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Fonar to Launch National TV Advertising Campaign

Fonar Corp. (Melville, NY), a manufacturer of medical imaging equipment, is set to launch a series of television commercials to promote its Upright line of magnetic resonance imaging (MRI) systems. Fonar has retained Leapfrog Advertising (New York City) to create and distribute the 30-second spots, which will run on national cable shows during both daytime and prime-time viewing hours.

“The Fonar Upright has immediate appeal to consumers, who respond very positively and are eager to talk to their physicians about it,” says Tom Attea, managing partner of Leapfrog Advertising. The agency reports that the number of scans and referring physicians went up dramatically in the markets where the introductory advertising ran. “The advertising also opened the door for the Fonar sales force and resulted in a number of MRI sales,” says Attea.

The commercials, which are expected to reach 23 million households across the country, depict what Fonar describes as “real-life patient experiences.” The spots tout the company's upright scanning technology—which is capable of scanning patients in a variety of sitting, standing, and lying positions—as being better able to detect diseases and disorders that may not show up in conventional scans in which patients are required to lie down.

With nearly 100 of its scanners installed across the country, Fonar reports that almost all potential MRI patients in the United States live within relatively close proximity to an Upright system, increasing its viability as a diagnostic option.

Damadian

Fonar's Damadian: Taking it to the masses.

“We believe patients all across America are eager to adapt to the latest and most-effective healthcare treatments,” said Raymond Damadian, MD, president and founder of Fonar. “It is up to Fonar to bring this advanced technology to the attention of consumers, and this new advertising campaign marks the beginning of a long-term effort with our marketing partner, Leapfrog Advertising, to get the Upright MRI in front of consumers and build the Fonar brand on a national basis. Our large number of installed MRIs has made a national effort feasible for the first time.”

No stranger to consumer promotion, Fonar has previously run both radio and television ads in the New York metro market. In addition, the company maintains a fully operational MRI unit at the Islandia Mall in suburban Long Island. The company's efforts represent another example of the medtech industry's slow but steady advance in the realm of direct-to-consumer (DTC) advertising, particularly in the orthopedic and imaging markets. Medtech's DTC efforts as a whole, however, remain dwarfed by those of the pharma industry.

Improving Clinical Compliance in the Medical Device Industry

REGULATORY OUTLOOK

Managers responsible for conducting clinical research in the medical device industry face unique challenges. In the highly dynamic medtech world, product life cycles are often dramatically shorter than those in other FDA-regulated industries. While development budgets may be smaller as well, however, the regulations are the same.

To generate data that are credible in the eyes of regulators and the public, sponsors of medical device clinical research must take a strategic approach to clinical studies compliance so they can meet scientific, regulatory, and business objectives and demonstrate to the public their firm commitment to their product's safety.

The Struggle against Noncompliance Trends

According to the Global GCP Compliance Report 2006 and compliance statistics from CDRH's Division of Bioresearch Monitoring (BIMO), the state of clinical compliance for medical devices was on a downward trend between 2002 and 2004. The number of serious violations doubled during that period.1,2

In addition, BIMO statistics show that the number of warning letters issued to clinical researchers, sponsors, and institutional review boards (IRBs) that involved medical device research increased from an average of 17 per year between FY 1998 and FY 2002 to 44 in FY 2004.2 The good news is that recently released 2005 compliance statistics indicate that industry and agency efforts have resulted in an improvement in compliance rates and a reduction in the number of warning letters.

During FY 2004, CDRH BIMO issued 10 warning letters to medical device clinical research sponsors and 24 to medical device clinical investigators.1 In that same period, the Center for Drug Evaluation and Research (CDER) did not issue any BIMO-related warning letters. The Center for Biologics Evaluation and Research (CBER) issued no warning letters to sponsors, and it issued five warning letters to clinical investigators.3

Figure 1. (Click to Enlarge) Inspection of research sponsors, investigators, and IRBs have generated an increasing rate of OAI reports, doubling from FY 2002 to FY 2004. NAI = no
action indicated; VAI = voluntary action indicated; OAI = official action indicated. Source: CDRH.

CDRH has provided a variety of statistical analyses of recent bioresearch monitoring compliance trends. As Figures 1–3 illustrate, inspections of research sponsors, investigators, and IRBs have generated an increasing rate of Official Action Indicated (OAI) reports, doubling from FY 2002 to FY 2004. It is important to note that during this period, CDRH BIMO staff have conducted approximately twice as many investigations as a result of external complaints than in previous years. These types of investigations yield a much higher rate of noncompliant conditions than the more common routine inspections.

