In Vitro Diagnostics System Development
Diagnostic innovation acceleration, from concept to product.
At TTP, we specialise in innovation acceleration in distributed and point-of-care (POC) in-vitro diagnostics. Our team of biologists, chemists, physicists, engineers and software experts can help you at every stage of the product development pathway. With an unrivalled track record – from product inception to marketed and approved devices – working with TTP reduces development risk and shortens your time to market.
Diagnostics systems tailored to your needs and timelines
When you're developing the next generation of in-vitro diagnostic (IVD) solutions, whether for point-of-care or distributed-testing applications, your priority is achieving market-ready impact, quickly and reliably.
Our team leverages decades of know-how, proven expertise and proprietary technologies to accelerate your development,all while being flexible to your evolving needs. From securing funding to meeting internal targets or hitting market windows, we work with urgency and precision to deliver diagnostics that make a difference, on your timeline.
This has the opportunity to be a truly transformative product in the field of management of UTIs – being able to provide guidance on treatment in 60 minutes and enable rapid confirmation of disease is an urgent need throughout the world.
Giles Sanders
Head of Diagnostics, TTP
ecoflex combines central lab quality quantisation with the affordability of lateral flow - all in a sustainable, paper-pulp design. Powered by the highly flexible MicroFlex fluidic technology, ecoflex simplifies the path of taking complex immunoassays out of the lab to the point-of-care, helping bring your diagnostics closer to patients, faster
Ben Metcalf
Project leader at TTP
We collaborated with Lumito in developing a novel tissue imaging system based on cutting-edge nanotechnology, significantly advancing diagnostic accuracy and enabling digitisation, automated analysis, and multiplex imaging in pathology. By uniting expertise in chemistry, immunoassay, and optics, we provided an integrated development on both the NIR imaging system and novel UCNP reagents, delivering unmatched imaging precision, addressing key challenges in cancer diagnostics and shaping a brighter future for patient care.
Wenshu Xu
Consultant at TTP
Driving innovation in IVD diagnostic systems
We have the expertise and capabilities to support the development of any diagnostic system, from early-stage concepts to fully integrated solutions. Our work spans the full spectrum of distributed diagnostics, including tissue imaging, women’s health, haematology, haemostasis, cytometry, sequencing, and clinical chemistry.
Two areas where our deep multidisciplinary strengths in assay design, engineering, and detection physics are particularly impactful include:
- Immunoassay - We specialise in translating clinical-grade immunoassay technologies into near-patient and point-of-care settings, without compromising on performance or reliability.
- Molecular Diagnostics – We design intuitive, sample-to-answer molecular systems that deliver market-leading speed and flexibility, enabling applications from central laboratories to at-home testing environments.
Integrated expertise for concept to production diagnostic system development
Systems thinking: We employ systems-thinking in development of diagnostic devices and instruments. This considers the interaction of assay, consumables and hardware to deliver high-quality, repeatable assay performance at the point of need.
Consumable cartridge design and development: With a focus on functional, manufacturable, low-cost devices, we develop cutting-edge fluidic and microfluidic devices that can incorporate complex biological steps.
Hardware: We design simple-to-use diagnostic instruments employ our extensive expertise in mechanical and electronic engineering. This includes thermal, fluidic, pneumatic and detection technologies (optical and electrochemical), all of which can be integrated into a compact and effective system to process the cartridge.
Assay design and integration: From initial concept through to testing and performance validation, we collaborate closely with you on assay design and refinement, ensuring robust integration with the diagnostic system.
Software: Our consultants have extensive experience in diagnostics software design and development under ISO 62304. We work closely with our broader TTP software team to scale solutions that meet the needs of your devices, regardless of classification.
Regulation: Our development process is ISO 13485:2016 accredited. We work with you to implement the appropriate regulatory controls as the programme evolves, supporting a clear path to approval.
Manufacturing support: Delivering a manufacturable product is critical to programme success. That’s why we consider manufacturability from the outset, engaging our internal manufacturing team and external partners early to address specific needs. Our in-house team also ensures that you have access to enough prototype cartridges and instruments for ongoing testing.
Usability: We design systems with simplicity and typically with CLIA-waiver goals in mind from day one. Our human factors experts guide you through all necessary formative and summative studies to ensure regulatory compliance and intuitive product use.
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Distributing diagnostics: locations, motivations, metrics
Distributed diagnostics add value for patients, healthcare systems and wider society in a surprising variety of ways.
