The CEO Who Sponsors Innovation but Bypasses the Process
BioNova is a 200-person medical-device company with a formal stage-gate process for new products. The CEO chairs a quarterly innovation council that is meant to review the portfolio, but he has missed three of the last four meetings. There is no approved innovation policy. Decision rights are unclear: a senior vice-president fast-tracked a personal project through the stage-gate without the required feasibility review. The project consumed 18% of the annual R&D budget and failed late because a regulatory pathway had not been assessed. Team leaders say that 'innovation is whatever the CEO says it is'. No one has been assigned authority for innovation performance, and there is no competence plan for innovation roles. The council minutes record only project updates, not decisions or actions. The quality manager wants to add a mandatory innovation training course and consider the leadership issue closed.
1. Identify the leadership and process nonconformities suggested by the BioNova scenario, with reference to ISO 56001 requirements.
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The scenario points to weaknesses in leadership commitment, innovation policy, roles, responsibilities and authorities, competence, and control of innovation operations. Top management is expected to demonstrate leadership by establishing policy, ensuring resources, integrating innovation into business processes, communicating direction and promoting improvement. A CEO who chairs a council but misses most meetings and allows a senior leader to bypass the stage-gate is not providing consistent governance. The absence of an approved innovation policy removes a key framework for objectives and decision-making. Unclear decision rights and no assigned authority for innovation performance mean accountability is not established. The fast-tracked project shows that the stage-gate process is not being applied as defined; the missing feasibility and regulatory review is a process control failure, not merely a bad project outcome. The council minutes that record only updates suggest the review is not performing a portfolio decision function. Finally, there is no competence plan for innovation roles. A mandatory training course may address awareness, but it does not fix policy, authority, decision rights or process control.
2. What should top management do to demonstrate leadership, and how should the bypassed project be handled within the innovation management system?
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Top management should approve and communicate an innovation policy, set innovation objectives, assign clear roles and authorities, and define decision rights for the stage-gate and portfolio reviews. The CEO should either attend the council consistently or delegate chairing with explicit authority, and the council should record decisions, resourcing and actions, not just updates. Leadership should also ensure that stage-gate criteria, including regulatory feasibility, are applied and that exceptions follow a defined escalation route. The bypassed project should be handled as a deviation or nonconformity: record what happened, assess the impact, determine root causes such as unclear authority or pressure to fast-track, and take corrective action. The organization should review whether the stage-gate process needs stronger regulatory screening and whether decision rights allow a single executive to override it. Lessons from the failed project should feed risk management and portfolio decisions. Training can support competence, but it should be part of a broader competence plan and should not be presented as a substitute for leadership accountability and process control.