Stage-gate process for life sciences and medical innovation investment

Abstract

Life science innovation has led to significant improvements in clinical outcomes and has been a source of financial growth for individuals and institutions capable of performing appropriate investments in this sector. Several groups have developed methodologies to assist medical technology innovators in the design and development activities. Unfortunately, these tools have not aided the general investment community to profit from these enterprises. This situation has contributed to a general reduction in risk capital directed towards life sciences compared to other industries. We review the current investment practices in the life science sector and present a comprehensive stage-gate model that aims to captures this investment process. An analysis of best practices and in-depth interviews with 68 life sciences investors and entrepreneurs worldwide are used to support such model. A single case-control study comparing life science investment execution within two similar investment firms was conducted to evaluate feasibility in the implementation of these practices. The stage-gate model includes (I) General vision and investment strategy definition; (II) Venture search, screening and rapid pre-evaluation; (III) Due diligence and negotiation of terms; (IV) Portfolio management, evaluation, and exit. The difference in execution of investment and results from a post-performance Root Cause Analysis were consistent with a reduction in perceived risk from the case company trained with the proposed model compared to the control. This suggests that our developed model and process may be useful in encouraging life sciences investment via evidence-based evaluations.