Cook® Medical - Developer and Manufacturer of Finished Medical Devices

Cook® Medical - Developer and Manufacturer of Finished Medical Devices

•  Cook established in 1963 – offers three products •  Today, 15,000+ products, 11,000+ employees worldwide,

16 medical entities, manufacturing on three continents, nine (9) strategic business units (SBUs), 2 shared service centers, distribution into more than 135 countries across more than 35 regulatory regions

•  Global representation interacting with 42 medical specialties focused on development of minimally-invasive and converging medical technologies (Devices, Biotechnology, Biopharma and Cell Therapy)

Cook® Medical - Developer and Manufacturer of Finished Medical Devices

Diagnostic Procedure

•  Upper GI: esophagogastroduodenoscopy (EGD)

•  Lower GI: colonoscopy or sigmoidoscopy

Cook® Medical - Developer and Manufacturer of Finished Medical Devices

Additive Technology (AT) currently being deployed in product or process

Challenges that AT targets for COOK:

-  Time/cost/resources required for robust product and process development

Traditionally: used primarily subtractive manufacturing processes (machining technologies - milling machines

(CNC), electrical discharge or “wire EDM”, CAD/CAM, etc.)

-  Required: skilled labor, space and $ machinery

Total R&D Spend

U.S. Mfg. Firms

$201+ Billion

Average Failure Rate =

40% $80+ Billion

The Best Performers

have a failure rate = 18%

($36+ Billion)

Cost of R&D Failure

Wolfe, M. (2013). Business R&D performance in the United States increased in 2011. National Science Foundation, September. Markham, L., & Lee, H. (2013). Product development and management association’s 2012 comparative performance assessment study. Journal of Product Innovation Management, 30(3), 408-429.

The “best” NPD performers: - highest project success rates, - higher usage of RP systems,

Additive Technology (AT) currently being deployed in product or process

Opportunity: Speed, cost (iterations)

3-D print applications/solutions:

-  (FDM) on-site,

-  others via manufacturing locations and outsourcing pending tolerance and surface requirements

FDM Machine

Provides the ability to design, develop, create, compare, review design options within a short time frame for evaluation. The primary applications of 3D printing at Cook Medical include:

•  Device Prototypes

•  Test Fixtures

•  Production Tools

Additive Technology – to expedite development

Quick, simple, molds to review potential design options

3D Printed Tray Prototype Final Tray

Device Prototype: Packaging Tray

Additive Technology – Test Fixture Development: Contact angle

No Fixture 3D Printed Fixture

Water droplet being placed onto tubing secured in fixture

Additive Technology – Test Fixture Development: Contact angle

Additive Technology – Test Fixture Development: Catheter Flexibility

No Fixture 3D Printed Fixture

Catheter slips off

plate

Catheter secured in fixture

Additive Technology – Test Fixture Development: Catheter Flexibility

Additive Technology – Production/Process/Tool/Fixture Development: Handle Organizer

Additive Technology – Production/Process/Tool/Fixture Development: Handle Organizer

Resources/skills/training

-  Computer-aided design (creating product, process, tool, fixture designs) -  CAD/CAM/CAE (knowledge, software, skills, etc.)

-  Increasingly include newer RP technologies -  Engineers, Technicians, Machinists, Designers

-  Programming, technical writing,

-  Computer-aided manufacturing (interacting with newer technologies that are being pulled into the production environment)

-  CAD/CAM/CAE (knowledge, software, skills, etc.) -  Operators, maintenance, etc.

Current exploration – not fully implemented…

-  Newer additive, layer processes directed to small parts with micron-size features.

-  Print mechanisms (assemblies) and not just components (to be assembled)