A review of CDRH warning letters issued to clinical research sponsors indicates that monitoring deficiencies—including failure to report adverse device effects, discrepancies between source documentation and data included in the premarket approval (PMA) application, and failure to identify clinical investigator protocol violations—constitute the largest proportion of items included in these letters.1 Other violations cited in these warning letters include failures to obtain prior CDRH or IRB approval of clinical investigations.

The largest category of observations included in BIMO-related warning letters addressed to clinical investigators was “failure to follow the investigational plan.” For example, investigators failed to conduct patient examinations or lab tests required in the study protocol, were unable to account for all of the investigational devices shipped to their site, enrolled patients that did not meet protocol eligibility criteria, or failed to report protocol deviations to the sponsor (see Tables I and II). This analysis also noted a considerable number of informed-consent problems such as failing to obtain consent, obtaining consent after the investigational procedure had been performed, and using consent forms that do not conform with 21 CFR 50.4

Compliance statistics from outside CDRH provide some context for the device data. The CDRH data translate to a long-term OAI rate of 13% for CDRH BIMO, compared with 3.2% for CDER BIMO inspections. CBER compliance data provide another type of comparison. CBER occupies a unique position within FDA due to its oversight of products approved via a biologic license application and via PMA or 510(k) processes.

Key Factors Affecting Compliance

According to Patricia Holobaugh, CBER BIMO branch chief, “[Smaller device companies] haven't come to understand the ‘culture of compliance' that many larger and more experienced firms have adopted to conduct quality studies.”1

Table I. (Click to Enlarge) Common sponsor deficiencies, FY 1998 through FY 2004.

Although culture is a central factor, there are other key factors at work in the medical device industry that are influencing compliance rates.

Fundamental differences exist between the medical device industry and the pharmaceutical and biologics industries.5 Certainly, these differences cannot excuse fundamental noncompliance; however, they may help identify possible root causes behind noncompliance issues. As mentioned earlier, the dramatic difference in product life-cycle time between the device industry and the pharmaceutical and biologics industries greatly influences project timing and resources.

Life-cycle issues are perhaps the strongest driving factors in structuring medical device clinical research programs. Other factors, including resources, clinical trial design, and site management, also have a great effect on compliance.

Resources and Planning: Budgets and Workloads. Medical device companies are typically much smaller than drug or biologics companies. In fact, many device companies are considered start-ups and have little or no internal development experience. They often employ people with a high level of technical expertise, but with less clinical compliance experience than in more-established organizations. Studies conducted by these smaller companies generally involve fewer patients than drug studies; however, overall complexity is often similar because of the tasks that are unique to device studies. This includes more-complicated analytical methodology required to reduce bias and to address issues such as device reliability and the training of device users.

These challenges are compounded by the vastly shorter product life cycle for most medical devices compared with a typical pharmaceutical or biologic. The need to rapidly enroll patients in a device study can, in some cases, cause sponsors to significantly modify their plans. For example, if a device sponsor expects to recruit a specific number of eligible patients per month from each site, but finds that actual recruitment rates are half of that, the sponsor may consider adding additional sites.

Clinical monitoring resources may not always be adjusted consistent with the increased number of sites. This results in overburdened clinical monitors and, consequently, clinical investigators who lack appropriate regulatory and protocol training and supervision. This scenario almost inevitably leads to noncompliances, although it is certainly not a universal occurrence.

Table II. (Click to Enlarge) Investigator deficiencies, FY 1998 through FY 2004.

Clinical Trial Design: Monitoring and Protocol Design. The vast majority of device studies, especially those for implantable devices, cannot be masked. The implanting surgeon is always aware of the type of device used for a particular case. Although masked assessors can reduce this source of bias, it frequently cannot be eliminated, as in drug studies where the use of a placebo control is considered routine. In addition, following the instructions in the protocol for the use of the investigational device is essential.

Administration of the test article in a drug study is usually a trivial task of asking a patient to swallow a tablet or submit to an injection. Devices, especially therapeutic devices, must be used in strict accordance with sponsor instructions. Clinical monitors have the added burden of ensuring that the device has been used in accordance with the protocol and of directing investigators' innovations into constructive channels. There are many competing interests when a protocol is designed. Sponsors should work to include procedures that are easily executed and easily documented.

Research Site: Selection and Training. Inventors of investigational devices are often involved either as clinical investigators or as company officials responsible for investigations. Many successful device development efforts closely involve the device developer in various aspects of the clinical investigation but, in some cases, their intense focus and dedication to the use of the device can lead to a reduced focus on regulatory compliance.

