How to get FDA to clear a mobile health app

December 1st, 2009

Since past few months, mobile health application developers have been looking for answer to their two questions: 1) When is FDA clearance required? 2) How to achieve FDA clearance?

Bradley Merrill Thompson has answered the above two questions in his article at mobilehealthnews . The article in 3rd in series where in first article, he outlined what factors FDA considers while deciding which products need to be regulated. In second article, he outlined basic steps for getting medical device cleared by FDA.

The article is must read for any mobile health application developers considering selling their applications in US.

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Medical automation market expected to grow to $23.2B by 2014

September 8th, 2009

According to article in HealthCareITNews, Medical automation market is expected to grow to $23.2B by 2014.

The market for medical automation technology is forecast to grow from $13.1 billion this year to $23.2 billion in 2014, according to BCC Research. The report, Medical Automation Technologies, Products and Markets, pegs the compound annual growth rate (CAGR) at 12.2 percent.

Among the technologies examined in the report are:

* Automated health assessment and monitoring technologies;
* Automated medical imaging and image analysis;
* Automated prescription fulfillment devices;
* Automated therapeutic (non-surgical) devices;
* Robotic and computer-assisted surgical equipment;
* Automated laboratory testing and analysis;
* Automated healthcare logistics, resource and patient tracking;
* Automated medical training.

Major end-user segments for automated medical technologies include hospitals, stand-alone outpatient surgical centers, physician practices, pharmacies and other retail establishments, home-care recipients, the military, medical research institutes and clinical laboratories and medical schools and other training programs.

Another reason for Android developers start developing  automated health assessment and monitoring technologies or automated healthcare logistics, resource and patient tracking applications or any of the above technologies , if they haven’t already.

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PediDoser:A easy to use reference guide for pediatric outpatients, available for Android, Palm, Iphone and more

July 30th, 2009

MeisterMed, the developer of handheld references ranked in the top three medical PDA resources in Family Practice Management (July 2006) recently announced PediDoser : A easy to use reference guide for pediatric outpatients.

PediDoser features include :

  • All common outpatient pediatric drugs
  • Find your drug fast by generic or brand name or by class
  • Use weight in pounds, weight in kilograms, or age to find the right dose.  No need to convert weight.
  • Scrolling pick lists are faster than typing in weight or age
  • Bookmark your favorite medications to get to them even faster

PediDoser comes in two flavors: the iPhone/iPod touch version (available from the App Store) and the iSilo version for everyone with PalmOS, Android,PocketPC, Blackberry and other devices (available from MeisterMed’s online store).

For more details about the features and medications list, visit http://www.pedidoser.com/isilo/features.html

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Zii Egg Plaszma: Android’s answer to Ipod Touch?

July 28th, 2009

ZiiLABS, a wholly-owned subsidiary of Creative Technology Ltd. today announced the launch of Plaszma – an open standards development platform. The Zii Plaszma Platform includes the Zii EGG StemCell Computer( also supports Android™) , Plaszma OS and Plaszma SDK.

The Zii EGG is an energy efficient handheld StemCell Computer based on the powerful ZiiLABS ZMS-05 media-rich applications processor. Besides its multi-touch 3.5-inch LCD screen, it can also output HD video at up to 1080p. The ZMS-05 has 24 floating-point processors that deliver up to 8 GFLOPS of raw processing power and its flexible StemCell computing architecture allows stunning 3D graphics on a small handheld battery-powered device.

Zii Optimized Android gives developers the chance to use the familiar Android OS, but with a difference. Harnessing StemCell Computing Technology found on the ZMS-05 Media Rich Processor, Android is now super-charged with seamless 3D graphics and High Definition video playback performance.

The Plaszma SDK Starter Kit is available for immediate purchase at US$399 on www.zii.com. This Starter Kit comes bundled comes with Plaszma OS, Plaszma SDK and the Zii Optimised Android OS.

As an introductory offer, ZiiLABS is offering a 32GB Zii EGG for FREE with the purchase of the Plaszma SDK Starter Kit, limited to one per customer while stocks last.

For customers who want to run the Android OS, an after-sales installer upgrade will be made available soon allowing them to change their operating system selection.

Another device for Android developers to be excited about.

Looks like Apple has really good competition for its Ipod Touch and Zii Egg Plasma will give Apple run for its money, if the marketing and launch of the device is done properly.

