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Medical Device Marketing

Originally Published MX September/October 2004

ADVERTISING, DISTRIBUTION, & SALES

Medtech marketers share their winning strategies for successful campaigns.

Courtney Harris

In today's landscape, medical technology marketing is experiencing change. New FDA policies regarding direct-to-consumer (DTC) advertising, for instance, are forcing marketers to adjust their approach. Fortunately, there are expert agencies that are ready to meet these demands.

Each year at its annual meeting, the Medical Marketing Association (MMA; San Francisco) presents the winners of its International Awards of Excellence (In-Awe) competition, honoring the best agencies and campaigns in medical marketing. In this article and accompanying sidebars, winning medical device marketing agencies describe their campaigns and strategies for success. A complete list of In-Awe winners in medical device categories can be found in the sidebar.

How Competitive Bidding Might Affect Manufacturers' Sales

Originally Published MX September/October 2004

GOVERNMENTAL & LEGAL AFFAIRS

Suppliers—not manufacturers—will be the bidders under the forthcoming competitive bidding system, just as Medicare reimburses suppliers and not manufacturers. Nonetheless, changes in the program of supplier reimbursement could profoundly affect sales by manufacturers of durable medical equipment, including related consumables.

How Medicare decides to group products into product categories for competitive bidding purposes may influence the market in a number of ways. For example, lumping less-expensive low-tech products with more-expensive high-tech versions in a single category could squeeze out sales of the higher-cost items. Also, a revision of current product groupings might eliminate some of the biggest spreads between the Medicare reimbursement for a product and the cost to a supplier of acquiring it, making the item less attractive for suppliers to purchase.

Another Attack on FDA’s Troy, This Time with a Sting

Originally Published MDDI September 2004

WASHINGTON WRAP-UP

Some worry that FDA's chief counsel is too eager to involve the agency in legal proceedings dealing with product liability damages.

James G. Dickinson

Risk-Based Bioresearch Monitoring Change | Sponsor-Monitor Reports Can't Be Shielded from FDA | Patient Lifts in Trouble  | Eye Laser Recalled Alternative Premarket Procedures Extended | Guidance on Export Certificates | Medical Leeches Are Devices

Since he joined FDA in August 2001, chief counsel Daniel E. Troy has never been far from controversy. First, it was for causing a major reduction in the number of warning letters the agency issues. This happened after regulated companies complained about them to FDA's parent Department of Health and Human Services.

Most recently, watchdogs have criticized his readiness to inject FDA into the state-court defense cases of FDA-regulated companies sued for product liability damages. Publicly, Troy has spoken little about this. But he has said that FDA's role in such cases is to uphold the agency's legal dominance rather than to comfort industry defendants.

In July, his latest critic, five-term congressman Maurice Hinchey (D-NY), added a monetary penalty against FDA for Troy's behavior. Hinchey accused the chief counsel of taking his FDA office in a “wholly unprecedented direction.” The congressman inserted an amendment in the agency's budget that passed overwhelmingly in the House. Under the amendment, $500,000 was removed from the commissioner's budget and placed in the Center for Drug Evaluation and Research budget instead. Why? Because, Hinchey said, the commissioner's office had obstructed Hinchey's staff in their efforts to investigate Troy's activities. 

“The mission of the Food and Drug Administration is to ensure that the public is protected from unsafe food, drugs, and other medical products,” Hinchey told a press conference. “Daniel Troy is instead making it the agency's mission to protect…companies from being held accountable when their products do serious harm. This is not merely a question of financial compensation for the victims and their families. Civil action is a vital tool in gaining information about medical products and protecting future users of those products. Mr. Troy is trying to take that tool away from the public his agency is supposed to protect.”

Hinchey said he had learned of at least four separate cases that support his allegations. In these cases, Troy's office submitted briefs supporting the defendant corporation against the families of people who died after using that corporation's product. In three of those cases, Hinchey said, he found evidence of inappropriate collusion or conflict of interest between Troy and the defendant companies. 

