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Spellman Introduces 6 kW High Voltage Power Supply

A provider of custom designed and standard ac-dc and dc-dc high voltage power converters for medical applications, has introduced its new STR series of 6 kW high voltage power supplies. The STR is available in positive or negative polarities in 19 different models with outputs ranging from 1 kV to 150 kV. It features a full featured front panel for easy local control, an extensive analog interface that provides comprehensive remote capability, and a standard Ethernet digital interface that simplifies system integration.

Hauppauge, NY
 

BioMed Diagnostics Signs Distribution Agreement With VWR International

BioMed Diagnostics Inc. (White City, OR), a manufacturer of microbiology devices that facilitate and enhance infectious disease diagnosis, has made a distribution agreement with VWR International, a global laboratory supply and distribution company. Under the agreement BioMed's InTray and InPouch product lines will now be available worldwide. The InPouch product is a fully enclosed oxygen-resistant plastic pouch for microbiology sample collection, transport, culture, and observation. BioMed's InTray product is a fully enclosed cassette for microbiology sample collection, transport and culture.  

Granite MEDSystems Announces Joint Venture with Bjorksten | bit 7

Granite MEDSystems (Mequon, WI),a global provider of complete, turnkey electro-mechanical solutions exclusively for medical OEMs has announced a joint venture with product design and product development consulting firm Bjorksten | bit 7 (Madison, WI). The working agreement will give clients accelerated product development and lower cost programs as well as true end-to-end medical device design and manufacturing, from concept to production, all under the umbrella of 13485 oversight. By unifying both organizations’ service capabilities into a single streamlined program. The new alliance unifies Granite MEDSystems’ decades of experience as a medical OEM with Bjorksten | bit 7’s ability to design, engineer, and prototype award winning medical products. 

PolyScience Introduces New Line of Open Tank Circulating Baths

A company that supplies liquid temperature control products to the medical sector has introduced a broad lineup of open tank circulating bath systems for laboratory use. Available with either stainless steel or polycarbonate tanks, these economical baths are offered in reservoir sizes ranging from 6 to 28 L and with three different temperature controllers, including a programmable model with a highly intuitive operator interface. All controllers display both actual and set point temperature on a readout that is easily read from across the lab. Heated circulating baths are often used in the determination of a plastic’s (e.g., medical polymer) properties at different temperatures.

Niles, IL
 

FDA Tracks Faulty Devices, But What about Faulty Cybersecurity?

Forbes reports that FDA's current surveillance system tracks such faulty medical devices as pacemakers, insulin pumps, defibrillators, and respiratory technologies. What the system does not do, however, is track such devices as Web-connected sensors and connectivity technologies used in such applications as wireless patient-data storage.

Based on "Security and Privacy Qualities of Medical Devices: An Analysis of FDA Postmarket Surveillance," a report in the journal PLOS, the Forbes article notes that flaws in medical devices that display data on a screen or transmit information between patients and physicians could be potentially harmful if hackers gain remote control of the software.

While the article notes that no known cases of malicious attacks on medical devices resulting in physical harm have been recorded to date, the federal postmarket surveillance system is unprepared to respond in a timely manner to healthcare-related cybersecurity threats. The threats, however, are real. For example, just last month, Google shut down the Website of medical device manufacturer CareFusion Inc. after discovering that updates streamed to the company's respiratory products contained Trojan horses and malware. In another instance, it took FDA nine months to process a report of faulty software in an automated external defibrillator, underscoring the potential dangers inherent in FDA's current system.

As excerpted below, the PLOS study, summarizes the issues surrounding FDA's current approach, providing an impetus to improve medical device-related cybersecurity.

"The rapid dissemination of medical devices capable of storing and transmitting patients' medical information and the theoretical possibility of remotely reprogramming implanted medical devices raise important concerns regarding security, privacy, and safety. Investigators have demonstrated limitations of the security functions for implantable cardioverter-defibrillators (ICDs), for example, by proving the feasibility of communicating with an ICD through an unauthorized radio-based approach that theoretically could interfere with appropriate device therapy. While there are hundreds of confirmed reports of conventional computer viruses infecting medical devices in radiology, cardiac catheterization labs, sleep labs, and other clinical departments, there are no known case reports of malevolent interference that specifically target medical device function. A growing list of confirmed cybersecurity vulnerabilities in medical devices pose challenging risks to patients whose privacy or disease management depends on the proper functioning of devices.

