Medical devices have long and highly regulated lifecycles, and the software and hardware connected to these devices have their own separate lifecycles — which are constantly changing. This can pose a problem for many medical device manufacturers. Finding a way to maintain and tend to both device and software/hardware lifecycles can be a hindrance, if manufacturers don’t have a concrete strategy in place to make sure all lifecycles are considered; one of the most critical parts of this strategy is working with an experienced IT partner that can fulfill many roles to manage the entire connected hardware lifecycle.
Having a strong IT partner to work with in this area, with robust but also highly nuanced capabilities, helps mitigate risks, reduce costs and bring medical device products to market faster — while ensuring compliance and security across all digital components in the devices. The current pandemic also shines a light on the importance of having an expert on hand to increase efficiency and maximize time — which virtually no company can afford to waste when it comes to quickly producing devices that deliver life-saving services in the medical field.
We have compiled a list of ten challenges and solutions that you should look for in an IT provider’s proposed plan of action, when it comes to strategies for relieving the stress of bringing a new medical device to market or keeping medical devices continuously up and running. These are key items to search for in identifying an IT provider that can partner with you to increase efficiency in the lifecycle management of your medical devices.
#1: Dedication to Specifications
Challenge: Our current supplier doesn’t offer the exact specs that our new medical device requires.
Solution: Seek out a supplier that can source technology hardware and software from hundreds of leading OEMs and distributors. They should be able to find the right replacement or add-on product — from the medical device manufacturer’s current provider or another one.
#2: Flexibility & Customizations
Challenge: This product spec is too granular. We’ll be stuck with a very short IT lifecycle.
Solution: Find a knowledgeable IT provider with deep expertise that offers flexible consultation and recommendations to build a custom product specification, solving for optimum configuration and lifecycle options to meet specifications.
#3: Extensive Marketplace Knowledge
Challenge: We’re locked into working with this OEM, so we don’t always know the other options available.
Solution: Product selection can be vendor-neutral with a technology partner that has relationships with many technology suppliers; a partner that can serve as the medical device manufacturer’s eyes and ears in the IT marketplace is critical, providing the medical device manufacturer options from the latest and best technology, from hundreds of leading sources.
#4: Foresight & Proactivity
Challenge: Can I count on this specific component to be in stock? Will they still offer it next year?
Solution: A partner that has advanced visibility into product roadmaps — and an automated end-of-life assessment and notification process — is important in proactively managing end-of-life, optimizing planning for product transitions and mitigating stock-out issues.
#5: End-of-Life Management
Challenge: This specific piece is critical. It’s going end-of-life, and a replacement hasn’t been validated.
Solution: Solution-driven IT professionals provide forecast management and collaborate with the medical device manufacturer to calculate last-time buys based on purchase history, maintaining the IT component’s availability pending the new product’s validation.
#6: Compliance, Consistence & Control
Challenge: This new product was substituted without notice or validation.
Solution: A compliant, consistent and controlled process is needed to ensure proactive management of transitions and validations. Medical device manufacturers should look for a partner who will never substitute a product — not even a small cable — without verification and/or validation.
#7: Adherence to Requirements
Challenge: We’ll ship this product globally, but it’s sourced in the U.S. Is it okay to import?
Solution: The right supplier should work with both the medical device manufacturer and the IT providers to ensure that any product sourced for a device’s global use will meet import requirements for each region or country.
#8: Broad Range of Tech Providers
Challenge: An IT product’s lifecycle is simply too short for the long life of our medical device.
Solution: Having access to hundreds of technology providers, and knowing which technology products offer longer lifecycle options, should be included in a good partner’s portfolio of expertise. For example, with the right choice of laptop computer, the typical 18-month product lifecycle can extend to 30 or even 36 months.
#9: All-in-One Management & Maintenance
Challenge: IT products from multiple OEMs require multi-vendor relationships.
Solution: Instead of integrating multiple vendors for a specific medical device need, look for a one-stop-shop IT provider that can manage the entire connected hardware lifecycle for product platforms and configuration transitions. Additionally, this IT provider should be able to deliver specification consulting, recommendations, product sourcing, project management, technical services, device record compliance, inventory management, quality management, warehousing and logistics management.
#10: Just-in-Time Inventory Management
Challenge: We’re overstocked with IT equipment, and we’re afraid it will become obsolete.
Solution: Providing just-in-time warehouse inventory management — stocking products and drop-shipping them directly to medical device manufacturers’ customers, as well as coordinating and managing supply chains — minimizes on-hand inventory.
Work With Us
Dynamic provides the solutions you need to ease lifecycle management for medical devices. Call 866-399-1084 or email us at firstname.lastname@example.org to get started.
Editor’s Note: This post was originally published in July 2019 and has been updated with new information for comprehensiveness.