Development and production of a small, lightweight, ergonomically designed arthroscopic device powerful enough to bridge the gap between different types of surgeries usually takes at least 24 months.

So when a market leader in endoscopy needed an improved arthroscopic handpiece that not only met those specifications, but also would be completed in a compressed time-to-market of one year, they were presenting a challenge that called for unconventional problem solving.

Additionally, new changes in European disinfection and sterilization regulations required the device to withstand higher pH levels — between 12 and 13 — when exposed to autoclaving in the dishwasher. This called for a new coating, design, and materials to ensure that the device maintained its quality and reliability in the field, while still meeting RA/QA stipulations.

The Endoscopy OEM had worked with Pro-Dex (Irvine, CA) on numerous other arthroscopic projects in the past, all within tight time frames. They worked together once again on this particular arthroscopic device to arrive at a successful end result.

However, a major challenge arose when, two to three months into the project, the OEM client wanted to add another button to their handpiece — not an inconsequential request. Adding a button involved creating another circuit board, developing another interface to the motor control board, protecting more electronics, and designing a completely new button system.

In spite of this curveball, the concurrent engineering model helped Pro-Dex and the endoscopy OEM continue to roll out an arthroscopic handpiece that had the desired blend of power, size, and weight, 12 months from the project start date as planned. The device’s ergonomic features allowed it to handle a range of applications, from small joint repair to larger surgeries. The special coating was designed for compliance with EU regulations to withstand higher pHs in harsher cleaning environments.

The Concurrent Engineering Model

As demonstrated by the previous example, today’s manufacturers must be faster and more nimble in their design processes if they want to successfully accommodate new requirements. Testing methods should be shorter and more scientific, without iterations in final validation results. However, this is easier said than done.

Many medical device OEMs are large corporations, offering a variety of product solutions with different areas of emphasis. Their limited time, expertise, and budget can often slow project completions or prevent product concepts from getting off the ground.

Conventional engineering usually follows a sequential strategy that can make it difficult to look backward or forward at each step to fix potential problems. If something goes wrong, the design is usually scrapped or heavily altered, causing unnecessary stress and wasting time and money.

In contrast, the concurrent engineering business model centers around two concepts: 1) A product’s full lifecycle must be taken into consideration early in the design phase; and 2) All design activities should occur simultaneously.

At first glance, this may sound simple, but it actually requires connecting people from multiple disciplines at multiple states of the project. This is an unconventional approach in medical device design, development, and manufacturing.

Due to the collaborative nature of concurrent product development, individual engineers and project managers are able to provide valuable input at every phase of the design process. Overall success relies on the ability of engineers and the project team to work together throughout each state — there is no one “expert” on an entire system.

A crucial element of the concurrent engineering strategy is the in-house model shop, which is able to produce many iterations as the project evolves, giving the team the ability to pinpoint reliable, effective, innovative solutions for the client. It also allows for rapid transfer from engineering to production; increases accuracy in predicting and meeting project plans, schedules, timelines, and budgets; and allows for verification testing without interfering with the manufacturing schedule.

Because the model shop works with the same machines used in production, it provides insight about what certain contours or features on a device could mean down the production line.

This results in quick introduction into machining processes because, for example, when Pro-Dex launches their production orders, they’ve already seen it, felt it, and tested it, so they know what to anticipate.

Model Shop Enhances a Surgical Screwdriver

Another project with a pioneering OEM provides a prime example of how the in-house model shop helped in the process of enhancing a surgical instrument. When performance issues with a surgical screwdriver threatened to jeopardize the OEM’s prominence in the highly competitive field of neurosurgical devices, it was essential to find a fast, effective solution.

Overwhelmed with other projects and lacking the time to pull a committee together, the OEM needed a turnkey resource that could pick up the project and run with it. Having worked extensively with this client over the years on other devices, Pro-Dex took on the project. In a tight three-month time frame, Pro-Dex was able to relaunch a significantly improved surgical screwdriver for the OEM client. The iterations created in the model shop for the surgical screwdriver played a valuable role in selecting revised sealing and material enhancements that would give the client a superior, more reliable product.

The concurrent engineering approach makes it possible for suppliers to plan, build, and manufacture defect-free products and get them to market on time and on budget — without cutting corners.

By obtaining input from as many functional areas as possible before the specifications are finalized, the product development team can clearly understand what the product requires in terms of mission performance, environmental conditions during operation, budget, and scheduling.

The overall result is an organized, synergetic culture that not only saves time and frustration, but also delivers more reliable products to market.

This article was written by Joe Rotino, Vice President RA/QA and Engineering for Pro-Dex, Irvine, CA. For more information, Click Here 

Medical Design Briefs Magazine

This article first appeared in the April, 2011 issue of Medical Design Briefs Magazine.

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