"In the United States, post-market surveillance of medical devices identifies potential risks and connects device malfunction to adverse events in patients. Post-market events may trigger recalls or advisories depending on the nature of the device problem that is identified. These reports may provide important information about safety and effectiveness, and have led to revision of regulatory practices for devices such as ICD leads and automated external defibrillators....

"The rapid proliferation of medical devices, and their growing sophistication, presents Internet-age challenges for multiple stakeholders. Without an understanding of security and privacy, it will be difficult for patients and clinicians to establish confidence in device safety and effectiveness. While this study provides some comfort in the lack of observed security or privacy breaches, the related adverse events or device malfunctions are not served well by the current approach to postmarket surveillance. This conclusion challenges regulators and manufacturers to carefully weigh the premarket evaluation of security and privacy elements of their devices and systems, and to design postmarket systems that enable effective collection of cybersecurity threat indicators for medical devices. While intentional interference may be much less likely to manifest clinically than other types of traditional malfunctions, it is clear that no effective system exists to detect signals of security or privacy problems. This conclusion is confirmed by the sharp contrast of security and privacy problems tabulated by the VA and the security and privacy problems tabulated with FDA databases. To detect a security or privacy problem that could harm patients, a more effective information sharing system for medical device cybersecurity should be established."

Weekly Vitals: Cook to Cancel Expansions, Medtech Expands Offshore, and More

All eyes last week were on Cook Medical's announcement that the provision in the Affordable Health Care for America Act imposing a 2.3% excise tax on the first sale of medical devices has forced the company to cancel plans to build five plants in the Midwest. Since then, voices are being raised that the tax will hurt Indiana. In other news, more medtech firms are starting up offshore operations, while Zimmer announced mixed quarterly results.

The History of the Proteus Ingestible Sensor

The History of the Proteus Ingestible Sensor

The ingestible sensor from Proteus Digital Health can be co-encapsulated with a drug capsule.

To learn about the story behind the technology, MD+DI got in touch with George Savage, MD, chief medical officer of Proteus Digital Health who is also one of the firm’s cofounders.

The story starts when Savage partnered with Andy Thompson, who is now the firm’s CEO, and Mark Zdeblick, PhD, who is its chief technology officer. The three men knew each other well (Savage and Thompson have worked together for about  25 years) and decided to work together to explore new medical opportunities for microelectromechanical systems technology. 

The Genesis of the Idea

The idea to develop an ingestible technology that bridges the gap between the medical device and the pharmaceutical industries came after Thompson visited a medical trade show. While at the event, he obeserved that the way that medical device companies highlighted their products differed greatly from what pharmaceutical firms were doing.

“Andy phoned me and commented that all of the medical device companies had booths that were stuffed with computers, which often had to do with customizing therapy to a patient, providing information to the doctor to help them tailor therapies for an individual,” Savage recalls. “If you think about Medtronic as an example, implanted pacemakers and defibrillators machines are really becoming powerful computers that record how your heart was performing.” This data can be used in conjunction with information on the administration of prescription drugs to ”paint a better picture" of how patients responding to their prescriptions. 

When compared to the medtech firms exhibiting at the trade show, the pharmaceutical companies at the event had booths that looked nearly empty. They had big booths staffed by people armed with the latest data concerning their product. “But otherwise, the booths were empty and the main technology on display would be something like a cappuccino machine in the middle,” Savage says.

Following the event, Savage, Zdeblick, and Thompson got together to ponder the following question: “Isn’t there something we could do for oral drug therapy?” Savage recalls. After all, a huge portion of modern healthcare is the administration of prescription drugs.

The men put this question to engineers on staff who were at first skeptical that much could be done. “But then we began thinking about it, using the human diet as a parts list,” Savage says. “This technology had to be extraordinarily safe, and also very inexpensive, therefore leveraging the semiconductor industry which has been able to mass produce things really inexpensively,” he recalls. “We got to work and came up with this ingestion sensor that we developed.”

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz. 

