When Medical Alley (St. Louis Park, Minnesota) hosts a program, says Don Gerhardt, president and CEO of the trade association that promotes Minnesota's healthcare industry, "It brings together a really diverse set of participants." You might, for instance, find a biomedical engineer who works on neurostimulation devices chatting with an attorney whose focus is corporate finance, while just a few feet away a clinician specializing in spinal problems visits with a public relations professional whose work centers on promoting clients' new products.

The organization is enjoying a major growth spurt even as the industry on which it is centered, like most others, battles economic uncertainty. "Over the last two years, we've had 45% growth each year," Gerhardt said last month. It has seen its rolls swell to about 340 members of all sizes, from med-tech industry colossus Medtronic to start-ups not much beyond the "well, we have this idea ..." stage. Medical Alley's purpose, put simply, is to focus more attention on Minnesota and its surroundings as a place where the healthcare products and services industry is flourishing, which in turn will help its members grow.

While the "alley" in Medical Alley is centered on a corridor that extends from Rochester in the southeastern part of Minnesota through the Twin Cities to the northern reaches of the state, it actually now has expanded to reach into Canada and the neighboring states of Wisconsin, Iowa, Illinois and the Dakotas. And even though Medical Alley is home to more than 800 medical device manufacturers, "there are a lot of people who don't know" about how this part of the Upper Midwest is the home to much that is new in med-tech, said Gerhardt. "This has been a quiet development," he said, adding that "maybe that quiet has helped us grow as a region," away from the bright lights that have been shone on some other parts of the country.

The fact is that the substantial swath of geography that represents the membership of Medical Alley is home to some of the most interesting developments occurring in an industrial sector where "Innovation" should be part of each company's name. With the attention regularly garnered by such sector mainstays as Medtronic and St. Jude Medical, along with emerging companies such as Acorn Cardiovascular and CHF Solutions, the Medical Alley tag may become as familiar a commercial reference point as Silicon Valley was at the height of the dot-com madness.

Gerhardt's organization certainly has benefited from the attention it has received as a major sponsor of the annual Medtech Investing Conference organized by International Business Forum (Rockville Centre, New York), held last month at the Minneapolis Marriott City Center hotel. Like Medical Alley, the conference enjoyed substantial growth from last year to this, with attendance up by between 15% and 20%. "We were very pleased with the turnout," Gerhardt said, adding the reminder that generating that kind of attendance increase in a time of both economic downturn and world uncertainty, and highlighted by the war with Iraq, was worth at least modest celebration. "And the response we've heard from those who participated has been very positive," he said.

Another of the conference sponsors, the law firm of Oppenheimer Wolff & Donnelly, said in a press release issued during the program that respondents to a survey listed Minneapolis/St. Paul atop the list of five primary geographic markets for med-tech investing opportunities, followed in order by Southern California, Boston, Silicon Valley and the Baltimore-Washington corridor.

The co-sponsorship of the Medtech Investing Conference is just one of the programs in which Medical Alley is involved. As part of its mission to provide education and training for healthcare professionals, it sponsors about 80 seminars a year, most of them focused on topics such as clinical studies, reimbursement, regulatory affairs and the like.

An interesting initiative in the formative stages is establishment of a venture fund, known as Alley Ventures, that will provide seed and early-stage financing for medical device and other life sciences companies. The investment size target is expected to be in the $50,000 to $1 million range. "We're building Alley Ventures because there is a vacuum in very early stage funding availability for emerging companies," said Gerhardt. "There is very little ability to get any funding in this range," he noted, adding that "nurturing small businesses is extremely important." He said that "no checks have been written" yet from investors who have expressed an interest in participating in Alley Ventures, but he expressed confidence that "we'll be on the ground with funds available inside this year."

Another recent effort on the part of the organization has been to work with the University of St. Thomas to offer a "mini MBA" in medical technology management. The 11-week program on the university's Minneapolis campus addresses a variety of issues key to operation of start-up medical technology companies and features a faculty largely made up of industry professionals.