Global demand for health equity has created an acute need for accessible diagnostic testing. Over the course of this series, the evidence and interviews with key opinion leaders that we've explored show a vast range of available products and technologies. In a saturated industry, developers of diagnostic products must reach beyond the confines of central lab facilities and enable decentralised solutions capable of delivering lab-quality results — all while minimising "time to results" and maintaining ease of interpretation. It is these solutions which will bring real gains in terms of patient benefit, healthcare efficiencies, and wider societal returns.
We are confident that, more than ever before, it is true to say that distributing diagnostics will help shape the future of healthcare.
How we can help
Software development
Our consultants have extensive expertise in diagnostics software development, and we work closely with our broader TTP Software team to scale and meet the needs of your devices, regardless of their class.
Medical device cyber security
Considering both hardware and software, we can support development and requirements for cyber security concerns
Compliance
Our development process is ISO13485:2016 compliant. Working with our clients, we move towards suitable regulatory controls as the programme evolves.
As part of the regulated development, we ensures that Requirement Capture, Programme Planning and Risk Management are managed through the relevant development lifecycle.
If needed, we can help our clients with the ‘Intended Use’ statement, and once this is available, we typically undertake a regulatory review to identify applicable directives and standards. These can include EMC, Electrical Safety, RoHS & WEEE, and others.
Central lab automation
If your needs concern central lab systems, we can support your development. With our extensive experience in automation, innovative thinking, and expertise in sensing, we can deliver improved central lab solutions.
Manufacture
Establishing a manufacturable product is clearly key to the success of any programme. That is why we consider manufacturability throughout any development.
Our network of manufacturing partners can be engaged early to ensure additional considerations are taken into account and to address any manufacturer-specific needs.
During any development, we engage our own internal manufacturing team throughout. They ensure that our clients can have suitable numbers of prototypes of cartridges and instruments to support their testing during a programme.
Additionally, we can continue to build instruments and cartridges for you (to ISO13485) at volumes suitable for clinical trials and early sales. We can then support transfer to a scale manufacturer.
Post-launch
Once production is stable, we typically drops away from the project unless the client wishes otherwise. We are always ready to re-engage. This can occur when and if the client wants to start the development of Gen 2 or if there is a step change in specification that requires a level of redesign.
Clinical trials and 510k submissions
Although the responsibility of our clients, we can provide manufacturing support and technical expertise during the clinical trial. Our Design History Files also provides data and supporting evidence for the 510k submission.
Software development
Our consultants have extensive expertise in diagnostics software development, and we work closely with our broader TTP Software team to scale and meet the needs of your devices, regardless of their class.
Medical device cyber security
Considering both hardware and software, we can support development and requirements for cyber security concerns
Compliance
Our development process is ISO13485:2016 compliant. Working with our clients, we move towards suitable regulatory controls as the programme evolves.
As part of the regulated development, we ensures that Requirement Capture, Programme Planning and Risk Management are managed through the relevant development lifecycle.
If needed, we can help our clients with the ‘Intended Use’ statement, and once this is available, we typically undertake a regulatory review to identify applicable directives and standards. These can include EMC, Electrical Safety, RoHS & WEEE, and others.
Central lab automation
If your needs concern central lab systems, we can support your development. With our extensive experience in automation, innovative thinking, and expertise in sensing, we can deliver improved central lab solutions.
Manufacture
Establishing a manufacturable product is clearly key to the success of any programme. That is why we consider manufacturability throughout any development.
Our network of manufacturing partners can be engaged early to ensure additional considerations are taken into account and to address any manufacturer-specific needs.
During any development, we engage our own internal manufacturing team throughout. They ensure that our clients can have suitable numbers of prototypes of cartridges and instruments to support their testing during a programme.
Additionally, we can continue to build instruments and cartridges for you (to ISO13485) at volumes suitable for clinical trials and early sales. We can then support transfer to a scale manufacturer.
Post-launch
Once production is stable, we typically drops away from the project unless the client wishes otherwise. We are always ready to re-engage. This can occur when and if the client wants to start the development of Gen 2 or if there is a step change in specification that requires a level of redesign.
Clinical trials and 510k submissions
Although the responsibility of our clients, we can provide manufacturing support and technical expertise during the clinical trial. Our Design History Files also provides data and supporting evidence for the 510k submission.
Our approach and capabilities
We deliver across the entire life of a project, from opportunity discovery to production engineering. Discover how our interdisciplinary teams of experts collaborate to tackle the toughest product development challenges.
Our campus and facilities
Our award-winning campus has been designed with a clear vision. To create a space which can support our people and our clients as we develop and deliver the very best technology solutions.
Meet some of the team
Giles Sanders
James Stein
Tim Keating
