FlexMedical Solutions

What FlexMedical Solutions does

FlexMedical Solutions is a Livingston, Scotland-based Contract Development and Manufacturing Organisation (CDMO) that takes point-of-care in vitro diagnostic (IVD) programs from concept through to commercial-scale manufacture. Founded in 2014 by ex-Alere executives (Kevin Fallon and Murray Whyte, later joined by CSO Donogh FitzGerald), the company specializes in electrochemical biosensors, microfluidic test cartridges, and reagent formulation for disposable IVD components. Core technical capabilities span high-precision screen printing and laser ablation of thin-film electrodes (carbon, gold, platinum, carbon nanotubes), reagent dispensing, surface functionalization and bioconjugation, and cleanroom manufacturing under an ISO 13485:2016 quality system that has also cleared prior US FDA audits.

The company's go-to-market is sales-led B2B contract services, with approximately 70% of revenue generated outside the United Kingdom across Europe, North America, Asia, and Australia. Customers range from early-stage start-ups and university spin-outs to established global diagnostics corporates, and span primary use cases in human diagnostics (cardiac, sepsis, diabetes, kidney, respiratory, AMR), wearable/continuous monitoring, and adjacent agri-food and environmental testing. Revenue mechanics are project- and contract-based (professional services + manufacturing services), with pricing negotiated per engagement and not publicly disclosed. FMS exhibits at industry trade shows including MEDICA, MedtecLIVE, and AACC, and supplements direct sales with content marketing, case studies, and academic partnerships.

The business is bootstrapped and founder-owned, profitable in every year of trading since incorporation, and has scaled from 5 employees (2017) to over 30 by end-2021 — doubling headcount and revenue in that year — and investing £1M in equipment and leasehold improvements in 2021 alone. Disclosed revenue was £3M for the year to April 2021, on track for approximately £4.5M in the following fiscal year. Strategic partnerships with Linxens (functionalized electrodes), Lepzi (Gates Foundation-funded preeclampsia test), and technology integrations with PalmSens and Solventum indicate active expansion into wearables and global health diagnostics alongside the core OEM CDMO franchise.

Name

FlexMedical Solutions

Legal name

FlexMedical Solutions Ltd

Website

https://flexmedical-solutions.com

Company type

Private

Founded year

2014

Operating status

Operating

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing (CDMO)

NAICS

Electromedical and Electrotherapeutic Apparatus Manufacturing (334510), Medical Equipment and Supplies Manufacturing (3391)

SIC

Electromedical & Electrotherapeutic Apparatus (3845), Surgical & Medical Instruments & Apparatus (3841)

akta.pro primary industry

Companion Diagnostics (CDx) & Precision Medicine IVD (HLAHAAAJ)

Keywords

• Contract manufacturing services
• In vitro diagnostics
• Point of care
• Biosensor development
• Medical device CDMO

Headquarters

HQ city

Livingston

HQ country

United Kingdom

HQ region

Europe

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Technology or R&D, Infrastructure, Operations, Marketing or Sales

Revenue model

1. Contract Design, Development and Manufacturing Services: FMS provides contract design, development, and manufacturing services to medical device OEMs for point-of-care in vitro diagnostic tests. The company serves as a CDMO focusing on the disposable component of diagnostic tests including biosensor fabrication, reagent formulation and deposition, and finished test cartridge assembly.

Go-to-market motion1 record

Distribution channels1 record

Marketing channels11 records

Core offering

FlexMedical Solutions is a Contract Development and Manufacturing Organisation (CDMO) providing design, development, and manufacturing services for point-of-care in vitro diagnostic (IVD) tests and biosensors. The company serves medical device OEMs across the full product lifecycle from concept to commercialisation, including assay development, electrode fabrication, reagent formulation and deposition, microfluidic test cartridge assembly, and biosensor production under ISO 13485:2016 quality systems.

Product overview

FlexMedical Solutions operates as a Contract Development and Manufacturing Organisation (CDMO) providing a comprehensive suite of services for point of care (POC) in vitro diagnostic (IVD) product development. The company offers an integrated service portfolio spanning Design Services, Develop Services, Manufacture Services, Quality Assurance Services, Science Services, and Electrode Products. These services cover the complete product lifecycle from concept through commercialisation, including assay development, biosensor fabrication, electrode functionalization, and microfluidic cartridge development. The company specialises in electrochemical biosensing technology with expertise in screen-printed electrodes and laser-ablated thin film electrodes, serving clients ranging from startups to global corporations in human diagnostics, agri-food, and environmental sectors.