HIMSS in electronic health records initiative

More than 70 major information technology (IT) companies and health systems and 80 senior executives from organizations across the country representing 38 states have signed a declaration issued by the Healthcare Information and Management Systems Society (HIMSS; Chicago, Illinois) calling for a summit and immediate action supporting the universal implementation of electronic health records (EHRs). In its declaration, "Bridging the Chasm: Realizing a Universal EHR," HIMSS pledges to convene the public and private sectors in an effort to achieve improved patient safety through EHRs.

The summit will be held "most likely within the next 45 to 90 days," said H. Stephen Lieber, president and CEO of HIMSS. "We are trying to build a coalition around this issue," he told The BBI Newsletter, with "the genesis [for the summit] resulting from conversations with the Department of Health and Human Services concerning the adoption of the electronic health record, particularly in ambulatory settings." He said that HIMMS "is the natural one to be engaged on this subject. It fits our philosophy" that adoption of an EHR will address what he called two big "umbrella issues," quality and cost.

He said that quality of care is improved with the integration of clinical data across a variety of settings. "On the cost side," Lieber continued, "the thing we hear most often is duplicate testing and that sort of thing."

Lieber outlined four objectives that would be focused on at the proposed summit and during follow-on activities:

To define the EHR and its functionality to facilitate widespread adoption and interoperability.

To develop a standard summary patient data set to achieve initial electronic interoperability among providers.

To support updated reimbursement policies and funding incentives that encourage the adoption and use of EHRs.

To seek federal support for real-world, "what is" EHR demonstration projects that can be easily and readily adopted by healthcare providers.

"We'll take these four tasks and come up with a game plan to address them," Lieber said. He said that a key barrier to the EHR thus far has been that "healthcare has not, historically, standardized hardly anything. It doesn't have standardized terminology, data structures, frameworks, integration across facilities because there is no matching up of applications or in some cases hardware and software. The architecture has just not been common enough for true integration and interoperatibility."

A very large purpose of the summit, he said, is "to get away from the thinking that the problem is so broad, so complex, so resource-consuming that little progress has been made." In particular, he said that the summit will attempt to lay out "what we can do, short-term, that's meaningful and doable." Those attending the summit, he said, "will be a representative mixture from the vendor, consulting, provider, government and payer sectors we have to have all of them there."

VA finds 'serious noncompliance'

Criticism of the Department of Veterans Affairs (VA; Washington) and its medical centers nationwide is growing both on Capitol Hill and several blocks down Pennsylvania Avenue at the White House. The administration has served notice it is keeping closer watch on the VA medical research program now that details from an internal review have come to light. The increased scrutiny comes after the VA in March abruptly ordered an internal review of its human research programs nationwide.

Following directions from a memo from director of research programs Nelda Wray, MD, the VA's 115 hospitals are conducting comprehensive reviews of ongoing clinical trials. The VA spends almost $1 billion each year on its research program, which involves about 15,000 studies and recruits more than 150,000 patients, according to VA statistics. As a result of the review, the VA has found "serious noncompliance" at its hospitals in Pittsburgh, Pennsylvania; Providence, Rhode Island; Martinez, California; and Long Beach, California. Less-serious problems have been discovered at hospitals in Northampton, Massachusetts, and Portland, Oregon. Investigators also discovered that an overdose of a prescription drug led to a patient's death in a Detroit hospital. More serious problems were found at a Fargo, North Dakota, hospital, where research has been halted following the death of a patient.

Senior officials with the VA consider the matter serious. "The rules are important. They reflect the ethical underpinnings for the conduct of research, the need to treat other human beings with dignity and respect," said John Mather, MD, chief of the VA's research compliance office. An additional 22 patients have suffered adverse reactions to drugs at the Fargo hospital, and the institutional review board did not promptly review the incidents, according to federal investigators.

Presidential candidate Sen. John Kerry (D-Massachusetts) added fuel to the fire over the VA's health services. Veterans are having to wait at least six months to see a VA physician, resulting in prescription drug benefit delays, Kerry said, citing the VA's own data. Veterans in New England 18,919 of them waited six months or longer for a non-emergency clinic visit at the end of 2002, the VA reported. Nationwide, there were 235,000 veterans on the waiting list.