Seattle, Washington Jun 26, 2025 – After a career spanning more than three decades in the biotech and medical device sectors, Donna Matuizek is now focusing her efforts on raising public awareness, improving education, and increasing support for medical quality systems and regulatory compliance.
“Most people don’t consider the safety of their medications until something goes wrong,” Matuizek stated. “However, every treatment is backed by a system of checks, controls, and dedicated individuals ensuring its effectiveness and safety.”
Matuizek is well-known for her leadership in introducing innovative medical technologies to the market. Her experience includes working on the first FDA-approved HIV blood screening test and Provenge®, the first approved cell therapy for prostate cancer. She has a proven track record of building compliant facilities quickly and securing approvals for impactful treatments.
She emphasizes, “Quality is more than just paperwork; it’s a form of protection.”
The Stakes Are Higher Than You Think
According to the Institute for Safe Medication Practices (ISMP), preventable medication errors affect over 1.5 million people in the U.S. annually. The FDA recalls approximately 4,500 medical devices and drugs each year, often due to process failures that could be prevented with stronger quality controls.
“People often view this as solely a ‘big pharma’ issue, but quality is important across the board – from startup labs to hospital pharmacies,” Matuizek explained. “Process failures endanger patients, making it crucial for everyone, from manufacturers to regulators to patients, to be concerned.”
The Role of Everyday Advocates
Although regulatory work may seem highly technical, Matuizek believes that everyone can contribute to promoting safer health outcomes.
“Ask questions, carefully read labels, and voice concerns if something doesn’t seem right,” she advises. “And for those in the industry, even at entry level, understand the importance of quality systems. We don’t take shortcuts because we can’t afford the consequences of failure.”
Throughout her career, she has emphasized team training and accountability. During her time leading quality at Just-Evotec Biologics, the clinical site achieved a 100% manufacturing success rate. Additionally, she led the quality requirements and qualified an entire biologics facility during the COVID-19 pandemic in only 18 months.
“It wasn’t about speed,” she clarified. “It was about ensuring it was done correctly the first time.”
Beyond the Lab
Matuizek applies the same discipline to her personal life, volunteering regularly to prepare meals at a women’s shelter. She is also an enthusiastic gardener, marathon runner, and supper club host.
“These activities keep me grounded,” she shared. “And they remind me that true quality extends beyond the lab and into how we consistently support others.”
A Call to Action
Donna encourages professionals and the public to take impactful, small steps:
- Stay informed. Understand the development process of your medications and devices.
- Ask healthcare providers about safety practices. Actively participate in your healthcare.
- Support organizations that champion patient safety standards.
- For professionals: prioritize training, voice concerns during audits, and never compromise the process.
“If everyone treated quality with the seriousness it deserves—as if their life depended on it, because it could—we would witness significant positive change,” Matuizek concluded.
About Donna Matuizek
Donna Matuizek, based in Seattle, is a biotech and regulatory affairs expert with over 35 years of experience. She has worked with leading companies such as Dendreon, Just Biotherapeutics, Magnolia Medical Technologies, and AGC Biologics, contributing to multiple FDA approvals and developing world-class quality systems for drugs, biologics, and medical devices.
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