Surgical Device Experience

Glaucoma

Andrews-Cooper was retained to perform technical assessments on two alternative implantable stents for treating Glaucoma plus their associated surgical insertion tools.  The scope of our evaluation included Design Controls Compliance, Product Design Robustness, Reliability and Manufacturability.  We leveraged our extensive engineering experience with design for manufacturability, knowledge of regulatory requirements, and experience generating design controls documents and records for medical devices.  After becoming familiar with each of their QMS, we reviewed DHF documents and records, interviewed design team members, and evaluated the physical products and the manufacturing lines.  Specific inspection criteria included 21 CFR 820.30, ISO 13485 and ISO 14971.  Our findings included identifying potential FDA inspection failures, potential safety risks and design defects, plus we cited areas where best industry practices were applied.  We also made recommendations for improving design documentation and records, and made suggestions for improving the robustness and manufacturability of the products.

Suture Crimping GunPicture25

The client challenge was to design a disposable, low-cost medical device to deploy suture crimps for heart valve replacement.

Solution

Andrews-Cooper designed and built a custom “crimp deployment” device that reduced surgery time.

Design Features

  • Innovative micro-mechanism for ratcheting, deploying and cutting to place product onto sutures
  • Ergonomic, one-hand operation

Heart Valve & Placement Device

Andrews-Cooper has been deeply involved in the design of multiple Heart Valves and design of the Placement Devices used in minimally invasive surgery.

The Approach

Andrews-Cooper works closely with clients to understand the engineering and usability challenges of their devices.  Through onsite research, testing and an open and iterative design process A-C is able to provide our clients with a total system solution.

A-C ResponsibilitiesPicture26

Our responsibilities included:

  • Field Research
  • Design
  • Prototype
  • Mechanical Engineering

The Projects

Medical professionals have many providers to choose from with respect to heart valves and their corresponding tools.  A-C’s job was to provide our client with tools and heart valve designs that were designed as a system.  Thus giving the provider the best tool for the job when choosing a heart valve product.

  • Engineers, Researchers and Industrial Designers worked with the client to clearly define their goals and requirements.
  • Multiple ideas were generated and proto-typed.
  • A-C helped the client down select the design through proven decision making analysis tools.
  • Full usability models were created and tested.

Detail

Key design objective and challenges included:

  • Design for usability
  • Single handed operation of tool.
  • Multi direction tool head
  • Design for sterilization
  • Valve material selection

Of course, the overriding design challenge was to allow for a smaller incision by integrating a compressible heart valve correctly with a well designed placement tool.

Peripheral Vascular

Andrews-Cooper has been deeply involved in multiple Peripheral Vascular projects.

A-C Responsibilities

Our responsibilities included:

  • Field Research
  • Design
  • Prototype
  • Mechanical Engineering

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The Approach

AC works closely with clients to understand the engineering and usability challenges of their devices.  Through onsite research and an open and iterative design process A-C is able to provide our clients with a total system solution.

Medical professionals have many tools at their disposal for use in peripheral vascular surgery.  A-C’s job was to provide new solutions to keep our client ahead of the completion as well as refreshing their old designs with major improvements to usability.

  • Engineers, Researchers and Industrial Designers worked with the client to clearly define their goals and requirements.
  • Onsite interviews with PV surgeons and technicians helped to steer the design direction.
  • Multiple ideas were generated and prototyped.
  • A-C helped the client down select the design through proven decision making analysis tools.
  • A full usability models were created and tested in mock surgical settings.

CTO Catheter

A-C engineers worked in conjunction with Industrial designers.  We provided a total system solution by integrating the client’s recanalization catheter with a major upgrade to the system console.  The console consisted of a power, pump and display unit that could easily mount to a standard hospital stand.  It also included a hand held control unit for starting and stopping device operation.  The console designed by A-C engineer’s utilized graphics and a touch screen interface to clearly direct the user on system operation.

Key design objective included:

  • Design for usability
  • Hand Held Unit
    • Single handed operation
    • Clear indicators of device status
  • Console designed for easy of sterilization via wipe down

Atherectomy Device

Andrews-Cooper took a bench top atherectomy device designed by our clients and did an intensive mechanical layout and industrial design study with respect to form, function and usability. A-C created multiple options and worked with our client to down select to the best solution.

Key objectives:

  • Design for usability
  • Differentiation from competitors

Re-entry Catheter

A-C’s client desired to expand their product offerings in the chronic total occlusion space by offering a true lumen re-entry catheter.  A-C was given the primary engineering responsibilities for project conceptualization and prototyping.

Key objectives:

  • Distal tip radial must location to be evident through fluoroscopy
  • Design for
  • Multiple conceptual solutions
  • Down selecting through decision matrix

Design Challenges
  • Scalability:  Providing solutions that scale up or down based on catheter sizes.
  • User Friendly:  Creating interface systems that clearly guide technicians and doctors on product usage.

Medical Product Case Studies