MedStarts follows a proven process for bringing medical devices to market. From idea generation to launching the business, we move rapidly to success using our model for the development of a new business.
The New Business Model Development Process relies on partnering with individual inventors, corporations, or universities as a source of new ideas for medical devices. We manage the portfolio of ideas to decide which ideas will enter the New Business Model Development Process. MedStarts uses a limited number of criteria that need to be met before the idea can progress to Stage 2. Examples include:
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Would the proposed idea really lead to the development of a new business?
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Does the proposed idea fit into the overall MedStarts strategy?
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Is there a reasonable expectation that the resulting business would create enough value to warrant exploration?
Additionally, the Stage 1 Plan and Approach document must be completed. This document indicates the financial and human resources requirements as well as the major milestones and expected value from Stage 2.
In the Develop Concept stage, the idea is taken from its raw state and refined into a conceptual offering. This conceptual offering serves as the basis from which a study is conducted to understand the venture’s market, financial, and technical merits. This stage is done to quickly develop the business concept and determine if it warrants the investment required for Stage 3.
Stage 3 is designed to assess the viability of the concept. The concept is elaborated upon and the business plan is developed. At the conclusion of the stage, there is a reasonable understanding of the business model, the business architecture required to support it, the regulatory hurdles, and the merit of the model. In assessing the merit of the model research is done with regards to the target market, the competition, the technical feasibility, the regulatory feasibility, and the financial viability. This research tends to include extensive external validation with customer and industry experts. Additionally, if the business architecture indicates any alliances, their practicality is assessed. In essence, this stage is the development of the business plan and provides an understanding of what is needed to build and run the business.
This stage builds the details of the required capabilities and adds details to the business plan developed in the previous stage. The objective is to prepare the venture for the pilot stage. This effort includes the capability development work that is required to bring the business to a pilot-ready state. Prudence dictates that the pilot starts small, but that the business is ready and able to scale fast, as indicated and required by market conditions.
This stage is a practical test of the organization’s ability to develop the required capabilities and validates the associated costs. A revision of the financial assessment of the business, with a more accurate understanding of revenue and an initial assessment of costs is used to form a better decision as to whether or not to proceed with a pilot of the business.
During this stage, a test market or limited customer base is engaged to allow the business to test its capabilities and gather feedback from representative customers and alliance partners. The results of the pilot are then used to make final changes to the business model and conduct a final evaluation of the business model before it is launched.
The pilot provides additional insight into the financial model associated with the business and serves as further means to gather accurate information about the merits of the business. Ultimately, the stage must provide the information needed to decide whether to proceed with the full scale-up.
Finally, the business plan is executed, all capabilities are developed and implemented and the business is made fully operational. At this point, the development process is concluded and the business enters into its growth phase. Standard business processes are implemented to achieve this growth and begin optimization of the business.