Even though some of the informed-consent citations included in CDRH BIMO warning letters refer to issues such as the complexity of the language in the consent form or the content of the form that should have been identified by IRBs, research sponsors still have a responsibility to review those forms and ensure that they are appropriate.

Some device industry representatives have suggested that clinical investigator inexperience may be a factor that should be considered. Certainly, investigator and study coordinator training during site initiation visits and investigator meetings can help to increase regulatory compliance, reduce administrative challenges, and keep the study on schedule and on budget.

Most clinical investigators participate in several clinical research studies at any given time. In many cases, pharmaceutical studies command more of their attention and resources than device studies. Industry observers suggest that this can be due to many factors, including higher monetary compensation for the investigator and institution, or academic prestige associated with the pharmaceutical studies. When possible, the selection of dedicated and focused investigators can improve compliance and speed patient recruitment.

Fostering Compliance: The Regulators' Approach

Figure 2. (Click to Enlarge) CDRH sponsor compliance rates. NAI = no action indicated; VAI = voluntary action indicated; OAI = official action indicated. Source: CDRH.

FDA has spent a considerable amount of time discussing clinical compliance issues with industry, investigators, and IRBs. Michael Marcarelli, PharmD, director of CDRH BIMO, has stated that additional guidance documents are in preparation, including one for sponsors describing how to monitor device clinical trials. He has also discussed applying the quality system regulation corrective and preventive action (CAPA) system to clinical research. Advantages of this approach include the fact that such systems already exist on the operations side of device companies.

Many of the medical device noncompliances cited in BIMO warning letters can be traced to problems found in routine clinical monitoring reports that are not followed up and rectified. CAPA systems include mechanisms to ensure that follow-up and corrective actions are completed and reviewed to confirm their effectiveness. However, CAPA systems are designed for use inside a company, and some industry sources have expressed concern that using them for clinical research where independent clinical investigators are involved would be counterproductive, eventually leading to poorer communications with research sites. Also, in many segments of the medical device industry, there is competition for alliances with investigators who possess special expertise and can rapidly recruit patients. Rather than devote additional time to CAPA responses, such investigators could choose a sponsor that does not use such a process.

As regulatory guidance evolves, medical device companies should provide input and focus on their own efforts to improve compliance performance.

Steps toward a Successful Compliance Focus

A medical device company can take several approaches to manage compliant trials. Often the highest return on the compliance investment occurs with actions taken early in the process to address key factors that affect compliance. These actions can include careful attention to protocol and case report design, selection of experienced investigators, and use of experienced trial managers.

As the trial moves forward, using experienced clinical research associates and training them and investigator site personnel to properly manage protocol requirements are key elements for success. Systems for capturing data, whether they are paper based or electronic, are also important. Matching resources and the workload so that the sponsor personnel and site personnel can effectively interact is an essential component throughout the course of the trial.

Figure 3. (Click to Enlarge) CDRH investigator compliance rates. NAI = no action indicated; VAI = voluntary action indicated; OAI = official action indicated. Source: CDRH.

Although solutions need to be customized to a particular company's business model, there are essential questions each organization needs to ask to help evaluate critical compliance issues and to begin to adopt a best-practice framework:

• Is there a mechanism in place to ensure that proper clinical monitoring resources are provided throughout the life of a clinical trial?
• Are protocols designed so that they can be easily executed and so key data can be easily documented?
• Is there a robust clinical auditing function within the organization or externally? How are the audit data used?
• Are root causes of noncompliances identified? Are research systems then modified to address those issues?
• Are the organization's clinical research and site personnel properly trained?
• Do existing processes such as investigator meetings and on-site training adequately prepare clinical investigators and staff to conduct studies?

Once a high-level evaluation has been conducted by answering these and other important questions, an organization can determine whether it should designate its own resources or whether it needs to seek outside assistance to help assess, plan, and implement preventive or corrective measures.

Conclusion

Industry, FDA, clinical investigators, and their institutions must all work together to improve compliance rates for medical device clinical research. High-quality data will benefit industry, resulting in faster approval and clearance times. It will also benefit FDA because all stakeholders in the clinical research process, including the general public, will continue to maintain their confidence in the process and in the industry's products.

Business concerns drive the device development process and dictate available time and financial resources. Both the industry and FDA need to identify systems and tools that can help to ensure compliance.


