The best way to have a busy and fairly mobile healthcare provider comply with EMR meaningful use requirements is to get her a handheld device for data entry. It's not occurring in every hospital, but it is notable trend in the most wired hospitals. As reported in CMIO (citing Kalorama Information's conclusions), the fastest growth in handhelds in healthcare has been in the administrative side, the type of handhelds used to perform data entry and look at patient records during visits. Though there are a number of factors, we think data entry for EMR is a significant one.
The handheld device market’s more than 10 percent growth since 2007 to $11 billion in 2011.
Kalorama Information's report on this topic can be obtained at our website. t The report includes revenue breakouts by type of device and applications.
Wednesday, February 15, 2012
Monday, February 13, 2012
FDA Moves Quickly On Illegal Handheld X-Rays
The spread of handheld devices in healthcare is not without its hiccups, as evidenced by the recent crackdown by the FDA on online sales of handheld X-ray units which do not comply with regulations. The units, shipped from outside the United States to U.S. dentists and vets, were not compliant with effectiveness standards of the FDA and may expose a patient to more radiation than the FDA permits (no patient was harmed according to the agency). X-ray units cleared by the FDA bear a permanent certification label/tag, a warning label, and an identification (ID) label/tag on the unit. This was not present in the questioned devices, which were noticed by the Washington State Department of Health and brought to the attention of the FDA.
"Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA's standards," said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health.
There are several handheld x-ray systems that do comply with FDA regulations; one is the Aribex NOMAD
The spread of handheld devices will create different regulatory responses which Kalorama Information has monitored. Last year the agency hinted it would regulate new handheld apps as very low-level (Class I) designation. That kind of flexibility would be needed for the market for medical handheld and corresponding apps to grow. However, when the device can do harm or influence a diagnosis, the agency is likely to be more aggressive. Kalorama Information has detailed the markets for handhelds and x-rays in two recent reports:
Handhelds in healthcare: http://www.kaloramainformation.com/Handhelds-Healthcare-Smartphones-6789230/
X-Ray Markets: http://www.kaloramainformation.com/Medical-Imaging-Ray-6404203/
"Health care professionals using these devices should verify they are purchasing and using those that have been reviewed and tested to meet FDA's standards," said Steve Silverman, director of the Office of Compliance in the FDA's Center for Devices and Radiological Health.
There are several handheld x-ray systems that do comply with FDA regulations; one is the Aribex NOMAD
The spread of handheld devices will create different regulatory responses which Kalorama Information has monitored. Last year the agency hinted it would regulate new handheld apps as very low-level (Class I) designation. That kind of flexibility would be needed for the market for medical handheld and corresponding apps to grow. However, when the device can do harm or influence a diagnosis, the agency is likely to be more aggressive. Kalorama Information has detailed the markets for handhelds and x-rays in two recent reports:
Handhelds in healthcare: http://www.kaloramainformation.com/Handhelds-Healthcare-Smartphones-6789230/
X-Ray Markets: http://www.kaloramainformation.com/Medical-Imaging-Ray-6404203/
Friday, February 10, 2012
Endoscopy Doesn't Have to Be Unsightly
Capsule Endoscopy can conjure up a negative image for patients; the leads and wires attached to their torso leading to a recording device that is worn on a belt or harness. This is needed in current systems due to the wireless technology used in transmitting the pictures captured by the capsule endoscope through radio-frequency signals.
Some products are looking to get the process down to no more than taking a pill. One such product, available for sale in the UK, France, Germany, and India, is Capsovision's Capsocam SV-1. The unit features a tiny, 360 degree camera available for sale in Europe and India through medical distributors. Pictures are downloaded, rather than transmitted by radio.
"The patient doesn't need to look like a bomber with a datarecorder and sensor attached to them anymore," says Tim O'Dwyer, Capsule Endoscopy Specialist for hte Saratoga, CA-based company. He recently spoke with Kalorama Information.
According to O'Dwyer, the new capsule Capsocam SV-1 has four cameras and 15hours of
battery operating time minimum and can take more pictures than the average unit.
"That's over half a million photographs compared to less than 80,000 taken by the market leader," O'Dwyer said.
Another system by Sayaka Corp uses an inner lens that constantly rotates so that a 3D image of the canal is taken. Sayaka's Capsule has a lens on the lateral surface of the capsule instead of the front. This new design obtains clear-cut lateral images of the gastrointestinal wall while the inner capsule spins in the digestive tract. The unit is battery free.
