Contract Package Testing
Q&A With Patrick Nolan
What’s driving the need for more outside expertise in contract testing and inspection?
Medical device manufacturers (MDM’s) make medical devices. That is their expertise and is their core competency. Packaging is an ancillary process that must be performed in order to get their products to market. There is a higher level of expertise in designing, developing and ensuring that the package is compliant with regulations that the MDM’s can support with their existing set of competencies; so they are outsourcing this function to consultants and other service businesses who have this expertise and can do it most efficiently. In addition, the cost of purchasing and maintaining an in-house testing lab will save on capital expenditures by letting a third party bear the investment costs as well as the overhead costs. Finally, there is significant activity in medical start-ups and with a one or two product focus. Outsourcing product development activities such as package engineering makes great sense for immediate access to technical expertise and effective use of venture capital funding.
Do you believe increased product development is fostering an increased need for testing? In what ways do you think this trend is fueling this need?
With the emergence of the ‘Baby Boomers’ as significant consumers of medical services and products, there is, and will continue to be, a major surge in new product development to treat new diseases, conditions and maladies. The increased demand for existing and new products will continue due to the aging population and this portends an increasing demand for services to design, manufacture and test these devices. Also, echoing the previous comment regarding the activity in medical start-ups, utilizing contract services and outsourcing services makes good business and technology sense in operations where the competencies are specific and focused.
Why do some companies find the testing process and requirements so vexing? What are some of the challenges they face in doing the work in house?
Package validation is not rocket science. The test methods and procedures used to perform package validation are relatively simple. One vexing aspect about package validation is the interpretation of the regulations. There is more than one path to compliance and each path may be more advantageous than another. It is not always necessary to perform the complete myriad of testing to be in compliance, so experts can evaluate each scenario and determine the best path to compliance. This can save incredible amount of time and money, since only those tests necessary for compliance will be performed. Since this is not the MDM’s core competency and without this expertise in house, in the long run they could spend more money and time to ensure compliance to regulations pertaining to their package system and process. Since time is often the linchpin to successful introduction of a new product, it is advantageous to off-load this function to the packaging professionals and service providers who are responsive, professional, customer service oriented, and, current with regulatory requirements. The outsourced packaging professionals have staff who are also package design and development experts and can assist the MDM at the earliest stages with package designs which will successfully satisfy the regulatory requirements, maintain sterility and meet both MDM and end users requirements. This expert, early stage guidance, greatly improves project and product success and eliminates the frustration with non-compliance and possibly package testing failures.
What are some of the advantages an OEM will gain in outsourcing these tasks?
An MDM will acquire the benefits of outsourcing by obtaining packaging expertise without the permanent overhead of an in-house staff and testing laboratory. The MDM can apply more pressure for increased performance and output on an outside staff easier than an in-house staff. If an FDA inspection or audit is conducted, data obtained from a third party, unbiased service provider minimizes the engagement of the MDM staff in demonstration of compliance to relevant procedures, keeping them focused on their project work. The focus is on the work of the service provider. The OEM gains access to the industry expertise of the service provider, whose core competency is testing and consulting on packaging engineering and related compliance issues. The service provider can share the latest industry trends and technology, without of course, violating other OEMs' confidentiality. In addition, a good, customer-oriented third party service provider will be available to support and defend the work that was performed as a value added service. Also, a long term cost savings will be realized by not investing in lab equipment and people…it is the service provider who will be making the capital and technology investments to keep their business competitive and world class and thus, the client benefits.
What are some of the challenges (eg, time demands, relationships, etc) that you face as a service provider to OEMs?
The MDM can wield significant clout in demanding a high level of performance from the service provider. The biggest challenge we face is meeting the timelines imposed by the MDMs as they strive to reduce the ‘time to market’. Packaging process development is often the last barrier to shipment of a finished medical device, so the pressure to complete package validation can be intense.
What types of testing (and related) services are most utilized by customers? What are some additional services you see being offered by service providers in the future as a means to offer value and remain competitive? In what ways are you expanding your service offerings to meet customers’ needs?
Third party service providers offer services for package design, package assembly, package testing and validation, regulatory affairs consulting and package manufacturing (e.g. pouches, thermoform trays, other packaging materials). The common package testing services include accelerated aging protocols to determine shelf life attributes of products and packages; distribution simulation testing to evaluate the effects of the dynamic inputs and hazards from shipping and handling (e.g. shock and vibration); sterile barrier system (primary package) testing for strength of seals (e.g. seal strength testing) and seal integrity (e.g. leak testing).
