Innovation Journey

This simplified model created by Cover Biomedical outlines the stages and flow that need to be considered in regard to a Medtech Innovation journey. Below are just some of the services Cover Biomedical offers inside this journey.

medtech registered innovation journey model

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Medtech Startup Journey Services

Corporate Support

Casual CPDO (Chief Product Development Officer)
- Executive support
- High level prioritisation, planning, resourcing and strategy
- Product development due diligence
- Product development execution and delivery
- Product development team leadership
- Product Development team support, mentorship and skills development

Education
- Design controls (framework, structure, terminology, approach, links with regulatory expectations)
- Biomedical Engineering best practice in transdisciplinary teams
- Risk Management for medical devices (ISO 14971)
- Medical device project management

Services within the MedTech Journey Model

Research & Feasibility
- Translation assessment, planning and strategy
- Due diligence assessment

Design and Development
- Project management frameworks, workflows and strategy
- Best practice in Risk Management and Design Controls, including Verification and Validation
- Process improvement and execution for efficiency
- Product pipeline support and strategy
- Team development and training in best practice

Quality Management Systems
- Process design (QMS, product development, project management, risk management)
- Design control framework and methodology
- Post-audit support and uplift
- Compliance health-check

Regulatory
- Market entry strategy (regulatory)
- Project prioritisation in product development
- Informed documentation preparation
- Compliance frameworks

Market Entry
- Post-market transition planning and support
- Audit preparation
- Non-conformance and CAPA assistance

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