David King
Leveraging Expertise In Steam Sterilization Validation for Reusable Orthopedic Devices
Leveraging Expertise In Steam Sterilization Validation for Reusable Orthopedic Devices These days, the business of orthopedics requires some gymnastics. Balancing ever-evolving regulatory compliance needs with continuity concerns can challenge even the world’s biggest, most successful firms. As technologies and markets diverge and diversify, staying ahead of competitors and on top of lead times is hard. Missteps and hiccups can lead
Five Reasons Why Supply Chain Visibility Matters in Medical Device Manufacturing
Five Reasons Why Supply Chain Visibility Matters in Medical Device Manufacturing You’ve heard the saying “what you don’t know can’t hurt you.” While it might be the case for feelings, what you don’t know or don’t see will definitely hurt your supply chain—and, by extension, everything about your business. Without good visibility into your complex, interconnected supply chain, risk increases,
Comprehensive Product Testing Expertise Reduces Risk for Medtech Manufacturers
How Comprehensive Product Testing Expertise Reduces Risk for Medtech Manufacturers When the lifesaving and lifechanging products you make are going into patients’ bodies, there is no room for error. Every medical device manufacturer knows this truth. So do regulatory bodies. Taken together, the focus on patient safety and compliance are the driving forces behind comprehensive product, packaging, and environmental testing.
Identifying and Evaluating Alternative Sterilization Methods for Medical Devices
Identifying and Evaluating Alternative Sterilization Methods for Medical Devices Mark Twain once said, “Success is a journey, not a destination. It requires constant effort, vigilance, and reevaluation.” While he could not have imagined today’s medical device manufacturing industry, he certainly nailed the idea of what it takes to stay at the cutting edge of a constantly evolving and highly complex
A Look Inside Managing Supply Chain Risk in the Medical Device Industry
A Look Inside Managing Supply Chain Risk in the Medical Device Industry While some of us in the medtech industry may dream of a day when “supply chain risk” is not top of mind, that day is not here yet. Ongoing supply chain disruption and continued global inflation are exerting continuing pressure on medical device manufacturers. So, it is definitely
Accelerating Time to Market by Streamlining Medical Device Testing
Accelerating Time to Market by Streamlining Medical Device Testing One of the biggest challenges in medical device manufacturing is simply getting the product to market quickly. Speed to launch isn’t just about competitive advantage; it’s also about making a difference in patients’ lives. The sooner you can bring your device or product to market, the sooner it can help the
Strengthening Your Sterilization Strategy to Minimize Disruptions
Strengthening Your Sterilization Strategy to Minimize Disruptions For four years now, medical device manufacturers have had to navigate significant and ongoing disruptions to device sterilization. Concerns over the harmful effects of ethylene oxide emissions shuttered facilities in late 2019. Suddenly, significantly reduced capacity upended production and sent OEMs scrambling for alternatives. Despite advances and alternatives, though, there are proposed regulatory
Four Advantages of Centralizing Supply Chain Management: A Game-Changer for Medical Device Manufacturers
Four Advantages of Centralizing Supply Chain Management: A Game-Changer for Medical Device Manufacturers Material shortages, shipping delays, forecasting difficulties, labor shortages, and regulatory compliance challenges. The supply chain disruptions and pressures of the last three years have certainly rattled medical device manufacturers and their partners. With lead times in some cases as long or longer than ever before, many OEMs
Implementing the Three Cs for a More Efficient Supply Chain
Implementing the Three Cs for a More Efficient Supply Chain In today’s dynamic and disrupted orthopedic market, the adage ‘time is money’ couldn’t ring truer. As the industry races to keep pace with demand, every second counts—in product launches and for ongoing production. It’s not just the clock, however, that poses a challenge; it’s also the compounded supply chain complexity
The Benefits of Outsourcing Medical Device Product Testing
The Benefits of Outsourcing Medical Device Product Testing As a medical device manufacturer, you know that every product you bring to market must meet rigorous testing standards to ensure patient safety. Product and packaging testing can be time-consuming, though, and require specialized knowledge, equipment, and resources. With increased regulatory and product complexity, it can be challenging to keep up with
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