Capsule Endoscopy is one of the faster growing market segments in GI and more competitors are expected. We've completed a whole market research study on this promising area. Kalorama Information's latest report can be found on our website:Gastrointestinal Devices market research report.
Some products are looking to get the process down to no more than taking a pill. One such product, available for sale in the UK, France, Germany, and India, is Capsovision's Capsocam SV-1. The unit features a tiny, 360 degree camera available for sale in Europe and India through medical distributors. Pictures are downloaded, rather than transmitted by radio.
"The patient doesn't need to look like a bomber with a datarecorder and sensor attached to them anymore," says Tim O'Dwyer, Capsule Endoscopy Specialist for hte Saratoga, CA-based company. He recently spoke with Kalorama Information.
According to O'Dwyer, the new capsule Capsocam SV-1 has four cameras and 15hours of
battery operating time minimum and can take more pictures than the average unit.
"That's over half a million photographs compared to less than 80,000 taken by the market leader," O'Dwyer said.
Another system by Sayaka Corp uses an inner lens that constantly rotates so that a 3D image of the canal is taken. Sayaka's Capsule has a lens on the lateral surface of the capsule instead of the front. This new design obtains clear-cut lateral images of the gastrointestinal wall while the inner capsule spins in the digestive tract. The unit is battery free.
Capsule Endoscopy is one of the faster growing market segments in GI and more competitors are expected. We've completed a whole market research study on this promising area. Kalorama Information's latest report can be found on our website:Gastrointestinal Devices market research report.
Wednesday, February 8, 2012
Cancer Biotherapy Revenues Settle Down, But Still Strong
In the last decade, one of the most promising new approaches in modern cancer treatment is immunotherapy or biotherapy, the development of methods to augment and enhance the body’s natural tendency to defend itself against malignant tumors without damaging healthy tissue. Therapies such as monoclonals or interleukins were growing at over 25% between 2005 and 2010.
That type of revenue growth could not have been sustained forever. As these products become an increasingly common part of treatment, we note that growth rates - while still very high - have slowed from previous levels. Kalorama notes in Cancer Therapeutics , our latest study, that biotherapies grew at 10% between 2010 and 2011. That new revenue growth rate though should hold long-term, at least the next five years, and still makes for a very comfortable atmosphere for new product introductions.
Cancer is the second most common cause of death in the industrialized world. Most cancer patients are treated with some combination of surgery, radiation, and chemotherapy. Unfortunately, radiation and chemotherapy destroy healthy as well as malignant cells and thus can cause severe side effects.
The rising incidence of cancer, particularly in the over 50 population, is likely have a significant impact on all areas of cancer treatment. However, for many cancer types, there remains a significant unmet need in effective treatment. Lung cancer is one example as patient survival is less than five years after diagnosis. Traditional therapies have failed to provide adequate treatment for these patients, signifying a need for an alternative treatment plan. Compassionate use has been granted for several therapies in the past and this trend is likely to continue.
That type of revenue growth could not have been sustained forever. As these products become an increasingly common part of treatment, we note that growth rates - while still very high - have slowed from previous levels. Kalorama notes in Cancer Therapeutics , our latest study, that biotherapies grew at 10% between 2010 and 2011. That new revenue growth rate though should hold long-term, at least the next five years, and still makes for a very comfortable atmosphere for new product introductions.
Cancer is the second most common cause of death in the industrialized world. Most cancer patients are treated with some combination of surgery, radiation, and chemotherapy. Unfortunately, radiation and chemotherapy destroy healthy as well as malignant cells and thus can cause severe side effects.
The rising incidence of cancer, particularly in the over 50 population, is likely have a significant impact on all areas of cancer treatment. However, for many cancer types, there remains a significant unmet need in effective treatment. Lung cancer is one example as patient survival is less than five years after diagnosis. Traditional therapies have failed to provide adequate treatment for these patients, signifying a need for an alternative treatment plan. Compassionate use has been granted for several therapies in the past and this trend is likely to continue.
Monday, February 6, 2012
Canada Moves Highlights Interest in Personalized Medicine
A challenge to anyone promoting a therapeutic or a medical device in healthcare markets currently is that no matter how good it is, even if it is better than current regimens, payors both in the U.S. and Europe are seeking to cut costs, and that usually doesn't present a good market for innovative but more expensive solutions. This austerity is lead by governments, and is echoed by private payors.
