A company that specializes in treating conditions of premature infants has received FDA clearance to market a device that helps babies learn to feed correctly. KCBioMediX Inc.’s (Shawnee, KS) NTrainer System combines hardware and software that assesses the patterns of a premature baby’s ability to coordinate breathing, swallowing, and sucking in order to feed (know as non-nutritive suck, or NNS). It examines the NNS patterns and helps establish the correct sucking patterns for babies, which benefits them because it promotes faster weight gain and physical growth. The system trains the baby’s brain in a sense, enabling the baby to speed up the ability to eat without a feeding tube.
KCBioMediX was founded to commercialize devices developed at the University of Kansas that assess the NNS of premature babies. It’s possible that that target market for the device could be worth more than $1 billion.
Premier Inc., one of the nation’s largest hospital group purchasing organizations, isn’t waiting for FDA to get around to requiring unique device identification. It announced in a release published on devicelink.com that it will require all medical device manufacturers it has contracts with to adhere to standards that essentially require unique device identification — which usually consists of bar codes or RFID and can help in tracking devices in case of recalls, and preventing medical errors.
Industry originally opposed unique device identification because of the difficulties in coming up with a single system that would work for all medical devices. FDA and industry have struggled to come up with one, and the process has taken a very long time, even though Congress finally mandated unique device identification in the FDA Amendments Act of 2007. Premier apparently had enough, and imposed its own standards. It hopes its action will force FDA to act.
Premier has adopted the GS1 supply chain standards. This includes a Global Trade Identification Number, the Global Location Number, and the Global Data Synchronization Network. The first is a standardized number used to identify medical devices at various packaging levels. The second is a standardized number used to identify who has been in contact with a device. The third stores data from the first two, and allows users to access information about each device.
There aren’t many devices approved for specific use in children in the United States. Some go abroad to get what they need; others forego treatment at great consequence. Most often, doctors use devices designed for adults off-label, or hand-make their own devices. The main problem is that the pediatric-use market isn’t large enough to justify the investment of developing a device for children. Last year’s FDA Amendments Act provided financial incentives for companies developing pediatric devices, but also required them to track patients at their own expense, so it doesn’t really do much to address the cost-of-development issue. Ethical issues also come in to play. Can you do a randomized clinical trial on children?
On Wednesday, reports Reuters, the National Institutes of Health is sponsoring a meeting on pediatric devices, and an AdvaMed spokeswoman says industry will look to it for guidance.
Arthrocare Corp. said it will restate its earnings for 2006 and 2007, as well as for the first quarter of 2008, after its audit committee determined “that the financial statements for such periods can no longer be relied upon.” Translation: Someone somewhere along the line made a big, big mistake. The new statements will reduce 2006 revenue by $4-7 million, 2007 revenue by $20-25 million, and 2008 revenue by $2-5 million.
Now, the company’s explanation makes it seem like there was no fraud at play, just a miscategorization. Here is how it categorizes the mistake: “The relationship between the company and DiscoCare, Inc. during the periods being restated was a sales agent relationship, rather than that of a traditional distributor; and the sales price of products sold to State of the Art Medical Products, Inc.(”SOTA”), Boracchia & Associates and Clinical Technology, Inc. cannot be considered fixed or determinable upon shipment by ArthroCare during the periods being restated. The company will therefore account for sales by ArthroCare of products to each of these entities from the third quarter of 2006 to March 31, 2008, under a sell-through revenue recognition method that is appropriate for both of these situations, as opposed to a sell-in method. Under the sell-through method, revenue is not recognized until after the surgery is performed or a subsequent sale to another customer occurs. Sales to these companies for periods prior to the third quarter of 2006 will continue to be accounted for under the previous method of revenue recognition, either sell-in or sell-through, depending on the terms of the previous contract with each company.”
Some other things from the affected financial statements will also be recategorized, and the audit committee will oversee a review of the firm’s internal controls — a review that will involve outside investigators and may expand beyond that scope if necessary.
Shares of Arthrocare, which makes a variety of surgical instruments that work by dissolving soft tissue, fell 21% in early trading, reports Reuters.
An FDA inspection of a Cardinal Health facility in Dublin, OH that distributes point-of-use sharps containers has determined that the facility does not have adequate management controls as part of an effective quality system. The inspection found that a number of a quality system procedures have not been established, according to a May 28 warning letter. Among the procedures lacking are written corrective and preventive action procedures, design change control procedures, complaint procedures, and medical device reporting procedures.
