We support the design and engineering of diagnostic instruments for laboratory and point-of-care applications, bringing together optics, fluidics, electronics and software into cohesive, manufacturable platforms. Our multidisciplinary teams work across instrument architecture, subsystem integration and full-system development to help customers move from concept through to production-ready design with greater confidence and control.

Alongside system development, we focus strongly on regulated design, design for manufacture and manufacturing scale-up so instruments can move successfully from prototype to full production.

Our development approach is underpinned by:

• Instrument architecture for laboratory and point-of-care systems
• Integration of optics, fluidics, electronics, and software
• Multidisciplinary engineering for complex platforms
• ISO 13485-compliant development processes
• Design controls aligned with FDA and IVDR
• Risk management, verification, and validation
• Transition from prototype to production-ready design
• Cost optimization for instruments and consumables
• Supply chain and manufacturing strategy
• Module, sub-system, and full instrument build
• Global manufacturing footprint (US, EU, APAC)
• Low-volume to full-scale production

G&H | ITL support the development of advanced diagnostic and analytical instruments across both laboratory and near-patient settings. Our experience spans a range of diagnostic platforms and system types, helping customers create instruments that are technically robust, commercially viable and ready for regulated markets.

• PCR and molecular diagnostic systems
• Immunoassay analyzers and platforms
• Microbiology and culture-based systems
• Point-of-care diagnostic devices
• Integrated diagnostic platforms and analyzers

Choosing the right partner for diagnostic instrument development is critical, especially where engineering complexity, regulatory design and scalable manufacture all need to progress together. G&H | ITL supports customers with integrated product development and manufacturing expertise, helping transform diagnostic concepts into regulated, commercially viable systems.

• From Concept to Production - In One Partner
  We combine product development, engineering, regulatory design and manufacturing, eliminating the gap between prototype and production.
• Built for Complex Diagnostic Systems
  We have deep expertise across IVD instruments, PCR platforms and automated diagnostic systems.
• Integrated Photonics + Device Engineering
  Unlike most development firms, we bring in-house optical and photonics expertise, which is critical for many diagnostic platforms.
• Designed for Scale
  We do not just build prototypes — we design systems that can be manufactured reliably and cost-effectively.

We partner with companies developing complex diagnostic systems across different stages of growth and commercialization. Whether the goal is to bring a first product to market, expand a diagnostic portfolio or upgrade an existing platform, G&H | ITL provides the engineering, regulatory and manufacturing support needed to move forward with confidence.

• Venture-backed diagnostic and life science startups
• Growth-stage medtech companies scaling their first commercial platform
• Established OEMs expanding or upgrading their diagnostic instrument portfolios

We partner with diagnostic OEMs and medtech innovators to design, develop and manufacture complex diagnostic instruments, from early-stage prototypes through to regulated, production-ready systems.

Whether you are developing a new diagnostic platform or scaling an existing system, G&H | ITL can support your journey from concept to commercialization.