Innovation in medical device packaging commonly arises from the need to operate within a highly regulated framework. Often medical products are sterilised in the package, and this sterility must be maintained throughout distribution to allow immediate safe use. Medical device regulations mean that packaging becomes inextricably linked with the medical device itself.
As Dario Pirovano, regulatory affairs consultant at Eucomed, the European body representing suppliers of medical technology, explains: “When devices are placed in their packaging and made sterile, the packaging – the so called sterile barrier system – becomes a component of the device itself according to the European Medical Device Directive. Manufacturers must ensure that the device arrives at the final user in the conditions indicated by the manufacturer for appropriate use.”
There are other regulatory imperatives. The reduction of packaging waste has become a major issue for suppliers as a result of measures such as the European Packaging and Packaging Waste Directive, which stipulates that manufacturers have to recover packaging either physically or through paying a contribution to have it dealt with appropriately. Sterile barrier systems are currently excluded from this requirement in most European countries but the exclusion is likely to be lifted soon.
Compact and sterile
So, key elements of innovation involve reducing the amount of packaging used, without compromising the level of protection offered.
One example is Perfecseal’s Ascent Gyrus thermoformed tray, which has recently earned a Gold Medal from the Society of Plastic Engineers. The tray uses strategically located, aggressive undercuts and gussets to hold the surgical device in place without requiring a separate retainer. It also acts as a shock dampening system to protect the product during distribution. The packaging is 100% recyclable and uses 20% less material than the original packaging.
Streamlining packaging by effectively organising devices within a flexible peelable pouch can offer a cost-efficient, space saving improvement to the sterile barrier system. Beacon Converters’ tie wraps are an example of this type of product.
They are die cut pieces of Medical Grade DuPont Tyvek that organise and can chain parts within a pouch or header bag during product distribution and aseptic presentation into the sterile barrier field. An easy-to-use, belt-like closure mechanism locks the tie wrap in place and secures itself without the use of adhesives. This enables multiple components to be held together and handled in a sterile environment in a secure way.
Packaging experts are increasingly faced with another challenge – protecting products that incorporate both a medical device and pharmaceutical elements.
The manufacturer has to keep the device sterile and protected, while also ensuring that drugs or biologics are protected against oxygen, moisture and light in order to retain stability during storage.
There is a fine line between providing sufficiently robust packaging to protect an expensive product, such as a drug-eluting cardiac stent (at around $2,000 a time), and making sure it is relatively easy for the healthcare practitioner to open.
When first introduced to the market, a drug-eluting cardiac stent was first placed in one pouch to allow sterilisation. This was then placed in another pouch to protect the drug. However, Perfecseal has developed a single-pouch, two-compartment design.
It involves creating a polyethylene Dupont Tyvek insert within Perfecseal’s foil Breather Bag in such a way as to create two separate pockets – one to hold the stent, and the other to contain the scavenger (a chemical agent designed to remove unwanted substances). After sterilisation, the foil portion of the Breather Bag is sealed, while the Tyvek compartment remains to absorb any moisture or gases that could harm the drug.
Packaging or device?
In addition to regulatory definitions, there are other ways in which the distinction between packaging and device has become blurred. Technological advances have encouraged greater integration of the various product elements, as has increased demand for reduced waste and products that are easier to use. The design of many drug delivery devices – such as injections, inhalers and sprays – means that the product itself now incorporates much of its own protection, reducing the need for additional packaging.
For example, Dr Gregory Berman, healthcare specialist at PA Consulting, comments: “A lot of pharma companies consider the autoinjector to be a packaging component of the drug”.
Berman also notes trends towards appreciating the needs of the individual more, and their differing dosage requirements, as well as an increased emphasis on encouraging compliance through the product itself. This is reflected in the availability of delivery devices that allow for variable doses and the types of prompts that they can now provide. For example, Sanner’s metered dose inhaler records how much an individual has taken and gives a warning signal when the individual is reaching the recommended dose.
Once we get past all the regulatory obligations, it needs to be remembered that image and branding are also important issues.
Tim Clarke, CEO at packaging design consultancy Burgopak, comments:
“First impressions are crucial – when a consumer receives their product their first interaction before even seeing the device is the packaging.
“These initial responses are starting to be better respected and more considered by medical device brands. Smart packaging can help to make the consumer feel more secure and well informed. Having a better understanding and respect for their medical device is likely to lead to improved compliance.”
Such an approach can also be seen in Eli Lilly’s starter kit for recently diagnosed diabetics. Whereas such kits have typically been packaged in corrugated boxes, this is a stylish box in white and green containing instructions, needle tips, and the pen used for injections, which also enables variable dosage.
In terms of adding value for healthcare practitioners, Gregory Berman notes that there has been another trend: a growing reliance on kits during operations. “A surgeon might be provided with quite a simple device they have to use in surgery. Quite often this will be presented in a kit with all sorts of other items that are needed for the operation.”
However, this does create the potential for additional waste as these are disposable kits and the surgeon may have to change the nature of the procedure mid-operation or else simply decide not to use various elements.
A development that illustrates the ongoing tension in the packaging world between adding value and keeping on the right side of regulatory requirements and society’s concerns.