01
Design
Biosensor and microfluidic cartridge design with volume manufacture in mind from the first sketch.
- Concept design and rapid prototypes
- Proof of feasibility
- Design for manufacture and for test
POCDiagnostics and wearables, concept to commercialisation
Bringing your point of care diagnostic idea to life.
We design, develop and manufacture the biosensors, test strips and microfluidic cartridges at the heart of your test. One ISO 13485 team, from first sketch to volume supply.
Flexible approach
Medical focus
Solutions driven
CACVSWVDPVOCPEIS
ISO 13485:2016Design, development and manufacture
Award winner 2025Scotland's Life Sciences Awards
ISO 13485
Certified quality system covering design, development and manufacture
6 disciplines
Design, development, manufacture, science, quality and electrodes under one roof
20 minutes
From Edinburgh Airport to our Livingston manufacturing facility
Spin-out to multinational
Clients at every stage, each with a project plan built around them
Accredited, connected and trusted across the life sciences
Gates Foundation-funded projectAssay partner to Lepzi
LinxensFunctionalised electrode partner
Heriot-Watt UniversityMSc Biomedical Engineering visits
University of StrathclydeSensor manufacturing client
Outstanding Skills DevelopmentScotland's Life Sciences Awards 2025
Our expertise
View all services
Everything the disposable part of your test needs.
Your electronics and instrument partners build the reader. We focus on the strip, card or cartridge your assay depends on, and we know what works because we manufacture them every day.
01
02
Develop
Structured design control that turns a working prototype into a validated, transferable product.
- Design and development plans
- Risk management from day one
- Verification and validation
03
Manufacture
Produce cartridges, cards and strips without investing in specialist capital equipment.
- Screen printing and laser ablation
- Robotic reagent deposition
- Lamination, assembly, filling and sealing
04
Science
Assay development led by Six Sigma methods and statistical design of experiments from the start.
- Immunoassays and enzymatic assays
- Electrochemistry and surface chemistry
- Calibration and control schemes
05
Quality Assurance
Certified to ISO 13485:2016 and designed to meet FDA 21 CFR 820 and cGMP requirements.
- Contactless dimensional measurement
- Peel, burst and wettability testing
- SPC by black belt trained engineers
06
Electrodes
Screen-printed carbon and thin-film gold electrodes, ready for your electrochemical assay.
- FMS-0008 screen-printed carbon
- FMS-0009 thin-film gold
- Sample packs and data sheets
Concept to commercialisation
Join us at any stage. We'll take it all the way.
Clients come to us at every point in the product lifecycle, from early university spin-outs to multinationals. Pick the stage you're at.
Stage 01
Make your product easy to picture.
Our design engineers model your target product in 2D and 3D CAD, then turn concepts into working prototypes on our own equipment. Investors, customers and stakeholders get something they can hold.
What you get
CAD models and prototypes
Core manufacturing capabilities
Make your test without buying the factory.
Our engineers and scientists choose the materials and processes with you. That saves you time and money and keeps quality where it needs to be, whatever your detection technology.
Fine-line automatic and semi-automatic screen printing lays down inks, pastes, reagents and adhesives accurately. Medical-grade drying systems keep the process capable and cost effective.
Our excimer laser tools produce inter-digitated electrodes and other sensors that need super-fine line and gap dimensions. Hybrid printed and ablated designs are possible too.
Several robotic dispensing systems give you fast, controlled reagent deposition, the step that makes or breaks a biosensor.
We design and build bespoke assembly equipment in-house, then tailor it to your product for a reproducible test card every time it comes off the line.
Laser cutting gives fast, accurate singulation in R&D with no die tooling to pay for. Die cutting takes over for repeatable volume production.
In-house plasma treatment tunes surface behaviour for microfluidic channels, so your sample flows where you designed it to.
Blister packs and on-board fluid delivery are a core competency. Our filling and sealing stations adapt to your design through bespoke tooling.
Our wet laboratory prepares reagents to your formulation on site, which removes the worry of shipping sensitive reagents between partners.
Screen printingLivingston manufacturing suite
CAD and CAM software lets us simulate manufacturing routings before any material reaches the machine, cutting lead times.
Wearables
Science
Assay science with manufacture always in view.
