IVD Technology Magazine | IVDT Article Index

Originally published July 1996

Rapid instrument development

Lev J. Leytes, Amer El-Hage, and Ann C. Petersen

The goal is to design an instrument quickly and beat competitors to market. The authors' system cuts development time in half.

A company that can produce instruments faster than its competitors will not just have the first product on the market. It will also have the best product because it can receive customer feedback and produce second- or even third-generation products in the time it takes competitors to get their first-generation product out.

This article describes a system developed by LJL BioSystems, Inc. (Sunnyvale, CA), for completing instrument development projects in half the usual time and with a reliability rate well above the industry average. For example, the automated chemiluminescence reader for DNA probe assays that LJL developed with Chiron Corp. (Emeryville, CA) took just 13 months from start to full production and worldwide shipment. Similar projects typically require 24 to 26 months at other facilities. The reader's mean time between failures is well above the industry average of 10,000 to 15,000 hours for this type of instrument. In fact, it has been so reliable that, unfortunately for LJL, Chiron has had no incentive to buy a maintenance contract at the end of the instrument's warranty period.

Most of LJL's secrets for rapid but thorough instrument development are not so much secrets as basic processes that could be applied by other instrument manufacturers as well. This article presents a few of these basic processes as LJL practices them.

Program Management

One of the keys to rapid instrument development is having a program management system that is both clearly defined and strictly enforced. Program management should be thought of as a discipline that is every bit as important as the various engineering disciplines that are required for instrument development.

The development process should be comprehensively documented, and the document should be provided to all employees. In addition, LJL presents a customized version of this document to every manufacturing partner (the term LJL prefers to use instead of customer). It provides a detailed outline of all the activities and milestones involved in the development process, broken down into four clearly defined phases: product definition, concept and feasibility, prototype development, and manufacturing transfer and production.

During phase one, product definition, the instrument concept is defined in terms of instrument attributes and engineering specifications. This instrument concept is then used to evaluate and define key instrument functions, human factors issues, industrial design issues, and an estimated development schedule and budget.

A clear product definition is vital to delivering a high- quality instrument. Specifications must be agreed upon and approved by all functional groups involved in the project (including marketing, development engineers and chemists, and manufacturing) before proceeding to phase two.

During phase two, concept and feasibility, LJL develops detailed concepts for the package industrial design, mechanical subsystems, user interface, electrical subsystems, and firmware/ software components. It builds an instrument that is functionally similar to the final production instrument but not necessarily identical in form. If the form is substantially different from that of the planned production instrument, a nonfunctional model of the packaging may also be created during this phase to obtain user feedback on human factors and the industrial design.

In phase three, prototype development, functional prototypes are built that look and perform like the final production instrument and may be used for preclinical or beta trials. The engineering efforts during this phase focus on achievement of the reliability, manufacturability, and cost targets of the instrument.

The goal of phase four is to transfer a quality product into production. Pilot production instruments are built during this phase, the manufacturing transfer process is completed, and final production instruments are manufactured. The final production instruments completed during this phase are built by manufacturing rather than by the engineering team. All engineering hardware, firmware, and software designs, and all fabrication, assembly, and test documentation are upgraded at this time to meet production and good manufacturing practices (GMP) requirements.

By having a defined program management process that is broken down into clear phases, we not only know exactly what the project involves and have a schedule that we follow meticulously, but we can also maintain momentum by completing the project in short bursts rather than in one long haul. Each phase of the project has a predefined and strictly enforced start and stop time, so team members know they have to accomplish a specific task in a set time. This allows the team to focus on an immediate goal rather than try to do everything at once. By meeting a series of interim goals, team members not only keep the project moving along rapidly, they also have the reward of a continuous string of short-term successes to keep them motivated. LJL offers additional motivation in the form of a bonus for on-time completion of all tasks. If any interim goal is not met on time, all team members forfeit a portion of their bonus. This provides an incentive for team members to cooperate, be creative, work hard--to do whatever it takes to get the task done on time.

Concurrent Product Development

Beginning with phase one, our project teams include staff from all functional groups: marketing, research and development, product design, manufacturing engineering, and quality control. These permanent project teams include experts in each critical engineering technology and are led by a project manager with a technical background and project management experience. On average, teams contain between 5 and 10 members. We also consider our customer to be a part of the team. All functional groups have input at all stages of the project, providing concurrent product development. This avoids the possibility that marketing will decide that a product needs significant modification during research and development or, even more costly and time-consuming, during scale-up for manufacturing. With this method, instead of passing the project from team to team, one integrated team moves from milestone to milestone.

