Fundraising Success and Increased Sales
- Raised multimillion-dollar angel and venture funding
- Revamped business models to obtain funding
- Obtained venture funding via authoring White Papers
- Assured BOD of device safety via authoring White Papers
- Determined mechanism of action as funding requirement
- Invented patented solution to M&A roadblock
- Increased sales revenues via authoring White Papers
- Founded combination product migraine/allergy treatment company
- As CEO for four years, exceeded Board milestones
- Co-founded four medical product companies
- Enabled specified market go/no go decisions
- Determined optimal product line-up for launch
- Assessed and recommended opportunities for market entry
- Provided pre-publication data as funding requirement
- Invented patented solutions to funding roadblocks
- Performed competitive intelligence at industry conference for Fortune 500 company
Solving Regulatory Roadblocks
- Reversed FDA decision of PMA path to a 510(k) path
- Obtained clearance for previously denied 510(k)s
- Obtained FDA acceptance of previously denied trial endpoints via a White Paper
- Reversed FDA mandatory animal model decision via a White Paper
- Reversed FDA decision re: 510(k) clinical data requirement
- Obtained previously denied IRB study approvals via a White Paper
- Obtained FDA acceptance of unique regulatory paths
- Solved lack of control data roadblocks via a White Paper
- Obtained 510(k) clearance ahead of schedule
- Solved insufficient clinical data roadblocks
Overcoming Technical & Clinical Hurdles
- Invented a $100M/year revenue medical product, first ultrasonic contrast agent
- Obtained mid-trial endpoint change via Bayesian approach
- Rescued clinical trials via specific data analyses
- Terminated trial run afoul at top institution for client
- Solved device scale-up technical hurdles
- Solved device loss of efficacy with time
- Solved lack of device efficacy in some patients
- Invented patented solution to device use in different specialty
- Designed and executed clinical trials in USA, Canada, Belgium, Germany, Austria, UK, Israel, South Africa, Japan, Australia
- Solved choice of control device hurdle
- Invented new in vitro and preclinical models
- Invented patented solution, drug vehicle, for previously uninjectable IV diagnostic
- Invented a new non-coil spring mattress
- Invented first all-in-one tracheostomy device
Partial Client List
| Abbott Vascular AccuVein LLC Aerojet Liquid Rocket Systems American Edwards Laboratories ArthroCare Corp Bay Technical Products Berliscan Inc Broncus Technologies Inc CAPNIA Inc Cardiox Inc Cartilix ClinicalPro Solutions Inc Covance EKOS Corp EMBOL-X Inc Entrovita Inc Fidus Medical Hansen Medical Inc Hitachi Ltd InnerDyne Inc Innovamedica Intact Medical Corp International Business Incubator IVAC Corp | J. D. Hill MD Inc Laser Concepts of Nevada Inc Medical Product Innovations Inc Menlo Care Inc Mission Medical Inc NeoThermia Corp Neverwet, LLC Orquest Inc OvaMed Corp Pacific Presbyterian Medical Center PathWork Informatics Inc Percutaneous Systems Inc (PercSys) PneumRx Inc Portaero Inc ProdigyWorks R2 Technology Rasor Associates Inc Schering AG Seven Dreamers Laboratories Shiley Inc Thoratec Laboratories Corp UC Davis Veterinary Medicine Surgery VidaMed Inc |