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  • March 2015 (Revised February 2022)
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CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies

By: Regina E. Herzlinger and Andrew Otazo
  • Format:Print
  • | Language:English
  • | Pages:22
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Abstract

Duke Rohlen (HBS MBA ’01) hoped to win over a prominent venture capital investor for Series B financing of his firm CVI that was creating a drug-eluting balloon (DES) to treat peripheral arterial disease. As a second-mover, Duke felt he was more likely to acquire funding because his primary competitors had already received FDA approval to conduct a trial and he had learned a great deal about how to improve the DES from the problems the first mover encountered. But Duke’s strategy ran counter to many business guru injunctions. Would these bar the investment? His second mover strategy was unconventional because many medical technology marketers believed that being the first technology to be adopted by clinicians was critical to future success. But Duke had spent no money on marketing .Instead, he spent his limited funds on R and D that would correct the problems experienced with other DESs. Then too, he had allowed a likely exit, Covidien, to invest early in CVI and used their balloon. Would Covidien’s relationships bar other bidders and lower the price CVI would receive? And instead fo using a CRO, Duke performed his own clinical trial of the DES. Did he have sufficient expertise to pass through the FDA’s stringent regulatory hurdles?

Keywords

CV Ingenuity; CVI; Drug Eluting Balloon; DEB; Drug Eluting Stent; Angioplasty Balloon; FoxHollow; Medical Device; Medical Device Startup; Premarket Approval; PMA; Lutonix; Stellarex; LEVANT; ILLUMENATE; Clinical Trials; Peripheral Arterial Disease; PAD; Healthcare Startups; Covidien; Health Care and Treatment; Health Testing and Trials; Business Startups; Commercialization; Health Industry; Medical Devices and Supplies Industry; United States; Europe

Citation

Herzlinger, Regina E., and Andrew Otazo. "CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies." Harvard Business School Case 315-045, March 2015. (Revised February 2022.)
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About The Author

Regina E. Herzlinger

General Management
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Related Work

    • March 2015 (Revised February 2022)
    • Faculty Research

    CV Ingenuity (B): Epilogue

    By: Regina E. Herzlinger and Andrew Otazo
    • April 2017
    • Faculty Research

    CV Ingenuity (A) and (B)

    By: Regina E. Herzlinger
    • March 2015 (Revised February 2022)
    • Faculty Research

    CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies

    By: Regina E. Herzlinger and Andrew Otazo
Related Work
  • CV Ingenuity (B): Epilogue By: Regina E. Herzlinger and Andrew Otazo
  • CV Ingenuity (A) and (B) By: Regina E. Herzlinger
  • CV Ingenuity (A): How to Evaluate the Commercial Viability of New Health Care Technologies By: Regina E. Herzlinger and Andrew Otazo
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