Lateral Flow Development – Don’t Leave the Packaging to the Last Minute – It’s What the Customer Sees!
Whilst lateral flow testing is a tried and tested technology, we are seeing significant growth in use of lateral flow testing across clinical, animal health, food, plant pathogen and environmental testing.
Quite rightly, there is much focus on the scientific elements of developing a lateral flow test, from the antibodies/antigens to the labels (e.g. gold, carbon etc.) to the nitrocellulose used etc. However, it is worth considering the packaging required and building this into the development plan. This is the first touch point for any user of the test and therefore a critical element of the user-experience.
Intended Use is Critical
- Number of tests per pack
- Number of ancillaries per pack (e.g. lancets, sample collectors etc)
- Need for foam or similar inserts
- Pack dimensions
- Outer Packaging design
- Labelling requirements
- Material selection
By way of example, Abingdon makes lateral flow self-tests that are consumer-focused which are sold in retailers – this informs not only the design (e.g. in many cases single tests) and size of the outer box (e.g. can it fit on a retail shelf or can it go through a standard post box) but also the shelf-ready packaging required by retailers to market the product. One thing to consider is the increasing demands from retailers (on behalf of the consumer) for this packaging to be environmentally friendly.
Abingdon also manufacture products for the point of care clinical market and non-clinical markets that may require a higher volume of tests per pack. Some clinical products we manufacture have 25 or 50 tests per pack and consideration needs to be made in the design of the packaging to cater for these tests but also the ancillaries required. One other element to consider is the transport of tests and the need to minimise the size of the packaging to ensure you’re not paying to transport “fresh air”. However, the robustness of the packaging is also a critical element to ensure that the product arrives in good condition and is not rejected by the customer on delivery. To inform this, one should consider the product journey in determining the packaging specification required.
The labelling requirements in many cases will be a regulatory requirement and a controlled process, for example the name of the device, the intended use, storage conditions, the expiry date, the lot number and the legal manufacturer. There may be additional requirement that you need to consider, for example the inclusion of a QR code to link to online instructions or an instructional video; and any requirements that your customer has, for example many retailers will require a specific barcode on the outer pack. Labelling is a critical element to get right and it is essential that this process is controlled. In the US, the regulatory requirements for labelling are set out in regulation 21 CFR Part 809. One key consideration is to ensure that whoever is managing your packaging requirements is doing so under a quality management system and this process is controlled. Incorrect labelling is a common issue seen in the marketplace and can lead to product recalls. Therefore, it is something that needs to be considered as an ongoing requirement and the packaging service provider should be considered in this context.
Testing Protocol Information
This varies considerably and this can be a critical element of the customer experience. A visual step-by-step guide to the product test protocol can be a real differentiator and provide the user with invaluable information in the form of a step-by-step guide. Complementary to this may be a QR code which links to an instructional video. If one looks back on the COVID-19 pandemic, this testing information was a critical differentiator with some products providing excellent user information which helped make the test easy and straightforward, whilst others were very difficult to follow. This product information can also play a key role in reducing user-error. Whilst it doesn’t replace the Instructions for Use, it is very complementary and allows the customer to sense check their approach as they are working through the test.
Define Your Packaging Materials and Source Them
There are various grades of carboard available, and the choice will be dependent on the use (e.g. printing required and strength required). Also, there are various sources of recycled cardboard. However, there are other potential sources of packaging material to consider. For example, plastic packaging sleeves are commonly used to pack lateral flow tests and we are seeing an increase in the use of plastic-free, environmentally friendly alternatives.
Identifying, designing and testing these materials during the development process is essential and it is also critical to secure surety of supply. Abingdon’s operational and supply chain team can work closely with you to make the right decision for your product and ensure the supply chain is established.
Packaging should form part of the overall discussion on the cost of the overall product and its competitiveness in the market. You should define essential requirements and desirable elements of your packaging choice and cost these different options up, allowing you to reach an informed decision. Sourcing the most cost-effective supply of the chosen materials will be essential and there may be good opportunities for economies of scale in purchasing decisions, particularly if the same packaging can be used across multiple products. This will be an important consideration in choosing the right material but also the right supplier. One other element to consider are transport costs. Abingdon works closely with customers and local suppliers to source local cost-effective supplier of packaging to reduce transport costs and carbon footprint.
Packaging Service Provider
It is essential to consider a number of factors in choosing the right packaging provider. For example, their track record of working with lateral flow tests, the conditions in which the products are packaged and stored, and the support they can provide in terms of design, material sourcing and capacity.
Packaging is an element of lateral flow product design that shouldn’t be overlooked or left to the last minute. It is an essential part of the user-experience and there may also be regulatory requirements to consider. Packaging should be considered early in the product development process to ensure the right material is chosen, the right designs are prepared and the supply chains are established.
The good news is that support is available through Abingdon Health’s in-house packaging experts from the design of packaging, to testing of packaging and through to putting in place the supply chain and managing ongoing requirements such as labelling. We also offer a packaging service to put together all the constituent parts of your lateral flow test in an efficient and controlled manner. Contact a member of our team to discuss this subject in confidence.