It’s important to consider packaging design early on during the medical device product design process, according to Jenn Goff, director of product marketing of Oliver Healthcare Packaging. During the recent webinar, "Medical Device Packaging as Told Through Design Control," Goff shared tips on design control requirements for packaging as well as advice for packaging engineers on getting involved in the design process. The webinar was part of the MD+DI series, “How the Medtech Industry Can Respond to Crisis.”
During the event Goff answered a number of attendee questions, and we asked her to expand upon those answers and address any additional questions we couldn’t include in the hour-long webinar. We encourage you to log on to the now-on-demand event for her presentation.
I have found that the design control process has been managed through the QA/QC staff. What is your experience with making sure that packaging is included in the whole process of documentation responsibilities?
Goff: The first step is identifying who owns the design control process. In my experience, this is typically someone from Quality or R&D. Once you have identified the process owner, I recommend you ask to get involved. If you receive pushback, help the process owner understand the value packaging brings to the overall process. Ask them to watch a recording of Oliver’s webinar with you and answer questions at the end. Or create your own Packaging 101 presentation and present to them or their team during a lunch and learn. The greatest tool you have is your packaging knowledge and how it impacts the overall process. Share lessons learned and help the process owner understand the value the information will bring. For example, easy-to-find information during an audit, documented evidence to support faster/smoother submission approvals, and minimize unnecessary project delays from device changes that impact packaging.
What functional area do you usually find that "owns" the design control process?
Goff: From my experience I’ve seen the design control process owned by R&D or Quality.
During the initial stage, do you involve Marketing, Sales, Regulatory, QA, Purchasing, and Manufacturing?
Goff: If by initial stage, you mean project kick-off/planning, then absolutely. All of those functions will have information necessary to design and develop the best sterile barrier system for your device and end user. In some cases, not all information you need will be available in the early stages of the project, such as make/buy decisions, manufacturing location, etc. Your partnership with marketing to understand the user needs for packaging will be key. If marketing hasn’t already begun this work, you can plant the seed and ask them to gather needed information as they continue to develop user needs.
Usually, what is the average duration of a typical project?
Goff: The average duration significantly varies from project to project. It can be anywhere from a few months for a next-generation device that falls within existing packaging and existing worst-case family justification, or it can be years for an innovative new device needing clinical trials. In my experience, the average new product development project lasts 18 months to two years.
Have you experienced a stand-alone sterile packaging DHF [design history file] for universal packaging being utilized across multiple product lines? So, this DHF number is referenced in other device DHFs when they move to implementing sterile packaging in its development phase.
Goff: No, I have not experienced this personally. This strategy sounds like a great idea for standard run-of-the-mill packaging requirements for a large family of devices or for devices that have the same user needs. However, this could also prevent you from identifying unique user needs for your specific packaging/product combination. For example, notches, hang holes, and specific procedural requirements could allow packaging to create a competitive advantage.
Having operator feedback is huge to packaging design and the equipment to be used (e.g., sealers). What would be a good practice for the packaging design engineers in how they should get involved if an already validated design is showing complaints?
Goff: The core team is typically composed of design engineer(s), marketing, quality, regulatory, and operations. Ensuring that the entire core team, or at a minimum the influencers, are aware of the complaints is key. Gathering quotes or information from operators and sharing their feedback with the core team can also be helpful. This allows the team to identify any potential risks when moving forward in the process.
For design verification testing...are there situations where you would just do transit conditioning (i.e., DC 13) and not include the environmental conditioning prior to transit conditioning?
Goff: No, not in my experience.
How would you define worst-case packaging samples (per ISO 11607-1) for performance DV testing?
Goff: Worst-case packaging samples are samples that represent the worst-case conditions when manufacturing, sterilizing, distributing, and using the product. At a minimum the following are considerations for a sterile barrier system: worst-case packaging configuration, worst-case product representation for a product family, worst-case distribution environment, worst-case sealing parameters, and worst-case sterilization process.
How much (clinician) user experience is now rolled into the ISO 11607-2019?
Goff: Section 7 of ISO 11607-2019 is designated for usability evaluation for aseptic presentation. It is up to the medical device manufacturer to determine the best method to meet the requirements in that section.
Are there several MDM companies with multiple packaging sample size requirements based on internal risk assessment?
Goff: It depends on the size of the medical device manufacturer (MDM) and the diversity of the product portfolio. Some large MDMs with multiple business units globally may have different sample size requirements within their procedures.
If bubble leak testing is performed on sterile pouches, do you think a peel test also needs to be performed?
Goff: In my opinion, yes. A peel test should be performed to either confirm you meet the minimum specification or create the minimum specification. This will depend on how the design verification protocol is designed and what level of detail/data was collected during process development.
What is your advice for guaranteeing lean documentation and avoiding over-engineering and over-documenting?
Goff: This is highly dependent on the organization you work for and their approach to compliance risk. For example, it would be challenging to create lean documentation in an organization that documents every detail. From the reverse perspective, giving an organization a lot of detail when they’re already lean would also be challenging. If you have identified opportunities for lean documentation, it doesn’t hurt to have a conversation with the project manager or process owner to align on best practices or potential lean activities. More documentation is not always better and can lead to unnecessary questions from internal and external auditors. Direct and to-the-point documentation that tells the whole story, while meeting the regulation, has been a successful approach in my experience.
What is your opinion about using green packaging product? How do you balance between cost, ruggedness, and recyclability while designing the packaging?
Goff: First priority is always patient safety. Second priority is compliance to the quality system in which you work. If both priorities are met, then you can start exploring different materials and identifying sustainable packaging opportunities. With that being said, it’s important to understand how the packaging will be used by the end user and if they have the ability to recycle the materials. This is something that should be explored when identifying user needs. Recyclable packaging materials can create a competitive advantage as well as decrease the cost and carbon footprint of some hospital systems. This information can then be used to justify a premium cost for innovative recyclable packaging materials.
In your experience, how have you dealt with long established parts that are not meeting drawing dimensions? In the past 5 lots, the supplier hasn't been able to meet the drawing on PET-to-Tyvek pouches. Supplier has a positive shipment history with items now out of spec for over 10 years. There have been no material, equipment, or supplier changes or supplier process or equipment related changes. How would one create a solid rationale to relax drawing without repeated DV testing? Supplier is having difficulty in finding root cause.
Goff: It is a red flag that there have been no issues for 10 years and then suddenly products are out of spec consecutively. It might make sense to review the internal process as well as the supplier’s process. Have there been changes in inspector personnel, measurement equipment, or inspection procedures that may be giving different results? If all checks out internally, it is critical that the supplier partners with you to identify root cause or at a minimum share resources to help you through the process. If a thorough root cause investigation has been completed internally and with the supplier, and there has been no resolution, it may benefit you to start with tolerances as opposed to the dimension itself. Some questions to ask yourself: What are the tolerances? Are the tolerances consistent across all packaging materials? Are other suppliers able to meet those tolerances? If you find that increasing tolerances within the drawing is the solution, a justification must be created to document how the change would not impact form, fit, or function. In my experience, the best way to do this is by looking across multiple product families and identifying any risks or lack thereof in those dimensions. This is also a great opportunity to partner with cross-functional team members within your organization to brainstorm ideas on how to solve the problem.