A client’s medical material was clinically successful but had not yet received FDA approval due to mounting production concerns regarding product quality. The FDA had informed the client that without a successful next trial, they would not entertain another review over other applicants for “a long while”, putting hundreds of millions in invested capital and valuation at risk.
Other technical experts had been retained without success. The challenge was that few truly knowledgeable experts existed who could cover manufacturing, chemistry and intellectual property simultaneously. This was a dire situation and the client needed a successful outcome over a short period of time, as commercial agreements were at risk of dissolution due to a lack of confidence.
We initiated a two-day ideation session where first a team of three consultants and experts engaged with a team of five manufacturing, senior research personnel and two senior executives. First, an overall context and understanding was developed by all sides regarding the firm, it’s status, it’s challenges and the specific perceived technical challenges. All production data was examined from the last several years. The key was realizing that the successful runs contained the data indicating the final solution. On the first day, via a facilitated, collaborative debate, the initial solution emerged based upon that production data alone. The second day, we completed a review followed by a designed experimental plan that also took into account the potential IP position, packaging methodologies as well as use by clinical personnel. Over the next several weeks, production testing was conducted.
Deliverables & Impact
After only a few weeks, the initial solution led to 14 straight production runs passing all quality tests and within 90 days FDA approval was received and the business was saved. Today this critical material provides the foundation for a high margin, billion-dollar annual business. Powerful intellectual property was established n a host of areas including formulation, packaging and use. The startup firm was acquired very profitably within three years.