Additionally, FDA’s letter says a management representative has not been appointed to ensure that the quality system requirements are met, and management reviews do not ensure that the quality system satisfies the requirements of CFR part 820. The letter also cites the firm for failing to conduct quality audits and failing to have a procedure for acceptance and rejection of incoming product.
–James G. Dickinson
FDA wants to know whether a registry could help standardize feasibility trials for local treatment of small breast cancers with different ablation devices and therapies, according to a Federal Register notice. FDA particularly wants to understand how such trials can be designed to provide standardized evaluation of tissue biopsy pathology, selection of tumors amenable to ablation, image guidance for ablation, postablation imaging and assessment, and tissue pathology of ablated specimens.
In 2003, the notice says, FDA’s General and Plastic Surgery Devices Advisory Panel discussed issues pertaining to the use of thermal ablation devices to noninvasively treat breast cancer. The panel also discussed clinical trial issues pertaining to local treatment of breast cancer using thermal ablation versus operative resection.
FDA says the panel’s discussion has significantly affected regulation of the technologies. And investigators studying feasibility of thermal ablation devices for treating breast cancers have refined their techniques to the point that there have been small studies demonstrating nearly 100% ablation accuracy. However, FDA says, a lack of uniformity among different feasibility study protocols has resulted in study results that can’ t be easily compared.
–James G. Dickinson
FDA announced that the agency and Advanced Bionics LLC have reached a settlement over alleged violations of federal law, stemming from a 2006 recall. The agency charged that Advanced Bionics shipped cochlear implants to customers in the United States without first filing appropriate supplemental information with the FDA, including notice of a change of a component supplier. The failure to submit supplemental information prevented the FDA from being able to evaluate the potential impact of the changes on the safety and effectiveness of the device. This, in turn, made the device adulterated, and posed a risk to patients. The product in question was the HiRes90k Implantable Cochlear Stimulator, a Class III device.
In March 2006, Advanced Bionics recalled unimplanted devices containing components from an unapproved supplier because of excessive moisture that could leak into the devices and cause device failure and possible surgery. But FDA alleged that in at least two cases, a version of the product with the unapproved supplier’s component was implanted in patients after the recall.
Under terms of the agreement, the firm will pay a $1.1 million civil money penalty, and its CEO, Jeffrey Greiner, will pay $75,000. They do not admit liability.
This kind of thing is why you see so many references in MD&DI and at conference sessions about the need to keep your supply chain under control.
Companies that manufacture devices to treat life-threatening conditions could be immune to the recent economic woes. Although there are patients who might put off having cosmetic procedures or elective surgery, those who suffer from serious conditions aren’t in the same position. St. Jude Medical’s CEO was hopeful after the recent release of the company’s quarterly results, and analyst Aaron Vaughn from Edwards Jones called St. Jude’s 48% increase in net income “fantastic.” The company even saw double-digit increases in its defibrillator sales, which have been sluggish in the past following product recalls. This doesn’t necessarily indicate a recession-proof atmosphere, but as companies like Boston Scientific and Medtronic report their financials in the near future, industry might have a better idea of where it stands during these difficult economic times.
Congress voted to override President Bush’s veto of the Medicare Improvement for Patients and Providers Act of 2008. The headlines are all about the bill’s provision that nixes proposed Medicare payment cuts to physicians. But it also has implications for two competitive-bidding programs that are of interest to the device industry. First, it delays a competitive-bidding program for durable medical equipment. Industry had complained that the bidding process was flawed, and that a price-based system would cause quality to suffer. Second, the bill repeals the clinical laboratory competitive-bidding project that had been halted by a federal judge in April. Industry complained that its requirements were unworkable and patients would suffer as a result.
Peter Carstensen, founder and leader of CDRH’s human factors engineering team, has retired from the agency and joined Wiklund Research & Design, a human factors and design consulting firm. Carstensen was CDRH’s chief authority on human factors and usability issues, and was instrumental in the center’s increased emphasis on proper usability testing and research. He participated in numerous product design reviews, drove the development of multiple human factors standards and guidance documents, and advised device manufacturers on how to incorporate human factors into their design processes when establishing a quality system. In his new position, he will help medical technology developers fulfill regulatory requirements pertaining to human factors, prepare an appropriate design history file, and respond effectively to regulatory actions.
Carstensen was named one of MD&DI’s 100 Notable People in the Medical Device Industry in 2004.
