Medical Device Product Development & Engineering Services
Home –Your Extended Engineering Team for Medical Device Innovation.
Design and Engineering
Founders at Sinnov8 bring more then 2 decades of experience in medical device design to the early stages of development. We offer following services.
- Concept Generation
- Design and Prototyping
- Feasibility Study
- Product concept and architecture.
- System engineering and requirements.
- Mechanical and electromechanical design.
- Feasibility and risk assessment.
- Design for Manufacturing (DFM).
- Product concept and architecture.
Development
With our integrated approach to product development, we ensure Design outputs are created while ensuring quality, regulatory, and manufacturing aspects. In-house or through our partners, we handle following areas.
- Mechanical Design including materials
- Electrical Systems
- Software & Firmware
- Embedded software development (C/C++).
- Embedded Linux and ARM-based platforms.
- Application software development.
- Qt/QML development.
- Electronics and hardware engineering.
- Medical device system integration.
- Cybersecurity engineering.
Human Factors Engineering (HFE) & Usability Engineering
Human Factors Engineering) has become increasingly important to global regulatory bodies—and central to medical device design. We help companies with entire life cycle.
We support medical device manufacturers in developing safe, intuitive and user-friendly medical devices through usability engineering activities aligned with IEC 62366-1 and applicable FDA and EU MDR requirements.
- Protocol development,
- Sourcing of Surgeons
- Perform HF study in accordance with FDA/MDR guidelines.
- Usability engineering planning.
- Use-related risk analysis.
- Formative usability evaluation.
- Summative usability validation.
- Usability engineering documentation.
Prototyping
Rather than trying to design and test every element at once, we suggest breaking down the process into isolated stages with their own focus, goals, and resource requirements. Staged prototyping is a proven, efficient path to success.
Verification & Validation
As a consultant to your internal team or as project managers taking on overall responsibility for a new projects, we identify the right tests to conduct, compose test protocols, coordinate the test, and write test reports for Design Verification and Design Validation.
- Design verification planning and execution.
- Design validation.
- Software verification and validation.
- System integration testing.
- Test protocol and report preparation.
- Traceability and design history documentation.
Manufacturing Support
We have partnerships with some of the best manufacturer in India and overseas.
We support medical device manufacturers in transitioning from product development to scalable manufacturing through design transfer, supplier identification, manufacturing documentation, process validation support and production readiness.
Medical product engineering services cover the design, development, and manufacturing of safe, effective, and regulatory-compliant medical devices and equipment.
COLLABORATION
Collaboration With Global MedTech Companies
Collaborate with Sinnov8 – Wherever Your Business Operates.
We partner with medical device startups, SMEs and established manufacturers across the United States and Europe, providing flexible product engineering capabilities to support their development programmes.
Our India-based engineering team works as an extension of your in-house R&D organization, offering multidisciplinary expertise across product design, embedded software, electronics, system integration, verification and validation.
Our Engagement Model is Designed for Seamless International Collaboration
Flexible Engagement Models
Project-based development, dedicated engineering teams or specialist technical resources.
Time-Zone Flexibility
Structured communication and overlapping working hours to support collaboration with U.S. and European teams.
Transparent Project Management
Defined milestones, deliverables, progress tracking and regular technical reviews.
Seamless Team Integration
Work directly with your engineering, product management and quality teams.
Regulatory-Aware Development
Engineering activities aligned with applicable medical device standards and regulatory requirements.
Scalable Resources
Scale engineering capabilities based on project requirements and development stages.
From early-stage product development to engineering support for established medical device manufacturers, Sinnov8 helps you extend your engineering capabilities with confidence.
