DÜSSELDORF, Germany – Heinz Schmersal said he knows a winner when he sees one, which is why without a single marketing study, nor a single distributor for his new product, he boldly invested in a first-rate, two-level exhibit booth at the famously pricey MEDICA exhibition.
"I wanted to wait until after this event and then we will see about the marketing," said the owner and chief executive of privately held Schmersal Holding GmbH & Co. (Wuppertal, Germany), with €165 million in revenues and 1,200 employees.
"It's my company, I know this market, and I know how to produce this product, so after this show I will know how I want to go ahead with this," he said.
It would be hard to find a more perfect model of the classic German engineer-turned-entrepreneur, a deep resource in this country that is driving the steady 8% annual growth in medical technology industry.
By the third day of MEDICA, Schmersal knew he was right about the Haemospect, a hand-held spectrometer that can kick out a quantitative analysis of oxygen saturation in blood in 10 seconds with no needles, just a light beam that "penetrates" less than 2 mm.
A very gentle acquisition of critical readings for premature babies or elderly patients, and so fast and portable that it is looking like Schmersal's instincts are on the beam that Haemospect will become a smash hit in emergency care as well.
"I have had 50 companies meet with me so far, and we will probably see more today," he said, adding that three inquiries have come from the U.S.
Transcutaneous reading of blood using light is a well-established technology in medical devices.
But where the near-infrared spectroscopy uses two wavelengths of light, the Haemospect technology uses the entire white light spectrum from 300 to 1,200 nanometers with a spectral resolution of 0.6 m.
A caregiver places the Haemospect wand on the skin of a patient, such as the palm of a hand.
A white light is projected into the underlying tissue via a waveguide and some part of the light is absorbed by the various components of tissue while some is reflected.
A second waveguide in the sensor head transmits the reflected light back to the device where a spectrometer breaks the light down into its wavelengths and the electronic evaluation unit, the hand-held device connected by a cord to the wand, analyses the light.
Algorithms developed by MBR process the data set and display the results.
"This gives us all the colors in the light spectrum coming from blood," he said, adding that the technology has a broad potential for any particle components of blood that are reflective, such as amino acids, drugs, metabolic biomarkers, and injected agents.
Schmersal said near-term medical applications include the measurement of vasomotion, tissue water content and capillary diameter.
While the price for the device is not yet known, he hinted there are "extremely attractive economic benefits and a rapid amortization of investment cost."
He also emphasized that the device eliminates all consumable products associated with blood draw, and of course, there are no laboratory charges.
Dr. Heike Rabe, neonatalogist at the Trevor Mann Baby Unit at Brighton & Sussex University Hospitals (Brighton, UK), conducted the initial validation study of Haemospect at the University of Muenster in Germany with 85 babies and is currently completing a second study of 80 infants at the University Hospital in Brighton.
She said the Haemospect can she is excited to begin applying the new device for blood bilirubin measurement for jaundiced infants.
"Blood drawn from the vein is the gold standard for hemoglobin," she said, "and this device performed at 98% against blood draws."
She said the advantage for Haemospect is that the measures take just 10 seconds, "and with no infection risk and without using any single-use disposables, which are both very big issues for hospitals."
During the studies the Haemospect has been shown superior to the current practice of capillary hemoglobin sampling from a finger-prick or ear-prick, she said, which is the alternative for infants and the elderly where a blood vessels is not available.
"The prototype I used in the clinical studies was as big as a refrigerator," she said, clearly enthusiastic over the final design that is a battery-powered, hand-held and portable device.
Results from those studies were published in 2005 in the Journal of the American Academy of Pediatrics.
The Haemospect technology was developed at Witten-Herdecke University Hospital (Witten, Germany) by Holger Jungmann, a mathematician and physicist in basic research, and Michael Schietzel, radiologist and oncologist, who both are affiliated with the Herdecke Cancer Research Association.
Schietzel has specialized for 20 years in the study of spectroscopic processes in the qualitative and quantitative analysis of substances.
Last year the three partners – Jungmann, Schietzel and Schmersal – set up MBR Optical Systems GmbH &Co. to bring the technology to market.
Serial entrepreneur Schmersal said the potential for spectral analysis of reflective components in liquids extends well beyond the medical field and the partners ill be exploring other applications, such as in the oil and gas industries and other industrial quality-control processes.