ETO vs. Irradiation, Autoclave, and Emerging Sterilization Methods: Choosing the Right Approach for Your Medical Device
Selecting the right sterilization method is one of the most critical decisions in medical device manufacturing. From ETO to irradiation, autoclave, and emerging modalities like chlorine dioxide and X-ray, each technology offers unique advantages and limitations. This article explores how ethylene oxide (ETO) continues to set the standard for complex and heat-sensitive devices—while comparing it to other leading sterilization methods in terms of compatibility, efficiency, and scalability.
PiSA USA’s Marie O’Malley to Join MassMEDIC Fireside Chat on Technology Challenges in MedTech
PiSA USA is excited to share that Marie O’Malley, Vice President of Commercial Operations, will be a featured speaker at MEDevice Boston 2025. O’Malley will join MassMEDIC’s Fireside Chat: Breaking Barriers — Leading Through Technology Challenges in MedTech on October 1, 2025, bringing nearly 30 years of industry expertise to the stage. Known for her leadership in innovation, supply chain, and regulatory compliance, O’Malley will discuss how collaboration and forward-thinking strategies can turn technology challenges into opportunities for safer, more sustainable solutions.
Mitigating Supply Chain Risk with Nearshore Manufacturing in Mexico
In today’s volatile global market, pharma and medical device companies can’t afford supply chain setbacks. That’s why more organizations are turning to nearshore manufacturing in Mexico—a solution that combines speed, cost efficiency, and regulatory confidence. At PiSA USA, our partnership with Centerpiece in Tijuana takes this a step further, offering end-to-end support from design and clean-room manufacturing to world-class ETO sterilization and compliant warehousing. Together, we’re helping companies cut lead times from weeks to days, reduce risk, and build resilient supply chains ready for tomorrow’s challenges.
Streamlining Development Processes: How PiSA USA Optimizes Efficiency and Reduces Time to Market
In the fast-paced world of medical devices and pharmaceuticals, optimizing development processes is essential to stay ahead of the competition. At PiSA USA, our integrated approach, cross-functional teams, advanced project management, regulatory expertise, state-of-the-art technology, agile methodologies, client-centric collaboration, and commitment to continuous improvement collectively contribute to streamlining development processes
Marie O’Malley Of PiSA USA On How We Can Increase Women’s Engagement in Leadership and Management
Our very own Marie O'Malley has been featured in a Medium article "Marie O’Malley Of PiSA USA On How We Can Increase Women’s Engagement in Leadership and Management." Read the full article here.
Safeguarding Quality: How Automation Enhances Compliance in Medical Device Manufacturing
In the fast-evolving landscape of medical device manufacturing, ensuring compliance with strict regulatory standards is paramount. For large OEM companies seeking contract manufacturing services, the ability of a partner to safeguard quality while maintaining compliance is non-negotiable. In this blog, we examine how automation plays a pivotal role in enhancing compliance within the realm of medical device manufacturing.
Navigating the Complexities of Medical Device Supply Chains - A Call to Action for Manufacturers
From medications and personal protective equipment (PPE) to medical devices and testing kits, hospitals across the nation grapple with acute shortages that pose a threat to patient care and safety. In this dire situation, medical device manufacturers stand at the forefront, holding the key to addressing the crisis and ensuring the resilience of the healthcare system.
Marie O'Malley, Sr. Vice President of Commercial Operations at PiSA USA, to Speak at MPO Summit 2023
Marie O'Malley, Sr. Vice President of Commercial Operations for PiSA USA, will be a panelist speaker at the MPO Summit on the topic, "Supply Chain Discovery: Are We There Yet?". This insightful panel discussion will delve into the current landscape of the medical device supply chain, addressing existing pain points and discussing crucial lessons learned from recent challenges.
Design and Development Process for Medical Device Manufacturing: From Concept to Reality
In the rapidly advancing realm of medical technology, the vital design and development of medical devices yield safe, efficient, and inventive products. For medical manufacturers, this process is their cornerstone, profoundly affecting device quality, functionality, patient well-being, and future earnings. This blog delves into the pivotal stages of medical device design and development, emphasizing each step's significance.