Increasing adoption of POC testing and stricter regulatory requirements drive need for a comprehensive approach. An interview with Peter Koerte of Siemens Healthcare Diagnostics.
On the eve of the 2012 AACC Annual Meeting in Los Angeles, IVD Technology quizzed Peter Koerte, vice president of global
|Peter Koerte, PhD, is vice president, global marketing, Point of Care business unit, Siemens Healthcare Diagnostics, since 2011. In 2007, Koerte joined Siemens’ corporate headquarters in Munich, Germany, as director of Strategic Transformation. Koerte received a master’s degree in industrial engineering from the Karlsruhe Institute of Technology in Germany and a PhD in strategic management from WHU-Otto Beisheim School of Management, also in Germany.|
marketing for Siemens Healthcare Diagnostics’ Point of Care business unit, about the state of POC markets and related emerging technologies. From a business perspective, high volume and low growth in the developed markets present an odd symmetry with low-volume, high-growth emerging economies. As for technological and commercial breakthroughs, they will occur on the periphery of instrumentation, the so-called POC ecosystem.
IVD Technology: From your vantage point, what is the state of point-of-care (POC) diagnostics? Can you give us some sense of its market share in various parts of the world? And where does Siemens fit into all of this?
Peter Koerte: POC testing is increasing, particularly for those diagnostic tests that provide actionable information to healthcare providers quickly, typically within 30 minutes or less. The decreased turnaround time that POC testing provides must have a direct effect on improving provider or patient workflow and convenience, or on improving patient outcomes.
The market share for POC testing is highest in developed countries, where process optimization and improved patient care are the prime objectives. Conversely, emerging markets seek to provide basic healthcare and coverage of their population. Therefore, you are currently more likely to find testing at a centralized location, where lower per-test costs prevail, but this will change in the future.
The largest POC markets are in North America, Western Europe and Japan, but growth is limited. The emerging markets, such as China, India, and Russia, are growing faster, but with much lower volumes.
Siemens’ POC has high market shares in these developed countries and is investing significantly to broaden the base in emerging markets.
How has the economic downturn affected the POC space and Siemens, in particular? Are there geographical disparities? Are you seeing any significant trends in Asia/Pacific or emerging economies?
In general, POC testing is not directly linked to the economic downturn, as testing is also required when the economy is not doing well.
However, emerging markets such as China, that fared much better during the crisis, continue to grow swiftly while the pressure on healthcare systems in mature markets has slowed growth in certain areas. The biggest impact of the European economic crisis has been in the southern countries.
Can you tell us about some of the emerging technologies in POC diagnostics that you are watching? What will be making headlines in the next couple of years?
Within the Siemens POC business unit, we believe that current technology trends will continue in the future, i.e., easier to use devices that can run multiple samples simultaneously and provide seamless connectivity.
However, we expect the biggest improvements to happen outside the instrument, what we call the “POC ecosystem.” As regulatory requirements are strengthened, operator management, compliance reporting, and training will be key areas for innovation and improvement.
What are the particular technological, regulatory, and commercial obstacles to developing successful POC diagnostic products?
Physicians and POC coordinators continually tell us that they would love to see hematology, chemistry, coagulation, and immunoassays made available at the point of care.
From a regulatory perspective, the criteria for obtaining CLIA-waived status get tighter all the time. Globally, we see regulatory requirements and approval timelines expanding.
From a commercial perspective, in most countries, the laboratory is still in control of all testing outside of the core lab and, hence, is responsible for proper QC testing, instrument maintenance, operator training, and so forth. This is where the POC ecosystem comes in. Companies that provide the tools to answer those issues are invaluable.
How crucial is user-centered design to the successful uptake of a POC IVD product? One industry observer has noted that designers/manufacturers need to be more attentive to the intuitiveness of a device. Would you agree?
As POC testing continues to expand, more users will have to operate an increasing number of devices. They will need to be
RAPIDPoint 500 Blood Gas System
trained accordingly to maintain an adequate level of proficiency.
A user-centered design that improves workflow and ease of use is a core focus in the Siemens POC development process. Our user experience design concept uses rapid prototyping and solicits customer input very early in the development process. This continues through to commercialization of the product.
The latest generation of glucose meters is a positive example of strong user-centered design processes.
You will be exhibiting at AACC this year. Will you be making any special announcements at the event? What do you hope to accomplish there?
Visitors to our booth at AACC this year can learn about our latest POC testing solutions, including new assays, such as lactate, now available for the RAPIDPoint 500 Blood Gas System for assessing lactic acidosis (abnormally high acidity of the blood), and our Stratus CS Acute Care Diagnostic System D-Dimer assay, which is able to exclude pulmonary embolism in conjunction with a non-high pretest probability model.
Also, we will be showcasing our CLINITEK Novus urin-alysis analyzer, which recently received the CE mark in Europe. The CLINITEK Novus analyzer combines proven dry-pad urine chemistry technology with an easy-to-use cassette test format, helping laboratories deliver reliable, trusted test results while maximizing productivity.
RAPIDPoint 500 product images: Siemens