Is investing 399 USD in a non phone device worthwhile? The question remains to be answered :)

For product information, please visit www.zii.com.

For more technical information, please visit www.ziilabs.com

For press release visit http://www.ziilabs.com/news/releases/pr20090728A.aspx

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ABI Research Report: 15 million remote monitoring wireless healthcare devices by 2012

July 22nd, 2009

According to recent report by ABI Research,  there will be 15 million wireless devices in use for remotely monitoring the well-being of elderly or at-risk peopleby early 2012. In next two years, medical devices with built in cellular capability will be driving force behind wireless telehealth.

North America, with its aging population and tech-oriented medical industry, is central to the telehealth market and is expected to remain so over the report’s forecast period which extends through 2014.

The report focuses on embedded cellular connectivity for remote patient monitoring and ambient assisted living, the monitoring of the well-being of elderly or at-risk people.

“Wireless telehealth systems can reduce healthcare costs in a couple of ways,” ABI research practice director Sam Lucero, said in a statement. “First, for patients with chronic conditions, wireless telehealth’s ability to monitor and track their status allows many problems to be nipped in the bud before they require expensive hospitalization and treatment.  “Second, the traditional approach to home health care requires regular visits by nurses to check on patients’ condition. By providing that same information automatically, wireless telehealth systems can reduce those labor and travel costs.”

In addition, Lucero notes, a secondary benefit is that more people will be able to remain in the safety and comfort of their own homes as they age, at the same time reducing the burden on medical and residential institutions.

ABI believes availability of coverage for telehealth systems by private insurers and Medicare/Medicaid could be  barrier to widespread adaption of telehealth devices.

“The industry believes reimbursement for telehealth systems should be more comprehensive and straightforward. Proposed legislation is generating optimism,” said Lucero.

For more details on the report, visit eWeek.

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73% of consumers ready to use biometric electronic remote monitoring services to track their condition and vital signs

July 21st, 2009

According to PWC Report ,  nearly three-quarters (73%) of consumers said they would use biometric electronic remote monitoring services to track their condition and vital signs.

PricewaterhouseCoopers’ research reveals that universal coverage could swamp the health system unless simultaneous steps are taken to create innovative, new care delivery models that will expand access to care without adding costs to the system. Research conclusions and survey findings are in a new PricewaterhouseCoopers’ Health Research Institute (HRI) paper entitled “Jammed access: Widening the front door to healthcare.”

Other interesting finds in the report:

  • Electronic interaction with providers and payers: One-half (50%) of consumers surveyed said they’d be willing to seek healthcare through the Internet or other computer technology as a substitute for a face-to-face, non-emergency visit. Of those, e-mail consultations was the preferred method of interaction (76%),  followed by telehealth, question/answer fee-based consults and an online forum/chat room monitored by a doctor.
  •  Retail and worksite clinics for patients: Of consumers surveyed,   37 percent said they’d be likely to use a worksite clinic, and 36 percent would use a retail health clinic. Ten percent of large employers surveyed in PricewaterhouseCoopers’ 2009 Annual Employer Barometer Survey said they are now providing worksite clinics, up from one percent in 2008.
  • Use of  telehealth technologies: Telehealth, the use of medical   information exchanged from one site to another via electronic   communications, such as video conferencing or bio-metric remote monitoring, is expanding access, particularly to specialty   physicians for patients in remote and underserved areas. Nearly   three-quarters (73%) of consumers said they would use biometric   electronic remote monitoring services to track their condition and vital signs.
  • Shared medical appointments: One in four (28%) of consumers  surveyed said they would be willing to participate in a shared   medical appointment, typically a 60- to 90-minute session that  includes a private or personal exam integrated with patient   education and discussion with a group of 10 to 15 people. Providers currently offering shared medical appointments have   found both patient and physician satisfaction has soared.  Instituting one shared medical appointment can increase patient access and a physician’s productivity by an additional six patients during a four-hour clinic session.

Another few reasons to look into developing Android medical mobile applications……………..

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Unbound Medicine Releases the Latest Point of Care Lab Test Guide for Android

July 17th, 2009

Unbound Medicine has released the latest version of the Pocket Guide to Diagnostic Tests for Android and other mobile platforms. The application provides point of care guidance on which lab tests to use, how to interpret them, and points toward additional clinical based information on relevant topics.

