Comprehensive Product Development

From the earliest stages of ideation through volume manufacturing and distribution, Medical Device Development Group helps you realize the potential of your product and bring it to market. 

You have a destination, we know the way. Every project starts with a comprehensive Commercialization Roadmap that is a business plan on steroids. We put extensive effort into the reseach and planning phase so that risks are defined for management, so that plans are not based on assumptions, and to ensure that there is high confidence for all the investors.

To accomplish this, Md2G uses a proprietary project management framework called Strategic Parallel Implementation™ (SPI™). Through this proven methodology Md2G ensures each critical component on the path to commercialization is successfully completed at the optimum time.

SPI consists of five phases, each of which concludes with a Formal Design Review (FDR):
1.Concept Confirmation
2.Design Approval
3.Design Lock
4.Clinical Approval
5.Final Launch Approval

1.Concept Confirmation
The experts at Md2G can help you determine whether your product is feasible, viable and realizable. The project management flow begins with this vital step, which includes creation of a business case, market intelligence, risk benefit analysis and development and review of any prototypes. At the completion of this stage, the developer and team have the information needed to confirm project viability.

Complete Phase 1 packages are usually between 50 and 150 pages when completed, including all reports, references, supporting documents, etc. This comprehensive business case document provides a very complete commercialization plan as well as the information needed to justify execution of that plan. For many early stage clients this document is a key fundraising tool.

2.Design Approval
The next stage is targeted to obtaining design approval. Technology feasibility is determined, along with strategies for risk management, intellectual property, supply chain, reimbursement, regulatory and compliance.

3.Design Lock
As the project moves closer to realization, the third stage focuses on finalizing plans and strategies. In addition to steps involved with business planning, marketing and legal, the project moves closer to clinical trial. Important feedback from users is processed and used to fine-tune the product design.

4.Clinical Approval
While clinical trials are a critical element in obtaining regulatory approval, the pre-clinical stage offers an important time for finalizing manufacturing, marketing, regulatory and risk management plans. Marketing, limited release and/or clinical trials are finalized in this phase.

5.Launch Approval
With the conclusion of clinical trials comes final approval for launch. At this stage all elements have been fine-tuned and are in place, materials are in stock and ready to ship, prepared for a successful product rollout.

Post-Launch
The SPI methodology does not end with the launch. In order to ensure long-term success and broad adoption, the marketing, training, service, manufacturing and IP support must all be in order.