In one case, Motus v. Pfizer, Hinchey said Troy was advocating on behalf of Pfizer. The company had paid $360,000 for Troy's legal services the year he accepted the FDA chief counsel position. In another, Murphree v. Pacesetter, Hinchey said evidence showed that the defendant's lawyer was directing FDA on how best to intervene. In the third case, Dowhal v. SmithKline Beecham Consumer Healthcare, Troy met with the defendant's lawyer before filing a brief, Hinchey said. “In none of the four cases did the court request an opinion from the FDA,” a news release said. “This unsolicited insinuation into state civil suits represents a radical departure from the FDA's established practices, a fact Troy and the FDA have tried to obscure.”

In March, at an Agriculture Appropriations Subcommittee hearing, Hinchey said he questioned FDA acting commissioner Lester Crawford about Troy's actions. “The FDA's response was intentionally misleading,” Hinchey's release said. This led the committee to “adopt legislative language written by Hinchey expressing concern about the agency's credibility.”

In a statement on FDA's Web site, Crawford responded to Hinchey's charges: “Daniel E. Troy is a dedicated and talented public servant who has provided excellent legal advice to FDA since his appointment in August 2001. He fully complied with the ethical requirement to recuse himself from any matter involving a past client for a year after beginning work in the public sector. FDA has accurately reported the scope and nature of Dan's private- sector work. Any allegation that he has not conducted himself in compliance with applicable legal and ethical rules is simply false. Dan has my utmost confidence, as well as my heartfelt gratitude, for his steadfast leadership and wise counsel during this important period in FDA's history.”

In May, former FDA chief counsel Peter Barton Hutt said Troy's criticized actions were neither new nor novel for FDA chief counsels.

As of press time it was unclear whether Hinchey's $500,000 penalty amendment would survive a House-Senate conference on FDA's budget.

Risk-Based Bioresearch Monitoring Change

FDA's bioresearch monitoring (BIMO) program will undergo a paradigm shift beginning later this year. The program inspects clinical trial data that support marketing applications for drugs, biologics, and medical devices. The shift is part of the agency's broadening risk management process, according to FDA clinical science and Good Clinical Practices director David Lepay. Speaking at the Drug Information Association's annual meeting in June, Lepay said he sees the monitoring program evolving so that its actions will not be as predictable as they are now. BIMO inspections today tend to look at data in marketing applications, have inspectors review three clinical sites per application, and focus on the largest clinical sites.

Lepay said that beginning next year, industry will see FDA focusing more on at-risk populations and higher-risk products and protocols. He said he would also like to see more attention given to complaints received at the agency. This would be especially true if there is enough information behind the complaints to allow a thorough evaluation.

FDA's GMP initiative has provided the impetus for a “quality systems approach” across the agency, including the BIMO program, Lepay said. “Out of that will come a broad look for us that hasn't happened since the 1970s when we put in place the BIMO program and our regulations,” he said.

Lepay said BIMO's inspections will need to assess how “less can be more. In fact you can do less of many things, and, if [what's done is] chosen properly and executed properly, your result and performance can be more.” He said the agency needs to get away from a cookie-cutter approach. For example, focusing on a reporting error instead of paying enough attention to the real safety parameters in a study is a drawback of such an approach.

Additionally, Lepay said FDA's new approach will see differences across each center. For example, device sponsors tend to be small, have small monitoring staffs, and lack systems controls, while large pharmaceutical companies have perfected much of what goes into monitoring. He said it might be beneficial to focus on a specific monitoring activity in the device area rather than in the drug area.

In response to an audience member's question on what current BIMO inspections are citing, Lepay said recent violations fall into five basic categories. These are protocol violations, recordkeeping, informed consent, product accountability, and adverse- event reporting.

Sponsor-Monitor Reports Can't Be Shielded from FDA

Sponsor-monitoring reports for clinical trials are not viewed as “internal audits.” Thus, FDA can review them during inspections, the agency said in a recent warning letter to pacemaker manufacturer Biotronik Inc. (Lake Oswego, OR). The letter was issued after Biotronik refused to provide the reports during an FDA inspection.

