Human Business

Human Business Mind Map

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Human Business by Mind Map: Human Business

1. Market Analysis

1.1. Reading Through Commercialization Plan

1.1.1. Consolidate Commercialization Plans Develop regulatory agnostic Plan

1.2. Look at South African BPCs

1.2.1. Identify what needs to be changed from India Research these change points and change them

2. Regulatory Affairs

2.1. Find Companies with free consultation

2.1.1. Categorize as regulatory strategy or regulatory execution companies Set up meetings

3. FOIA Predicate

3.1. Identify FOIA expert

3.1.1. Reach out to expert

4. Connections to Users

4.1. Reach out to Dr. Harvey

4.2. Talk to someone in India

5. Clinical Trials

5.1. Compile list of testing companies

5.1.1. Reach out and talk to testing companies

6. Marketing

6.1. Research whether or not we can market?

6.2. Find expert

6.2.1. Reach out to expert

7. Packaging, Pricing, IFUs

8. Hologic Demo

8.1. $ and time to get 510k approval (assuming we have regulatory expertise, include costs of testing facilities, expected tests etc. and FDA timelines

8.2. Define key inflection points for human biz (testing for 510k, 510k submission, approval, human trials)

8.2.1. $ and time estimates for key inflection points

8.3. Basic human technology valuation for now and projections post-510(k)

8.4. Additional numbers/figures that may be good for Hologic demo