Enhanced Dyes Improve Nanoparticle Fluorescence

The use of fluorescent nanoparticles loaded with organic light-emitting dyes are expected to transform live-animal imaging technologies because they are optically stable and nontoxic. In addition, they can be easily modified with functional groups, making them suitable when targeting specific tissues. However, traditional dyes aggregate and lose their emission intensity when incorporated into nanoparticles at high concentrations. In response, researchers at the A*STAR Institute of Materials Research and Engineering (Singapore) have designed a family of dyes with enhanced fluorescence upon aggregation.

Traditional dyes consist of a planar chromophore known as triphenylamine-modified dicyanomethylene, which emits red light in dilute solutions but fluoresces weakly when aggregated. The A*STAR team, led by Bin Liu and Ben Zhong Tang, reversed this phenomenon by attaching propeller-shaped tetraphenylethene pendants to each extremity of the chromophore. Contrary to planar compounds, the shape of the propellers prevents strong stacking interactions between chromophores, blocking the aggregation-caused quenching process. The physical confinement also prevents these propellers from rotating freely, enabling light emission.

The team formulated the dyes using a bovine serum albumin (BSA) matrix -- a biocompatible and clinically used polymer -- and evaluated their performance as probes. Experimental characterization showed that the wavelength of the emission maximum of the nanoparticles remained unchanged upon encapsulation, and that the intensity of the emitted light increased with the dye loading.

Live imaging of breast cancer cells revealed that the nanoparticles displayed more intense and homogeneously distributed red fluorescence in the cytoplasms than free aggregates, suggesting that BSA boosted the cellular uptake of the dyes. The team also found that the nanoparticles were optically stable in biological media and displayed good biocompatibility.

The researchers intravenously injected the nanoparticles in liver-tumor-bearing mice for in vivo imaging studies. They found that unlike free aggregates, the nanoparticles selectively accumulated in the tumor, clearly highlighting the cancerous tissue in the animals. "This demonstration underscores new research opportunities to explore similar diagnostic probes with potential clinical applications," Liu remarks.

The team is currently investigating near-infrared emissive biological probes for targeted in vivo tumor imaging applications. The nanoparticles can also be utilized to understand cancer metastasis or the fate of transplanted stem cells. "These probes are promising in multimodal imaging applications through integration with magnetic resonance imaging or nuclear imaging reagents," Liu says.
 

The Biggest Mistake Companies Make in FDA Inspections

 "Companies do not utilize their internal audit process or management reviews to assure they are fully prepared for when an external review is done of their quality system. This is particularly true when they are having annual Notified Body audits and the maintenance of the quality system is not effective, resulting in a poor audit or difficult inspection," he explains.

In some cases, he says, companies might not give themselves enough time to prepare or devote enough resources to the project. "Generally, FDA gives one to two weeks of notification, during which the company should be 'all hands on deck' preparing for the inspection. The company should work diligently in those couple of weeks to ensure that the facility is tidy, quality records are available, and important processes like customer complaints and corrective action have gone through a thorough review," Vincins says.

In a new webcast,Vincins plans to share his wisdom with attendees on the value of proper preparation. Issues addressed will include key differences between inspection and audit processes; setting up mock inspections and audits to prepare a firm for the real thing; and common mistakes to avoid when dealing with FDA inspectors or Notified Body auditors. In addition, the webinar will cover:

  • Dealing with nonconformities
  • Inspection and audit timelines
  • Logistics involved
  • Proper selection of Notified Bodies

Vincins also says that he will explore the latest FDA proposal to give companies an option in choosing either FDA QSR Inspections or having a notified body conduct an audit.The ISO audits are conducted on a yearly basis, while QSR inspections are conducted every 2 years. Of course, QSR inspections are based on FDA availability. Vincins says OEMs should proceed with caution, based on their size and capabilities. "Small to medium size companies may not have an FDA inspection for many years; this voluntary program would basically be giving FDA the company deficiencies annually."

However, medium to large companies might see the program as an opportunity to combine their Notified Body audits with already occurring routine inspections by FDA. "Organizations have to realize that Notified Body audits are performed from a different perspective than FDA inspections, possibly resulting in unwanted regulatory impact when the company's audit report (from the third party) is sent to the FDA," he says.

The Webcast, "How to Prepare for, and Manage, an FDA Inspection or Notified Body Audit," takes place on August 7, 2012 at 2 PM ET | 1 PM CT | 11 AM PT.

—Heather Thompson