The entire team is required to attend all design review meetings, which are held weekly during phase one and less frequently during subsequent phases, with a minimum of three to four meetings per phase. Meetings may take all day, but they save weeks over the course of the project because issues are resolved and specifications updated and agreed on before the meeting ends. We bring a computer attached to an overhead projector and printer into all design review meetings. Team members can clearly see what is being discussed and, when they leave, always take with them a printout of the agreed-upon design specifications and action items.

An additional value to having all team members present at all meetings is that it enforces communication. People who tend to be task rather than people oriented sometimes need this inducement to discuss their individual projects in the context of the completed instrument. One of the biggest challenges in instrument development is to integrate the different engineering disciplines and systems with the chemistry requirements. Through the scheduling of frequent design review meetings, communication and preintegration are automatically built into the project. This ensures that the various elements that have been designed separately (e.g., packaging, mechanical, electrical, optical, software) will fit together more elegantly and integrate more easily with the chemistry.

The Right People

We have found that smaller teams work best because they generally require less management, which means less red tape, which means faster movement of the project. In addition, small permanent teams have a greater sense of ownership of the project, and all members share their expertise to solve whatever problems arise.

Basic to having a small team is hiring the right people. We prefer to hire high-end, experienced people and have fewer of them. Although well-seasoned people are expensive, they can make the initial product definition much easier and contribute significantly to the thought process that avoids last-minute issues. An additional value is that, if last-minute issues do arise, well-seasoned employees are much better equipped to resolve them with minimum risk because they know from experience what the risk parameters are. Thus, the price for these employees may be higher, but the overall costs to the company are actually lower. We prefer employees who have been through some product development scrapes, and we always ask when interviewing prospective employees whether they have been through a full product launch, all the way to market, dealing with the various issues that turn up during each separate phase of the process.

The right people are also versatile. An engineer who understands both hardware and software is invaluable because there is never any need for an outside arbitrator to help decide whether the instrument in development has a software or a hardware problem. If the same person is responsible for solving either problem, problem ownership is clear. Also, having a mechanical engineer with experience in design avoids the common situation of having the designer say, "It should look like this," and the engineer replying, "Well, it won't fit in that box." With these two disciplines combined, form will always follow function.

Inside/Outside

The right people do not always have to be in-house (see sidebar, "When and how to outsource"). Having a network of consultants can be far more cost-effective than hiring specialists who may not be needed for every project. Here it is critical to locate and maintain contact with technology centers that are a rich source of technical expertise. For example, LJL is fortunate to be located in the heart of Silicon Valley, one of the premier technology centers in the United States. We benefit greatly from regular contact with the many vital, innovative technology leaders in the area.

In addition, not every part needs to be or even should be manufactured in house. A good balance must be maintained between what is made in house and what is bought from a network of specialized and cost-effective vendors who supply both custom and commercial parts.

Deciding what should be made and what should be bought can be difficult. During phase one, we involve all of our functional groups in defining which components are high-risk, low-risk, high-return, and low-return, and then give each component a make or buy designation. We consider our own in-house capabilities when making these decisions. If a vendor can provide a component more quickly, less expensively, and with better quality than we can make it in house (all three criteria must be met), we buy it rather than make it.

It is critical to decide at the outset of the project who will make what, in order to know how much each component will cost and what the lead times will be. Plus, by making these decisions in advance, we can include our vendors in the project team. They are often involved in the design of the instrument and always in its transfer to manufacturing. This way, manufacturing knows whom to go to with questions, and the vendor knows exactly what manufacturing requires. As a part of the team, vendors see the instrument as it is being created and can better integrate their efforts with those of the in-house staff.

Using vendors for standard components also leaves in-house staff free to focus on elements of the instrument design that can make a difference in the marketplace. Tough projects are good because they provide a motivating challenge; out of them come new solutions and technologies. For example, given the challenge of designing a low-cost, highly reliable controller for one instrument, we used PIC (programmable integrated circuit) technology to create an electronic brain for this instrument that we can modify and transplant into any instrument we design in the future.