Other services being offered by outsource service providers include package design and prototyping. The time-to-market can be shortened by prototyping concepts and ideas and performing qualification testing on the prototype package. Any unforeseen problems or design flaws can be discovered at this stage and changes can be made prior before the finished package is submitted for package validation. If this is performed in a parallel path to product development, it greatly facilitates the on-time or ahead of schedule completion of the package engineering functions; supporting a clinical trial activity or market launch date. This prevents the package development from being a barrier to product introduction and market release.
With many of the same advantages offered by package validation testing, medical device product testing is becoming outsourced more to third party service providers. If the product and package testing services can be provided by one vendor, there is potential economies of scale by dealing with fewer vendors; and the potential for parallel path development could be enhanced. There have been several occasions where DDL has performed both product and package testing for the same device in a parallel path, resulting in completion nof those development functions and a similar time.
How are more complex technologies making testing more difficult? Can you provide examples of any newer equipment on the market that made testing a challenge, and explain why? Which categories of devices (eg, combination products, reusable devices, orthopedic, cardiovascular, etc) are raising newer issues in testing, and why?
The trend towards more ‘kits’ which are generally assembled into larger packages has been one challenge for package validations. Also, percutaneous delivery systems for devices are by nature very long and cumbersome and thus the packaging is correspondingly a challenge to handle and evaluate. Larger thermoforms for kits are more difficult to leak test for evaluating seal integrity. So, package size makes testing more difficult. Package size can also be a concern relative to internal environmental chamber space, necessary to environmentally condition the package.
Combination packages are definitely more challenging as the first question to ask is what are the regulatory burdens and compliance issues (e.g. CDRH or CDER or CBER). Beyond that, the testing for package compliance is similar to most other devices. Combination products present the challenge of multiple barrier requirements---sterile barrier, moisture barrier and oxygen barrier, which requires a more elaborate testing protocol, which may include humidity and oxygen measurements over time. Combination products may contain biologics which may require cold chain protection and thus thermal package efficacy testing (thermal mapping) will be required.
Product testing has become much more complex with the introduction of new and sophisticated medical devices that challenge the test standards writing community. Many devices have no test standards developed to evaluate their performance attributes, so custom test procedures must be developed. DDL is very good at developing test method for product testing.
Similarly, is there any new technology that contract testing providers (including your company) are using to make the testing process easier, more precise, more efficient, or more cost-effective?
We have made vast improvements in how we obtain data from the test procedures such as digital acquisition and analysis of test data in real time. A barcoding system allows us to track every test specimen and monitor its progress through the test sequence or protocol. We have developed test report templates that have streamlined the documentation process. Delivery of documentation in electronic formats have reduced completion of projects by days.
How do needs differ (if at all) between larger OEMs and smaller companies? In what ways do you approach their needs?
Larger MDMs usually have a large volume of projects and their projects are bigger in scope than the smaller MDMs. The larger MDMs will require more resources as the sheer volume of materials flowing through the lab is much higher. The time constraints imposed are no different, as both sizes of MDM’s want to gain market share by being first to market with their products.
How (if at all) is the international outsourcing trend affecting your business? If it’s having any impact, how are you remaining competitive against foreign service providers?
We recently had one of our own customers ask for help in sourcing an international service provider to do package testing. The thought was that time could be reduced by doing the testing in close proximity to where the devices were being manufactured and packaged. Upon further analysis the customer determined that there was no advantage to doing the testing with an inexperienced international testing lab and routed the business back to us.
What advice would you offer an OEM looking to use outside expertise in testing and inspection? What should an OEM look for in evaluating a potential partner? What are some warning signs that it might not be a good fit?
Since time-to-market is critical in the medical device industry, the MDM should use a third party service provider that provides superior expertise in packaging and is extremely responsive to customer requests. This competitive attribute includes responding to initial inquiries, providing quick delivery of quotations and protocols, providing short lead times for completing testing projects, and delivering final documentation quickly after completion of the testing. Further, deficiencies in experience with the needed testing standards can be a warning sign of a lab that is not really prepared to do the required testing. Thee should be some level of value-added consultative services. A world class service provider will give away some valuable information to ensure the customer succeeds. Longer term contracts can be developed to provide a complete project management function.
How can OEMs optimize their relationships with their testing service provider? What goes into building and maintaining a successful partnership?
Ab MDM could optimize the relationship with the third party service provider by trying to look ahead and plan for package validations so that the testing could be scheduled into the lab with shorter lead times. Giving consideration to testing early in the product development process will improve the chances that the test portion of the development will proceed smoothly, and not adversely affect time-to-market. Partnering with the client to develop a strategic approach to their testing needs, for example providing them with the perspective of developing a master validation plan such that they can adopt product line extensions into their package design, again, always looking for the value added in package design, development and validation.
