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It seems the biggest ideas get the most attention, and nothing could be more true than when launching a new medical technology, and/or devices. The development time and cost is daunting; the testing and trials can be unnerving; and the financials can keep everyone on their toes (and on antacids) for months or even years. Given all this, it would seem the simple task of developing the cabling and interconnects for a new medical device should be “easy” compared to the rest, but, the fact is, if you are not careful, your new device could be late to plan, over cost targets, or worse, judged deficient, due to avoidable problems in the 11th hour of development. Here are some useful development process insights regarding cables and interconnects that can help keep your new medical device launch on track.

Key Steps to Successful Medical Device Interconnects

Fig. 1 – Key steps in the Product Design Process.
Knowing what you are dealing with, and covering all the possible requirements and constraints requires a robust development process. Requirements definition, which includes identifiable constraints, is the logical starting place. What many people don’t realize is that definition and documentation of requirements may precede the new product by years. Especially when extensive R&D effort is required. (See Figure 1)

Requirements definition includes asking (and documenting) the obvious, like: What problem are we actually solving with this technology/device? And, of course, what constraints are we faced with, such as cost, schedule, testing, trials, competitors’ products, etc. Just the competitive analysis may be an onerous task all by itself. As difficult as it may be, shortcutting the requirements definition phase, is a surefire way to get into a high-risk situation and difficulties down the road.

This is especially true with cables and interconnects. As soon as the need for cables and interconnects is identified, it’s time to start defining what is needed. The best way to do this is to involve the cable developer as soon as possible. In fact, they may be able to help adjust base requirements towards a better, lower cost solution, when involved before the constraints are all fixed.

Process integration across disciplines, and including suppliers, will pay huge dividends as the transition to production gets underway. Some of the keys to getting your cable and interconnection needs met, on time, and at the lowest cost, hinge on a number of critical design, performance, and production parameters. These include:

  1. Product requirement definition and achieving stability of requirements.
  2. Thorough risk analysis, including FEMA and PFEMA.
  3. Thorough definition of regulatory requirements and constraints.
  4. Sound engineering processes and expertise.
  5. Definition of all testing and performance documentation needed.
  6. Comprehensive transition to production plan.
  7. Estimates of manufacturing volumes and ramp up plans.
  8. Tooling, processing, configuration control and quality systems.
  9. Targeting suppliers who have capability, capacity and qualifications needed.
  10. Sound project management, including milestone and risk reviews.

Most of these items will get a knowing nod from any good design engineer, but they will quickly tell you any number of horror stories about one of more of these process areas running badly off track at some time in their background. Nearly every engineer has been on the receiving end of a project in which the stress levels went through the roof from decisions made long before their input and support was requested. So how do you line up all the key players to achieve great products, on time, at the lowest achievable cost? Reviewing the key process areas above, we can deduce some common threads for success in each area.

Requirements Definition

Defining and stabilizing requirements requires a clear problem statement and exceptional communication and documentation skills with customers and users (they may not be the same people) such as regulators, program/project managers, engineers, testers, suppliers, and manufacturers. The greater the integration and communication, the lower the risk becomes and the more predictable the development outcome will be. In the case of cable and interconnect developers, defining basic questions about electrical wiring parameters such as voltage, current, shielding, and materials, as well as connection frequency, environment, and reliability are critical in avoiding late program cost increases and schedule delays.

Risk Analysis

The importance of risk analysis, early and often, has made this an industry standard practice. In fact, conducting risk analysis has steadily been incorporated into many quality standards. This is even true for the new ISO 9001-2015 standard, which has become an accepted minimum standard across many industries. A risk analysis for wires and connectors should include overall product requirements definition and stability, design innovations, materials, producibility, testability, quality, reliability, and capability and capacity analysis.

The more innovative the design, the higher the risk tends to be, since many new bridges will need to be crossed. The more that tested and proven processes, materials, and products can be incorporated into the new product, the lower the risk and cost will become.

Regulatory Requirements and Constraints

“Just because you can, doesn’t mean you should.” Regulators are not likely to be impressed with your new technology or device if it does not map clearly to existing regulatory requirements. This is a burden innovators have always had to deal with, so the sooner you include the known constraints into your design and test plans, the faster you can make it through the tests and trials.

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