Accelerating the Product Development Cycle

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, 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 were a way to accelerate the development of new products by minimizing the need for formal 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 12–18 months.
 

Although concurrent engineering is important in the development of any new product, it is essential in the design of medical devices. In medical device development the main goal is the release of products that are safe and effective for patient use. Therefore, the understanding of intended use is critical at the early stages of development. In looking at different vantage points from engineering design, regulatory compliance, project timelines, or manufacturability, concurrent engineering gives the development team early insight into the verification and validation stages. By being able to understand product function and reliability, or sterilization and biocompatibility requirements, or manufacturing materials and processing issues, the team has a more-structured and more-predictable approach to the design verification outcome. This approach results in efficient scientific tests that lead to final validation results. Ultimately, it helps meet product management timelines and release of the product, without subsequent testing.
 

Much has been written about concurrent engineering, mostly about the technical science and conceptual model (see the sidebar “More on Concurrent Engineering [4]”). We’ve seen flow charts 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 is one that 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. A well-thought-out 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 problems.
 

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 and 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. Although it’s not unique to have a whole department sitting in one area, it’s 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 quality assurance and regulatory afairs (QA/RA), is critical and is specific to each company.
 

Such a culture of open communication in the everyday working environment is also beneficial to formal meetings. The conference room discussion becomes more concise and 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, or 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.
 

In concurrent engineering, business tasks should work as a function of time. This chart demonstrates at what point in the process departments should be involved in product development and what their expected duties entail.

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 handheld, battery-powered surgical spinal 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, all the way down to normal handling by the sales force. This limitation was discussed with the customer, who quickly changed the design requirement to an alkaline battery type 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 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 effect 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, and 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 a point at which 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 the 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 during design verification 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 lay out 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
 

The essential benefit of concurrent engineering 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 to shepherd the device 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.

Joe Rotino is vice president of QA/RA and acting vice president of engineering for Pro-Dex Inc. (Irvine, CA).