Differentiator

Problem solved

Functional benefit

Products and services

• Design Services
• Develop Services
• Manufacture Services
• Quality Assurance Services
• Science Services
• Electrode Products

Quantifiable outcome

• Buffer delivery system case study: empirically measured shelf life conformed closely to theoretical calculations and within customer-specified value; puncture within specified force window; buffer fluid delivered successfully; customer met investor milestones and progressed to next development stage.
• +2 more outcomes

Named customers7 records

Segments4 records

Ideal customer profiles4 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

Feature6 records

Partnerships

Four partnerships are on record, tiered minor and core.

• Heriot-Watt UniversityminorStrategic or Co-development Partner · 9 February 2026Partnership to host MSc Biomedical Engineering students for an immersive facility visit bridging academic theory and real-world medical device development. Includes guided tour of FMS facility, cleanroom environments, and presentation on Design for Manufacture (DfM) principles.
• LepzicoreStrategic or Co-development Partner · 13 November 2025FMS is a key partner in delivery of a Gates Foundation grant awarded to Lepzi for next-generation diagnostics for preeclampsia. Collaboration involves development of a PLGF assay as a critical component of an innovative dual-biomarker (PLGF + sFlt-1) point-of-care test for diagnosis of pregnant women at risk of preeclampsia, targeting low- and middle-income countries.
• LinxenscoreStrategic or Co-development Partner · 10 June 2025Strategic collaboration under the Linxens Healthcare brand to deliver ready-to-use functionalized electrodes for next-generation biosensors. Combines Linxens' high-volume roll-to-roll manufacturing capabilities with FMS's expertise in assay development and electrode surface functionalization. Joint offering targets disposable diagnostic components such as test strips, cards, and cartridges using electrochemical sensing technologies.
• Aspire HighlandminorOthersFMS partnered with Aspire Highland for Six Sigma Green Belt training tailored to FlexMedical. Four individuals across Science, Engineering, and Manufacturing functions received certification. As of 2024, 65% of Manufacturing, Science, and Engineering team had been through Six Sigma training.

Scale indicators10 records

Recent moves10 records

Expansion highlights5 records

Direct peers

• Abingdon Health: UK-based contract development and manufacturing organisation focused on lateral flow and rapid diagnostic tests, headquartered in York. Direct competitor to FMS in the point-of-care IVD CDMO space, serving similar OEM and startup clients with comparable assay-development-to-manufacturing service scope.
• DCN Diagnostics: US-based lateral flow and rapid diagnostic CDMO providing contract development, manufacturing, and regulatory support for point-of-care IVD developers. Closely comparable to FMS in serving early-stage IVD companies through the full design-to-commercialisation workflow.
• BBI Solutions: UK-headquartered (Crumlin, Wales) immunoassay and lateral-flow diagnostics CDMO, formerly part of BBI Group and acquired by Eurofins. Directly comparable to FMS in offering custom assay development, reagent formulation, and contract manufacturing of diagnostic strips for IVD OEMs.

Others

• Catalent: Large US-headquartered contract development and manufacturing organisation with diagnostics, biologics, and consumer health capabilities. Less specialised than FMS in electrochemical biosensors but a potential strategic acquirer or partner for scaled-up IVD CDMO programs.
• Recipharm: European CDMO providing contract development and manufacturing services across multiple dosage forms. Pharma-skewed relative to FMS but adjacent as a strategic reference point for CDMO valuation and as a potential consolidator of small specialised CDMOs.

Broad incumbents

• Eurofins Scientific: Global life-sciences testing and diagnostics services group that acquired BBI Solutions in 2021. Overlaps with FMS in IVD contract development and manufacturing and offers substantially broader scale, geographic reach, and reagent supply capabilities.
• Phillips-Medisize: Large global medical device and diagnostics contract manufacturer owned by Molex (Koch). Broader portfolio than FMS but competes for POC IVD OEM outsourcing programs requiring design, development, and high-volume manufacturing capabilities.
• QuidelOrtho: Major in vitro diagnostics company formed from the Quidel-Ortho Clinical Diagnostics merger, with a strong point-of-care rapid diagnostics franchise. Overlaps with FMS in POC IVD end markets but operates primarily as a finished-product manufacturer rather than a CDMO.
• Jabil Healthcare: Healthcare-focused division of Jabil, one of the world's largest contract manufacturers, offering medical device and diagnostics manufacturing at global scale. Competes with FMS for IVD OEM contract work and has the balance-sheet capacity to bid on larger programs.

Emerging players

• Sona Nanotech: Canadian developer of lateral flow rapid diagnostic tests with in-house manufacturing capabilities for POC applications. Smaller and earlier-stage than FMS but addresses overlapping customer segments of startups seeking rapid-test CDMO support.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks5 records

Key highlights7 records

Customer concentration

• Xx.com/flexmedsol
• LinkedInlinkedin.com/company/flexmedical-solutions
• Instagraminstagram.com/explore/locations/536661709863546/flexmedical-solutions

Compliance1 record

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about FlexMedical Solutions