In the development of a medical device, packaging, when treated as an afterthought, can become a time consuming and expensive problem to remedy, according to packaging design, test and consultancy specialists STERIS. There are strict validation criteria to be met around medical devices and their packaging. Medical device packaging is designed to maintain a sterile barrier until point of use. It must meet ISO 11607, the Medical Device Packaging Directive to comply with regulatory requirements. Packaging is essential for the safe delivery of a product from manufacturer to point of use. Problems can arise when it is not given due consideration at the early stages of the design process. It can lead to the appearance of failures and cause a bottleneck at the critical Design Verification (DV) stage.
“Once you get into the prototype stage with a medical device you want to be in a position where you are also in a prototype stage with the packaging so that you are marrying the two,” explains Jason Delaney from STERIS’s Consultancy Services division. “In order to minimize the cost and disruption to the product development critical path any changes to packaging need to be made as early in the process as possible. For example, consideration of reliability up front will minimize the need for changes to the first-off packaging. Then considering form, fit and function, any necessary design changes can be made before hard tooling.”
When it comes to the practicality and usability of a product there are factors that can often be overlooked by producers. According to Jason when it comes to packaging, optimization is the key or as he says, it’s all about “best fit”. “Best fit’ is a packaging solution that meets all of the requirements in terms of reliability, usability and cost. Through the packaging testing experience gained by STERIS over the years, we have seen repeated failures in a wide variety of packaging. The test experience gained by STERIS and similar companies means that we can predict failures inherent in particular types of medical device packaging and take preventative measures to deal with potential issues before they arise,” he says.
When it comes to reliability the question is, can your packaging survive the impacts, temperature, and humidity inherent in mass product transportation? Once your packaging has survived the journey, has it retained its sterile barrier?
“We look at the product and packaging journey from manufacture to point of use to ensure all factors are considered,” says Project Manager Noel Gibbons. “For example when a product is being transported to its end user there are a number of options for getting from point ‘A’ to point ‘B’. These include air, road, rail and sea transportation. For air and road, the question has to be asked as to what type of packaging is being used. Where the packaging is non-porous there is a possibility that it could be affected by altitude. It may also be exposed to high and low extremes of temperature and humidity which may weaken the packaging or damage the internal product. It will also be exposed to mechanical and manual handling procedures which may expose the product and packaging to shock and vibration. What impact will this transportation have on the packaging or product in terms of maintaining a sterile barrier or internal product damage? These need to be assessed as part of the distribution study.”
These issues must be considered by medical device manufacturers but are not the only challenges presented by packaging. The danger of treating packaging as an “afterthought” leads to failures that can be costly to resolve. “Failures start eating up resources in order to get product and packaging to pass test. While trying to find out what the issue is, the company may end up with several iterations of packaging ‘tweaks’ and the chances are likely that they will have further failures,” he says.
The knock-on effect can result in significant costs at the back end of a project such as redesigning the packaging or product and the requirement to revise specifications, drawings etc. to reflect the redesign. Packaging redesign may have an effect on the sterilization validation with significant associated cost. It may require a repeat and or delay of the shelf life studies as these are required for the final packaging technical file and submission to the relevant regulatory body. The Design Verification milestone will also be delayed which can have a further impact on regulatory submissions and ultimately product to market.
One of the biggest burdens can be the opportunity cost in terms of people. It is likely that Business Planning is expecting to redeploy resources; this will now be delayed as they are caught up in dealing with these problems.
“Your in-house engineering resources that should have been deployed to another project are now focused on remediation of packaging failures. It costs money, it costs time and ultimately it is to the detriment of other projects,” says Jason.
Point of use
Marketing departments know, when you end up getting something to the market, you need to maximize the window of opportunity. If front line staff find that they don’t like your particular package and don’t like using it, the chances are you will miss your opportunity. “One aspect of use is how easy it is to open the packaging and take the device out. If, for example, you are peeling open a pouch and excessive force is needed to open the pouch this may cause the product to land on the floor, the chances are that the product will do the same in a real world setting in the hands of the end user. If it does that once or twice in a front line medical environment, the surgeon is not going to use your product again. “The price of the product, e.g. a drug eluting stent catheter could be up to €2,000, so it is a significantly expensive device, therefore if your packaging is causing a problem the user will switch to another product and not necessarily tell you about it,” says Jason.
As well as minimizing costs, consideration must be given to the markets your company may be dealing with. Potential markets create further issues when a company is considering a medical device packaging solution. Different markets bring with them different regulations, which CE and FDA compliance may solve but other “nuances” still present themselves.
“For example, if you are dealing with a German hospital and you present a big shiny box with layers of packaging around the product, they won’t like that. In their market they want to see minimized packaging, they want to see efficient use of that packaging and they want the material to be recyclable.
“Different countries have different nuances and if you can consider them at the start of the design process then you can standardize your packaging to meet differing local requirements, customs, and physical conditions. What companies with test expertise like STERIS are trying to do is ensure that packaging meets its requirements to ISO 11607 first time, whilst considering usability and cost. In other words, it all comes back to ‘best fit’,” he says.
STERIS has over a decade’s experience testing packaging for the pharmaceutical and medical devices sectors. It is their assertion that packaging consultancy is a valuable tool in preventing what can be significant financial burdens and delays when packaging failures occur at the end of the design and build process. “During product development you are operating on a timeline to get a product out to market so if packaging consultation is running in parallel to that, you are able to put prototype tests in place, do some robustness testing and give considerations for use long before it becomes critical in the process,” explains Jason Delaney.
STERIS is accredited to ISO 17025:2005 and certified under ISO 9000:2008. Their experts insist the type of services offered by a test laboratory do not undermine those offered by packaging suppliers. “Companies in our field can provide support services throughout the packaging development process and deal with potential issues before they arise. We do not replace packaging suppliers’ advice but compliment the process as an independent expert from a test and design point of view.
We provide remediation and preventative services to help save time and money,” says Jason. Jason adds that with consultation on packaging at the earliest stages of design it will not only prevent costly failures but ensure a simple passage through validation. “When you have applied expertise in packaging and testing early on and you get to the point of validation, you are going to have a high level of certainty that it is going to pass that first time. That has a serious impact in terms of timelines, resources, and cost. It means that everything is running smoothly, you get your product to market and you can redeploy your resources to other projects, only incurring relevant costs once,” says Jason.
Screening for Adverse and Inhibitory Substances
Test method validation for adverse and/or inhibitory substances is important to ensure that the measurement of contamination on a device is not impacted by substances present in the test. Adverse substances and/or inhibitory substances (e.g. antimicrob
What is Bioburden Recovery Efficiency and How to Approach Lower Than Desired Recovery Results
What is Recovery Efficiency (RE)? Recovery Efficiency (RE) is an important part of the validation of the bioburden test method. It is intended to provide an assessment of the efficiency of the extraction technique to remove viable microorganisms from a
The Basics of Bioburden Testing
What is bioburden? Bioburden is the quantity and types of native bacterial and fungal flora present on or in a device, substrate, or chemical (test unit). Bioburden plays a large role in determining what is necessary to achieve sterility, and can impac
Custom laboratory and in-line test equipment.
We build a wide range of laboratory and in-line test equipment to suit our customers’ exact needs.