Web Industries - Medical Overview Brochure

PRECISION

The Proven CMO to market leading medical companies

CONVERTING & CONTRACT MANUFACTURING

Improving the lives of patients, customers & each other

Market-leading companies turn to Web Industries to bring their new products from pilots and engineering studies through full-scale commercial launch.

The largest names in medical diagnostic devices, components, and consumables have called on Web Industries to manufacture flexible materials and active components for their most important programs.

• Know-how - Biochemistry and 50 years of roll-to-roll processing expertise in one supplier

• Scale - A track record of ramping facilities, processes, and staffing for programs as large as two million units per week

• Risk Management - A robust tech transfer/NPI process and FDA compliance

• Relationships - Customer intimacy, innovation, engagement - these are our strategic anchors for building long-term relationships

Web Industries has proven success in manufacturing with a solid portfolio of diagnostic components, devices, and turnkey kits in a variety of formats:

• Lateral Flow Assays (LFAs)

• Vertical Flow-through Assays

• Electrochemical Assays

• Molecular Diagnostics

• Cartridges, Consumables, Components

Clinical Dx

Acute-care hospitals and medical centers rely on laboratory testing for 70% of clinical decisions. Web Industries has supplied flexible materials, components, and turnkey consumables in this segment for 40 years.

• Turnkey manufacturing of consumable cartridges

• Over three billion patient immunoassays per year

• Flexible materials processing, automated assembly, and kitting for distribution

Animal Health Dx

POC and at-home tests are increasingly lowering costs and improving care for both pets and farm animals.

• Whole blood immunoassay

• Improving safety and productivity for ranchers and veterinarians

• Formulation, deposition, lamination, automated assembly, and kitting

POC Dx

Point of Care testing has dramatically increased in demand for accurate and rapid testing.

• Turnkey manufacturing of FDAregulated lateral flow assays

• Formulation, deposition, lamination, packaging, and kitting for distribution

AHT/OTC Dx

At-home/OTC testing combines ease of use and lower cost with the promise of early detection for improved health outcomes.

• Turnkey manufacturing of at-home/OTC test kits for infectious disease

• Demonstrated scale to tens of millions of tests

• Full-automation, just-in-time production, zero defects, ship to distribution

Wearable Diagnostics

Consumer demand for wearable devices that track health, fitness, and health data continues to increase.

• Emerging diagnostics in areas such as blood alcohol content, risks of age-dependent diseases, documentation of care activities, high-resolution ultrasound imaging, cortisol monitoring, glucose, blood oxygen, sweat rate, and levels of uric acid and ions

• Formulation, deposition, lamination, die cutting, automated assembly, and kitting

Cartridges, Consumables, Components

Web Industries provides medical contract converting, assembly, packaging, and kitting services for cartridges, consumables, and components used in blood gas analyzers and integrated clinical analyzers.

Web Industries is deeply passionate about improving people’s lives. We combine our expertise in biochemistry, flexible material converting, and medical device manufacturing to deliver high commercial volumes, consistency, and overall quality. As a trusted contract manufacturing organization with a reputation for ingenuity with a personal touch, we support multiple market segments.

Contract Manufacturing Solutions

As full-service CMO, Web Industries has combined deep know-how in biochemistry with 50 years of experience in flexible materials converting to offer full-service contract manufacturing of diagnostics devices.

Formulation & Testing

• Multiple biochemistry labs including isolated prep areas and BSL2 labs

• Centrifuge, spectrophotometry

• Solution prep, production support/ troubleshooting, and functional testing

Deposition

• Multiple reel-to-reel deposition lines for continuous dipping, spraying, striping, or spotting

• In-line automated inspection and bad-part marking

• Climate-controlled environments with in-line drying

• Customized equipment drives improved repeatability, tolerances, and yields

Lamination/Die Cutting/ Converting

• Multiple modular lines for continuous lamination, die cutting, and converting

• Standard setups for LFI, flowthrough stacks, and micro-fluidic laminates

• In-line automated inspection and bad-part marking

• Climate-controlled environments

• Customized equipment drives improved repeatability, tolerances, and yields

Assembly

• Assembly solutions tailored for program scale and complexity

• Manual, semi-automated, or fully automated options to optimize speed, reliability, unit cost, and capital cost

• In-line inspection and packaging options

• Climate-controlled environments

Packaging and Kitting

• Pouching, vialing, and/or kitting customized by product

• Manual, semi-automated, or fully automated solutions

• Final product testing and certification

• Ship direct to distribution

Outsourced Contract Services

• Web Industries supplier management program includes selection, evaluation, and management for key suppliers such as injection molding, buffer filling, and lyophilization

• In special circumstances, we bring such services in-house

New Product Introduction Process

The essence of life is relationships – this is Web’s founding principle. It shows up as we engage customers in our process to onboard new programs. Our project managers lead teams of design engineers, biochemists, manufacturing process owners, and supply chain specialists in a five-step Technical Transfer/NPI Process.

Web Industries’ process ensures a thorough, streamlined, and FDA-compliant technical transfer. The process applies to new programs, transfer of legacy programs, and change control for existing programs. Customers involve Web Industries early in design for manufacturability that significantly reduces risk, capital cost, device cost, and project timelines. Our collaboration process connects your team, the contract design organization, the automation house, and Web Industries for best results.

Other Core Competencies

We have what takes to help you win.

Quality Management Systems

• ISO 13485 registered

• FDA/GxP compliant systems

• Cloud-based QMS with full document control, change control, CAPAs, and risk management

Facilities

• Our facilities and QMS are ISO-13485 certified and FDA registered

• Holliston, MA and Dayville, CT

• Multiple biochem labs, deposition rooms, and dry rooms

• Environmentally controlled and monitored warehousing

ERP

• Cloud-based ERP with full BOMs, routings, and material traceability

• Constraint-based planning supports inventory management, just-in-time manufacturing, and on-time delivery