Pro-dex

Concurrent Engineering Concept Speeds Device Development and Time to Market

By Joe Rotino

The supervisor has called a meeting. After everyone trickles into the conference room, trades small talk about last night's ballgame and the kids' school projects, fills their coffee mugs from the pot on the table, and settles into their seats, the supervisor looks up from his PowerPoint presentation and finally speaks to his subordinates. "We're going to meet all day - every day - until we figure out why no work gets done around here," he tells them.

Like many workplace jokes, this groaner has the sting of truth in it, and it's a truth that applies to medical device manufacturing as much as any other industry. Meetings, of course, are necessary vehicles for sharing information and for planning. Just as often, however, they stall innovation and become ends in themselves.

What if there was a way to accelerate the development of new products by minimizing the need for formal conference room gatherings, improving meeting efficiency, and streamlining the entire process from design through engineering to the finished device or component?

Concurrent engineering is that vehicle. The concept offers a fluid approach to product development by fully integrating all department functions from the very beginning of a project. In a world of tight budgets and fast time-to-market, accelerating the design process in order to get the work to the production floor is the difference between introducing a new device in 12 months or 18.

Much has been written about concurrent engineering, mostly about the technical science and conceptual model. We've seen flowcharts and diagrams about how it works. But at its very core, concurrent engineering is about connecting people from multiple disciplines at multiple stages of a project. This connection should be facilitated by the physical layout of the building, the cultural underpinnings of the organization, and the model for conducting business.

The right physical layout frees all associates to pursue calm, deliberative discussions outside the confines of the formal meeting room. This level of seamless interaction is best achieved by laying out the work environment to facilitate ease of communication. Ideally, the footprint of the building from cubicle to cubicle and function to function should allow a production manager, for example, to stand up in her cubicle and ask her colleagues in planning and material management a question regarding the delivery of materials. Meanwhile, the QA manager a few cubicles over may overhear her and remind planning that he would like to schedule a meeting with their supplier. The layout also encourages impromptu meetings to resolve real-time issues in simple, collaborative, and time-efficient ways. Ten minutes with the right three people can solve many a problem.

Completely In Sync
Concurrent engineering practices entail examining the way the entire business is conducted, including first customer contact, project feasibility, proof of concept, design/development, verification, and validation.

Being able to walk down an aisle to the far end of the building to discuss work-related matters is a good example of this open-architecture approach in action. While it's not unique to have a whole department sitting in one area, it's just as important to have complementary departments sitting near each other. Figuring out the right functional placement for each department, such as business development to engineering and engineering to QA/RA, is critical and specific to each company.

There is an additional upside to this culture of open communication in the everyday working environment. It has a beneficial effect on formal meetings. The conference-room discussion becomes more concise and more technically focused. The workplace layout leads to better logistics, which increases the level of communication, creating a more fluid and efficient corporate culture both inside and outside the meeting room.

Regulatory Focus
Whatever the setting for effective communications, the concurrent engineering concept also applies across departments, with QA/RA playing a central role. It entails an understanding of the part each employee plays in design and manufacturing in order to reduce the development cycle while ensuring that all products are safe, effective, and reliable once they reach the OR, doctor's office, and home.

A key element is to design new products with regulatory guidelines in mind. This includes factors such as material biocompatibility, sterilization validation, design verification testing, and process validation. It also includes complete documentation for the design history file.

Given the importance of QA/RA to this best practice approach, it is crucial to first understand the regulatory requirements of each new product and then evaluate the administrative and financial impact the requirements have on the development process. This evaluation may include special testing, registrations, licensing, design dossiers, and approval from regulatory agencies.

The importance of QA/RA's early involvement during the initial evaluation of a customer's product can be seen in a real-life example involving the design and manufacture of a new battery-powered device. The power requirements demanded a large grouping of lithium cells to meet the device's speed and torque requirements. In this case, one battery would have been classified as hazardous material. This classification meant that special certification, training, and transportation would be required to handle each battery. This limitation was discussed with the customer, who quickly changed the design requirement to a different battery type in order to eliminate the restriction.

In the concurrent engineering concept, all department functions are involved in the first, or feasibility, stage of the project. This coordination becomes critical in the second, or proof of concept, stage. In the second phase, communications and documentation give manufacturing the opportunity to evaluate the product design in order to determine whether any new technologies or production methods will be needed to fabricate the device or component. In addition, the materials group is brought in to determine the impact on the supply chain, to evaluate new technologies, and to see whether new suppliers will be needed. Regarding timelines on a new product, it's necessary to first perform a product feasibility study and estimate how long the entire development cycle will take then calculate a release date.

Design Control Emphasized
The primary trend affecting medical device development cycles involves regulations. Over the past five years, both U.S. and international regulatory guidelines have changed to emphasize design control requirements and documentation, supplier controls, and programs for corrective and preventive actions. The regulatory environment has shifted to the point where business development, engineering, and operations must each fully understand and comply with regulatory guidelines in the development of a new product, further increasing the importance of concurrent engineering.

This change ultimately affects all departments from the initial phases of design to production and distribution. It is necessary to continually update all employees with these regulatory changes, revise procedures accordingly, and retrain workers in the aspects of the revisions that affect their job functions.

Concurrent engineering thrives on open communication between all employees, including the key connection between the engineering and manufacturing teams. One major opportunity to benefit from this connection occurs during the design verification phase when the production team is building devices for the first time. It's the perfect chance for the engineers to capture any nuances of each assembly step and build them into the final release of the assembly and test procedure.

Companies that do not take advantage of concurrent engineering practices may see unfavorable results. When this connection is missed, production adapts its assembly process to blindly follow the methods and instructions from the stated procedure, causing engineering to lose visibility of potential improvements or corrections it could make in the design or assembly procedure. This practice can result in inefficiencies that remain in the manufacturing process for years to come.

Concurrent engineering doesn't stop when the product is designed, but continues with the manufacturing force through cross training. From a production standpoint, it is important to layout the manufacturing floor in a way that optimizes workflow and efficiency. Manufacturing cells should facilitate cross training. Multiple jobs should be run through certain setups so that the production manager can look across the machine floor and observe the entire scope of manufacturing operations. This approach allows managers and employees alike to see immediate gains in efficiency.

A hanging dispatch board is another useful efficiency tool. The board's colored boxes track the status of each job, making two weeks of staged operations visible from one vantage point. The board allows manufacturing employees to see all the jobs and their sequencing from machine to machine, with the prioritization built in.

Out of the Gate
Concurrent engineering's essence is accessibility. Every employee in the office and on the floor knows the priorities and understands the proper sequence of events and the focus required on a certain project in order to shepherd the device or component from the design stage to the manufacturing plant in an appropriate way. Every element from the capture forms at the beginning of the process to the product spec sheets to the product timelines works hand-in-glove with the business model. Even the financial collection points along the way are built into the operating template. Out of the gate, both the customer and the manufacturer know which event comes first and which is going to be the 147th.

With an integrated business model and product development process, concurrent engineering enables every department to contribute fully to the timely launch of a successful product. And that's no joke.