Fallout at Meridian Health Systems

Instructions

This simulation is inspired by real-world events and will unfold over three steps. At each stage, you should select all of the responses that you feel are appropriate given the information you have received up to that moment. After each submission, your selections will be checked and the scoring rationale for each choice will be provided.

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Reexamining Innovation Oversight and Scientific Governance

Meridian Health Systems, a high-profile healthtech company, is in crisis after serious doubts have emerged about the efficacy of its breakthrough blood-testing device. A whistleblower from within the company’s research unit revealed that clinical accuracy results were selectively reported, and that regulatory filings were incomplete or misleading. The board had enthusiastically endorsed the CEO-founder’s vision and fast-tracked market expansion after being told that the device had “FDA alignment.” However, no independent review of clinical results was ever commissioned. The board’s Technology and Growth Committee had oversight of product milestones but did not include directors with clinical or regulatory expertise. Now, regulatory scrutiny looms, and the board must act decisively. What should the board do at this point?

Rebuilding Trust Amid Investor and Media Scrutiny

With mounting press attention and growing skepticism among investors, Meridian’s board is under pressure to explain its oversight of clinical validation and regulatory compliance. Investor groups are questioning how the board allowed such a major product to scale without direct independent review. Social media commentators have framed the story as “Theranos 2.0,” and congressional staffers are reportedly preparing inquiries. Regulatory agencies have not yet announced formal investigations, but the damage to reputation is growing by the day. The board must determine how to engage stakeholders without compromising legal risk or undermining investigative processes underway. What should the board do now?

Strengthening Long-Term Oversight of Regulated Innovation

As investigations and audits begin, Meridian’s board recognizes the need to address deeper structural issues. Directors acknowledge they did not adequately challenge optimistic performance claims and were overly reliant on the CEO’s narrative. Some directors lacked experience with regulated clinical products, and committee charters failed to define clear oversight pathways for scientific risk. The board now seeks to institutionalize new governance practices to prevent such lapses in the future and build a framework for ongoing oversight of innovation with public health implications. What should the board do now?