This URL, www.MedicalDevice.com, is available for lease, contactjsrasor@medicaldevice.com

Consulting Services

Business/ Management Turnaround, Troubleshooting Fundraising Assistance, Venture Capital, Angel Opportunity Assessment, Due Diligence Interim Executive Management, CXO Chief Executive Officer (CEO) Chief Science Officer (CSO) Chief Strategy Officer (CSO) Prudent Cash Management Strategy Cross-Functional Big Picture Strategy Entrepreneur, Founder, Start-up CEO Board of Directors (BOD) Business Model Market Research, Product Line-up Bass Diffusion Modeling of Revenue Forecast Customer Research, Surveys Competitor Research Business Development Marketing, Increasing Sales Project Management (PM) Subcontracting/Subcontractor Clinical/ Technical Scientific Advisory Board (SAB) Clinical Research Organization (CRO) Research and Development (R&D) Intellectual property (IP), Patents Clinical Study Design, Data Analysis Clinical Study Monitoring Preclinical Study Design, Data Analysis In Vitro Models In Vivo Models Data and Statistics, Bayesian and Frequentist Medical Writing, White Papers, Publications

Regulatory IDE, 510(k), PMA, ANDA, NDA Liaison with FDA Responses to FDA Questions Gaining FDA agreement to new regulatory paths Gaining FDA agreement to optimal endpoints Global Regulatory Strategies Quality CAPA's Quality System Regulations IS0 13485 QMS Audits European CE Marking Technical Files STED Japan PAL China SFDA Sterilization Canadian Licenses Internal and Supplier Audits FDA Mock Audits 483 & Warning Letter Responses ISO 14971 Validations Design Control Risk Analysis & Management DHF Development CMDCAS GMP Resolving Consent Decrees Drug Listing, Registration, and Master Files

Dollar Resource Periodicals

Rasor Resource Newsletters

Over the years we have discovered, and colleagues have shared, a plethora of useful tools we have utilized to assist clients, leading to results of pivotal importance. They can be downloaded for one dollar each in the Rasor Resource Newsletter section below.

Volume 1, Issue 1 - 2009 Designing and Testing for Usability of a Medical Device   Volume 1, Issue 3 - 2009 Medical Device Development Phases and Functional Activities (courtesy of the Stanford Biodesign program)   Volume 1, Issue 5 - 2009 Angel vs. Venture Capital - Chair, Life Science/Biotech Industry Group, Band of Angels   Volume 2, Issue 1 - 2010 How to Evaluate the Competition for Free using Government Websites - Part 2   Volume 2, Issue 3 - 2010            Guest Feature - Part 2 How to avoid falling into the time chasm of the months to years between FDA approval and universal coverage		Volume 1, Issue 2 - 2009 Value of the "Rule of Three" in Clinical Trial Sample Size Determination when Evaluating Device Safety   Volume 1, Issue 4 - 2009 Quantitative Decision Making Process - The Decision Matrix Tool   Volume 1, Issue 6 - 2009 How to Evaluate the Competition for Free using Government Websites - Part 1   Volume 2, Issue 2 - 2010            Guest Feature - Part 1 How to facilitate market uptake by crossing the chasm between FDA approval and third party payment   Volume 3, Issue 1 - 2011            Guest Feature How to Build a Stellar Revenue Forecast - Bass Diffusion Model

Rasor Resource Industry Information

Timely information, events, and the principal's talk presentation and publication materials, that may be of interest to those in the medical device industry and to entrepreneurs, are available for download for one dollar each.

Publication Alert The Science of Friction - biomaterial sources diagram and excerpts from publication on spider web silk biomaterial use in devices Talk Alert Entrepreneurship in Silicon Valley, Annual Santa Clara University Women in Business Conference - Investment statistics in the USA and in Silicon Valley Talk Alert Idea to 510(k), Saturday Seminar Series, ISIS Services, LLC - Cross-functional management tool Talk Alert The Versatility and Power of the White Paper, Bio2Design - Multifunctional Chief Strategy Officer Scorecard Talk Presentation Slides Valuable Proven Tools for Medical Device Industry Executives: Learned from a 50+ Company Industry Experience - nine valuable tools presented to SJSU Master's Degree, Medical Product Development Management class FDA Alert FDA Deadline for Submission of Safety & Effectiveness Information for Certain Class III Devices - list of devices affected Talk Alert How to invent things Presented to Thursday Morning Dialog group		Paper Publication The Science of Friction - overview of tribology, asperites, fretting, and how to minimize friction when developing new medical devices. Special Feature Paper published in MedicalDevice-Network by SPG Media Limited, in association with Frost Sullivan, Eucomed and the Medical Device Manufacturers Association (MDMA) Talk Presentation Slides Entrepreneurship in Silicon Valley, Annual Santa Clara University Women in Business Conference - Entrepreneurial traits, fundraising tips, strategy and change Talk Presentation Slides Idea to 510(k), Saturday Seminar Series, ISIS Services, LLC - example business model flowcharts, fundraising metrics, and study design tips Talk Presentation Slides The Versatility and Power of the White Paper, Bio2Design - case studies and approximately 30 ways to effectively use a white paper Talk Presentation Slides Medical Device Invention and Founding Device Companies - case studies of speaker's inventions and experience founding 5 companies presented to SJSU Master's Degree, Medical Product Development Management class MPO Keynote Speech Slides Medical Product Outsourcing Symposium Keynote Speech "Breaking the Barriers of Organizational Silos" How to invent things Presented to Thursday Morning Dialog group - Discussion includes the Innovation Equation: Innovation = Creativity X Risk-taking