References

1. Global GCP Compliance Report 2006: US, EU, Japan (Philadelphia: Barnett Educational Services Div., Medical Marketing Services, Parexel Intl., 2006).
2. CDRH BIMO Division [online] (Rockville, MD); available from Internet: www.fda.gov/cdrh/comp/bimo.html.
3. FDA Warning Letter database [online] (Rockville, MD: FDA, 2006 [cited 3 January 2006]); available from Internet: www.accessdata.fda.gov/scripts/wlcfm/searchwl.cfm.
4. Code of Federal Regulations, 21 CFR 50.
5. J Toth-Allen, “Medical Device Aspects of Clinical Research,” SoCRA Source 45 (2005): 32–37.

Barry Sall is a senior regulatory consultant at Parexel International Corp. (Waltham, MA). He can be e-mailed at barry.sall@parexel.com.

Copyright ©2006 Medical Device & Diagnostic Industry

Cookson Sells Coatings Company

OUTSOURCING NEWS

Cookson Group Plc, a materials science company, has sold Specialty Coatings Systems (SCS; Indianapolis) for $55.5 million. SCS forms part of the Assembly Materials sector of Cookson's electronics division, located in Jersey City, NJ. With the sale of SCS, London-based Cookson Group continues its strategy of reducing debt through noncore business disposals.

SCS comprises a group of companies and business assets throughout the United States, Europe, and Asia. Its primary business is the application of parylene, a conformal coating, to medical devices including surgical hardware, catheters, endoscopic surgical devices, and implanted pacemakers and defibrillators. David Zerfoss, president of Cookson Assembly Materials Group, says the sale is part of the electronics division's effort to increase focus on its core technology. “SCS is an excellent business with both strong financial and product technology foundations,” he noted. “However, its future growth is not strategically aligned with Assembly Materials Group's markets.”

In January 2005, Cookson announced its target of £100 million (approximately $178 million) from business disposals. With the sale of SCS, along with the sale of Cookson's laminates business for $91 million, Cookson has reached its target.

Nick Salmon, CEO of Cookson Group, echoed Zerfoss's sentiments in a statement: “SCS is a good quality business, as reflected by the price achieved. However, it does not fit with our core electronics business, and the sale represents further significant progress in terms of our strategy of progressive debt reduction.”

Cookson Group provides materials, processes, and services to customers worldwide. The group's operations are formed into three divisions: electronics, ceramics, and precious metals. Cookson Electronics' Assembly Materials sector supplies materials to assemblers of printed circuit boards, primarily to the semiconductor packaging industry. However, it also includes SCS's parylene coating business.

Turning the Corner

Originally Published MX March/April 2006

COVER STORY

Interview by Steve Halasey

For an emerging medical technology company, having access to a platform technology—an intellectual property portfolio that offers a wide range of potential medical applications—isn't a bad way to begin. That was certainly the starting point for RITA Medical Systems (Fremont, CA), which was founded in 1994 to develop the medical applications of a technology for radio-frequency interstitial tissue ablation (hence the acronym, RITA). After receiving a general FDA clearance for the use of its technology in ablating soft tissue, the company began to explore additional applications and received clearance for intended uses against unresectable liver tumors.

But the blessings of a widely applicable technology can also become a company executive's worst nightmare. With limited staff time—and sometimes even scarcer funding—prioritizing company efforts to conduct clinical research, gain regulatory approvals, approach a wide variety of clinical specialists, and gain reimbursement coverage can become an all-absorbing challenge.

RITA Medical's president and CEO Joseph M. DeVivo on turning acquisition and integration into sector leadership
Photo by KENT CLEMENCO

Harnessing Academic Innovation

Originally Published MX March/April 2006

BUSINESS PLANNING & TECHNOLOGY DEVELOPMENT

Medtech companies can find valuable partners in universities that have recognized the value of commercialization.

Lori Luechtefeld

Innovation and technology development, particularly in the medical world, are inherent in university systems, where faculty and students are continually testing new theories and protocols. Both established and start-up medical device companies can gain valuable access to cutting-edge technologies by partnering with educational institutions on commercialization activities. However, doing so often requires company executives to recognize and respect the differences between industry and academia, and put special effort into bridging this sometimes-expansive gap.

BD’s Ludwig Begins Term as AdvaMed Chairman

Ludwig

BD's Ludwig: At AdvaMed's helm.

