Stories from the front line – a Biotech industry study
I’m truly excited to publish this case study which is to be the first in an occasional series entitled ‘Stories from the front line’.
Case studies are useful reference tools for PMs. They allow us to examine and better understand a project path, in effect, what happened and why. They also allow us to analyse and identify real-life, real-time problems, and in doing so, the how, why and ’what the?’ questions are more easily isolated & unravelled. Of course no project, program or portfolio follows the same path, but the hindsights of thoroughly researched case studies enable us to implement effective solutions and improve best practice strategies. I encourage you to comment on this biotech study – send me your thoughts!
Aim of the project: New product to market.
Constraints: Sensitive to:
- Time as the company was aware of a competitor’s progress in the same direction
- COGS as the company needed government reimbursement (in all global regions) to get adoption
- Regulatory because of the FDA and other national and regional regulatory bodies.
- Market as the release date had been announced to the distribution channels (with the effect that orders for the current product were slowing down and sales channels were teasing the market with the new product)
- Share price as failure to deliver to expectations could wipe significant value off the company’s value.
History: The project had commenced two years earlier and was nearing the release date (three months out). The CEO was worried though as he ‘smelled’ a problem. All the project reports were showing green or amber and the budget was totally on track.
Review: My role was to review the project for the CEO and provide comfort or suggestions for moving forward.
Findings:
- The project was being managed under an adaptation of Prince II (meaning there were stage gates and approvals prior to moving to the next stage)
- In today’s language it was really a program rather than a project as it involved projects from engineering (electrical, mechanical, software), clinical, marketing, regulatory, manufacturing etc
- There was a tilt at earned value in as much as they knew what they should have spent by when.
- The project manager held weekly update meetings and updated the plan to reflect where they were up to.
- After watching the project for one month, it was clear that no progress at all was being made – except spending on schedule.
- Risks were being recorded in a ‘risk register’ but there was no active mitigation
- Everything was waiting for one activity that simply wasn’t progressing
- The reports and updates were all being done but progress had completely stalled.
- People on the project were completely comfortable with this as the process called for sequential effort and they were committed to not breaching the process (ostensibly for regulatory reasons)
- Everyone on the project loved the PM – a totally accommodating and understanding fellow.
- Because it was such a large and long project the one monthly stalling had not yet crossed the 10% variant tolerance
- There was absolutely no movement or idea about how to unblock the stalled part – it was as though they were waiting to break the variation tolerance so them they would know what to do.
- Estimated that left as it was, the project would complete at least 12 months later than predicted.
Remedy:
- Replaced the PM with someone who looked forward rather than simply reporting from a ‘rear vision mirror’ perspective.
- Removed the linear approach so all other parts of the project could continue (there was no actual dependency on the stalled part for at least six weeks)
- Introduced progressive integrated testing rather than testing only as planned at or near the end of development
- Installed some urgency via reporting on actual progress as against schedule for spending
- Suspended stoplight reports (RAG) in favour of reporting what was actually supposed to have happened by when
- Disallowed all % complete reporting and insisted that something was either done or not done (this introduced a level of discomfort that caused push back but was insisted on)
- Reworked the deliverables so there were clear achievement points (black and white) well ahead of the overall activity completing
- Brought together the people who could solve the ‘problem’ that had been ‘holding up’ the program – and solved it quickly once the right people felt free to contribute
- Focussed on the core requirements of traceability and regulation
- Orchestrated a coming together of the project elements at the right time rather than a linear arrival.
- Reforecast the project adding 16 weeks – and additional funding as the budget had been being spent without progress
- Delivered on schedule (as reforecast) – to the bewilderment of the project team and the original PM
- Reworked the implementation of Prince II to accommodate the desirability and benefit of parallel activities.
Outcomes:
All regulatory, clinical, testing and compliance requirements were met. The product remains in the market and there have been no recalls or problems outside the industry and company accepted tolerances.