Diagnostics

Award-winning design and manufacturing for medical diagnostic devices

Helping you deliver point-of-care collection and diagnostic solutions to inform timely and accurate care

Our experts work closely with businesses like yours to create innovative solutions that enable rapid diagnosis and monitoring in decentralized settings, and empower people to take greater control of their own health at home.

Two people using XpressCollect(TM) sample collection device.
Expertise

Designing your device for use in diagnostics

Partner with us and you’ll not only benefit from our decades of experience in designing devices for diagnostic settings. You’ll also access our comprehensive global manufacturing facilities for high quality, cost-effective delivery at scale.

  • 25 +
    Years in diagnostic device design
  • ISO 7 & 8 cleanrooms for injection molding & assembly
  • 90 million
    Monthly production capability for sample collection units
  • Edison Awards Innovation winner 2022
We’re ready to bring your in vitro diagnostic device to life
Point of care diagnostics

Manufacturing more accessible point of care tests

Demand is increasing for testing platforms suitable for use in decentralized and in-home settings. Decentralized solutions must successfully support ease of use, while maintaining accuracy, and addressing the challenge of capturing results remotely. There are also challenges around safe transportation.

Our expertise spans the design of diagnostic platforms, to the manufacture of single-use, sterile consumables for collection, transport and processing of samples. With injection molding, assembly and packing in our ISO class 7 and 8 cleanrooms, you can be reassured our processes have been designed with secure transport in mind.

Sample collection devices

A trusted partner for high-quality, low-cost sample collection

SteriPack supports clients seeking to outsource the design and manufacturing of their sample collection devices and packaging. With experience in producing over 90 million sample collection device units monthly – each individually packaged, labeled in our certified cleanrooms, and sterilized – our ability to deliver at scale, while complying with applicable regulatory, shelf life and shipping requirements, is proven.

SteriPack's sterile packed swab.
Xpresscollect™

Easier, faster and more accurate sample collection

Our XpressCollect™ sample collection device – both FDA and CE registered – won gold at the 2022 Edison Awards for its innovation and quality. Developed with the support of the Gates Foundation, XpressCollect™ is an integrated swab and dry tube sample collection device that’s a third of the size of nasopharyngeal swabs used for testing.

Why it won:

Easier sample collection: no liquids or breaking swabs, and less waste.

Faster and more accurate lab processing: automated barcode scanning for accurate matching and tracking; automated decapping and recapping; automated removal of swabs for further processing.

XpressCollect™: Award-winning, compact sample collection device.
Capabilities

All the services you need to design and build better diagnostics

Explore our full range of services to find out how we can customize a solution to your specific diagnostic device challenge.

Explore all capabilities

Contract Packing

We specialize in creating fast, flexible, customized packing solutions for medical device and pharmaceutical products with complex requirements such as low to medium volumes, variable batch sizes or multi-SKUs.

Capabilities:
Quality & compliance

The power to meet global quality standards

At SteriPack, we design in-vitro diagnostic devices to applicable standards, optimizing usability and managing risk across your product’s lifecycle. And we manufacture specimen collection devices in our own FDA-audited cleanroom facilities.

Contact us

Say yes to better diagnostics by design

Meet your experts for in vitro diagnostic design and manufacture – all under one roof.