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A Perspective on the Device Manufacturing Supply Chain

A Perspective on the Device Manufacturing Supply Chain. Massachusetts Advanced Manufacturing Summit DCU Center Worcester, MA April 29, 2014. OK, well not really …. Quality Cost Delivery. What Device Manufacturers are looking for. Quality Quality System readiness cGMP adherence

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A Perspective on the Device Manufacturing Supply Chain

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  1. A Perspective on the Device Manufacturing Supply Chain

    Massachusetts Advanced Manufacturing Summit DCU Center Worcester, MA April 29, 2014
  2. OK, well not really … Quality Cost Delivery
  3. What Device Manufacturers are looking for Quality Quality System readiness cGMP adherence Supplier Quality (Tier 2, 3, etc.) Cost Materials Labor Vendors LCC Delivery 99% + No product outages!
  4. Call me Captain Obvious but …
  5. How are you reducing risk for your customers? So, having a Quality System that can pass 3rd Party Audits, Customer Audits, and FDA Inspections is one thing … Delivering cost effective components, sub-assemblies, and even completed devices is another … but …
  6. Measurement, Reduction, & Elimination of Risk Do you have a method to measure risk? Do you understand where risk resides within your organization? How confident are you in this: Do you feel your organization is behaving in a manner that is consistent with your expectations?
  7. Your People Your biggest asset And also your biggest risk Are they engaged? Do they understand your expectations? What happens if their behaviors do not align with your expectations?
  8. What everyone wants to avoid … … offered to settle all DePuy ASR lawsuits for roughly $4 billion … … to pay more than $11 million in … damages to a woman … injured by Gynecare Prolift mesh. FDA Fines Genzyme … agreed to pay … $175 million penalty … in connection with long-standing manufacturing problems … already cost the company millions.
  9. There are tools that can help … Predictive Behavioral Analytics Measuring the behaviors in the organization What are the accepted norms or culture? How is business REALLY being done? Does it deviate from goals & objectives? From cGMP? Analyze the results of the measurement Where are the gaps between expectations and actual behaviors? Plan to implement solutions Work with the organization’s team to plan & implement solutions Creating a ‘MAP’ can ALWAYS be done at a fraction of the cost of a major recall, cGMP violation, or worse …
  10. Getting Ahead of Risk and Org Alignment Issues Treat the cause, not the symptom You have to dig deep into the organization Assess from bottom to top Are behaviors throughout the organization consistent w/ goals & objectives? Putting solutions in place Address Root Cause Need to be owned & implemented by the organization Utilize metrics/dashboards to monitor progress
  11. So, what do you need to do? Ensure that you can block & tackle Execute on the basics Be proactive, not reactive Reduce and eliminate risk Think differently The world of healthcare is changing rapidly Those that can adapt will thrive
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