part medical sensor, part digital display, and fully on your eye?

Career Advice worth exploring

From R&D to RA in Medtech: You Already Have What Matters Most

You don’t need to start from scratch to move into RA. The hardest part, knowing the product inside-out, you already have. You have the understanding of how the device works and why it’s safe.

Next, show that your work was structured, documented, and compliant. RA recruiters want proof you can operate in a regulated environment. Here’s how:

1. Map your R&D work to ISO standards

• Did you follow lab protocols? → “Executed experiments in accordance with SOPs aligned with ISO 13485 quality standards.”

• Did you document results? → “Maintained accurate records for design verification and validation activities.”

• Did you run tests repeatedly or troubleshoot methods? → “Performed design verification testing ensuring compliance with regulatory and quality requirements.”

2. Highlight your compliance mindset
   Everything you did in R&D (protocols, validation, reporting) is already RA-relevant. Frame it like RA tasks: risk assessment, technical documentation, or clinical evaluation support.

3. Show cross-functional experience
   Worked with QA, manufacturing, or clinical teams? Emphasize it. RA is collaboration-heavy, and understanding multiple perspectives shows you can manage submissions and technical files.

4. Learn the RA terminology
   Now that you can show your structured work, sprinkle in keywords like MDR, IVDR, Notified Body, PMS, risk management. Learn regulations via free courses, or paid certifications. Recruiters immediately see you speak the language.

Good luck with your applications!

Before you go, tell me:

That is it for this week! :)

Have a great week and see you in the next issue!

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