Warwick Consulting

12/25/2025

Behind every smooth delivery is thoughtful preparation. Warwick wishes you a Merry Christmas and a joyful holiday season.

12/23/2025

Real clinical environments are loud, busy, and cognitively demanding. Hence, testing should reflect that. Quiet-room studies often hide the errors that only appear under pressure.

Simulating noise, multitasking, and time stress reveals true usability risks.

12/18/2025

Our Boston team got together for a lovely evening.
It was a chance to unwind, connect, and enjoy time outside the usual workday.
Appreciative of the people who make this team what it is.

12/17/2025

This isn't an arbitrary number.

The FDA's "15 users per group" benchmark for summative human factors testing comes from an evidence-based model. The goal is problem-discovery saturation, which is testing enough people to uncover the vast majority of critical use errors.

Key nuance: The 15 must be truly representative of the actual user group. Diversity in skill and experience is non-negotiable.

What's the biggest hurdle in recruiting a representative sample of 15?

12/12/2025

Most teams see QMS as a burden.
The best teams use it as a growth engine for faster approvals, fewer redesigns, and stronger investor confidence.

Is your quality system slowing you down or scaling you up?

12/05/2025

Automation bias, when users trust AI outputs over their own judgment, is a critical risk in medical devices.

At Warwick, our human factors approach designs intentional friction to combat this:
✅ Context checks that align AI suggestions with the clinical picture
✅ Clear confidence indicators, not just binary outputs
✅ Discrepancy alerts that flag inconsistencies for review

This keeps the clinician in control, creating safer human-AI collaboration.

How is your team designing out automation bias?

11/24/2025

That blood analyzer, ultrasound machine, or insulin pump in a closed-loop system... if it has software, the FDA's June 2025 final guidance defines it as a 'cyber device.'

The risk shifts from external hackers to internal integrity: ensuring software functions reliably, patient data isn't corrupted, and clinical decisions are based on accurate information.

For MedTech, cybersecurity is now synonymous with quality system software validation and patient safety.

How is your team adapting to this new reality? Share your challenges below.

11/19/2025

The FDA’s 2025 software rules are now set, and each one changes how devices must be designed and validated:

* Cybersecurity (June 2025): Every software-powered device is now a cyber device → threat modelling, SBOM, and lifecycle security become mandatory.

* AI/ML PCCP (Aug 2025): You must pre-define how your algorithm can change after approval → no more ad-hoc updates.

* CSA (Sep 2025): Software validation now shifts from documentation-heavy to risk-based testing → fewer templates, more intent.

If your submission strategy doesn’t reflect these shifts, it’s already outdated.

Warwick helps MedTech teams operationalize these requirements with clarity and speed.

11/17/2025

Risk gaps, unclear intended use, and late cybersecurity are behind most approval delays.
The good news? They’re all preventable.
Warwick partners with device teams to align everything early and accelerate approval.

11/10/2023

🚀 We are thrilled to announce the launch of Warwick Consulting on Facebook! 🚀

Since 2011, Warwick Consulting has been at the vanguard of medical device development, combining deep industry expertise with cutting-edge innovation. Our mission is simple yet ambitious: to revolutionize healthcare by empowering our clients to bring superior medical devices from the concept to the hands of professionals swiftly and efficiently.

💡 With over a decade of success, our portfolio boasts:

300+ Design History Files crafted.
35+ innovative medical devices commercialised.
A diverse clientele including Fortune 500 companies and agile startups.
Expertise spanning 25+ distinct therapeutic areas.

As we step into the spotlight on Facebook, we invite you to join us on this exhilarating journey. Follow us for insights into , behind-the-scenes looks at , and conversations that drive the .

✨ Stay tuned for updates, thought leadership, industry trends, and more.

Here’s to transforming the future of healthcare, together.

Visit our Website for more info:

https://warwick.consulting/

Warwick Consulting is your trusted partner for medical device solutions. Discover our comprehensive services & track record of empowering healthcare innovation.