Eric Eggers

About Eric Eggers

I provide deep domain experience to digital health companies and investors on available FDA regulatory paths as Principal of Digital Health Consult, which depending on product type and intended use could take the form of clinical decision support (CDS) software or general wellness products not regulated by FDA (enforcement discretion). This includes advising on artificial intelligence (AI) health products to determine paths that may be unregulated, and where products are FDA regulated, finding the lowest friction routes to the market. I also perform AI evaluation services for model developers to grade if AI / LLM products are staying within the guardrails of unregulated products, or if regulated, staying on target with their specific product requirements. As Principal of 510konsult LLC, I provide depth and expertise to FDA regulated medical device companies and investors on clinical, QA and regulatory matters for FDA class I / II 510(k) exempt products, class II 510(k)/ de novo classification / premarket approval (PMA) marketing submission required products, as well as pre-submissions (Q-subs) with FDA, including Q-subs seeking a Breakthrough Device Designation (BDD). Founder/CEO of kBLASTER®, an actionable insight tool for FDA 510(k) predicate search to aid regulatory strategy and maximize 510(k) clearance success.

Experience

1. Founder and CEO

   Kblaster Llc

   Apr 2011 — Present

   kBLASTER® is an actionable insight tool for search of the entire contents of publicly available FDA 510(k) summaries and de novo classification summaries. But only kBLASTER® transforms result management with effective tools, sorting, My Favorites, Saved Search and Search History.

Education

• Kenyon College

  BA, Anthropology

  1990 — 1994

Skills

• Clinical Trials
• U.s. Food and Drug Administration (Fda)
• Market Development
• New Business Development
• Cross-Functional Team Leadership
• Strategy
• Product Development
• Medical Devices
• Patents
• Fda
• Regulatory Affairs
• Product Design
• Product Launch
• Product Management
• Commercialization
• Hardware Diagnostics
• Entrepreneurship
• Start-Ups