Optimizing a Clinical Research Program

Originally Published MX September/October 2003

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

An early-stage company can save time and money if it develops a suitable program.

Cynthia Fink and Beth Silverstein

Managers of medical device firms must realize that having an effective clinical research program in place from the beginning is vital. Executives of early-stage medical technology companies know that investors concentrate on funding later-stage companies with viable products to offer. However, small medtech companies in a hurry to meet milestones imposed by investors, or under other business pressures, all too often rush to get a device into clinical study without fully understanding what data are needed for marketing approval. As a result, time to market may be extended as the company revises clinical study protocols, adds investigational sites, considers adding new research end points, increases the sample size, performs more statistical analyses, or undertakes further studies.