Case studies documenting how similar problems were overcome in the past can provide reminders of forgotten solutions. And, for problems that are unprecedented, historical analyses may improve our understanding of why these problems did not previously arise and suggest ideas for what might be done to solve them now.
Studying “who did what, when and why” should be particularly useful in addressing problems of bottlenecks and linkages. Scholars of technological innovation have shown that the successful development and widespread use of new products and services is the result of extended interactions between many individuals and organizations. These include scientists, engineers, designers, marketers, financiers, regulators and not the least, users, who contribute different kinds of skills, knowledge, and resources and solve related but different problems. Technological advances are thus the result of what one of us has previously called an ongoing, massively multiplayer game.
Bottlenecks and incongruencies are inevitable in such a game. In medicine for instance fundamental scientific breakthroughs may run ahead of the development of treatments. And the best treatments under well-controlled experimental conditions may be inferior in large scale deployment (for instance because of inadequate mechanisms to ensure patient compliance). Case studies encompassing multiple players and how they interacted with each other and over time to solve resolve bottlenecks and incongruencies should provide useful rules of thumb about effective rules for reforming the current medical advances game.
More broadly, studying medical advances could improve our understanding of “useful knowledge.” Scholars of the history of technology like Vincenti have persuasively argued that engineering is not merely applied science although it often draws on – and contributes to — the natural sciences. Natural sciences focus on discovering “how the world works” in ways that may not be suited to fields such as engineering, medicine, business, education and public administration whose principal purpose is to develop artifacts that don’t exist in nature and are intended to make the world a better place. Thus Amar Bhidé, Srikant Datar and David Roux both the natural sciences and fields of useful knowledge may aspire to be evidence based, but the kind of data collected and how it is used can be materially different.
In medicine for instance, Gawande’s WHO team blended expert hypotheses with rough and ready iterative testing to develop surgical checklists. Medical devices are also developed through similar processes. These would not be considered good practice in traditional scientific research.
Understanding and highlighting the distinctive features of useful medical research (as has already been done in engineering) should help prevent the dogmatic misapplication of the scientific method and possibly improve appropriate alternative practices. Moreover, the benefits could extend beyond medicine into fields such as economic development and financial regulation. The recent fashion for randomized experiment in the social sciences, if not appropriately bounded, has the potential for considerable waste of resources and even outright harm.
We plan to proceed incrementally, learning as we go. Thus in the first phase, lasting approximately two years we will pick five (or possibly ten) advances which would be on anyone’s list of significant advances. We have tentatively decided to pick these advances from the list in a paper by Fuchs and Sox of the top 30 innovations between 1975 and 2000.
We have no particular hypotheses in mind at this point other than the presumption of a protracted multiplayer game. Thus the case histories will cover the key individuals and organizations (including universities and dedicated research institutions); the nature and source of any underlying science; the main technical, commercial, and regulatory obstacles overcome; and, the amount and sources of funding.
The objectives of this phase will be 1) to test whether this research can provide real insights rather than just producing a collection of stories and 2) Gain a practical understanding of how long a comprehensive case study takes and the kinds of resources required.
Without waiting for the completion of this first set of case studies we will also start investigating what the larger set of 100 innovations might comprise. Our goal is to pick advances that would be widely accepted to have produced real health benefits and that also span a wide range, so that they include new drugs (prophylactic and therapeutic), vaccines, surgical procedures, diagnostic techniques, radiological interventions, hospital routines and medical devices. In making the selection we would expect to rely upon existing lists as well as the views of a panel of recognized authorities. We would hope such a panel would also provide feedback on the preliminary case studies and their analyses.
In scaling up to the full sample of case histories, we would like to assemble a team to do the research rather than do it entirely on our own. It would be infeasible for one or two individuals to compile comprehensive case-histories of 100 advances. Using a team of researchers will provide the additional benefit of bringing to bear different perspectives and limiting the effects of a single researcher’s bias. At this stage however it is premature to speculate how long each case would take or cost. Finding that out would be an important goal of the first stage of the research.