“Quality audits or ‘internal audits' as required by the quality system regulation (21 CFR Part 820) refer to manufacturing processes and are generally exempt from FDA review,” the letter said. Because Biotronik refused to produce the reports, FDA said it could not determine if the inspected study's monitoring could ensure investigator compliance.

FDA also cited Biotronik for failing to secure a clinical investigator's compliance with the investigational plan and applicable FDA regulations. FDA said, “despite periodic clinical monitoring visits from your firm's designated monitors, violations were repeatedly committed at the sites during the clinical investigation.”

Patient Lifts in Trouble 

Two device makers came under public scrutiny in July for failures involving patient lifts. The first case involved 26 Faaborg Patient Lifts (Models PL, VL, and Solution/Nordic Series) FDA seized from their U.S. distributor, Moving Solutions Inc. (Downers Grove, IL). The agency said the devices could break, causing serious harm to patients. The seizure followed a complaint filed in federal court. According to a press release from the Northern Illinois U.S. Attorney's Office, the complaint alleges that the company violated the FD&C Act. 
The lifts were described as mechanical slings used to lift and move patients from a bed to a wheelchair. About 850 were distributed to hospitals, nursing homes, and private parties, the release said. FDA received reports about one patient dying and another being seriously injured. A bolt that supports the hanger bar and the patient sling broke from excessive wear, causing patients to be dropped, the reports alleged. The release said Moving Solutions failed to report the patient death to FDA. Earlier this year, FDA reported that the firm was conducting a Class 1 recall of 865 patient lifts because of a faulty design. Class 1 recalls are the agency's most serious category.

The second case involved a Class 1 recall issued by Arjo Inc. (Roselle, IL) for its Alenti Lift Hygiene Chair because of serious injuries from tipping incidents. The chairs are designed to lift and move patients for bathing. FDA's recall notice said “reported causes of the incidents include lift instability on sloped floors, casters falling off of the lift while in use, patients leaning or shifting weight in the seat, and brakes not being applied. Additionally, the device labeling does not properly instruct the healthcare professional on how to properly secure the patient.”

Eye Laser Recalled 

FDA says Carl Zeiss Meditec (Dublin, CA) is recalling its eye laser Visulas 532s with Visulink 532/U because of a defect with the laser's mirror. According to the Class 1 recall notice, the reflective mirror coating can tear and loosen from the mirror surface. “The faulty mirror may misdirect the laser beam to an unintended target in or on the eye resulting in retinal bleeding and/or burns due to excessive laser energy in the eye,” it says.

Alternative Premarket Procedures Extended 

FDA in July issued a guidance for industry and FDA staff titled A Pilot Program to Evaluate a Proposed Globally Harmonized Alternative for Premarket Procedures. The new document supplements a June 2003 guidance on the topic. The pilot program is being extended for a second year and will remain active until at least June 2005.

According to FDA, the program will assess the feasibility of using an internationally harmonized format and content for premarket approval and 510(k) submissions. 

This guidance supplements the Global Harmonization Task Force draft STED document (Summary Technical Documentation for Demonstrating Conformity to the Essential Principles of Safety and Performance of Medical Devices) in two ways:

•It provides administrative information and guidance to device manufacturers who are considering using the draft STED document to submit a PMA application or 510(k) premarket notification in a harmonized format.
•It describes the extent to which harmonized documentation may need to be supplemented by additional information to ensure compliance with U.S. requirements.

To access the guidance, visit FDA's Web site at www.fda.gov/cdrh/ode/guidance/1347.html

Guidance on Export Certificates 

A newly issued guidance for industry is called FDA Export Certificates. It provides a general description of FDA export certificates that are issued to industry and foreign governments. The certificates assist firms that export products from the United States to countries that require proof of their U.S. regulatory status. The guidance lists the seven types of export certificates issued by FDA and explains the regulations covering their issuance using a question-and-answer format. 

Included are reasons why FDA would refuse to issue a certificate, charges made for export certificates, and legal requirements for exporting adulterated or misbranded products. In addition, the guidance lists current good manufacturing practices requirements for drugs, devices, and biologics.

