Medical Device Development and Manufacturing: MedTech Engineering

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This training program on medical device development and manufacturing is designed for research and development professionals in the medtech sector. It addresses challenges in product design, material selection, manufacturing processes, and regulatory compliance that impact product quality and market readiness. Participants will gain the ability to design, develop, and commercialize medical devices using structured engineering […]

By Sunil Gulab

Last updated May 25, 2026

Course Content

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Classification of medical consumables and devices (risk-based approach) • Functional requirements and intended use

Key performance attributes: Safety, Reliability, Biocompatibility and Usability

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Product development lifecycle: Concept → Design → Prototype → Validation → Commercialization

Design inputs: Clinical requirements, User needs and Regulatory considerations

Design outputs: Drawings, Specifications and Acceptance criteria

Risk management integration

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Material types: Polymers, Metals and Elastomers

Selection criteria: Biocompatibility, Mechanical properties and Chemical resistance

Surface modification: Coatings and Functional treatments

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Core manufacturing processes: Extrusion, Molding, Forming and Assembly & bonding

Supporting processes: Cleaning, Inspection and Packaging

Cleanroom requirements: ISO Class 7 / 8

Equipment planning and automation strategy

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Device classification (risk-based)

Regulatory approvals in India: Manufacturing licenses and Test licenses

Quality management system: ISO 13485

Key standards: ISO 14971 (Risk Management) and ISO 10993 (Biocompatibility)

Technical documentation: Technical File / Design Dossier

Audit readiness and compliance

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Cost components: Raw materials, Manufacturing and Overheads

Capital investment planning

Pricing strategies: Tender-based and Private market

Business models: OEM / Contract Manufacturing and Own brand

Profitability and ROI

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Market entry strategy

Distribution channels

Supply chain developmen

Scaling production: Manual vs automation

Risk factors: Regulatory delays, Quality issues and Cost control

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Case Study: Develop and Commercialize a Medical Consumable or Device

Meet Your Instructor

Sunil Gulab

1 Courses

1 Students

Sunil Godambe is a MedTech expert with 15+ years of experience in designing, developing, and scaling complex interventional medical devices. His expertise spans product innovation, manufacturing setup, process engineering, and large-scale production across cardiovascular, neurovascular, gastroenterology, and urology domains. At Meril Life Sciences, he has led end-to-end development and manufacturing of advanced guidewire and catheter technologies, benchmarking performance against global leaders to achieve internationally competitive standards. Previously, he drove product and process innovation at Biorad Medisys, enhancing efficiency through scalable manufacturing and automation. With strong experience in ISO 13485, CE, USFDA, and CDSCO compliance, Sunil excels in building high-performance teams and robust MedTech manufacturing systems, contributing to the advancement of next-generation medical technologies.