Edward J. Ludwig, president and CEO of Becton, Dickinson, and Co. ( Franklin Lakes, NJ), has taken the reins as chair of the AdvaMed board of directors. Ludwig's induction took place earlier this month at the annual meeting of the industry association. He succeeds Arthur D. Collins Jr., chairman and CEO of Medtronic Inc. (Minneapolis), whose tenure was marked by unprecedented growth in the association's membership.

Voted chairman-elect last year, Ludwig has chaired AdvaMed's technology and regulation committee since 2004. The association reports that he was instrumental in guiding AdvaMed's policy positions during negotiations with Congress and FDA that led to the 2005 passage of the Medical Device User Fee Stabilization Act.

“My goals (as AdvaMed chairman) include improving our partnerships around the world; improving public understanding of our industry's value to individual health and to the healthcare system; continuing to drive commitment to ethics, candor, and transparency; and ensuring international competitiveness,” Ludwig says. “We'll consider broadly expanding our existing partnerships to work more closely with healthcare economists, academics, advocacy groups, health insurance associations, and trade associations such as BIO, PhRMA, the American Hospital Association, the American Medical Association, and more.”

A Little Disclosure Might Go a Long Way

From the Editors

Ethics issues concerning the medical device industry have made the news again. While the ethical practices of most device companies are beyond reproach and industry has established strict guidelines, the public perception may, in fact, be the opposite. Does the device industry need to do anything to change this?

On January 25, the Journal of the American Medical Association (JAMA) published an article written by a group of doctors calling for an outright ban on gifts to physicians. It argued that when device and drug companies offer gifts, and free products and classes to caregivers, patients are harmed and good medical care is undermined.

The day before, ethics accusations in a whistleblower lawsuit against Medtronic Inc. (Minneapolis) were publicized. The accuser claimed that Medtronic gave spine surgeons “excessive remuneration, unlawful perquisites, and bribes in other forms for purchasing goods and medical devices.” Among the allegations was that one surgeon received $400,000 per year in consulting fees but was only required to work eight days. Medtronic has responded that it takes the complaint seriously and does not condone illegal or unethical conduct.

All of this publicity and outcry comes despite sweeping industry reforms in recent years and the widespread adoption of AdvaMed's Code of Ethics. This code outlines appropriate consulting arrangements and puts restrictions on compensation for training and education.

Where the JAMA article errs is in its lumping together of drug- and device-industry practices. The relationship between device manufacturers and physicians is necessarily symbiotic. Physicians have to be trained on how to use a new device, but the same is not true for administering most new drugs. And many ideas for new devices or for improving on existing designs come from physicians who know from experience that there needs to be a better way.

While the JAMA article makes some good points, banning reimbursement of training expenses, especially for travel, could be extremely problematic, says Mark Brager, AdvaMed's director of communications. “The nature of the device industry is that physicians need to know how to use new technology,” he says.

“Without [reimbursement for travel], physicians might be likely to not make the effort to learn how to use something new.”

The issue doesn't necessarily add up economically, either. “The physician is in the business of making people better,” says Mark Leahey, executive director of the Medical Device Manufacturers Association. “The liability he can incur from using the wrong treatment is phenomenal. It's far greater than what he could obtain in even the most excessive agreement.”

The public perception of ethical lapses appears greater than the reality. That being said, instead of making unnecessary reforms, why not do what can be done to change the perception? Doctors already disclose any development and consulting arrangements they have when making presentations to professional societies.

Why not disclose them to patients, too? Industry is in favor of patient disclosure in other cases, such as when a reprocessed single-use device (SUD) is going to be used.

Brager argues that the two issues have nothing to do with each other, because the SUD situation is a patient-safety issue and the ethics situation isn't. And he's right, to some degree. Still, what's the harm in disclosure to patients? It could be a powerful tool to change public perception. The public reads about allegations of impropriety, such as in the Medtronic case, but never about the overwhelming majority of physicians and companies that practice the proper ethics. Regular disclosure could counteract that. And it's unlikely most patients would refuse a treatment or demand a different one because of it. In many cases, in fact, it could reassure them to know that their doctor had a hand in developing the procedure to be used on them.

It's not a good idea to adopt the ban that JAMA calls for or to make more vast reforms. But it may not be the best idea to maintain the status quo, either.

Copyright ©2006 Medical Device & Diagnostic Industry

CDRH Begins Reform of Postmarket Monitoring

NewsTrends

Figure 1. The CDRH postmarket safety framework operates through three integrated areas: postmarket problem identification, postmarket problem assessment, and postmarket public health response.

FDA and industry have taken the first steps toward overhauling the agency's monitoring of the safety of medical devices once they reach the market.