The guidance can be accessed at FDA's Web site, www.fda.gov/cber/gdlns/exprtcert.htm

Medical Leeches Are Devices 

FDA in July cleared a Ricarimpex SAS 510(k) for using medicinal leeches to “help heal skin grafts by removing blood pooled under the graft and restore blood circulation in blocked veins by removing pooled blood.” According to an FDA press release, the French company has been breeding leeches for 150 years. They are currently handled in a certified facility that tracks each lot. FDA based its clearance on published literature detailing the use of leeches in medicine and safety data provided by the firm. “FDA also reviewed information on how the leeches are fed, their environment, and the personnel who handle them,” the release said. 

This follows FDA's decision in January to regulate the use of maggots for medical use. The disinfected fly larvae, when applied to a wound and covered with a cagelike dressing, can liquefy dead tissue, kill harmful bacteria, and stimulate healing.   

Copyright ©2004 Medical Device & Diagnostic Industry

Healthcare Information and Management Systems Society

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

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Visions of the Future

Founded in 1961, the (HIMSS) is a professional association of information systems professionals who work in the healthcare area. Established long before the computer age began to impinge on healthcare, HIMSS prides itself on being the only national organization devoted to information and management systems in this specialized field.

The 14,000 individual members of the association are people who design, operate, and maintain the IT systems that healthcare providers must have. For these members, the organization offers certification of competency in the field.

HIMSS also includes 220 corporate members, which all together employ more than 1 million people. These corporate members—predominantly hospital groups and independent healthcare sites—have great buying power, controlling budgets averaging in the millions of dollars.

Medtech Leadership for the IT Future

Originally Published MX September/October 2004

EDITOR'S PAGE

In July, the U.S. Department of Health and Human Services brought together a wide range of public officials and private-sector leaders for a Secretarial Summit on Health Information Technology. The central event of the summit was the release of a progress report on the healthcare technology agenda announced by President Bush earlier this year.

The report, The Decade of Health Information Technology; Delivering Consumer-Centric and Information-Rich Health Care: Framework for Strategic Action, outlines strategies for implementing a nationwide electronic health record system within the next 10 years. It is expected that such an IT-based system will reduce medical errors and variations in care, make individual medical records available in a portable and protected format, and enable physicians to spend more time on patient care.

Plugged, Unplugged

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

Medtech manufacturers should play a more active role in developing products for clinical connectivity.

Art Kerley

Information technology (IT) in the healthcare sector is making a lot of headlines these days. President Bush has called for the nationwide implementation of electronic health records within 10 years, while Secretary of Health and Human Services Tommy Thompson has appointed an IT healthcare czar to coordinate and expedite the effort.

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Healthcare has been at best a marginal participant in the IT revolution that has brought profound productivity gains to large and small commercial and industrial businesses over the past 25 to 30 years. While IT has made significant inroads in the administrative area (billing, scheduling, and the like), implementation on the clinical side—which, after all, is the business of healthcare—has been lackluster.

Healthcare's Slow Response

Manufacturer Input

Originally Published MX September/October 2004

GOVERNMENTAL & LEGAL AFFAIRS

CMS is beginning to assemble an advisory and oversight committee, as mandated by Congress, to help it design and implement the competitive bidding program on which much future Medicare reimbursement will be based. The agency intends to appoint 12 to 15 committee members, who will be representatives of the consumer, physician, supplier, and manufacturer communities. Manufacturers anticipating that the new Medicare reimbursement regime will have a substantial impact on their business should plan to inform CMS and the advisory committee of their positions on product category groupings, geographic boundaries for competitive bidding, and other pertinent issues.

No formal mechanism for submitting comments to CMS or to the advisory committee being formed is yet defined or in place. It is expected that, over the coming year, CMS and its advisory committee will announce public meetings and other means by which manufacturers and other affected parties may provide their input.

Copyright ©2004 MX

Probe Could Improve Breast-Cancer Detection

Originally Published MDDI September 2004

R&D DIGEST



Erik Swain

The probe measures absorbed and reflected light to help determine the nature of tissue during a biopsy. (Inset) Although the probe is less than 1¼4–in. wide, researchers hope to make it even smaller and less invasive. 

