Pack up your troubles - Packaging optimisation Ronan-Maher-Anecto

1. Pack up your troubles
By Ronan Maher, Anecto
Abstract
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 Anecto Ltd. 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 Anecto’s Consultancy Services division. “In order to minimise 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
minimise 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, optimisation 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 Anecto over the years we have seen repeated failures in a wide variety of packaging.
The test experience gained by Anecto 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.
Reliability
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
Anecto Ltd. Trusted Test Experts, Ballybrit Business Park, Galway, Ireland
Tel: +353 (0)91 757404 | Fax: +353 (0)91 757387
Email: sales@anecto.com | Web: www.anecto.com

2. 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.
Cost
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
maximise 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.
Potential Markets
As well as minimising 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.
Anecto Ltd. Trusted Test Experts, Ballybrit Business Park, Galway, Ireland
Tel: +353 (0)91 757404 | Fax: +353 (0)91 757387
Email: sales@anecto.com | Web: www.anecto.com

3. 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
minimised 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 standardise your packaging to meet differing local requirements,
customs and physical conditions. What companies with test expertise like Anecto 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.
Packaging Consultancy
Anecto Ltd 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.
Anecto 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.
Anecto Ltd. Trusted Test Experts, Ballybrit Business Park, Galway, Ireland
Tel: +353 (0)91 757404 | Fax: +353 (0)91 757387
Email: sales@anecto.com | Web: www.anecto.com