Our science team has launched products on laboratory instruments and portable POC systems. We apply Six Sigma and statistical design of experiments from the start, so your project reaches the right technical decisions sooner.
Client labs beside the production floor
Dedicated sensor development labs sit next to manufacturing, so R&D and operations stay aligned on design for manufacture.
Calibration, controls and claims
We build traceability, calibration strategies and external controls that stand up to regulatory review.
Ready for wearables
From continuous lactate sensing to artificial skin testing, we extend low-cost biosensors into health monitoring.
Electrodes
Electrodes you can put to work today.
Start your electrochemical assay on proven FlexMedical electrodes, then scale on the same lines that made them.
FMS-0008
FMS-0008 carbon electrodes
Screen printed in Livingston on our fine-line printing lines. A cost-effective working surface for sensor development and volume production alike.
Suitable techniques
CAChronoamperometry
CVCyclic voltammetry
SWVSquare wave voltammetry
DPVDifferential pulse voltammetry
OCPOpen circuit potentiometry
EISImpedance spectroscopy
Case study
Read the full case study
A buffer delivery system that kept the funding coming.
A young life science company needed on-board buffer storage and a reliable release mechanism for its novel diagnostics platform. We delivered both phases, and the client went on to its next stage of development.
- 12 months' shelf life for a fixed buffer volume in a flexible, easily punctured blister pouch
- A puncture mechanism that fits a fixed space inside an existing device and instrument
- Puncture force held inside the instrument's minimum and maximum limits
- Materials comparison and moisture loss modelling to pick the right substrate on data
- 3D printed and vacuum cast concepts to test pierce and burst mechanisms fast
- Prototype injection mould tooling and in-house assembly of pre-production modules
- Measured shelf life matched our theoretical calculations and the customer's specification
- Every module punctured inside the specified force window and delivered buffer on demand
- The customer met its investor milestones and moved to the next development stage
12 monthsTarget shelf life, met
2 phasesDelivered end to end
MilestonesMet for investors
Quality assurance
Our quality commitment
Quality without compromise. Our reputation depends on it.
Everyone at FlexMedical owns quality. Clients and regulators audit us, and we review our systems continuously. Early-stage clients also get our support with regulatory submissions.
ISO 13485:2016Certified QMS for medical devices
21 CFR Part 820Designed to meet FDA requirements
cGMPDesign, development and manufacture
Six SigmaGreen and black belt trained team
Test and inspection, in-house
7 capabilitiesContactless dimensional measurementMulti-sensor x, y and z capture with SPC data
OGP CMMWettability and coatingContact angle, surface energy, surface tension
KrüssSurface topographyContact and non-contact surface analysis
Universal testingBlister burst forces and foil pouch peel strength
InstronMoisture and thermo-gravimetric analysisRetained moisture in cured reagents
Projectors and digital microscopesElectrode definition and assembly tolerances
Viscosity and rheologyConsistency of inks, pastes and liquids
Brookfield
Our facility
Step inside our Livingston facility.
Our state-of-the-art premises near Edinburgh keep growing, with continued investment in R&D, manufacturing and equipment. We're well placed to serve Scotland, the UK and beyond.
20minEdinburgh Airport
30minGlasgow
30minStirling
Watch the film
What our clients say
Clients come back. Then they tell people.
Feedback from our clients is first class, and we intend to keep it that way. We hold our reputation by meeting or beating expectations on every project.
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Winner, Outstanding Skills DevelopmentScotland's Life Sciences Awards 2025
Our people
Scientists, engineers and technicians who've done this before.
Our leadership team has worked for some of the world's leading diagnostics companies and brought several patient self-test and near-patient products to market. They've lived the full product development lifecycle, and so will your project.
KFKevin Fallon
MWMurray Whyte
DFDonogh FitzGerald
Innovation. We encourage creativity and create opportunities to drive improvement.
Insights
All insights
News and thinking from the lab.
BlogFDA readiness: the gap between 'working' and 'ready'
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NewsHosting Heriot-Watt University's MSc Biomedical Engineering students
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NewsPartnering with Lepzi on a Gates Foundation-funded preeclampsia diagnostic
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NewsFlexMedical picks up a major award at Scotland's Life Sciences Awards
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Get in touch
Together we can journey towards excellence.
Whether you need stand-alone electrode manufacture or full biosensor cartridge development, we'll listen, understand and add value to your project.