Technical update on PPH Technologies: High quality, affordable - - PowerPoint PPT Presentation

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Technical update on PPH Technologies: High quality, affordable - - PowerPoint PPT Presentation

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Technical update on PPH Technologies: High quality, affordable NASG; balloon Tamponade; and haemostatic Agents Paul LaBarre, MME Technical Officer, PATH January 25, 2011 Drivers of affordability and quality initiatives High cost of the

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Technical update on PPH Technologies:

High quality, affordable NASG; balloon Tamponade; and haemostatic Agents

January 25, 2011

Paul LaBarre, MME Technical Officer, PATH

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Drivers of affordability and quality initiatives

  • High cost of the
  • riginal NASG
  • Additional costs

incurred through logistics inefficiencies

  • Quality issues

Photo credit: Suellen Miller

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SLIDE 3

Process toward affordable, quality NASG

  • Fingerprint mapping
  • DMR (Device Master Record)
  • Sourcing
  • Quality plan
  • Ordering
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Process (finger print mapping)

Photo collage credit: A. Beddoe, PATH

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SLIDE 5

Process (DMR)

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SLIDE 6

Process (sourcing)

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SLIDE 7

Process (Quality Plan)

  • Ensures high quality of samples is carried
  • ut through production
  • Development of the QP includes risk

assessment, understanding supplier motives

  • Qualified materials
  • Final Inspection (3rd party) prior to shipment
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SLIDE 8

PO No change

to Design or Material No No

YES YES

Material Certification Testing

(PATH or 3rd party)

Approved to Criteria

(PATH or 3rd party)

YES YES

Preproduction preparation and raw material procurement

(Manufacturer)

Incoming QC

(Manufacturer)

CoC incoming materials

(Material Supplier)

Begin Production

(Manufacturer)

Outgoing QC

(PATH or 3rd party)

YES YES

Final Random Inspection (FRI)

(PATH or 3rd party)

Approved for goods to ship

(PATH or 3rd party) Certificate

  • f

Compliance (CoC) required for: Velcro Neoprene Foam Ball

YES YES

NO NO

Production Ex-factory

(Manufacturer)

Order Fulfillment Manufacturing Design and Material Control

Rework

(Manufacturer) CoC packaged w/ goods for: Velcro Neoprene Foam Ball

Inline Production QC

(Manufacturer)

Sample Confirmation

(PATH or 3rd party) NO NO

Change Requires Sampling

(PATH or 3rd party)

Change Requires Testing

(PATH or 3rd party)

Required for changes to: Velcro Neoprene Foam Ball

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Results

  • Fully qualified large NASG manufacturer in

China who can supply the garment at a price

  • f US$54 (freight on board [FOB]).
  • Technology transfer completed to a large

NASG manufacturer in India who can supply the garment at a price of US$65 (FOB). Qualification of this manufacturer is still in progress.

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SLIDE 10

Photo collage credit: 3rd Stone Design

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Remaining challenges

  • Vissco – Indian supplier
  • Multiple Sizes
  • Demand, minimum order quantities and lead

times

  • Cleaning logistics and protocol
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Vissco

Photos courtesy: Vissco Photo credit: A. Beddoe Photo credit: A. Beddoe

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Demand, minimum order, lead times

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NASG Sizes

CURRENT RECENT HISTORY ANCIENT HISTORY LARGE standard geometry but with 4-5" added to panels 5 and 6 standard geometry but with 4-5" added to panels 5/6 standard geometry but with 4-5" added to panels 5 and 6 MEDIUM standard geometry standard geometry standard geometry SMALL small geometry designed for India N/A N/A

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Cleaning logistics and protocol

Photo courtesy: Pathfinder

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Other emerging PPH technologies

  • Balloon tamponade
  • Hemostatic agents
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SLIDE 17

Photo credit: P. LaBarre Photo credit: P. LaBarre

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Hemostatic agents

  • Haemostatic agents: have gained widespread use for pelvic surgery in

last few years. Specifically, they are good for use in areas of difficult

  • accessibility. (Shah, 2009)
  • Uterine Atony: “FlowSeal delivered to the oozing area through single

syringe, Hemostasis was achieved instantaneously – recommended as an adjunct to conventional methods” (Moriarity, 2007)

  • Challenges with mixing/packaging: Further research needs to be

conducted to improve product use. Current challenges include ease of mixing, form factor not specifically designed for uterine application, delivery method, pre-measured dose packaging.

  • Price negotiations
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Large NASG ordering details

Price: $53.76 USD FOB China Lead time: 60 days Minimum order: 1000 units Manufacturer: Neil Pryde Performance Manufacturing, China Orders placed to: Blue Fuzion Group Ltd- Hong Kong http://www.bluefuziongroup.com/ Contact: julian.cosgrave@bfgroup.asia Questions: contact Paul LaBarre, PATH; plabarre@path.org

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NASG Team Acknowledgments

PATH Team

– Bill Van Lew – Lloryn Hubbard – Justin Roth – Fay Venegas – Keith Neuroutsos – Andy Beddoe – Shannon Mills – Jill Sherman Konkle – Noah Perin – Elizabeth Abu-Haydar – Mike Eisenstein – Trish Coffey – Dave Sylvester

Consultants

  • 3rd Stone Design
  • Betsy Wilskie

Collaborators

  • UCSF, Suellen Miller
  • Pathfinder:
  • Susan Collins,
  • Cathy Solter,
  • Dr. Faruke,
  • Dr. Titilola Duro-Aina,
  • Maryam Buba
  • Rema Nanda
  • Sachin Kothari

Interns

  • Colm Fay
  • Mike Watt
  • Nathan Schmidt

Donors

  • Health Innovation

Portfolio

  • USAID, HealthTech
  • MacArthur

Foundation