How a Strong Quality Culture Drives Successful Acquisitions in MedTech
MedTech: A Growing Industry for Mergers and Acquisitions The MedTech industry creates life-changing products to improve patient care. Companies in this field often merge, buy, or sell to grow their businesses. But these deals do not always succeed. Problems can arise when companies do not plan well or fail to focus on quality. A strong […]
Cost of Poor Quality (COPQ) in Healthcare
The Cost of Poor Quality (COPQ) in the healthcare sector—particularly in medical devices, pharmaceuticals, and biopharmaceuticals—has profound implications for patients, employees, and shareholders. This analysis delves into the impact of the cost of poor quality across these key stakeholder groups. Impact on Patients Poor quality in healthcare can lead to severe consequences for patients, including: […]
Navigating Your Quality Journey: Crafting a 3-Year Road Map
In today’s rapidly evolving regulatory landscape, ensuring a robust quality culture is essential for any organization in the biopharmaceutical industry. Our latest infographic below offers a clear visual guide on how Compliance Architects can help you map out your quality strategy over the next three years. See the infographic below. The Journey Begins: Check Your […]
Why Change Management Efforts Fail
A Quality Professional’s Perspective on Why Change Management Efforts Fail When you get to the point of your career I now find myself in, you will have seen many change management efforts falter or fail. While some common themes and pitfalls contribute to all such failures, I want to emphasize those that I think are […]
Creating a Sustainable Quality Culture: Balancing Ethics, Efficiency, and Employee Well-Being
“Quality is never an accident; it is always the result of Intelligent effort.” …John Ruskin I have spent the last 20+ years in the biopharmaceutical industry. My journey began modestly, starting with washing lab glassware, researching, and working as a QC environmental monitoring sampler. From there, I advanced to line supervisor and lab manager roles, […]
Why is Achieving a Robust Quality Culture in the Medical Device Industry Challenging?
Aristotle once said, “Quality is not an act; it’s a habit.” This is the first in a series of articles on Quality Culture in the Medical Device Industry. In this first article, we focus on the unique challenges we face in creating a strong quality culture in the medical device industry and considerations for the […]
Quality Pulse: What Type of Companies Could Benefit?
The Quality Pulse® culture diagnostic tool is appropriate for all companies in biopharma and pharma, in regulated consumer products, in devices, and in combination products. Companies that do not have a culture supportive of enabling quality…they suffer poor health authority outcomes, there is a lack of trust amongst healthcare providers and patients, there are unplanned […]
The Road to Poor Quality
“How did you go bankrupt?” Bill asked. “Two ways,” Mike said. “Gradually and then suddenly.” -Ernest Hemingway, The Sun Also Rises. Gradually, Then Suddenly In Ernest Hemingway’s novel “The Sun Also Rises,” the quote above refers to the character’s financial predicament. However, most of us can see that this sentiment resonates far beyond financial matters and […]
What Makes Quality Pulse Unique?
The following article is a transcript from the “How is Quality Pulse different from other tools on the market?” video with Teresa, Kenneth, and Jerry. Jerry Appert: Great, great discussion. When you think about all of the different applications and use cases that you both articulated so nicely, maybe one of the questions I started […]
Visualizing Quality Culture Data – Analyzing 2 Scenarios
The following article is taken from June 15th Webinar – “Create a Quality Culture data to Aid Risk Management: Dynamic Behaviors that Achieve Quality and Business Objectives”. Challenges of Weak or Ambiguous Quality Culture Data Now let’s look at a third quality culture scenario, where you have a weak or ambiguous culture. Notice in this one that […]
