Taking an Idea and getting it to the Market

1. Taking an Idea and getting it to the Market Concept Development Feasibility Implementation Market Market Size Market Segmentation Market Drivers Competitive Analysis Customer Customer Habits & Practices Customer Usage & Attitudes Customer Ratings & Preferences Process Product/Service Definition Intellectual Property Considerations Process to deliver Regulatory Considerations Financials Product/Service COGS Cash Flow Requirements P&L Balance Sheet Entity Legal Structure Equity Arrangements Milestones Full Funding Partial funding may occur earlier Complete Business Plan Final Product/Service Definition Concept Definition Overall Plan

2. Target% Completion (end of Phase) Concept Development Feasibility Implementation Market Market Size Market Segmentation Market Drivers Competitive Analysis 80 % 85% 90% 100% Customer Customer Habits & Practices Customer Usage & Attitudes Customer Ratings & Preferences 60 % 90% 100% 100% Process Product/Service Definition Intellectual Property Considerations Process to deliver Regulatory Considerations 50 % 70% 95% 100% Financials Product/Service COGS Cash Flow Requirements P&L Balance Sheet Entity Legal Structure Equity Arrangements 40 % 60% 85% 100% Milestones Full Funding Partial funding may occur earlier Final Product/Service Definition Complete Business Plan Concept Definition Overall Plan

3. It’s not really that linear • Know how it fits into the marketplace before you start; including competitive IP • Know what the customer needs are and what problem it solves in order to define it • Know what it is before you make it • Know how to make it before you sell it IT = your product or service

4. Market What is the market definition, size and growth rate?   How is the market defined? What are the major segments? Where does this opportunity fit?   Define the global market today ($, units, # SKU’s);   What is the global growth rate and why?   Define the competitive landscape: % share, # SKU’s, pricing, etc.   How does this product compare to the current gold standard in the market?   Identify competitors and develop a SWOT chart for each.   Describe the go-to-market strategy by region.   Define the patent estate for competitors.   What have been the trends and market introductions?   What new products and/or technologies have been introduced in the last two years?   What has been the competitive reaction to these new products?   What competitive response (marketing, product development, etc.) is expected to this introduction?  

5. Customer What have been the trends and market introductions? What new products and/or technologies have been introduced in the last two years? What has been the competitive reaction to these new products? What competitive response (marketing, product development, etc.) is expected to this introduction? Value Proposition/Customer Requirements What are the customer needs? Define safety, efficacy, preference Define overall product objectives and how they address customer needs and existing product gaps. Are international needs different from the U.S.?   Does the customer recognize the need?   Do the proposed product characteristics go against customer habits?   Do the proposed product characteristics require the customer to do things differently. Define the customer testing protocol- focus groups, small base testing, etc.

6. Process Define the expected SKU lineup, what SKU’s will be deleted?   Describe the product characteristics – features and benefits   Overview the patent strategy, including international filings   Define elements – regulatory clearance, claims, economic outcomes, etc.   What is the regulatory plan, including international?   Is special testing required? Safety- UL, ETL, EMC, Skin Sensitivity, etc. The labeling and literature requirements?   Define the product development plan and funding Are design of experiments (DOE) necessary? What are the product specifications? Define MSDS sheets What are the results of the Manufacturing Trials?   Confirm process stability and capability   How much inventory was produced during these trials and now available?

7. Financials Estimate Growth (+/- 10%)   $ revenue- international and domestic   Units growth   % share change   Define capital requirements and impact on manufacturing.   Develop a Year I through Year V Pro Forma P/L and Projected NPV   Summarize Project Costs   Identify any capital expense during development Identify Regulatory, Clinical and Customer Research costs   Identify total development costs.   Identify ad, brochure and trade show expenses. Define legal entity structure and put it in place Define any partnership relationships and expectations Define valuation of near term and long term of the venture

8. Getting to Market Establish the Target Market Which countries will be included in Wave I? Describe the customer segmentation & target audience Who are key champions and how are they going to be leveraged? How is the Product being positioned? Positioning is the process of conceptualizing the product offering (as distinct from the product itself) and related communications to achieve a distinct competitive advantage. How is the product positioned in the absolute? Versus the competition What is the Marketing Campaign? Define the Marketing Communications strategy relative to: Advertising   e-Marketing   Public Relations   Advocacy   Clinicals Sampling   The copy strategy should clearly state the basic benefit(s) that the product promises and which constitutes the principal basis for purchase. It should state those features that make the benefit(s) possible- permission to believe, unique selling proposition.   What are the benefits and proof sources?   How will superiority be communicated?   Define the Brochures, Trade Shows and Ads   Define the Trade magazine ad campaign.   Provide final artwork on all aspects of marketing and advertising.  

9. Getting to Market Pricing Strategy What is the pricing strategy   Describe the value proposition to target audiences?   Develop a matrix on $/SKU versus current product and competition. Provide rationale for differences.   Sales Plan Develop Sales Presentation and additional materials Provide a twelve (12) month forecast by units.   How much inventory needs to be on hand at launch?   What is the expected run rate for the six month time frame?   Outline the Sales Training program including dates and length of training.   Define the Trade Show strategy   What trade shows will this program be launched at?   How will the booth communicate the program/products?    Have the top accounts per sales rep been identified and a plan established on how to sell them?   Who and when will call upon major accounts?