Medical Devices Company

The Situation:

  • Lost virtually all of their business.  The business was in crisis.
  • Their biggest customers accused them of “bait and switch” and they decided not to use them anymore.
  • There was no reasonable competitive advantage and they were losing all the bids to their competitors.
  • Everyone was scared, finger pointing was rampant, nobody knew what to do, everyone was waiting to find out what was next.
  • All the talent of the company was leaving.

The Wants:

  • A way to differentiate themselves to the competition so that they could save themselves.
  • A methodology where they could predict if a project was in trouble or on track for time and budget.
  • A happier work environment that would attract the talent they needed to grow the business.

The Level II Six Month Project:

  • Listened and spent time uncovering their concerns.
  • Allowed their voices to be heard to senior management where everyone was calibrated on the current state and current reality of the business.  Where everyone was made aware of the cause and effect of the current reality.
  • This started the alignment process where people started looking ahead instead of behind.   When people are heard they can let go of their baggage.
  • A team was formed to figure out the best way to do product development work.
  • A set of project management methodologies and constructs were presented to the team.  SCRUM was discussed but it had failed in the past.  Since looking at the past was no longer permitted the team started to explore the possibility of using a SCRUM based project management construct.
  • The team started to mastermind and looked at how SCRUM could be integrated within the usually accepted stage gate methodology (waterfall) described in PMBOK…Process Management Body of Knowledge.  PMBOK was the accepted standard of the FDA.
  • The team figured out how to integrate SCRUM with what was required by the FDA within the PMBOK methodology they were use to.  What was thought to be impossible was not with the collaboration of the team which was able to create an innovative project management construct based on SCRUM.
  • The team then worked with the field engineers, application engineers, and sales engineers, to develop a new format for developing requests for quotation, proposals, and contracts.
  • They were able to outbid the competition not based on price, but on being substantially faster in the development and commercialization time for a new medical device.
  • Not only that, in something unheard of in the industry, they were able to present to the customer fixed bid contracts.  This eliminated the risk of a client customer of feeling like they would be vulnerable to a bait and switch.

The Result:

  • The business went from losing hundreds of thousands of dollars a quarter to making hundreds of thousands of dollars per quarter.
  • Instead of having virtually no customers for design of new medical devices, proposals were accepted and they quickly had to move into a hiring mode in order to meet the demand in an ever growing backlog.
  • Work became fun again.  Workers, engineers, and customers became confident in the new process and everyone overcame obstacles rapidly because everyone was collaborating, including the customer, with the team.
  • Contracts were fulfilled on time.  New medical devices were taking 8 months or less to design and commercialize where the industry standard for the same level of sophistication was 18 to 24 months.
  • The costs of the contracts were millions of dollars less then what was typical using the stage gate or waterfall project management that was the standard for the medical device industry.
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