Medical device startups need discipline of stage-gate process
Despite the many challenges that larger companies have in developing new products, to their credit, most medical device companies have mastered the process of Stage-gate portfolio management. Startups and single product development efforts don’t typically manage a portfolio of projects, and hence have not paid as close attention to following a stage-gated approach.
According to the company fittingly named Stage-Gate International, “a Stage-Gate Process is a conceptual and operational roadmap for moving a new-product project from idea to launch.” Teams must complete pre-defined tasks in each stage prior to gaining approval to proceed to the next development stage.
Although startups and clinical innovators need to avoid the confining chains of large company bureaucracy, the discipline of a stage-gate process leads to greater freedom for the development team. The team has defined deliverables and funding to reach a decision point or “Gate.” In this fashion, a stage-gate process contributes to focus and aligning expectations.
Although a startup or individual physician inventor should consider the larger product development life cycle, one key to providing discipline to a creative and ambitious team is to focus on one stage at a time.
Concentrating on the Concept/Feasibility phase, for example, the deliverables may be stated as:
- Initial working prototypes and testing
- Preliminary customer feedback
- Business case analysis
- Intellectual property (i.e. patents) landscape.
Prior to proceeding to the full development stage, the management team can assess whether the outputs to these parameters merit further investment or whether other opportunities provide better return on investment. Additionally, time windows should be defined for stages, since excessive durations must trigger a stage-gate interim-review to avoid never-ending stages.
Typically, each subsequent stage is more expensive than the previous. As such, a stage-gate process not only provides discipline and dovetails with FDA Design Control requirements for Design Reviews, but limits expenditures prior to the team demonstrating sufficient support for investments.
Don’t be fooled into thinking that stage-gate is for the big guys or will add needless processes and procedures. To ensure the greatest success in your medical device innovation, you must be willing to quit while you are ahead. Without a formalized stage-gate, gaining consensus on stopping a project leads to wasted time and money. And, that means less time and money for your more viable ideas and projects.
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