The features include:

  • Over 350 laboratory and diagnostic tests
  • Evidence-based information
  • Convenient tables and algorithms
  • Expanded coverage of molecular and genetic testing
  • Intuitive navigation, optimized for your device
  • Personalized favorites
  • Quick links to the medical literature

For more details, refer to Unbound Medicine’s product page.

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FDA may regulate certain mobile phones, accessories

July 13th, 2009

According to Bradley Merrill Thompson, Partner, Epstein Becker & Green, P.C., that FDA might regulate certain equipment like cell phones that companies are planning to put at the center of connected health services.

In his article, he outlines the factors that FDA considers when deciding whether to regulate such equipment.

The Section 201(h) of the Federal Food, Drug, and Cosmetic Act defines a medical device as:

“… an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is … [either]
intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals … [or]
intended to affect the structure or any function of the body of man or other animals.”

For more details, visit mobihealthnews

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Bluetooth: healthcare’s new standard for mobility?

July 13th, 2009

Bluetooth, is it healthcare’s new standard for mobility? The key features of Bluetooth Technology are robustness, low power, and low cost which are well suited for mobile healthcare solutions as the need for mobility in healthcare is rising due to the adoption of new forms of healthcare service delivery, including telemedicine, home healthcare and managed care.

According to the report by Infiniti Research Limited, the above mentioned new diagnostic and treatment modalities have also increased the need for flexibility and leveraged usage of staff driving the healthcare industry to adopt Bluetooth technology. As most mobile devices today are already equipped with the technology, healthcare organizations and patients are leveraging the technology to perform various tasks including medication management, measuring, transferring, and accessing patient records etc., in a wide range of healthcare environments.

The report forecasts the size of Bluetooth Market in the Healthcare Industry over the period 2008-2012. It segments the Bluetooth Market by applications and into various geographic regions. Further, it discusses the key market drivers and challenges of this market in the Healthcare Industry, and profiles some of the key market players of this Industry.

Last month, the non-profit, open-industry coalition for technology healthcare, Continua Health Alliance, announced that Bluetooth technology will be adopted as a healthcare device standard in version two of its guidelines for low-energy wireless communication.

“Continua’s choice of Bluetooth low-energy technology – a specification in development at this time and expected to be adopted by the end of the year – underscores the excitement and need for this Bluetooth wireless standard in the telehealth arena,” said Michael Foley, executive director of the Bluetooth SIG (Special Interest Group).

The Bluetooth SIG brings not only a superb wireless technology to our design guidelines, but a state-of-the-art testing and qualification program to our members,” said Rick Cnossen, Continua president and chairman of the board of directors.

“The continued choice to work with Bluetooth wireless technology and the Bluetooth SIG is a natural extension for Continua.”

Continua certifies many telehealth devices, ranging from health-monitoring (pulse oximeter, blood-pressure cuff, thermometer, weight scale, glucose meter) to cardiovascular fitness devices to independent living monitors for the elderly or frail.

For more details, refer to the article in SiliconRepublic.

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Report:Revenue from Wi-Fi-enabled Healthcare Products to Reach Nearly $5 Billion in 2014

July 12th, 2009

Another report to entice developers to develop healthcare products for future. The revenue from sales of WiFi-enabled healthcare products will reach nearly $5 billion in 2014, according to a recent report from ABI Research. The figure represents an increase of almost 70 percent over today’s market.

“It’s a pretty big business,” notes ABI Research vice president Stan Schatt in a classic understatement. “The strong uptake of Wi-Fi in the health industry is underpinned by its need for improved asset management, staff mobility, transfer of digitized records, and standardized administration of medications. In addition, government security requirements including HIPAA often mean replacing older wireless equipment with modern versions.”

Among the benefits of increased Wi-Fi penetration are reductions in operating costs, which is also a theme stressed by the Obama administration in its drive for healthcare reform.

However, healthcare Wi-Fi is no one-stop-shop. “No one vendor has all the necessary pieces to make a complete system for a major medical institution,” says Schatt. “It is truly a Tower of Babel.” So there is a premium on partnerships and systems integration. Generally it’s the wireless LAN equipment channel partner that integrates all these things and makes them work together. The manufacturers have to develop technology partnerships too, and share information so that devices can be optimized for their systems.

For more details , refer to press release by ABI research.

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