One of the most important aspects of a sterile medical device product launch that often gets overlooked is medical device packaging validation.
Being packaging experts, we know there is a lot of planning that goes into launching your product and distributing your medical device. That is why we put together this shortlist of what MDM’s should consider as they search for a medical device packaging validation partner!
When Should I Start Thinking About Medical Device Packaging Design and Validation?
The sooner discussions about medical device packaging validation enters the product launch process, the better. Too often, small start-up MDM’s do not discuss packaging options until the end of product development. It is then that they discover that packaging design, development, and validation can take between 12 to 18 months.
This can cause problems for a couple of reasons. First, the MDM might not be able to extend its product launch. A year is a long time to wait when there are likely sales goals set around the device’s product launch. Second, if the assumption is that packaging is just a matter of throwing the device in a box, then the likelihood of them having the budget for packaging design and validation is slim.
Lab Accreditation
ISO 17025
The first thing MDM’s should look for in a medical device packaging design & validation lab are their accreditations. Being ISO 17025 accredited means the lab has a quality management system that is based on a consensus standard that sets rules for labs to follow.
To be accredited, an accrediting body audits the labs’ systems and processes and then analyzes the test methods being performed to make sure they are indeed following their specific rules. An ISO 17025 accreditation gives current and potential clients the confidence that the quality management system has been reviewed and that they are working appropriately.
A2LA
A2LA is an accrediting body for many kinds of labs in various industries. Outside of ISO 17025, A2LA has its own policies that a lab must follow when seeking accreditation. Having an A2LA accreditation means the authoritative body (A2LA) has given formal recognition that a Conformity Assessment Body (CAB) fulfills requirements and is competent to perform specific tasks.
By observing the human element of CAB, clients can be sure their data is accurate. What they look at during their audit specifically is a lab Quality Management System (QMS) and Scope of Testing.
Review the Scope of Their Testing
The scope of testing is the tests that have been observed being performed by a regulating body, such as ISO 17025. Reviewing the scope of testing can help you determine if the lab is a medically focused lab.
While labs that are not medically focused can offer the same tests that medical labs do, they might not have as rigorous of a quality system that is going to give you the level of documentation that the FDA is expecting of a medical device.
Bonuses Things to Look for in Medical Device Packaging Validation Lab
College Educated Lab Technicians
A college education is not required for lab technicians at other packaging validation labs. The lab technicians at PCL are college-educated with degrees in Chemistry, Bio-Medical Sciences, or related field of study. This gives clients further confidence that their testing is performed by a knowledgeable and trusted source.
Clean and Organized Lab
Due to our Vice President coming from a manufacturing background, we are well versed in Lean Manufacturing and have applied those principles to the layout of our lab. This ensures projects move through the lab in a swift manner which allows us to maintain our KPI of 95% on-time delivery of a project to wrap up.
Pre-COVID we frequently invite potential customers to our Grand Rapids facility and to give a tour of the lab if they would like to see where their testing will take place.
In-House Medical Device Packaging Engineers
A common challenge for start-up MDM’s is that there might not be enough people on their team who have the experience that is required for getting a product launch past the finish line. The cherry on top of the sundae that is PCL is our in-house team of medical device packaging engineers. Our engineers can either be extra firepower to your existing technical team or we can be the engineering team for you.
Often when a package fails at a larger packaging validation lab, the failed samples are sent back to the MDM where it becomes their job to figure out what created the failure. Whereas if packages fail at PCL, we have packaging engineers in house that can perform a root cause analysis who can determine the cause of failure for you and then provide a solution.
Whether you’re in the early stages of product development or nearing the end, we’d love to learn how we can be of assistance to your team. To schedule a discovery meeting for your medical device product launch, contact us today!