Seattle, Washington Jun 26, 2025 (Issuewire.com) - After more than three decades in the biotech and medical device industry, Donna Matuizek is turning her focus to the public: calling for greater awareness, education, and support regarding medical quality systems and regulatory compliance.
Most people never think about how safe their medicine is until something goes wrong, said Matuizek. But behind every therapy, theres a system of checks, controls, and people making sure that what reaches you is effectiveand safe.
Matuizek is recognized for her leadership in bringing groundbreaking medical technologies to market. Shes worked on everything from the first FDA-approved HIV blood screening test to Provenge®, the first approved cell therapy for prostate cancer. Shes built compliant facilities in record time and helped secure approvals for high-impact treatments.
Yet, shes clear: Quality isnt paperwork. Its protection.
The Stakes Are Higher Than You Think
According to the Institute for Safe Medication Practices (ISMP), preventable medication errors harm over 1.5 million people in the U.S. each year. The FDA recalls roughly 4,500 medical devices and drugs annually, many of which are due to process failures that could have been avoided with stronger quality controls.
People think this is just a big pharma issue, but quality happens everywherefrom startup labs to hospital pharmacies, said Matuizek. If a process breaks, it puts patients at risk. Everyone from manufacturers to regulators to patients themselves should care.
The Role of Everyday Advocates
Though regulatory work may seem technical, Matuizek insists that everyone can play a role in supporting safer health outcomes.
Ask questions. Read the labels. Speak up if something feels off, she advises. And if youre in the industryeven at an entry levelunderstand why quality systems matter. We dont cut corners, because we cant afford the cost of failure.
In her own career, she has emphasized team education and accountability. While leading quality at Just-Evotec Biologics, the clinical site achieved a 100% manufacturing success rate, and she led the quality requirements and qualified an entire biologics facility during the COVID-19 pandemic in just 18 months.
It wasnt about moving fast, she said. It was about doing it right, the first time.
Beyond the Lab
Matuizek brings the same discipline to her personal life. She volunteers regularly by preparing meals for a womens shelter. Shes also an avid gardener, marathon runner, and leads a supper club.
These things keep me grounded, she said. And they remind me that real quality isnt only in labs. Its in how we show up for peopleconsistently.
A Call to Action
Donna is encouraging professionals and citizens alike to take small but powerful steps:
If everyone treated quality like their life depended on itbecause it mightwed see real change, Matuizek concluded.
About Donna Matuizek
Donna Matuizek is a Seattle-based biotech and regulatory affairs professional with over 35 years of experience in the field. She has worked at leading companies including Dendreon, Just Biotherapeutics, Magnolia Medical Technologies, and AGC Biologics. She has contributed to multiple FDA approvals and built world-class quality systems for drugs, biologics, and medical devices.
Source :Donna Matuizek
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