Jeff McHugh is group vice president of the lab systems and routine testing business center at Beckman Coulter Inc. (Fullerton, CA). He is responsible for the clinical chemistry, proteins, automation, and data management product lines. He has held positions at Beckman that include vice president, Americas; director of sales; director of marketing and business planning; and manager, business planning and service quality. He can be reached at jjmchugh@ beckmancoulter.com.

Automation and connectivity have become the center of attention in instrument development arenas for IVD manufacturers. The automation invasion has infiltrated every aspect of instrumentation from product development and strategic planning to technical support and product marketing. The rising customer mandate for faster sample handling and analysis has prompted IVD manufacturers to reevaluate the market and to come up with strategies for meeting this demand.

At the same time, another current trend for today's IVD companies is to integrate—both physically and virtually—different testing formats, while consolidating preanalytical through postanalytical activities to conserve elements of labor. Customers are beginning to expect complete solutions to address preanalytical through postanalytical work flow, and to demand access to information in real time. IVD manufacturers face the challenge of providing instruments to meet these needs, while keeping those instruments user-friendly. 

To find out how instrument manufacturers are responding to the call for automation, IVD Technology editor Richard Park spoke with Jeff McHugh, group vice president of the lab systems and routine testing business center at Beckman Coulter Inc. (Fullerton, CA). In this interview, McHugh gives a rationale for the movement toward automation and discusses the importance of soliciting customer feedback.

IVD Technology: What have been the biggest technological advances in instrumentation development during the past few years?

Jeff McHugh: The biggest change during the past few years is that instrument systems are being developed to require less human involvement. There has been a movement toward more walk-away systems. Due to a continuing shortage of laboratory labor, Beckman has experienced a growing desire from customers to help them operate with less labor. This translates into work cells combining chemistry and immunoassay instruments and into products that can be connected by automation lines or tracks. Every product has to be able to send messages to a data management system that will enable faster integration of the results and will get information to the doctors more quickly.

We are also aiming to enhance customer lab operations with remote management systems through proactive customer support. We are developing instruments that deliver messages to us, either through the customer's lab portal or hospital Internet, with an alert to potential issues. These systems will alert us to possible problems so that we can dispatch a service engineer and provide immediate service. Advance knowledge of a potential instrument problem will enable us to get out to the client with the right part even before the system is down and will keep the operation moving.

What other factors have contributed to technological advances in instrumentation development?

Another motivation for advancing instrument technologies is rooted in the desire for improved lab safety and more-efficient lab work. The goals are to reduce biohazard exposures, to reduce repetitive-motion injury, and to increase laboratory efficiency. We are trying to eliminate—we call them wait states—places where the tube is waiting for the next part of the process.

We develop instruments that will ensure that the laboratory contributes to the patient safety initiatives that most hospitals are initiating and implementing. This is about ensuring that the bar codes are read properly so we match the results with the right patient, and also about ensuring the tubes are stored in a refrigerated stock area or a place where they can be easily retrieved for an add-on test.

What are the latest trends that have emerged in instrumentation development?

Beckman is improving product development tools to aid the efficiency of the development process and to speed enhancements and improvements to our instrument systems. We have more-advanced software tools available, like computer-aided design systems, to improve our productivity. At the end of the day, we are all software companies and the user interface is the connection to the customer. Our strategy is to simplify, to automate, and to innovate.

Our priority is quality. Of course, everybody talks about quality, but the way we look at it is in terms of key dimensions. The first key dimension is reliability. What I hear from customers is, “eliminate my downtime; make it so I don't have to have a back-up system.” We understand they cannot afford to have their systems down at all. A second dimension is ease-of-use. We now have lab workers who have received less-intensive training, so the software needs to have a simpler user interface; less complexity is better. We also provide tools for simple online troubleshooting and e-maintenance.

The overall message that we continually hear from customers is “make sure you give me results that can be trusted.” We continue to improve the integration of our system's hardware and software to ensure that customers can have the most efficient lab processes.

With regard to the development of instruments themselves, we look at emerging technologies like biosensors, microfluidics, and miniaturization. Instrument development is driven by new analytical methodologies and assays.

More-Efficient Testing

How have trends toward point-of-care technology affected instrumentation development?

In general, I see point-of-care testing as complementary to instrument testing. When our customers evaluate whether they should have point-of-care testing for critical assays in the emergency room, that puts pressure on the central laboratory to improve its turnaround times. Does an emergency room really need point-of-care devices for cardiac tests if it gets efficient results from the central laboratory? Our focus is on the central laboratory and providing faster, more-integrated solutions. There is a place for point-of-care testing, but the volume and clinical benefit may not warrant putting a point-of-care assay on an instrument platform.

When I visit customers, their responses are all over the map. In some instances, there is zero point-of-care testing going on within hospitals beyond glucose monitoring. I do see a clear trend for where point-of-care testing is heading. But in the cases where successful point-of-care testing programs are used in the hospital, they are complementary to the central lab instruments. Results need to be managed by the central laboratory to ensure quality control. Point-of-care testing provides a good challenge for the instrument developers to improve turnaround times and lab efficiency.

How do IVD manufacturers evaluate the market for point-of-care versus lab instrumentation?

