PARIS — Often repeated, commonly understood, but infuriatingly persistent, is the conventional wisdom that “markets are local” in Europe.

On a high level, Europe is only an idea. There is a flag and an anthem, but the government behind these symbols has neither a constitution nor a mandate to regulate health policies and practices, yet it continues to build one of the world’s most complex bureaucracies.

On the ground, Europe presents a bewildering landscape of 27 independent nations and as many as 270 autonomous local markets, each with different rules regulating medical devices, distinct reimbursement policies and unique distribution systems.

This is a problem only if you hold onto the memory of a vast market where everything is consistent from “sea to shining sea.”

“Vive la difference!” was the shared theme coming out of conversations with several manufacturers of medical devices, presenting novel products at the 13th annual European Congress of General Practice here last week under the umbrella of the World Organization of Family Doctors (WONCA).

• Microlife Europe (Widnau, Switzerland) introduced a blood pressure monitor that it hopes will change general practitioners’ treatment of hypertension, a key risk factor for stroke.

Wolfgang Hummel, VP for business development at Microlife, said that currently physicians take a single reading of blood pressure (BP) from patients during an office visit and then quickly prescribe a medication.

In line with a conference theme urging greater evidence for medical practice, the WatchBP unit from Microlife enables a patient to monitor BP four times each day for seven days, providing 28 readings. The physician version of Microlife Watch BP provides software to analyze the results.

“A more complete set of data quite likely could change a physician’s decision on which medication to prescribe resulting in a therapy more appropriate to a specific patient,” Hummel said.

Microlife’s blood pressure monitoring is integrated into Microsoft’s (Redmond, Washington) newly launched consumer health platform, HealthVault (Medical Device Daily; Oct. 8, 2007).

Developed in cooperation with the European Society of Hypertension (ESH), the WatchBP line includes a double-cuff unit for measurement at the physician’s office as well as the computer interface for analyzing and storing patient data, a portable model loaded with pre-set functions for an ambulatory setting, and the home model for patient self-measurement. After a week of regular measurements, patients return to the physician’s office with the unit and the stored data for a consultation.

Hummel said the company is looking to add a feature for remote data transmission, likely using general packet radio service (GPRS) on Europe’s global system for mobile (GSM) networks. This feature would be included for the final version to be released in Europe in early 2008.

Bluetooth remote transmission of data is included in the ambulatory model so that a patient’s blood pressure can be measured in the physician’s office or in a public screening setting, but away from the doctor to avoid the so-called “white coat syndrome” – readings elevated because the presence of a doctor or medical assistant makes the patient nervous.

“We have many competitors for blood pressure monitors, obviously, but we are the only company working with ESH for measurements validated by international protocols,” said Hummel. “Their endorsement comes from the fact that results from WatchBP are automated and reproducible, providing greater evidence for treatment.

“We believe that we can capture a majority of GPs in Europe by 2015 using our promotion of a science-based product development,” he said.

In Germany alone there are 2,400 cardiologists, and the number of potential GPs would be “easily 10 times that number,” Hummel said, adding that Microlife can justify the costs of the product launch based on success in Germany alone.

Reimbursement will be the make-or-break factor for Microlife in its approach to any market, he said, with the company’s go-to-market ’08 strategy in Germany based on winning insurance company support. BP monitoring, Hummel said, is not presently reimbursed in Germany, nor is hypertension treatment recognized. Instead, physicians receive a general fee for the consultation.

Distribution will be through German pharmacies, with physicians prescribing the home unit, at a cost of about €100 ($142), and with private insurers reimbursing the patient.

“We need to show the insurers, and there are hundreds of them in Germany, that if hypertension management is correctly done their costs per patient will fall dramatically compared to treatment through drugs and therapies,” Hummel said. Clinical studies to support the argument are currently being conducted.

For the Dutch market, the company will need to develop a different business model, he said, because that country’s primary care model is predominantly hospital-based and there are “not so many independent GP offices.” Reimbursement requirements also will need to be considered.

Microlife has submitted an FDA 510(k) application, and Hummel said the company anticipates U.S. product launch later in 2008.

“I am going to be learning a lot about the American market before Christmas,” he said. “From what I have seen, we will not be using the pharmacy model for distribution, but we have not yet determined our strategy.”

• HemoCue (Angelhom, Sweden) presented its point-of-care white blood cell (WBC) test, drawing a crowd of doctors from Greece to the UK for the demonstration of the desk-top unit.

Winning headlines after its introduction at the 2006 annual meeting of the American Association for Clinical Chemistry (MDD; Aug. 2, 2006) the HemoCue WBC to date has only been distributed in the home market of Sweden, according to Global Product Manager Annika Eriksson.

A droplet of the patient’s blood is drawn with a micro-cuvette and then mixed with an onboard staining agent. The cuvette is placed into the HemoCue WBC unit and after three minutes the built-in testing unit displays results on a screen.

From an increased total WBC, a physician can infer a bacterial infection, and the test thus provides immediate guidance for whether or not to prescribe antibiotics. Over-prescription of antibiotics has become a concern in many European countries facing elevated drug reimbursement expenses and has created a public health issue as bacteria develop antibiotic resistance.

“We are ready for a good acceptance in the other Nordic countries but have not completed plans for the rest of Europe,” Eriksson said. HemoCue WBC is priced at €400 ($564).

“Germany traditionally has been a very good market for us,” she said. “France is more challenging because GPs do not perform tests in their office. Italy presents a similar challenge. In the UK there is a good market opportunity for us through community blood donor clinics. Our strategy is based on identifying where there are strong test-based practices in the primary care setting. And then everything depends on reimbursement.”

Introduction to the U.S. is planned for some time in 2008, contingent on receiving a Clinical Laboratory Improvement Act (CLIA) waiver so that non-clinical staff in a general practice office are authorized to perform the test.

• Orion Diagnostica (Espoo, Finland) presented its QuickRead C-reactive protein (CRP) test, also a desk-top diagnostic unit that provides results in a few minutes from a finger-stick blood sample to aid in a decision for prescribing antibiotics.

Present in very low concentrations in the blood of a healthy patient the CRP level can increase slightly with viral infections but shows markedly high elevation for bacterial infections where an antibiotic could prove effective.

“We are introducing a new thinking for doctors in many European countries,” said a company sales director who preferred not to be named.

“It has proven a challenge,” he said, to get the unit placed in general practice offices over the past 18 months since the current product has been available, “though such testing has been available in different versions for many years.”

He added, “This is not blood pressure measurement and physicians are not used to performing biochemical tests.”

Germany is not going very well, he said. “There is reimbursement for CRP, but it is at a very low rate and physicians would need to see an increase to trigger a buying decision.” France is encouraging, but there is not a culture for testing, though recently strep testing has been successful, he said

He said Orion Diagnostica is making good progress in Spain and Italy with sales of the CRP test.

As for the UK, “it is very different, always, with the British,” he said.