State-of-the-Art Equipment

To develop technological innovations rapidly, in-house staff needs the right equipment. Powerful advanced mechanical and electrical computer-aided design (CAD) packages allow sophisticated computer modeling that reduces the number of design iterations and the duration of the engineering programs. For example, we have nine CAD workstations for mechanical and package design: five Sun systems and four Silicon Graphics systems. All of these systems currently use the Pro-E software package from Parametric Technology Corp. (Waltham, MA), all are connected to the same network, and so all are able to share the same files. File sharing allows one engineer to access another's design, ensuring better integration of separate components.

These CAD systems also offer paperless prototyping. We have a direct link via modem to several vendors that produce models or even finished parts directly from our CAD files within 48 hours. All electronics design is done on CAD systems as well. We have an in-house system, Quick Circuit, linked to our CAD network that makes prototype circuit boards right from our CAD files, so we can go directly from the design of mechanical or electrical systems to prototypes without the need for any intermediate drawings or schematics (Figure 1). This allows production of prototypes in a matter of hours or days, not weeks or months. Further, building tooling directly from CAD databases is a significant money saver.

Modular Design Approach

Perhaps most important to LJL's rapid development capability is that when we develop a subsystem (such as a robotic arm, or a printed circuit board, or an optics system, or a piece of software), we think ahead to other applications for it in other markets. By doing this, we are developing a subsystem not only for the current customer but for the next one as well. LJL makes it a condition that we, rather than the customer, retain the manufacturing rights to these subsystems, which we can then modify for use in a wide range of instruments for various markets. This modular design approach is of value to any instrument manufacturer because it not only accelerates the design process but also improves reliability by allowing subsystems to be pretested independently of the completed instrument. Figure 2 illustrates how technology developed by LJL for one product was adapted for use in several others. Having a base of these core subsystems or technologies gives us an edge in getting an instrument to market quickly.

Conclusion

There are no real secrets to rapid instrument development. All it takes is small, focused, sharing, highly competent, well-equipped technical teams and a clear, proven process. Having a clearly defined process speeds development by reducing the amount of change: change of mind, change of personnel, change of project. Although a company must always accommodate some level of change, the rate of change should never exceed the rate of progress. Controlling change by having and enforcing a well-defined process reduces the risk of running out of time and ensures being able do all that was planned and more.

Lev J. Leytes is president and chief executive officer of LJL BioSystems, Inc. (Sunnyvale, CA). Amer El-Hage is director of program management for LJL. Ann C. Petersen is a technical writer specializing in the diagnostics industry.

When and how to outsource

Sometimes the quickest way to get something done is to give it to an outside vendor. The engineering teams of OEM (original equipment manufacturer) companies are experienced with a wide variety of projects, are usually in tune with the latest engineering technologies, and get a great deal of practice in the rapid development process. A vendor that has kept abreast of the new technologies and business processes can often provide cost-effective and technologically advanced products quite rapidly.

In many cases, the decision to outsource can be based solely on the amount of practice your company has or wants to have in a particular field. If you have a great deal of experience producing certain components, they should be manufactured in house. However, if expertise in a particular area does not reside in house and is not needed on a continuing basis, the project should be outsourced.

When choosing a vendor, size should not be a ruling factor. The largest vendor candidate may not automatically guarantee dependable service, because your project may be less important to a larger company with multiple projects than to a smaller one focused on a few important projects. Concentrate on the quality of the company's people and its track record with projects similar to yours.

Keep in mind, too, that the lowest bidder is not a bargain if it can't deliver to your quality standards and you have to change vendors. Check the prospective vendor's record of on-time deliveries with other customers. If a vendor misses shipments to you, your revenues from new instrument installations will be delayed and may be lost. Also, look beyond the quoted prices and evaluate the total costs over the lifetime of the program. Consider the costs of maintenance, repair, and downtime. Make sure that the quoted price includes adequate testing of the instrument during the development phases. Correcting problems that arise in the field because they were not tested for and corrected during development can be extremely costly in both dollars and reputation. Check for built-in loops that allow the vendor to come back for more money.

Choose vendors that can demonstrate a commitment to both price stability and quality. Look for those that will link their success with yours rather than merely play back your requirements to get your order. You do not want an outside contractor to come back and tell you that the program has failed because they took direction from you.

Consider offering the supplier exclusive rights to specific technologies it develops for your project but may want to use in future projects for other customers. This can motivate a supplier to invest its full creativity into the project and also allow you to get better pricing.

By outsourcing, you can dedicate precious internal assets to those activities that generate the best return and the highest shareholder value, while distributing functions that are peripheral to or do not match your company's core competence to other companies that specialize in those functions.