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Pragmatic approaches to improving productivity

DIA Euro Meeting 2016 Hamburg. Waife & Associates, Inc. April 2016. Pragmatic approaches to improving productivity. Why Process Improvement?. Not such an obvious question Well-executed process improvement really can lead to: Fewer crises Smoother audits

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Pragmatic approaches to improving productivity

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  1. DIA Euro Meeting 2016 Hamburg Waife & Associates, Inc. April 2016 Pragmatic approaches to improving productivity

  2. Why Process Improvement? • Not such an obvious question • Well-executed process improvement really can lead to: • Fewer crises • Smoother audits • Preserving and protecting staffing • Improved control over internal and third-party resources • Reducing some delays • Saving some money!

  3. Improving Clinical Trials Productivity • New methods and technologies • RBM • Accelerating protocol development • Using mHealth to improve compliance • Diversifying patient enrollment approaches • New policies can be followed • Reduce protocol amendments • Tighten vendor oversight • Eliminate data “triple-checking” • Streamline Study Startup • But underlying all of these initiatives are processes • The way we work

  4. Process Improvement: Do We Need New Targets or New Methods? • Clinical development management is often frustrated with process improvement projects • Some companies express an abstract desire for “innovation” without knowing how to get there • There are examples of how innovation+focus can make up for enterprise ineffectiveness • But: • We aren’t done achieving the traditional targets (we didn’t aim well) • “Innovative” targets may also be missed in those companies who do not execute innovation well

  5. The Demise of Operational Excellence • “Operational Excellence” has been a popular euphemism for process improvement • We needed a euphemism because of PI’s bad reputation • Instead though, we are sliding toward “Operational Mediocrity” in improvement execution • Why do we end up closing our TQM/Process Improvement/Operational Excellence/Change Management/Eight Sigma/Program Office departments? • Why isn’t our innovative science backed by innovative process?

  6. What Is Wrong with Process Improvement? • Insincere Management intent and support • “Change Fatigue” • Under-funding • Change skepticism • Nothing happens • Anti-climactic conclusions • Job-threatening conclusions • Misunderstanding Change Management • It’s more than posters in the hallways

  7. Dangerous Language • “Being disruptive” is the new “operational excellence” • Disruptive? Seriously? • Anyone ready to “disrupt” if it means firing people or seriously changing assumptions and history? • Another linguistic breeder of skepticism

  8. “It Hurts Plenty”

  9. Pragmatism and Incremental Success Overcomes Fatigue and Skepticism There is a path to process improvement activities which can achieve crucially important changes: • Holding key business drivers in mind, • Select an impactful but manageable target, • Avoid elaborate techniques and jargon, • Identify a small knowledgeable working group, • Design an improved process for a small piece of the puzzle, • Implement, learn, iterate, • “Rinse and Repeat”

  10. “EBM” • Instead of Disruption, and posters-in-the-hallways, and Hungry-8-sigma, I would suggest “EBM” • Evidence-Based Methods, like Evidence-Based Medicine • As compared to… • ABM (Academic-Based Methods) • JBM (Jargon-Based Methods) • PBM (Profit-Based Methods)

  11. Evidence-Based Methods Work Like This Understand your Key Business Drivers Break down target into pieces Get 360-degree view from anyone affected Workshop with knowledgeable and/or key participants Design resulting improved process for first piece Implement Learn Iterate (revise) Meanwhile, start on the next piece

  12. Examples Where It Has Been Applied eTMF RBM New-gen EDC PV Case Processing Study Site Start-Up CRO Oversight Non-CRF Data Processing Etc…

  13. Key Issue: Process Improvement Governance • This is a key to failure and frustration • How should process change be governed? By whom? How often? • Do we need dedicated departments, executives or facilitators? (Maybe) • Can in-house personnel be permanent roving facilitators? • The risk of separating operational domain knowledge from process knowledge • Should process doers own their processes (and their improvement)? (Probably) • The advantage of the objective domain-expert process professional

  14. Improving Process Improvement We can’t give up out of frustration, anymore than we can stop researching because the failure rate is so high A pragmatic strategy that focuses on iterative steps of success will re-build confidence and achieve true, meaningful improvements in how we develop drugs.

  15. Reach the Speaker ronwaife@waife.com +1 781 449 7032 www.waife.com

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