Tuesday, November 22, 2011

The Playbook For Medical Innovation Success (and a great example)

Along with co-authors Robert Epstein, Jean-Pierre Lehner and Tehseen Salimi, the unrelenting Disease Management Care Blog has penned yet another peer-reviewed article (on page 9 here), this time in the newly established Journal of Comparative Effectiveness Research.  While the title "Integrating Scientific and Real-World Evidence Within and Beyond the Drug Development Process" speaks to the development of pharmaceuticals, the DMCB humbly submits that the article's lessons can be applied to any medical innovation.  That includes not only medical devices but population-based disease and care management, the Patient Centered Medical Home, value-based purchasing, ACOs and bundled payments.

The DMCB argues that in order for medical innovations to succeed, there has to be a readily identifiable value proposition. The challenge for innovators is that this perception of "value" varies greatly between patients, physicians, payers and government.  Meeting the expectations of these disparate stakeholders means creating a three phase process of integrating clinical data, economic information, patient centered outcomes, population-based and observational real-world evidence obtained from networks, communities, countries and populations:  

1) The Definition Phase: understand unmet needs and catalog how any potential benefits will meet those needs.

2) The Generation Phase:  formulate and validate the benefits by collecting the information that spans population health science, clinical epidemiology, economic modeling, patient reported outcomes, econometric studies, clinical trials and observational data bases.

3) The Translation Phase: establish the benefits from the very outset of any implementation through continuous monitoring and updating of any and all outcomes data for an increasingly sophisticated marketplace.

What ingredients are necessary to sustain the three phases?

1) Informatics that aggregate qualitative and quantitative analyses that include not only all that traditional research but spans meta-analyses, public databases, insurance networks and social networks that integrate patient, provider and payer insights.  This has to evolve in tandem with shifting market conditions;

2) An on-line and highly accessible intelligence repository that functions simultaneously as a database, library and registry;

3) A dossier that catalogs all quantitative and qualitative assessments that build the clinical and economic case for coverage and reimbursement;

4) High performing and interdependent expert teams that can interact with multiple stakeholders.

The DMCB thinks that the success of the Patient Centered Primary Care Collaborative can be credited to following this playbook.  Click around its web site and it's patently obvious that this coalition has worked to align the vision of transformed primary care with society's unmet needs, have prospectively collected any and all study outcomes and are continuously monitoring its impact in the real world.  Their PCPCC web site is a target rich collection of informatics, databases, dossiers and teams.

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