Turning your idea into reality can be an overwhelming process. But when you’ve got a good product, it deserves to make it to market so it can help exactly how you imagined it would.
At C3 Medical Device Consulting, our team uses extensive market knowledge and technical expertise to take your product from conception to production. We do this by implementing a development plan, which leads the design process and ensures product quality objectives are met. The development plan is always prepared and maintained by a project manager, then reviewed and approved by a manager, as well as the client.
Here’s what goes into a typical development plan.
- Identification of the project organization, including the core team members and project team members, along with their approval authorities and specific responsibilities for implementation.
- Project deliverables.
- Description of the project communication plan at a high level.
- Management plan, which identifies the high-level program objectives, and includes key issues, which may include critical timing requirements, relationships with other projects, technical and resource issues, and regulatory issues.
- Research and development plan, which includes a high-level description of the product, plus the major activities for designing and developing the device, accessories, labeling, and packaging, if applicable.
- Project schedule, including major design and development activities and milestones. Note: A detailed project schedule may be maintained separately from the development plan.
- Planned project phases and required design reviews.
- Verification and validation plans, which should discuss, at a high level, the types of activities that will be conducted.
- Quality plan, which should provide reliability goals and plans for achieving them.
Here’s what we expect you to provide to accompany a development plan:
- Marketing plan, which includes product strategy, sales strategy, marketing strategy, and training strategy.
- Manufacturing plan, which should describe the plans for manufacturing the product and any interfaces with contract manufacturers and/or key suppliers.
- Financial analysis.
- Regulatory plan, which should establish the initial regulatory path/strategy, including any required submissions (and their contents as applicable) to the applicable regulatory agencies and/or bodies.
- Clinical plan, which should describe, at a high level, the overall strategy for clinical investigation(s).
- Localization plan, which identifies the countries in which the product will be marketed. It should include any material or design issues related to distribution of the product into the identified countries. It should also identify the control of the release schedule into the identified countries.
- Technical support plan, which should describe the high level service and support strategy.
Bring Your Product to Market!
If you’re ready to bring your product to market, contact our team today. It’s time to make a development plan and turn innovation into creation. Don’t wait! Who knows how many people you can help once your device makes it to market?
