Invetech works with diagnostics, medical devices, life sciences, drug discovery and pharmaceutical companies worldwide to develop instruments, medical devices, consumables and the manufacturing systems that produce them.

Our development services deliver break-through products and solve complex automation challenges, whilst our contract manufacturing capability specializes in new and complex instruments with a focus on product support and the implementation of cost-reduction strategies.

Our team of in-house engineers, scientists and manufacturing specialists combine high-calibre technical and business consulting across the full journey, from idea to market, so our clients can be confident of achieving a successful commercial outcome.

Design, Engineering & Contract Manufacturing

Contract development services for:

• Instruments for Laboratory and Point-of-Care
• Medical Devices for on-patient use
• Custom automation for research and production

Contract manufacturing for biomedical instruments & devices:

• Wide-range scale & expertise in re-design for manufacturing & cost analysis, and
• Manufacturing flexibility across facilities in San Diego, Melbourne (Australia), Shanghai (China) & Singapore.

Our involvement may include:

• System definition, design and development,
• process automation and optimization,
• equipment development,
• production scale-up,
• contract manufacturing, &
• sustaining engineering.

Expertise

• Structured innovation processes to develop breakthrough ideas.
• Proven system definition techniques to achieve market success and manage commercial trade-offs.
• Project Management and systems engineering methodology to manage complex developments.
• In-house specialists including industrial designers, software, mechanical & electronics engineers, chemists, physicists, scientists and manufacturers.
• Rigorous application of reliability engineering principles.
• Industrial design & human factors engineering for ease of use and user error reduction.
• Fully automated assay techniques including chemistry, immuno, molecular and cellular systems.
• Consumables design & manufacturing technology from reagent packaging to complex microfluidics devices.
• Automatic handling & assembly of a wide range of consumables (slides, tubes, racks etc.).
• Sample analysis, inspection & quality control through advanced optical and electrical techniques.
• Flexible and scaleable manufacturing.
• Metrics driven manufacturing & cost analysis using Lean Manufacturing, Kanban & Kaizen methodologies.
• Proactive product life cycle management to reduce risk, lower costs and increase reliability.

Regulatory Compliances

• FDA 21 CFR 820 compliant
• ISO 13485:2003 & ISO 9001:2008 certified production facility.
• Software development based on IEC 62304, classes A, B and C.
• Experienced in design for CLIA Waiver.
• Experience with regulatory class I, II, and III devices.
• Experienced in current EU directives for IVD devices & MDD devices requiring the CE Mark.