By Sean Fenske, Editor-in-Chief
 
Throughout the medical device industry, it would be challenging to find a company unaffected by labor shortages as well as supply chain and availability costs. These issues have hit every organization, either directly or through their manufacturing partners. As such, finding solutions that can alleviate the concerns that come from these problems is almost as troublesome as addressing the cause itself.
 
Fortunately, there are supply partners who are focused on specific answers that can ease frustrations at different aspects of the production process. One such company is Life Science Outsourcing (LSO), which provides packaging options, including pre-validated solutions. The organization can also resolve issues involved with sterilization. Further, these can be coupled with full-service contract manufacturing capabilities.
 
To address the packaging and sterilization opportunities, Andrew Gladd, sales & program manager, and Alan Evans, medical package testing manager, of LSO took time to respond to several questions around labor and costs, as well as their connection to solutions through packaging and sterilization options LSO offers.
 
Sean Fenske: What feedback are you getting from your customers with regard to the labor shortage and its impact on their firms?
 
Andrew Gladd: It’s no secret many industries will continue to struggle with labor availability and rising labor costs in 2023. Such polarizing challenges are impacting medical device continuity of supply and risk mitigation. Finding external solutions has become a necessity. Companies have found that partnering with vendors like Life Science Outsourcing Inc. for high quality medical device production and methods allowed them to successfully weather labor challenges and continue moving forward. One fantastic example of an outsourcing solution is using pre-validated packaging to mitigate lead-time risks. Such innovative approaches help our customers meet existing production goals, product launches, and the associated financial impact all in an expedited manner, without labor-related interruptions or budget surprises.
 
Fenske: How have supply chain challenges impacted your customers and their availability costs?
 
Gladd: Recent supply chain challenges have had a sweeping, negative domino effect on all aspects of delivery and execution. Companies have struggled due to extreme lead times needed to meet commitments—both internal and external. To that extent, the financial impact has been tremendous and further intensified by inflationary aspects. Yet many companies have found success in navigating these difficulties with early planning access and systems that mitigate the availability of materials. Some rely on strategic vendor partnerships to standardize their supply chain. Conversely, some large OEMs swung the pendulum too far and overcompensated for material shortages and extended lead times caused by the pandemic. These OEMs now find themselves in an overstock condition that must now be managed.
 
Fenske: How does your company leverage its capabilities in medical packaging and packaging testing to help ease these concerns?
 
Alan Evans: At LSO, we support all stages of the product lifecycle and can perform assembly, packaging, sterilization, sterilization validation, and package testing under one roof. We are uniquely positioned to test and validate custom packaging or leverage cost-effective pre-validated packaging options that provide cost savings and reduce time to market. LSO can quickly respond to custom requirements by leveraging a wide array of resources and capabilities. We are ready to perform in–house heat seal validation, distribution simulation, accelerated aging, and real-time aging in compliance with ISO 11607. Conversely, we can also leverage off-the-shelf, pre-validated packaging configurations that can alleviate common supply chain issues. In addition, we can help define specific packaging testing requirements and appropriate sample population in order to reduce cost and accelerate time to market.
 
Fenske: Can you speak specifically to the role pre-validated packaging can play in addressing these issues?
 
Evans: Pre-validated packaging is a game changer. By definition, it refers to reduction of risk while increasing the leverage of associated lead times and time to production and market. Its functional benefits are many, including the elimination of design qualification or stability testing. Customers often find LSO can solve their labor availability issues across the account management level and manufacturing stages with our expansive packaging services and expertise, including accelerated aging and OQ/PQ.
 
Fenske: On the sterilization side, how does your company help to address challenges that tie to sterilization and its validation?
 
Gladd: We’ve placed a priority on helping our customers through a variety of industry and business challenges, including medical device sterilization and validation processes. We have on-staff validation engineers and a microbiologist, which is not widely done. We are one of the few outsourcing partners with such expertise in house.
 
There are additional ways we address sterilization and validation challenges for our customers, such as:
 

• Same facility sterilizer equipment
• In-house BI testing
• Supply chain simplification
• Long history of validation work
• Audit-vetted
• Ever-evolving as regulatory world experiences change

 
Fenske: Do these capabilities and services complement other offerings your company provides to medical device manufacturers to ease the pain of the labor shortage and availability costs? If so, how?
 
Gladd: LSO integrated services and expertise resolve labor shortage and availability costs with in-house talent, resources, state-of-the-art facilities and equipment, and our ability to pivot into new solutions and strategies that benefit the medical device industry. A specific example is our end-to-end medical package capabilities, which can accommodate the entire continuum of medical package testing. Another is our washing capabilities, with a dedicated washroom inside our ISO 7 cleanroom. We have our own deionized water system feeding the room along with many of the common medical device cleaning agents. We have various ultrasonic cleaners qualified along with the various equipment needed to process orthopedic devices. A third example would be our Lancer 74 cubic ft. contract steam sterilizer for pharma. LSO is also CDER registered for drug sterilization.
 
Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?
 
Evans: As part of a global expansion strategy, Life Science Outsourcing Inc. recently acquired J-Pac Medical, a manufacturing, packaging, and sterilization outsourcing partner to medical device and diagnostic companies. By combining our specialized capabilities and expanding across a larger geographic area, we can support a greater number of medical device and diagnostic organizations to accelerate their development and manufacturing capabilities. In addition, LSO can help our customers mitigate labor challenges by supporting them with creative nearshore production options.
 
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