Researchers in Wisconsin are developing a light-sensitive probe that could lead to more accurate detection of breast cancer. Missed diagnoses occur for as many as 70,000 U.S. women per year, and an additional 60,000 need a second biopsy because the first was inconclusive. 

A team from the biomedical engineering department of the University of Wisconsin at Madison has developed a thin fiber-optic probe that can be threaded through the hollow channel of a biopsy needle to its tip. Used in conjunction with x-ray or ultrasound images, it could ensure that the biopsy needle reaches and samples the target area. The technology also has the potential to minimize trauma associated with the biopsy procedure.

Preliminary tests using ultraviolet-visible fluorescent light showed that the technology correctly identified cancer with more than 90% accuracy. A larger test, using both fluorescent and near-infrared light, has just begun on 250 patients. Results from the first test were published in the January issue of the Annals of Surgical Oncology. 

Near-infrared light has been used with breast biopsies, but never in the body, while fluorescent light has been used inside the body to detect cancer, but never breast cancer. And neither has been used inside a biopsy needle. The test will help determine whether one approach is better than the other, or whether both can be used in conjunction, said Carmalyn Lubawy, a university biomedical engineering graduate student who is on the research team.

The probe works by emitting light at certain wavelengths and collecting the reflected light and fluorescence. The researchers analyze how much light is absorbed by the tissue and reemitted as fluorescence, and measure how much light is scattered. The absorption rate for tumors is different than that for other components of tissue. The team has also been able to reduce the number of light wavelengths needed to make a diagnosis, which should make the process more efficient.

The team, led by Nirmala Ramanujam, an assistant professor of biomedical engineering at the university, had been looking at a number of issues related to breast cancer and decided to tackle the inefficiencies of the biopsy process, Lubawy said. 

The initial tests were done on tissue removed by lumpectomy. The current tests will determine whether the probe can work when used on a biopsy needle. 

Designing the probe proved to be challenging, Lubawy said.“One obstacle is that biopsy needles have side apertures. Light has to go down the optical fibers and make a 90-degree turn so it can go into the tissue,” she said. “We couldn't get the direction right on the first biopsy needle we tried, so we had to change needles. We also had to work out problems with light leakage and signal levels. But we are confident that the design we have now will work.” 

The probes are thin enough to fit through a needle smaller than the standard 1¼4-in. biopsy device, which could make the procedure less invasive. In fact, Lubawy said, the next step in development is to get the probe to work with even thinner needles. “This way [the procedure] removes less tissue and is less traumatic to the patient while maintaining high accuracy,” she said. 

Initial funding for the project came from a Whitaker Foundation Biomedical Engineering Research Grant in 2001. The team has since won $1.2 million in grants from the National Cancer Institute and the National Institute of Biomedical Imaging and Bioengineering. The research team also includes radiologist Elizabeth Burnside and Wisconsin graduate student Changfang Zhu.

Copyright ©2004 Medical Device & Diagnostic Industry

Connecting for Health

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

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Visions of the Future

is one of the broadest-based entities in the world of healthcare information technology. It was founded in 2002 by the Markle Institute, whose mission is to accelerate the use of technology for critical public needs—especially in health and national security. It receives additional support from the Robert Wood Johnson Foundation, another leader in healthcare philanthropy.

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The Manufacturing Edge

Originally Published MX September/October 2004

SPECIAL REPORT: IT IN HEALTHCARE

Creating the advanced IT-based healthcare system of the future starts with the building blocks used in everyday operations.

Christina Elston

The key for getting medtech manufacturers to take advantage of information technologies lies in a single word: compliance. Whatever cost-efficiencies or quality benefits IT systems may promise, medical device manufacturers will be slow to adopt systems that are not certified to be compliant with applicable regulations.

Moving device manufacturers in such a direction also promises benefits for the healthcare system as a whole. But before medtech companies will expand their product lines with devices that are reliant on IT, they first need to be comfortable with the use of such IT systems—and especially with their ability to comply with regulations. And that process starts with internal systems—tools that manufacturers use for their everyday operations. Following is a discussion of several key areas in which manufacturers have already begun to adopt IT systems.

Building Blocks for Automation