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
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:
- Product requirement definition and achieving stability of requirements.
- Thorough risk analysis, including FEMA and PFEMA.
- Thorough definition of regulatory requirements and constraints.
- Sound engineering processes and expertise.
- Definition of all testing and performance documentation needed.
- Comprehensive transition to production plan.
- Estimates of manufacturing volumes and ramp up plans.
- Tooling, processing, configuration control and quality systems.
- Targeting suppliers who have capability, capacity and qualifications needed.
- 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.
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.
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.
For cables and interconnects, factors include the need for bio-compatibility of materials, life cycle and reliability needs, reuse versus disposable designs, configuration and process controls, prohibited materials, and of course, production controls and standards, for example ISO 13485. Defining the controls and constraints environment, over the life of the product, is an essential part of the design and risk management process.
Engineering Processes and Capability
Virtually any organization that engages in design engineering activity has to recognize the liability that comes with owning a design. This virtually assures that most engineers will be familiar with engineering process controls. Most engineering systems that go through any meaningful process certification must have well defined design processes and standards. That doesn’t mean they are good or efficient, just “compliant” to some minimum standard. For cables and interconnect assemblies, “minimum requirements” might be a risky path to take, since downstream support costs could easily eat up any cost advantage in design cost savings.
This is where it is critical to ensure that the engineering group has the capability and capacity to execute the design to customer expectations. Problems in this area might come from several peripheral assumptions, such as when an R&D organization is tasked with “innovating” a new technology, and then after demonstrating feasibility, development engineering is given a cost and schedule to “productionize” the technology. This is highly risky, since R&D may not have considered all regulatory or manufacturing constraints in their work. Addressing these unseen challenges after cost and schedule are defined rarely works.
This problem has been so pervasive in Department of Defense technology developments, that entire risk and transition protocols were developed to stop the wild cost over runs as developers tried to design amazing new products, that no one could build for anywhere near the estimated costs or schedules. The same thing can happen, on a smaller scale of course, with cable and interconnect innovations. The adage here is “Fore-warned is fore-armed.” Make sure that development engineering, even if it’s external to your organization, is adequately involved in technology assessments to head off bad surprises in cable and interconnect designs, including producibility and cost assessments.
Testing and Performance Requirements
When the design is completed, this can be a pretty straightforward task, however, the old design adage, “test early and test often” is worth repeating. Money and time spent on product development testing will invariably pay huge dividends if the product heads to production. In fact, test failures should force a hard look at the concept for production feasibility. If engineering can’t reliably get the product through test, how will manufacturing be able to build it, especially in volume?
Many organizations are tempted to cut costs and development schedule by reducing the test program scope. This will rarely yield real savings and at worst may allow huge cost “sinkholes” and schedule delays to show up in manufacturing that will make the testing costs saved look like peanuts. Test plans should be developed at the earliest possible design phase with an eye towards thoroughly proving the feasibility of both the design’s capability to meet performance requirements and production’s ability to manufacture to the projected cost and schedule. (See Figure 2)
Transition to Production Planning
As soon as the design process gets underway, links to manufacturing need to be considered and explored. In businesses where the design engineering group is used to working closely with manufacturing, this can happen somewhat informally, since the engineers will be familiar with all the necessary manufacturing processes used by that business. In businesses where the manufacturing may be subcontracted, a more robust transition to production plan needs to be implemented.
Historically, this approach was called the Concurrent Design approach. Later the idea of Integrated Product Development Teams was evolved to ensure that the transition to production was considered from the earliest possible point in the design. There are a number of methods used to accomplish this, and the only unacceptable method seems to be no plan at all. Ensure your design teams are fully integrated by whatever method works for your business.
Manufacturing Ramp-up Plans
There are few things that will affect a design engineer’s early decisions more than telling them the production ramp-up expectations. There is a world of difference between needing ten prototypes next month and needing a million deliverable parts next year. This is, of course, a catch-22, since it can be hard to predict ramp-up volumes of new products. For new products, estimating sales is not exactly a science, because there are so many variables involved. Still, if the engineer is directed to minimize development cost and schedule, and focus on testable prototypes, that will yield a distinctly different design than if they are given a volume production ramp-up plan. (See Figure 3)
If volumes are unknown, most engineers will default to existing practices for prototypes and testing. This would imply minimal documentation, tooling, testing, and lots of hands-on engineering oversight. This is where astute program management plays a critical role, as it is really a business risk assessment to determine the value of designing and building production-ready products, which may or may not ever be ordered again.
If needed information on volume is unavailable, the engineering group will invariably apply sound judgement and experience to estimate the best and worst cases, and do what makes the most sense for the business. Expecting anything different than that will likely yield unpleasant surprises, so it is incumbent on program management and/or the marketing group to take ownership of such estimates, realizing they will impact product development costs.
Manufacturing Systems and Processes
Of all the pieces in the product development puzzle, this is generally the most well-developed and stable part, since predictability is the hallmark of a well-run manufacturing organization. That said, the integration of the manufacturing organization into the product development process is often hit and miss, especially when subcontracted manufacturing is involved. It is imperative that the design team take into account manufacturing capability, capacity, priorities, and preferences. This is so basic to successful product development, that it was written into the ISO 9001 Quality Standard decades ago, but still, examples of poor integration abound. For most organizations looking for big improvements in performance, this is usually a great piece of low-hanging fruit to exploit as soon as possible.
Supplier Selection and Integration
This is another area of product development that is often rife with opportunities for improvement. For example, eliminating conflicting priorities. We want the best possible product, we want it on time, and we want it at the lowest possible cost. The problem of course, is, what do you want the most? For example, setting incentives for purchasing to reduce cost without proper balance for quality and schedule will yield supplier shakeups, and shake-downs, but not necessarily quality products on time. This is where the idea of partnering with your suppliers really needs to be explored more.
Understanding the whole value stream, and communicating that understanding, from a value perspective, will do more to improve bottom line, than multiple isolated efforts at process improvement, and would be a great first step in solving a litany of problems for many businesses.
Project/Program Management and Milestone Reviews
Establishing sound Program and Project Management practices, and especially milestone reviews is one of the best risk mitigators an organization can undertake. There are many approaches to this, but essentially, it amounts to defining what you need, when you need it, and who will do it, complemented by regular reviews to make sure that, what everyone signed up for, i.e., tasks (that’s right—they need to be part of the process to define the plan) are getting done according to the plan.
Milestone reviews should represent logical review points in design and transition to production, and not just weekly meetings or teleconferences, which tend to become unproductive quickly. For example, review points should include risk analysis completed, orders placed, drawings/models released, materials and tools ordered, etc. The reviews should coincide with key deliverable dates on important programs.
When developing new products and/or technologies, there is a logical chain of events and tasks to plan and monitor. For cables and interconnections, this often crosses many boundaries, including multiple external suppliers for assemblies and materials. Following these basic design steps will ensure a smoother new product launch, happier customers, and satisfied business goals. After all, everyone likes the idea of quality products, delivered on time, at the lowest achievable cost.
This article was written by Steve Pape, Design Engineering Manager, Minnesota Wire, St. Paul, MN. For more information, Click Here " target="_blank" rel="noopener noreferrer">http://info.hotims.com/61057-166.