A biotech company formed an alliance with a large medical device manufacturer to develop and commercialize three device and reagent combination products. Cost and lack of resource availability dictated a staggered development approach, with the anticipation that revenues generated from the first commercialized product would support development of the subsequent products. However, sales from the first marketed product fell short of projections, which resulted in termination of the program. Further complicating the partnership was miscommunication between executive managers from both sides.
After a one-year lapse and upon securing additional capital, the alliance partners resumed development activities and made an aggressive commitment to submit the CE Mark application on the second product within eleven months. Since the original alliance project team had been largely disbanded, a new team was formed that questioned the aggressive milestone.
The biotech partner did not have an internal project management competency; however, they realized that this know-how would be critical to guiding the newly re-formed alliance team through successful development and execution of the CE Mark submission. Consequently, the biotech company retained the services of Integrated Project Management Company, Inc. (IPM) to fill this gap. IPM rapidly fielded an experienced project manager to work with functional teams across the alliance to identify the activities and deliverables required for the submission. Once a baseline plan was established, IPM worked with the team to find opportunities to complete activities in parallel to compress the schedule. Although the alliance team agreed the optimized plan was achievable, there was minimal room for either error or delay. To keep the project on track, IPM provided on-site assistance to ensure all alliance team members remained focused to their interrelated project activities and deliverables, and to keep the team apprised of project status and issues. IPM introduced numerous processes and tools into the alliance to facilitate execution.
Additionally, IPM facilitated the development of a risk management plan that included identification and communication of potential risks, development of mitigation strategies, and vigilant monitoring of risk triggers throughout project execution. When the team hit one of these triggers, it caused tension in the alliance due to corporate culture differences, perceptions of differing stakes in project success, and the poor relationship history. In lieu of imposing new contractual language that might further agitate the relationship and potentially mire the alliance project team in executive level issues, IPM objectively facilitated project team discussions toward a solution. Through focused communications, IPM ensured the project interface points were monitored, the project team remained attentive to project deliverables, and the overall project stayed on track.
IPM’s effective alliance management approach resulted in the submission of a robust CE Mark application that was well within the aggressive project schedule and budgetary constraints. The quality of the application was substantiated when, after an initial review, the reviewing authority for the European Union indicated the approval timeline would likely be reduced by two months. Despite alliance tensions, both organizations acknowledge the collective dedication and focus of the alliance project team to the project objective, which ultimately led to success.
Service: Product Development
Industry: Life Sciences