During the COVID-19 pandemic, medical device and diagnostics companies and their partners have been responding with rapid solutions to meet urgent healthcare needs. Much has been learned from the quick response that could help the medical device industry prepare for future pandemics, disasters, and other potential supply-chain disruptions.
MD+DI will be exploring such lessons in the webinar series, How the Medtech Industry Can Respond to Crisis. The six individual webinars held the week of June 22 include:
- June 23, 11 am EDT: Respond and Restore: Best Practices for Responding to a Pandemic (and Other Crises)
- June 23, 2 pm EDT: Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE)
- June 24, 11 am EDT: Medical Device Packaging as Told Through Design Control
- June 24, 2 pm EDT: Secrets to a Stable Sensor Supply: What You Should Consider
- June 25 11 am EDT: The UK Ventilator Challenge: A Developer's Story
- June 25 2 pm EDT: Preventing Component Shortages During a Crisis
These events aim to help attendees learn how to:
- Develop a plan to respond to a pandemic, crisis, or other potential supply chain disruption.
- Expedite the design process for urgently needed products.
- Work with regulators on an expedited pathway.
- Work with suppliers and other partners to prevent shortages of materials and components and ensure a stable supply chain.
- Address critical needs for disinfection, sterile processing, and packaging.
- And develop other best practices for responding to the next crisis.
Kicking off the week of webinars will be risk management experts from Grant Thornton, which has been advising both large and small medical device manufacturers on the COVID-19 pandemic and more. The firm has developed a Pandemic Risk Model to help companies take a risk-based approach to crisis planning. Speaking from Grant Thornton during the webinar, Respond and Restore: Best Practices for Responding to a Pandemic (and Other Crises), will be Yvette Connor, principal, regulatory and compliance solutions; Pat Shafer, managing director, regulatory risk and quality effectiveness; Lisa Walkush, principal, life sciences sector leader; and Andy Mechavich, director, human capital services.
According to the team: “Current risk management capabilities assume a normal probability of known risk factors to occur, but they miss the unexpected, low probability events that result in the most severe supply chain disruptions like the COVID-19 Pandemic.” The speakers will explore key impact zones, risk factors, and strategies for responding and restoring operations.
During another webinar, The UK Ventilator Challenge: A Developer's Story, Sagentia will share how it responded to the UK's Ventilator Challenge by developing a new ventilator in under 7 weeks. The company devised new ways of collaborating with supply-chain partners, competitors, regulators, and clinicians to develop a solution. Speakers Rob Morgan, VP – medical, and Carl Hewett, senior product development consultant, both with Sagentia, will share how their experiences could influence future product developments.
Nelson Laboratories and Sterigenics, leading providers of mission critical services in the healthcare industry, will share recent learnings and insights about novel approaches to decontamination/sterile processing of items such as personal protective equipment (PPE) in Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE). “The presentation will provide the audience with a complete picture of the challenges faced when working with novel methods for decontamination/sterilization for items that are meant to be single-use devices,” said Alpa Patel, principal scientist for Nelson Labs. Aaron DeMent, vice president of technical services, will join Patel to present the importance of testing all critical parameters even when developing accelerated or abbreviated test methods.
There are also steps medtech companies can take for a more secure components supply chain. Maxon and Tekscan, for instance, will share ideas in their respective Webinars, Preventing Component Shortages During a Crisis and Secrets to a Stable Sensor Supply: What You Should Consider, respectively.
Christian Fritz, director of business development and applications engineering for maxon USA, which provides motion control components, will examine how smart product design, collaboration with key partners, and crisis planning can lessen the impact of unplanned events. He will explore the benefits of modular components and discuss the concept of minimum viable product. Using maxon’s product and services offering as an example, Fritz will outline how a close collaboration with supply chain partners allows companies to overcome sourcing issues in times of rapidly rising demand.
“As we all move through these unprecedented times with the COVID-19 pandemic, we have learned the importance of critical mission readiness. I will share some proven strategies that can prevent component shortages and fulfill the increased demand of critical equipment and gear,” Fritz told MD+DI.
Charlie Malacaria, vice president of business development for Tekscan, which provides embedded components such as force sensors, will share how healthcare products manufacturers can reduce supply chain risks through a deeper understanding of component manufacturing. He will explore how insights into component manufacturing processes, application and engineering support, and company stability could help mediate possible risks. Attendees will also learn how assess the long-term stability of their suppliers.
Ensuring successful packaging designs while on an expedited timeline will also be covered in Medical Device Packaging as Told Through Design Control. Oliver Healthcare Packaging's Director of Product Marketing Jenn Goff will discuss why including packaging early during the design requirement process is so important, especially during times of crisis. The webinar will help product design engineers develop a deeper understanding of packaging’s role as well as experienced packaging engineers implement design control practices.
“Designing and developing sterile medical packaging is like telling a story—it’s a stream of chronological events that takes place," Goff told MD+DI. "In sterile medical packaging, it starts with the end-user’s needs and concludes with detailed documentation. The documentation shows how each user need was determined along the way, how it was translated into specific design inputs, and then how it was validated. Each event in the design control process is an important part of the story to ensure a compliant end product.”
Be sure to join us June 23-25 for these informative webinars:
- June 23: Respond and Restore: Best Practices for Responding to a Pandemic (and Other Crises)
- June 23: Method Development for Decontamination and Sterile Processing of Personal Protective Equipment (PPE)
- June 24: Medical Device Packaging as Told Through Design Control
- June 24: Secrets to a Stable Sensor Supply: What You Should Consider
- June 25: The UK Ventilator Challenge: A Developer's Story
- June 25: Preventing Component Shortages During a Crisis