Think B Squared LLC

True Program Management for Medical Device Startups

Program management is the development of an overall strategic plan, and project management is the tactical implementation of the various elements of the plan. In medical device startups with limited resources and small teams, project and program planning are often blurred together, with a bias toward the work in progress, which can put teams in a reactive state. We give your executive team a forum and tools to proactively analyze overall impact of changes, assess the value of adding or removing work, understand risks, and identify opportunities, all in real time and without disturbing the team and work that is already underway.

Live Dashboard

We work with existing project schedules to create a live program dashboard that shows all of the most important project information on one page. The program view is quick to update and flexible to accommodate changes easily.

The live, interactive dashboard provides executive team the tools and information needed to do proper long-range planning.

Integration with Existing Schedules

No need to re-create schedules, buy new software, or learn new techniques. We integrate your existing project schedules into the program schedule. Keep doing your business and we'll build on that to create an interactive program dashboard that unlocks powerful strategic planning capabilities.

Program Management Process

  1. Deep dive

    1. Review existing schedules and update as necessary. No need to re-do any planning that has already been done; our process is compatible with all project management methods and software.

    2. Create any schedules as needed. This includes timelines for future work such as additional clinical trials, interim commercial filings, commercial launch in various geographies, next generation product development, etc.

  2. Create custom program dashboard

    1. Reduce the information. Identify key activities that gate other cross-functional workstreams (R&D phase reviews, clinical submissions, commercial submissions, regulatory and clinical approvals, etc.) from project schedules. This isn't always critical path items.

    2. Identify key events that need to be tracked e.g. tooling purchase, design verification or clinical build start, fundraising triggers, filing decisions, commercialization decisions, etc.

    3. Build a program level Gantt chart. Add durations and predecessors to tasks, schedule, and review project for accuracy.

    4. Create and review program dashboard. Fine tune layout and information presented.

  3. Go live

    1. Review and update schedule monthly or quarterly, and following completion of a milestone, major change in scope, prior to a board meeting, etc.

    2. Schedule major revisions as needed (unplanned design change, additional clinical trial, regulatory classification change, etc.)

Benefits

Facilitate strategic discussions. We provide the executive team neutral ground and the information needed to properly plan.

We come up to speed quickly. Dedicated time is spent in the beginning of the project to learn the technology, meet the team, and review timelines and plans, in order to become productive as soon as possible.

See how the entire schedule is impacted by changes. Because of how we reduce the information used to build the program Gantt, the impact of schedule changes to the important milestones, triggers, decision points, etc. are easily visible.

Minimize burden to your team. By leveraging existing schedules, we avoid the extra time and cost that would be required to rebuild them.

Traditional Project Management

We continue to provide traditional project management services, such as:

  • Creating and updating detailed project schedules, such as R&D, regulatory, clinical, operations, marketing

  • Hosting recurring team meetings, creating agendas, minutes, tracking action items

  • Creating and maintaining Design History Files

  • Coordinating and hosting Phase Reviews

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