SPIE Medical Imaging 2014 Workshop: Commercialization of Medical Research. Guy Shechter Philips Healthcare

Transcription

1 SPIE Medical Imaging 2014 Workshop: Commercialization of Medical Research Guy Shechter Philips Healthcare

2 A look back to 2004, a personal story: Prospective motion correction of X-ray images for coronary interventions

3 University Tech Transfer Office: Provisional patent application but bring us an interested vendor. Just because we can do it, doesn t mean we should do it. There may exist other means to the same end. What s it going to cost and who s going to pay for it?

4 Pay for it? It s just a small software mod Quality systems Regulatory Evidence development Market education

5 Value Proposition Call it a value proposition, a unique selling point, whatever it is, you need to clarify what you do, who you do it for and what makes it different from everyone else into a simple, clear believable statement Marketing Assassin Blog

6 Complexity of a value proposition in healthcare Multiple stakeholders Patient Physician Hospital Administration (ie. CFO, purchasing) Payer Changes to clinical pathways may upset the balance Pursuit of the Triple Aim (Donald Berwick) Improving the experience of care Improving the health of populations Reducing the per-capita costs of healthcare

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8 Obstacles to the Pursuit of the Triple Aim Supply driven demand. New technology with limited impact on outcomes. Physician-centric care. Little or no foreign competition. Little appreciation of system knowledge among clinicians. Transparency in quality metrics. Accurate cost accounting.

9 The Role of an Integrator Only a single organization (not a market dynamic), can induce coordinative behavior among health service suppliers to work as a system for the defined population. Involving individuals and families Strengthen the role of primary care teams / medical home Increase preventive behavior Allocate resources within the defined population Define, measure, and make transparent the costs of care Approach new technologies and capital investments with skepticism Deliver care that is evidence-based and highly reliable

10 The Triple Aim Paradox? Interdependent goals: Changes pursuing any one goal can affect the other two, sometimes negatively and sometimes positively. These changes may occur at different times. Should your business focus on one, two or all three goals? Principal-agent problem: From the viewpoint of a national entity, the Triple Aim is essential. From the viewpoint of an individual actor responding to market forces, pursuing all three aims at once in not in their immediate self interest. Should your business focus on the principal or the agent?

11 Medical Regulatory Is it a medical device? Shantanu Nundy, et al. Mobile phone diabetes project led to improved glycemic control and net savings for Chicago plan participants. Health Affairs 2014; 33(2):

12 Medical Regulatory Class I, II, or III 510(k) vs. PMA Regulatory clearance/ approval allows one to market a product, but doesn t guarantee market adoption. Barbara Buch. FDA Medical Device Approval: Things you didn t learn in medical school or residency. Am J Orthop. 2007; 36(8):

13 Evidence Development Start planning for both regulatory and market acceptance The required level of evidence will be decided by the one in need of convincing. Efficacy Does X cause an effect in ideal situations? Homogenous test groups. Subjects who deviate from a protocol may be excluded from analysis. Effectiveness Does X work in the real world? Heterogeneous test groups. All subjects might be included in the analysis based on an intent to treat.

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