Steak at McDonalds???

This is probably my first post that begins to allude to what I actually do for a living.  While I am a biostatistician, it is for a corporation and management is an underlying theme to my everyday life.

I have noticed in recent times that research & development is one of the most stressed areas in healthcare corporations.  I see a burning desire to speed the time to market and cut months, days, and sometimes even hours from timelines.  I am not kidding. People actually look at MS Project gantt charts and question, "Do you need 4.5 hours to do task x?".  I like to call this the phenomena of wanting steak at McDonald's.

You're probably saying to yourself that Mike is exaggerating and this is just another one of his funny lines.  Let me assure you that I am not.  McDonald's is really good at taking a short menu with a few permutations (combo's) and setting up a system that can crank out anything you want within those confines in less than a few moments.  You cannot ask for grilled mahi mahi, or crusted halibut at McDonald's.  Before a new menu item can be added, it is judged for various qualities to determine if it will fit the McDonald's model.  Can raw materials be easily sourced?  Does the time from source to distributor to store to customer fit into the current supply chain?  Does prep require additional training?  Will existing equipment fit the preparation needs?  Can it be priced to return a reasonable profit given all of the above?

Healthcare R&D that develops new drugs, devices, and therapeutics operates under some rather strict guidelines.  A true clinical study cannot simply be started without going through a number of hoops that each require time that a company cannot completely control or even influence with money.  Among these are FDA approval to test on humans, IRB approval to conduct a study, site recruitment and training.  These remain largely untouched by the phenomena I am taking about.  The parts of the process that companies have decided to treat like the McDonald's model are protocol writing, data specifications, analysis plans, data management, case report form generation, data analysis, data reporting, and other things they feel they have control over.

Existing processes at good companies were geared to be fully accountable.  This happened after years of fear of failure in the public eye and the desire to seem perfect to regulating agencies.  In the current day, management wants the same inscrutable system but faster.  An admirable desire but not one the industry was prepared for.  It is like they want to keep their steak but order it at McDonald's.

The fact that the industry is as developed as it is and we still have no efficient way to deal with these items is amazing.  Any company wanting to work through these obstacles is basically left to develop a custom system or customize an existing set of tools and systems to make it work.  I could be a millionaire if I could solve this problem.

Bottom line is that if you want to tackle a problem that will revolutionize product development in healthcare, find a way to make these parts of the system seamless - I will be your friend.  Statisticians just want clean data shaped to their specifications.