The launch of a new medical device can generate a lot of excitement, as it presents an opportunity to enhance patient health and drive revenue growth for manufacturers. However, this excitement can also be accompanied by anxiety, particularly for start-up medical device companies who may not fully comprehend the packaging requirements for their product.
It is important to have a strong understanding of the packaging process to avoid making assumptions about shipping and packaging materials or even the right types of sealers. Such assumptions can lead to delays in the launch process, as the lead times for packaging and sealing equipment may be longer and more complicated than expected. This can leave manufacturers feeling overwhelmed, disappointed, and uncertain about the necessary steps to get their launch back on track.
Medical Packaging Design Guidance Questions and Checklist
Life Science Outsourcing (LSO) is here to help make the entire process easier and even faster. We have created a packaging planning checklist that can be an invaluable aid in anticipating the necessary requirements for your sterile packaging, thereby facilitating a smooth product launch. Whether you choose to collaborate with the LSO team to ensure compliance with ISO 11607 for validating sterilized medical device packaging or are interested in LSO’s contract packaging services, utilizing our packaging checklist can help you achieve your product launch objectives.
Before reviewing the checklist, you’ll want to answer these important questions:
1. Is the initial packaging concept for your device appropriate?
Various factors, such as annual volumes, budget and environmental sensitivities need to be considered to determine the most appropriate packaging design solution. Other considerations would include:
• Device dimensions
• Weight and materials
• Special regulatory requirements
• Sterilization compatibility
• Temperature and moisture issues for the device
• If multiple or combination layers are necessary
• Where and how it will be stored
• Label requirements
2. Is pre-validated packaging the ideal choice for your device?
Custom packaging can add more time and cost to your packaging process. Depending on your device, pre-validated packaging options may be a way to get to market faster and under budget. Orthopedic device manufacturers often find these to be a viable solution. These pre-validated packaging options have already undergone necessary testing to protect a device and ensure a robust sterile barrier, as well as known ability to withstand the sterilization process. Examples include:
• Tyvek lids
• Tyvek/poly pouches
• Header bags
• Poly/poly bags
3. Are you looking for a customized packaging solution?
While some pre-validated packs and trays may be suitable for certain devices, others may require more customized options. Customized packaging is designed to specifically fit your device and its dimensions. This process can take more time, so be prepared to work closely with your packaging partner to ensure your packaging meets your needs, while also achieving necessary standards.
4. What level of medical device packaging expertise does your in-house team possess?
Relying solely on your in-house staff and resources could result in difficulties when operating sophisticated packaging equipment. Additionally, maintaining and adjusting process settings can be challenging. This is where a reliable packaging partner comes in and can work together with your team to design and validate packaging in a manner you can rely on and that meets all regulatory requirements.
5. What information do you need to provide to management to help them understand the packaging process requirements as part of the product launch plan?
Executives are interested in understanding the details that will impact the bottom line, while also wanting a clear thirty-thousand-foot view of the project. Creating an easy-to-understand spreadsheet outlining the packaging launch plan, including complete costs, tooling fees, lead times, material comparisons, volume tiers, etc., will help them comprehend the entire picture. Be sure to outline any benefits upfront, such as opportunities to utilize pre-validated packaging, where lead time can be reduced, how the packaging plan will achieve a timely launch, and where budget can be streamlined.
The Medical Package Design Checklist
After reviewing the above questions and considering your ideal approach, you’ll be ready to work through our easy-to-use checklist. You can even print it out for future reference. The medical package design process can seem intimidating at first, but with careful planning, the right information, and the right packaging partner, you’ll be launching in no time.
Looking for more information on medical packaging? Read Medical Package Testing: Anatomy of a Protocol.
Start up. Speed up. Scale up. Founded in 1997, Life Sciences Outsourcing is an FDA-registered and ISO 13485-certified organization with services and capabilities spanning the entire medical device product life-cycle – from turnkey manufacturing, testing, validation, and sterilization to precision packaging, fulfillment, and distribution. Email us at info@lso-inc.com or call (714) 672-1090 today to get started.
