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Manufacturers Should Establish a Validation Plan

News Trends

Establishing a validation process is part of the price of staying in business, according to Brian Callahan, president of EEC & Associates (Middletown, MA). As a critical part of the quality system, validation also plays a role in the inspection process. Callahan encouraged attendees at MD&M West to set up a master plan that provides the basis for their firm's validation method.

Testing a System

Callahan broke the validation system down into four testable areas:

• Installation qualification performed on all process equipment ensures that it meets manufacturer specifications.

• Operational qualification defines the functioning bounds for equipment. It involves running equipment and making certain that a process meets defined requirements based on a product's intended use.

• Performance qualification determines that a process consistently manufactures a product that meets the requirements.

• Process validation is performed when subsequent inspection and testing cannot completely verify process results.

A validation master plan identifies company rationales, activities, objectives, and responsibilities. Although such a plan isn't specified in FDA regulations, the agency regards it as a CGMP, said Callahan. It should be referred to and updated whenever design changes are made in a process or product. He advised firms to start writing one as soon as possible to avoid mistakes and to keep all employees in the loop.

FDA is supposed to inspect manufacturers of Class II and III devices at least once every two years. The agency cannot even meet its own internal requirements. However, when FDA comes knocking, a company's first line of defense should be a validation master plan. The plan will keep FDA from going on a “hunting expedition,” said Callahan.

Copyright ©2006 Medical Device & Diagnostic Industry

Signalife, Rubbermaid to Jointly Market Heart Monitor

Bunes

Signalife's Bunes: Premier choice.

Signalife Inc. (Greenville, SC) and Rubbermaid Medical Solutions, a division of Rubbermaid Commercial Products LLC (Winchester, VA), have entered into an exclusive, multiyear marketing agreement. Under the terms of the agreement, both companies will jointly brand, market, and distribute Signalife's Fidelity 100 electrocardiogram ( ECG) heart monitor. The agreement may also include other products as they are developed.

Rubbermaid will be responsible for all marketing activities for Signalife, including advertising, promotions, media, trade shows, and exhibits, as well as the establishment and maintenance of a sales force. Signalife will provide sales and technical support, manufacturing and quality control, and product fulfillment. The companies plan to market the Signalife products together with Rubbermaid's mobile computing stations, which according to the joint announcement are “uniquely suitable for charting, clinical documentation, respiratory and cardiovascular therapy, and operative room use.”

Roberts

Rubbermaid's Roberts: Growing a medical platform.

Rubbermaid is widely known for its familiar household products, but is looking to make a name for itself in medical circles. According to Rubbermaid group president James J. Roberts, “As Rubbermaid continues to invest in expanding our presence in the medical arena, we have been looking for new technologies that complement our growing medical platform. We believe that Signalife has developed an innovative platform, and we are thrilled to be their partner.”

Fidelity system

First offering: The Fidelity 100 ECG monitor.

Rubbermaid Medical Solutions was launched in 2003 with the introduction of the Electronic Medication Administration Records (eMar) delivery system. According to Christina Fortner, product manager, the eMar system was developed with the extensive input of nurses, pharmacists, information technology specialists, hospital administrators, and construction designers, “to ensure that the system optimizes care when compared with more-conventional medication delivery vehicles.” The company also manufactures mobile computing stations, carts, and expansion modules for healthcare applications.

Describing Rubbermaid as “the premier choice” for a partner, Signalife chairman, CEO, and president, Pamela M. Bunes, said, “Rubbermaid's proven expertise at developing and growing world-class brands is unequalled.”

Recom Managed Systems Inc. changed its name to Signalife Inc. in 2005. The Fidelity 100 ECG heart monitor is the company's first product. It features patented biomedical signal acquisition, classification, and evaluation technology, which, according to the company, creates a unique platform that makes possible the first real-time, high-quality, 12-lead heart monitoring of patients in motion.

Rubbermaid and Signalife will make their first joint product presentation in Boston on May 20, during the annual scientific sessions of the Heart Rhythm Society (Washington, DC).

© 2006 Canon Communications LLC

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Registering with FDA Requires Manufacturer Savvy

News Trends

Registering a medical device firm with FDA and establishing a medical device listing are two crucial steps to marketing a medical device in the United States. The registration establishes an OEM as just that—a device maker that plans to introduce products to market.

Sounds simple, right? It is—if you make a Class I device that does not need a 510(k) clearance. For other cases, it gets more complicated.

“The registration lets FDA know where you are and that you're doing something that requires GMP or QSR compliance,” explained William Sutton, deputy director of DSMICA. Sutton spoke at MD&M West. Not every entity that is subject to the Quality System Regulation (QSR) is required to register. Domestic U.S. contract manufacturers and contract sterilizers who do not commercially distribute devices are subject to the QSR but are exempt from registration and listing

The listing of devices tells the agency the type and class of device the owner or operator is introducing into commercial distribution. There is no approval process to be registered or to have a device listed, and all device manufacturers must register and list their devices with FDA.