Again, I see it as two different markets. Our focus is on developing faster, more-integrated, connectable instrument solutions. In addition, there might be some assays from point-of-care devices that we would need to evaluate to determine whether or not the volume is there to put it onto an instrument platform. For example, brain natriuretic peptide (BNP) is one of those that started off on a point-of-care device but the volume skyrocketed. So from an economic standpoint, it clearly needed to be put on an instrument, and most of the IVD companies did that pretty quickly.

How have advances in molecular diagnostics affected instrumentation development?

I hear constantly from customers that molecular diagnostic testing is very labor intensive. They do not have the staff to run manual tests even though the demand for molecular diagnostic testing is growing. So I get frequent requests from customers for ways to automate molecular diagnostic testing.

The growth in molecular diagnostics testing has been putting even more pressure on the routine clinical laboratories to be able to survive in the face of a labor shortage. This again relates to everything that I have been saying about developing faster, more-integrated systems requiring less labor and not just building isolated boxes.

Beckman's strategy regarding molecular diagnostics is that we want to deliver an automated molecular diagnostics solution to the hospital. As more molecular diagnostic testing is kept in-house and not sent out, we want to have an instrument that follows our strategy to simplify, to automate, and to innovate that whole process. In other words, sample preparation that allows less labor being needed to produce the test results.

Protocols and Standards

What are the primary obstacles that IVD manufacturers encounter when developing their instruments?

We are seeing more global compliance requirements not only from Europe but also from China and other countries, and this often results from a growing concern for environmental issues. The Restriction of Hazardous Substances Directive (RoHS) has led to a number of suppliers going through their components to remove these restricted materials. This means that IVD manufacturers need to revalidate their instrument systems to make sure they still function properly with these new components.

This requires a much stronger and closer relationship with suppliers. Beckman has reengineered its supplier quality program to get suppliers involved earlier in the development process. We have put together a supplier monitoring partnership to ensure that we are aware early on about changes they are making to their products or assembly systems relative to being compliant with RoHS. We get suppliers involved early and ensure that there are no questions about the specifications. We give suppliers time to communicate issues, and we move forward while staying closely involved.

We run all of our instrument systems through product testing for electronic emissions and other environmental factors. By the end of 2009, all products must meet a new radio-frequency emissions standard, and this has shaped our product testing process.

We are seeing more environmental restrictions as we move forward, and the regulatory requirements have also increased over the past 10–15 years. The IVD industry is different now than it was 15 years ago. There are now more documentation and testing requirements than ever before. We are leveraging these quality system requirements to make a better product.

This leads to another big issue for us, which is translation. We used to release an instrument system in only English, French, Italian, German, Spanish, and Japanese. Now we translate into a total of 17 languages—Turkish, Russian, Bulgarian, Lithuanian, Polish, simplified Chinese, and Korean, to name a few. The language demands on manufacturers for translations, not only on the software system but also for all the manuals, continue to skyrocket. We have to creatively find ways to deliver total solutions in the local language, and we are doing this with enhanced labeling and by providing service and operating manuals, and other product documentation, in varying languages on our Web site as opposed to paper copies.

Future Instrumentation Development

In what ways do IVD manufacturers analyze the market and plan for the future?

We are consistently surveying the instrument market. We regularly connect to our customers via surveys, panels, focus groups, and we even have a number of people going around the world, visiting labs, and talking to customers about a specific new product. This process started a few months ago and will be continuing the rest of the year. We are visiting about 500–600 sites around the world asking, “What exactly do you need?” and “What are you looking for?” The key to success in any development process is getting the customer requirements right. We gather input on the solutions that the customer has in mind, we present solutions, and we gauge the viability of those solutions.

We are also taking advantage of increased opportunities in global markets. For instance, we have experienced increased demand in India for not only basic analyzers but also products in all of the disciplines: hematology, chemistry, and immunoassay. We have created our own direct sales organization in India. Along with this comes the need to create customer support infrastructure, and we are making investments in this area as well.

We are having success in China with our automation systems. More laboratories in China are interested in implementing the latest technology in their labs to improve efficiency and to build prestige. We are also experiencing increased demand now for our automation solutions throughout Asia.

In the product development process, are manufacturers more inclined to build new instruments or to expand on current instrumentation offerings?

We have to create value for our customers. Most IVD companies are trying to build upon the foundation that is already in place. There are exceptions to this and certainly Beckman has exceptions. We have instrument systems in development where approximately 80–90% of the system is new and the rest involves updating components, developing new software, or adding new features.

There is a balance between developing instrumentation with enough differentiation and new features to meet customer needs. What is also important is providing the product in a time frame when you can participate in the market window while the demand exists.

What new trends can we expect to see this year and in the future in instrumentation development?

Improving quality and productivity will continue to be big trends. Recent developments and processes that we ourselves are employing are Six Sigma and lean principles. We are helping customers to implement Six Sigma and lean in their labs to eliminate waste and streamline processes.

In the next year or two, I do not see evidence of disruptive or displacement technologies, but rather a continued focus on connectivity, whether it is in chemistry, immunoassay or hematology, or by eliminating workstations or improving a menu on a particular workstation. The major trends primarily revolve around integrated solutions that simplify, automate, and innovate lab processes.