1 / 11

Navigating Innovation: The Journey of Kerberos Proximal Solutions, Inc. in Medical Device Development

This document outlines the timeline and strategic decisions of Kerberos Proximal Solutions, Inc., from 1999 to 2006, focusing on their development of embolic protection devices in medical applications. It covers idea generation, technology evolution, competition, regulatory challenges, and critical decision points. Key transitions include pivots from carotid protection to saphenous vein grafts, acute myocardial infarction, and finally to peripheral arterial disease. The importance of adaptability and the ability to seize market opportunities are emphasized through lessons learned over the years.

lola
Télécharger la présentation

Navigating Innovation: The Journey of Kerberos Proximal Solutions, Inc. in Medical Device Development

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Kerberos Proximal Solutions, Inc. Tom Goff Fred Khosravi John MacMahon Carl Simpson

  2. Mar 01 Dec 01 Jun 03 Dec 04 Timeline

  3. 1999-2001Idea Generation & Evaluation Carotid Embolic Protection • Medical Device Design class (precursor to BioDesign) • Company formation • Technology evolution • “Engineering” approach • Competition / intellectual property • Clinical trial/regulatory hurdles

  4. Audience Response Critical Decision #1: What should the company do next? • Develop their own carotid stent for testing with the protection device • Sell the company to a carotid stent developer • Find a new application for the technology

  5. 2001-2002Indication Reevaluation Refocus on saphenous vein graft (SVG) embolic protection • Venture funding • Further technology development • Human clinical study under IDE • Complexity of approach/workflow integration issues • Product sizing requirements

  6. Audience Response Critical Decision #2: What should the company do next? • Redesign the product for easier usage in SVGs • Sell the company’s assets • Find a new application for the technology

  7. 2003-2005Indication Reevaluation & Product Redesign Refocus on acute myocardial infarction (AMI)/thrombectomy • Boston Scientific investment • Product redesign • 510(k) approval for peripheral indication • Human clinical studies in AMI • AMI competitor failures & study design issues • Difficulty of AMI sales

  8. Audience Response Critical Decision #3: What should the company do next? • Keep the company focused on selling the product for AMIs • Establish a corporate partnership for help in positioning/selling the product for AMIs • Sell the company’s assets • Find a new application for the technology

  9. 2005-2006Indication Reevaluation Refocus on peripheral arterial disease (PAD) • PAD clinical study data not required • Rapidly expanding market opportunity/easier sale • Use in combination with stenting/angioplasty/ atherectomy • Revenue from AMI and PAD sales • Company acquired!

  10. Mar 01 Dec 01 Jun 03 Dec 04 Evolution Summary TechnologyProximal Embolic ProtectionRinspiration Thrombectomy

  11. Summary LessonBe Nimble, Be Quick ! Market and product configuration should not be set in stone upfront Need for constantly evaluate: • Intellectual property • Clinical study design requirements • Product design • Work flow integration • Clinical study results • Competition • Expanding market opportunities Need ability to refocus/evolve quickly

More Related