Greetings, welcome to the April issue of the Device Discourse.

As more people start to receive their COVID-19 vaccinations, I’m optimistic that business is starting to return to normal. 

This month, we’re highlighting regulatory updates to ethylene oxide (EO) sterilization cycles. If you utilize EO sterilization for your medical device, let’s set up a discovery call to discuss revalidation of your sterilization cycle.  

After a relatively quiet year due to the pandemic, the medtech market is bouncing back with cash and a flurry of mergers and acquisitions.

As you ramp up to get your product to market, don’t overlook the importance of a quality-first approach. Learn how to prioritize quality assurance and regulatory compliance at every stage of the product life-cycle in our latest white paper, The MedTech Startup Guide to Quality.

What quality assurance, regulatory compliance, or microbiology and sterilization topics are keeping you up at night? 

Maybe it’s time for a gap analysis to check on the health of your quality systems. We offer complimentary 30-minute discovery calls to help you identify potential hazards and areas for improvement.
Best,
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EO Sterilization and What Medical Device Manufacturers Need to Know About New Revalidation Requirements

As a result of recent regulations, manufacturers will need to validate a new ethylene oxide (EO) sterilization cycle for medical devices using a lower gas concentration. 

Learn more about the impending changes and why now is the time to revisit your device’s sterilization protocols and processes. 

Checklist: 7 Quality Must-Haves 

Quality is the foundation of a successful medical device product launch. 

Developing a quality system early in a project reduces the risks associated with bringing your product to market and saves you from a significant hit to your bottom line due to the unexpected costs of poor quality. 

Make sure your quality system includes these seven must-haves.
Get to Know Our Experts

Three Questions with
Amber Hilfiger, MSE, CQA
QA Consulting Director of Operations and Senior Quality Engineering Consultant
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1. What is your primary area of medical device expertise?

While I work on projects across our three core competencies of quality, regulatory, and microbiology, my sweet spot is compliance and remediation for medical device quality systems.  

I’ve performed dozens of internal and supplier audits and assisted in many FDA and notified body audits. I also managed QA’s quality system and hosted each of our audits since we first received ISO 13485 certification in 2014.  

I’ve worked in quality for 11.5 years. Before joining QA, I worked at a DNA testing laboratory and at a firm that facilitates due diligence healthcare research for market investors. My experience in healthcare research for investors gives me a unique perspective on the work we do. While medical device quality can be narrowly focused, it reminds me to stop and think about the impact of what I do from a macroscopic perspective.
2. What medical device innovations are you most excited about in 2021? 

As a mom of three little ones, I’m most interested in pediatric and women’s health innovations.  

The market for new (what my mom friends call) “gadgets” (but what I know to be medical devices), such as hands-free breast pumps, has exploded in just the past five years since I had my first child.  

With the rise of social media, companies can easily market products to new moms, and they have responded, buying every new and improved innovation as it is released.
3. What’s one thing we’d be surprised to know about you? 

One of my favorite activities is fishing, yet people are surprised to learn that I’ve never baited my own hook!  

Growing up, I’d go fishing for catfish with my grandfather every weekend in the summer. I even won a fishing tournament one year for having caught the biggest fish. 

I’ve been on several deep-sea fishing trips in the Gulf of Mexico and the Florida Keys. In the Keys, I spent nearly 2 hours reeling in a 200 lb Tarpon. This past November, my husband and I went fishing at Fort Gibson Lake in Oklahoma for spoonbill paddlefish, which are internationally sought after for their caviar.    

All of these fishing adventures, and I’ve still managed to avoid baiting my own hook. 
FDA Corner



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