A new brand for GPA Global

News

Collection devices for home medical tests from GPA Global

medical test kits manufacturers - GPA Global

Our collection devices for at-home medical tests are made using sophisticated injection-molding techniques, and incorporate documentation, serialization, packaging and fulfillment.

medical test kits manufacturers - GPA Global

The 2010s was a decade in which face-to-face services became digitized, people turned to remote working, and the smartphone became a tool for everything from banking to calorie tracking.

Even within healthcare we’ve seen a huge shift towards the digital – a trend made possible by the greater availability of fast, reliable broadband, and precipitated by the unique challenges of the coronavirus pandemic.
 
Today, healthcare providers are able to capitalize on this trend with at-home medical tests that can be ordered online, delivered directly to the consumer, and processed in a lab space, all without the need for face-to-face interaction.

A growing home medical test kits market


The coronavirus pandemic has introduced a new market for healthcare & pharmaceutical companies incorporating masks, hand sanitizers, and – most significantly – at-home tests. Current forecasts predict that the COVID-19 sample collection kits market alone will reach $16.56 billion by 2028.
 
We’ll also continue to see growth within the blood testing market, which was valued at $73.9 billion in 2020 and is set to expand at a fast rate within the next seven years. Overall, the infectious disease diagnostic market looks set to balloon to a worth of over $40 billion by 2027.

Global blood testing sharemarket size 2020
 
But it’s not just healthcare services that can profit – companies that specialize in genealogy products are also enjoying healthy expansion, and have already been valued at over $12 billion.

Supply chain delays

If you’re a company that specializes in at home test kits, you may have encountered delays in the supply chain – recently, the CDC warned of shortages of rapid COVID-19 tests. The reason for this is simple: demand for reliable at-home test kits for COVID-19 has exploded, leaving manufacturers with a backlog of orders they simply don’t have the time or resources to fill.
 
The good news is, other manufacturers are stepping in to fill the gap. Here at GPA Global, we have begun designing and manufacturing our own range of collection devices for medical test kits, which have been carefully developed and rigorously tested to ensure suitability across every relevant sector and application.
 
If you’re a company working with home test kits – whether for COVID-19, STDs or genealogy mapping – you could benefit from our comprehensive service.

GPA Global’s turnkey manufacturing solutions for medical devices

Our team brings decades of combined expertise within the packaging sector to the new challenge of manufacturing legally compliant, industry-certified collection devices. We understand the complexities of producing kit and devices within the healthcare & pharmaceuticals sector, and can guarantee compliance with all regulations.

GPA Global Capabilities
Beyond manufacturing, our standard offering also incorporates the design and production of packaging materials and documentation, as well as global logistics. With sophisticated production sites around the globe, we’re able to offer regional supply chain solutions, reducing costs – both financial and environmental – for brands situated in Asia and North America.

What’s included in our home medical test kits

Engineering of collection devices

Our approach to the engineering of our collection devices is methodical and comprehensive. We begin by addressing regulatory aspects, to ensure that the product is fully compliant with local legislation.
 
The next step is design. What are the needs of this particular client? How should the device perform and how do we make it easy and safe for the end user? With a product brief finalized, we use rigorous testing and risk management techniques to ensure that the collection kit checks the boxes for functionality, usability and reliability, and that any potential problems are safely mitigated.

Injection molding techniques

We use advanced injection molding techniques to manufacture our medical-grade collection kits and devices. Within healthcare & pharmaceuticals, injection molding is a highly effective approach, as it offers the following:

  • Cost-efficiency
  • High level of accuracy
  • Durability
  • Resistance to contamination

Once manufactured, our devices are sterilized to ensure safety and efficacy.

Stabilization fluid

An essential component of collection devices for at-home blood or saliva tests is stabilization fluid. We manufacture the stabilization fluid, and carry out the process of injecting it into the collection device, which is then securely sealed.

Design and production of packaging materials and documentation

When it comes to at-home medical test kits, the packaging and documentation are just as important as the device itself. This is because home test kits rely on two things:

  1. Correct collection of the sample
  2. Safe delivery to the lab environment

We print instruction booklets and other accompanying material to aid the end user in collecting their sample correctly and safely. We also print additional inserts that allow the user to package up and post their sample without risking contamination, leakage or breakage.
 
Some of the packaging and documentation materials we can supply include:

  • Bio bags to hold the sample
  • Return mailer boxes to post the sample back
  • Stickers for sample bottles
  • Postage labels
  • Absorbent pads

Serialization

Serialization is the process of assigning a unique number to a product which corresponds to information about its origin, batch number and expiration date.
 
Within healthcare & pharmaceuticals, serialization is the best way to guard against counterfeiting. It’s also an essential practice when manufacturing at-home medical test kits, as it allows each individual test to be traced.
 
This is an aspect of our collection devices that we take very seriously, always ensuring it is part of our turnkey offering.

ISO 14385 and FDA approval

All our medical collection devices meet the International Standard for Quality Management Systems for Medical Devices, as set out in ISO 13485:2016. We also ensure that all our devices are approved and authorized by the Food and Drug Administration (FDA) when they are being manufactured and distributed within the United States.

ISO 14385 and FDA approved

Kitting and fulfillment

The final part of the process is kitting and fulfillment globally. Our team will assemble the varied components of your testing kit and distribute it wherever it needs to be.

Case studies

Client 1

We produced a saliva collection kit to enable DNA testing for leading genealogy website. In addition to the saliva collection device and stabilization fluid, we also manufactured the following:

  • Winged kit box
  • Kit box tray and claim code label
  • Blister pack sub-assembly
  • Return mailer box and label
  • Bio bag
  • Absorbent pad
  • IFU and IFU activation code label

Client 2 

We produced a saliva collection kit to test for COVID-19 for a patient-centric genomics company that is based in California. The SARS-CoV-2 RT-PCR test kits we manufactured are authorized by the FDA and allow for simple, painless and non-invasive sample collection, reducing the risk of mistakes by the end user.
 
Client 3 

This client is a biotechnology company based in Georgia that specializes in developing innovative new methods for blood and plasma collection and testing. We manufactured a blood plasma collection kit, complete with a finger-prick device and secure pouch for sending the sample back to the lab.

Contact GPA Global today

If you’re a company working with any kind of at-home medical device, get in touch with the GPA Global team to find out what we can offer.

GET IN TOUCH!


 

Sustainability

Discover how GPA Global are tackling the world's plastic issues

Learn more