Product Resources Collaborates on the Design and Manufacturing of a Robot-Assisted Surgical Device.

 

Background

Medical Devices are one category of product that must be manufactured with care and control suitable for the risk to the patients and users.

Recognizing the seriousness of the subject, there are special quality standards developed to allow for the proper design, manufacture, and use of these products in a medical environment.

With Product Resources’ quality system covering the medical device standards, we have been asked to manufacture complete medical devices or instruments, as well as build sub-assemblies for incorporation into a larger medical device or system

 

The Challenge

In 2020, we were approached by a major manufacturer of medical equipment that needed a quick turnaround on the design and manufacture of a sheet metal enclosure and bracketry for the computer control unit of a new surgical device.

The surgical device was a breakthrough robotic-assisted medical device with many components and sub-assemblies.

This initial project has evolved into an ongoing relationship involving a series of similar projects for the same end-product.

 

Project 1

This initial assignment called for the design of a sheet metal enclosure and bracketry for a control unit for a robotic-assisted surgical device. We were also responsible for the thermal design of the system to keep the components within their temperature limits.

We were given very specific instructions in terms of which components to use and how they should be connected.  We were also given very specific design requirements as well as an alpha prototype for reference.

Once the design was completed, we built five prototypes that incorporated a set of custom cables for Beta testing of the system at our customers engineering facility.

We were then tasked with designing the manufacturing process, PFMEA, and validation protocol for that process.

Project 2

This second assignment followed the same pattern as the first assignment except that involved creating an enclosure and electrical design for a system to drive a satellite console for the same larger end-product.

We were given the product requirements and a mechanical mockup of the desired system.

We then developed a design for the enclosure and electronics, followed by a manufacturing process, PFMEA, and validation protocol.

Project 3

For this third project, we were asked to execute the validation protocol for both the main console (project 1) and the satellite console (project 2).

This process included:

  • Verifying the supply chain organization and risk assessment was complete.
  • Verifying the process flow for each component was properly documented and executed.
  • Verifying the sub-assembly processes were documented and executed as intended.
  • Verifying the test procedures properly captured the operation of the system and were sensitive to the identified failure modes.
  • Verifying that the packaging for the unit was adequate for shipment to various locations.

 

Project 4

As is often the case, we were later asked to update the design of the main console by incorporating some new features that had been recommended by customers.

This was a Gen 2 project with improvements to the original product.

The project included the design of new hardware and cabling and prototyping for three units to be used for additional development and regulatory testing. We also were tasked with the manufacturing process modifications and FMEAs required as well as a validation of the modifications.

 

The power of being nimble

We were told from the beginning we were assigned this project because we had the ability to be nimble in our approach to design and manufacturing – as well as our ability to handle “change control” without missing a beat.

Of course, we had to meet all the necessary requirements as a qualified contract manufacturer, but we also had to meet some very difficult deadlines.

Because this was a medical device project, we had to meet the enhanced process controls as required, and we had to meet them in a timely manner.

Learn more

Find out more about Product Resources and how our design, engineering and manufacturing services could fit into your product development process.

Call 978-524-8500.