Diagnostic devices
Developing hardware for your diagnostic products.
We develop and optimize In Vitro Diagnostic platforms, including instrumentation and disposables. Working from early-stage research through to formal verification, our end-to-end diagnostic specialists ensure the technical effectiveness of products that speed up, diversify or innovate the testing and diagnosis process.
Proven experience in developing accurate, reliable diagnostic platforms
Whether for in-lab, point-of-care or patient self-testing, we have developed a range of diagnostic projects to the point of product launch.
Driving diagnostic innovation through close collaboration
Whether developing a new IVD platform, exploring novel detection technologies or seeking to improve usability of your existing device, a collaborative approach is key to managing the development of technically and commercially successful diagnostic assays, disposables and instrumentation.
We have considerable experience working closely with start-up teams through to large organizations on the development of new platforms and new assays, underpinned with our holistic understanding of the full IVD development process, working directly with you to the point of hardware and test clearance or approval by the FDA and CE-mark in Europe.
Developing new diagnostic instrumentation
Our team are committed to supporting you in making advancements in how patients are prescribed, by innovating the way diseases are tested and diagnosed – whether in a clinical care setting or at home.
Many of our clients are leading experts in diagnostic science but are seeking to more fully understand the user and market opportunity for new instrumentation, or the specialist technical, engineering or commercial aspects of device design.
We help you bridge that gap by undertaking early market research to define the product vision, through to the detailed design process using our industrial design, mechanical engineering, software, electronics, fluidics and dedicated project management function.
Our instrument capabilities include:
- Platform concept generation
- User workflow analysis
- User interface design and app development
- Turnkey development including design, mechanical engineering, optics, electronics, and software
- Integration of connectivity, data gathering and cybersecurity
- In-house prototyping
Single-use cartridge development
We consider the manufacture of your disposable product from the outset, leaning on considerable manufacturing and supply chain expertise in the wider Ensera business to ensure that any design meets your cost of goods targets.
Talk to us about:
- Design for manufacture
- Assembly and integration of reagents
- Fluidic design and analysis, including reagent storage and release
- Test cartridge manufacture
Technical review and detection system optimization
We have extensive experience in optical, electro-chemical and ferromagnetic detection systems, optimizing detection algorithms, signal processing techniques and machine vision.
We prepare end-to-end system models to replicate and understand system behaviour, identifying opportunities to optimize both hardware and software.
System value proposition
Our dedicated research and strategy team is experienced in recruiting and gaining feedback from patients, healthcare professionals and payers from an early stage of the development process to ensure the suitability of your diagnostic system design.
- Market research and voice of customer input
- Reimbursement and payment models
- Eco-system mapping
- Service blueprints
- Feature roadmaps
Design for quality and submission
Our programs are compliant with ISO13485 certified processes, meeting the requirements of ISO14971, IEC 62366-1 and the IVDR frameworks. Your Design History File, including Risk Management and User Files, will be a direct
output of any development process, in readiness for FDA or European Notified Body submissions.
Our areas of experience include:
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Instrument development -
Disposable cartridge development -
Microfluidics -
Software and algorithms -
Electronics -
UX/UI design
A people-first approach
Close partnership underpins everything we do – with our clients, with users, and with each other. We think laterally and with empathy, building agile, cross-functional teams around each innovation challenge, so we can achieve a tangible impact on health outcomes together.
Our expertise:
Designing for today’s healthcare priorities
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Connected devices
Specialist electronics, software and digital expertise for future-proof product development.
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Sustainable devices
Unlock the business benefits of auditing and optimizing your product’s full lifecycle.
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Women’s health
Developing products designed for and with women’s healthcare priorities, underpinned by robust insight.
Speak to our experts about your In-Vitro Diagnostic design challenge.
From specialist device components to sample collection, single-use cartridges and electromechanical readers, we are ready to help solve your diagnostic innovation challenge.