For example, a company with a device that requires 510(k) clearance to market the device cannot fill out FDA-2892, the medical device listing form, until the product is cleared. “There is a line on the form that asks for the 510(k) approval number,” said Sutton, “and if you leave it blank, FDA will send the form right back to you.”

What about contract manufacturers, or firms that provide services or parts to an OEM? Domestic contract manufacturers that do not commercially distribute a device are not subject to registration and listing. However, they are subject to the QSR and FDA inspection. Foreign contract manufacturers that ship finished devices, as defined by 21 CFR 820.3(l), to the United States are subject to registration and listing. Firms that solely provide services or parts to an OEM are not required to register and list. If these services or parts are commercially distributed by the firm to the OEM's customers, then they may have to register and list.

But now consider firms that provide spare parts or replacements. Each of these instances must be considered carefully. “The questions to ask are, ‘Where are these parts coming from, and who is getting them?'” Sutton noted. Manufacturers of parts are not usually required to register. If they do have to register, then they also have to list. The only parts manufacturers that register or list are those that sell classified devices or accessories to the end user. If they only sell to the OEM, they are not required to register and list.

Third-party aftermarket repair, refurbishing, or reprocessing firms are not required to register with FDA or to list the devices. Although FDA does have concerns with third party refurbishers and continues to monitor these types of establishments, limited resources do not currently allow the FDA to expend resources to routinely inspect these establishments. However, he cautioned, such situations are not to be confused with single-use device reprocessors, which are now regulated by FDA. Recent FDA regulations have mandated that reprocessing firms must not only register with the agency, but they must also demonstrate that the reprocessed devices are as safe and effective as the predicate devices.

Sutton pointed to FDA's Web site as a good starting place to decide whether a company should be registered and have a medical device listing. He also pointed out that the offices within CDRH, such as DSMICA, are excellent resources and can answer many questions on this topic.

Copyright ©2006 Medical Device & Diagnostic Industry

Visicu Issues IPO

Telemedicine company Visicu Inc. (Baltimore) fared well in its initial public offering (IPO) this month, with shares soaring from its offering price of $16 to more than $24 on the day of its trading debut.

Sample

Visicu's Sample: Taking it public.

Headed by chairman and CEO Frank T. Sample, the company develops and markets a remote monitoring system called the eICU. Designed for intensive care units (ICUs), the system aims to boost the productivity of intensive care specialists. Visicu was formed in 1998 by Brian Rosenfeld, MD, and Michael Breslow, MD, intensivists who managed adult critical care at Johns Hopkins Hospital for more than 25 years. Rosenfeld and Breslow remain with the company as executive vice president and chief medical officer, and executive vice president for clinical research and development, respectively.

The company reports that widespread market acceptance of its eICU program will be necessary for Visicu to achieve profitability, and the company notes in its prospectus that this milestone might never be reached. As of the end of December, the company had set up 27 eICU centers that serve 173 ICUs in 97 hospitals, where the company monitors approximately 2250 beds.

Among the business risks listed in its prospectus, which include those typical of a public company, Visicu noted several threats related to its patent. One of the company's competitors, iMDsoft Ltd. (Tel Aviv, Israel), has requested that the U.S. Patent & Trademark Office declare an interference and revoke Visicu's only issued U.S. patent. The company also requested that it be issued a patent with identical claims. In a separate case, Cerner Corp. (Kansas City, MO) has filed a lawsuit against Visicu seeking a declaration that the company's patent is invalid and unenforceable.

Visicu noted in its prospectus that any loss or narrowing of its patent could subject the company to increased competition. Several days later, however, the company reported that the U.S. Patent Office had issued a notice of intent to allow all claims of Visicu's patent after reexamination. “We are pleased that the U.S. Patent Office has decided to allow all 26 of our amended patent claims after a rigorous review through the reexamination proceeding,” Sample said. “This once again reinforces for us and our clients that our system for the advanced remote monitoring of ICU patients is a novel invention worthy of patent protection.”

Visicu, which now trades on the Nasdaq under the symbol EICU, has incurred significant operating losses since its inception in March 1998. It incurred operating losses of about $8.4 million in 2003, $8.1 million in 2004, and $1.7 million in 2005. The company reports in its prospectus that its accumulated deficit was about $34.9 million as of December 31, 2005. Visicu expects its operating expenses to increase as it expands its sales and marketing activities, increases product development efforts, hires additional personnel, and works to comply with the requirements related to being a public company.

In 2005, the company reported net income of $10.1 million on revenue of $18.4 million, compared with a net loss of $4.1 million on revenue of $5.5 million in 2004.

© 2006 Canon Communications LLC

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