Most major governments have undergone some type of cost-cutting program. In the U.S., while healthcare reform will likely expand the insured population, it also can be considered at least partially a 'cost-cutting' program that features payment decreases to providers and fees on devices.
It's possible that tests may be different, particularly those molecular tests that can improve patient outcomes and lessen the use of a therapeutic in a case where it has little probability of working. Canada's recent move to provide millions for personalized medicine products highlights how even in an austerity time, a product that can cut costs long-term has promise.
Kalorama has always discussed personalized medicine in its IVD reports, but we have recently completed our first full market research study on the concept. Personalized Medicine Diagnostics is available for pre-publication orders now and will publish on March 1st, 2012.
Most major governments have undergone some type of cost-cutting program. In the U.S., while healthcare reform will likely expand the insured population, it also can be considered at least partially a 'cost-cutting' program that features payment decreases to providers and fees on devices.
It's possible that tests may be different, particularly those molecular tests that can improve patient outcomes and lessen the use of a therapeutic in a case where it has little probability of working. Canada's recent move to provide millions for personalized medicine products highlights how even in an austerity time, a product that can cut costs long-term has promise.
Kalorama has always discussed personalized medicine in its IVD reports, but we have recently completed our first full market research study on the concept. Personalized Medicine Diagnostics is available for pre-publication orders now and will publish on March 1st, 2012.
Wednesday, February 1, 2012
Will New Hep C Combo Drugs Change Treatment Scenario?
Last year saw the approval of Merck's Victrelis (boceprevir) drug and J&J's Incivek, (telaprevir), protease inhibitors which, along with other pharmaceuticals, enhance the attack on the Hepatitis C (HCV) virus. In 2012 we may see the market effects. It's possible the drugs may change what was previously a very dreary treatment scenario for this serious condition.
Hepatitis C affects both men and women. It is the leading cause of acute liver inflammation and liver cancer and the most common cause of needing a liver transplant. More than 170 million people worldwide are infected, while 3-4 million people are diagnosed each year. In the United States, approximately 4 million are living with this disease, while in Europe and Japan another 4 million and 2 million are living with the disease, respectively.
Used in combinations, the new drugs showed in clinical trials that they can succeed at as high as a 70% response rate, about 30% higher than the therapies on the market. Diagnostic companies should be interested in this development: there's now a realistic treatment, thus more tests may be needed.
Kalorama breaks out the market opportunity for pharmaceuticals treating infection by infection type (including HCV and HIV) in a new study on the subject:
http://www.kaloramainformation.com/Anti-Infectives-Antifungals-6772957/
Hepatitis C affects both men and women. It is the leading cause of acute liver inflammation and liver cancer and the most common cause of needing a liver transplant. More than 170 million people worldwide are infected, while 3-4 million people are diagnosed each year. In the United States, approximately 4 million are living with this disease, while in Europe and Japan another 4 million and 2 million are living with the disease, respectively.
Used in combinations, the new drugs showed in clinical trials that they can succeed at as high as a 70% response rate, about 30% higher than the therapies on the market. Diagnostic companies should be interested in this development: there's now a realistic treatment, thus more tests may be needed.
Kalorama breaks out the market opportunity for pharmaceuticals treating infection by infection type (including HCV and HIV) in a new study on the subject:
http://www.kaloramainformation.com/Anti-Infectives-Antifungals-6772957/
Monday, January 30, 2012
Interview with Illumina CEO Flatley Points to Clinical Sequencing
Lest anyone wonder why Illumina is a target for a very persistent Roche, and why they in turn are adopting strong defensive measures, it's important to consider the role of sequencing in clinical diagnostics, especially in cancer applications. Washington Post.com video interview with Illumina CEO Jay Flatley points to the company's vision of a future in clinical applications for sequencing. If you've sequenced a tumor, you've got a 'much better roadmap" to treatment.
It's likely that payors would agree, given the drop in costs. With sequencing costs expected to get down to one thousand dollars, it's not hard to imagine that a DNA sequencing of a tumor will be seen as a reasonable investment for care of a patient if the outcome can be improved at all by a sequencing, and if it can better target the therapeutic steps. It's therefore not a business that a major marketer of IVD can ignore.
It's likely that payors would agree, given the drop in costs. With sequencing costs expected to get down to one thousand dollars, it's not hard to imagine that a DNA sequencing of a tumor will be seen as a reasonable investment for care of a patient if the outcome can be improved at all by a sequencing, and if it can better target the therapeutic steps. It's therefore not a business that a major marketer of IVD can ignore.
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