The Postmarket Transformation Initiative was announced in January. It aims to identify, analyze, and respond to problems in the field more quickly. It also intends to alert the public faster of potential problems concerning devices.

In February, CDRH and AdvaMed held a joint workshop, the first of several to help put the initiative into practice. Its main purpose was to “identify potential gaps in coverage,” says Mark Brager, AdvaMed's director of communications.

The agency's postmarket surveillance practices had come under intense criticism in the past year. At first, the focus of the complaints was on drugs. But attention shifted to CDRH after problems with implantable cardioverter-defibrillators from Indianapolis-based Guidant Corp. were revealed.

At the core of the initiative are the agency's efforts to devise an electronic reporting system for adverse events and to improve device information in patient records. CDRH will also reform how it collaborates internally on postmarket safety issues. This reform began last year when CDRH shifted responsibility for monitoring postmarket clinical studies to the Office of Surveillance and Biometrics.

CDRH and AdvaMed took away three major points from the February meeting, says Brager.

The first was identifying areas where FDA and industry could use enhanced training. These were quality systems, postapproval studies, recall procedures, and reporting of adverse events.

The second was agreeing to set up joint workshops on specific topics. These workshops will cover recalls, annual reports, condition-of-approval studies, and unique device identifiers. As part of the initiative, CDRH promised to come up with unique ways to identify devices, so that the agency can more easily recognize problems mentioned in reports. Brager says that AdvaMed is uncertain about that proposal, however. “We are always concerned about any regulation or legislation that has a ‘one size fits all' solution to a problem that we are not sure exists,” he says. “It's important that the discussion involve the hospital and physician communities, because they are the ones that have to identify the devices.”

The third point was setting up more-formal workshops on topics such as risk management and human factors.

“We have established clear goals to promptly identify and analyze adverse events related to devices once they are on the market and to alert device users of potential risks,” said CDRH director Daniel Schultz in an agency press release. “Specifically, we are strengthening the requirements for industry-sponsored studies once their devices are on the market; improving our targeted surveillance systems to identify adverse events; enhancing our risk-based approach to inspecting manufacturing sites, including implementing third-party inspections; improving our communication of risk-benefit information to the public and healthcare providers; and increasing use of automated information systems.”

The initiative came about after a yearlong investigation of the tools CDRH uses to monitor postmarket safety. Senior FDA management and several consultants have been tapped to guide the implementation of the initiative.

“We are committed to work with the agency to identify and review any problems that come to light,” says Brager. “But the bottom line is that any changes that are made must be things that can be shown to improve the public health. Nice ideas that won't improve the public health are not the purpose here.”

Mark Leahey, executive director of the Medical Device Manufacturers Association, agrees. “We want to make sure these issues are addressed, but not in a way that makes the requirements overly burdensome, so companies are not able to transmit information efficiently and effectively,” he says. “We want to get information to the agency more quickly without reinventing the wheel. And if they need more information, we need to figure out how to do that without compromising proprietary situations.”

More information about the initiative can be found at www.fda.gov/cdrh/postmarket/mdpi.html.

Copyright ©2006 Medical Device & Diagnostic Industry

Oliver's New Plant to Serve West Coast

OUTSOURCING NEWS

Oliver Medical (Grand Rapids, MI) has announced plans to construct a facility for medical device manufacturing in Salt Lake City. The facility will have a Class 8 cleanroom, along with high-speed pouch and bag manufacturing. The company hopes the plant will help reduce lead times for its West Coast clients and provide them with opportunities to reduce costs for shipping.

Oliver Medical provides packaging and adhesives for the medical device industry. For more than 30 years, privately held Oliver Products Co. has produced sterile-grade medical packaging materials. In 2004, Oliver Medical was created as a distinct business unit to underscore its focus on the needs of medical device manufacturers worldwide.

Business Savvy

Originally Published MX March/April 2006

EDITORIAL ADVISORY BOARD

Newly appointed members of the MX editorial advisory board offer guidance on achieving strategic and financial success in the medtech industry.

In the realm of medical technologies, growing a business often requires a lot more than just a good product idea and a ready marketplace. With resources stretched thin, company leaders are often pressed to develop detailed business plans that project their market potential as well as their regulatory and reimbursement strategies, management team growth, marketing plan, and more.

In turn, such detailed business planning makes it possible for emerging medtech companies to attract the attention of the financial community—including investors ranging from angels to large commercial banks. Such investors are increasingly specialized in the area of medical technology, and they can be a hard group to impress.