December 18, 2009
BOSTON (Reuters) - Celgene Corp said Friday that initial results from a clinical trial showed multiple myeloma patients who took its drug Revlimid following a stem cell transplant had a 58 percent reduction in risk of their disease progressing.
The company's shares rose nearly 10 percent to $55.60 in afternoon trading on Nasdaq.
"We anticipated Revlimid would likely be effective in this setting, but these results come sooner than expected and indicate robust Revlimid benefits," said Brian Abrahams, an analyst at Oppenheimer & Co. "We believe this news provides important momentum for Celgene entering 2010."
Revlimid is already approved in combination with dexamethasone to treat patients with multiple myeloma who have received at least one prior treatment.
The latest study was led by the Cancer and Leukemia Group B (CALGB). The group's independent data and safety monitoring board reported the trial had met its main goal of showing a statistically significant improvement in time to disease progression.
As a result, the trial was stopped early.
The study was sponsored by the National Institutes of Health under a clinical trials agreement with Celgene.
The data are important because they add weight to the theory that giving patients Revlimid as a maintenance therapy, either after first receiving other drugs or after receiving a stem cell transplant, could improve outcomes.
Earlier this month, Celgene reported data that showed patients who took Revlimid plus the standard drugs melphalan and prednisone, and followed by Revlimid alone, did better in delaying disease progression than those who took melphalan and prednisone alone.
"This is now a second piece of powerful evidence that Revlimid confers substantial benefit when used as maintenance therapy in multiple myeloma patients," said Geoffrey Porges, an analyst at Sanford Bernstein."
If Revlimid can be shown to add benefit as a maintenance therapy and is approved as a first line treatment, it could increase sales from an expected $1.7 billion this year to $3.6 billion by 2013, according to the consensus forecast from Thomson Pharma.
Autologous blood stem cell transplantation is a procedure in which a patient's own blood stem cells are removed, the patient is then treated with high doses of chemotherapy or radiation or both to kill the cancer and then the blood stem cells are put back into the patient.
A total of 568 patients with multiple myeloma who had received no more than 12 months of prior therapy and no prior transplant were enrolled in the trial. The patients all received a transplant followed by melphalan. After the transplant, patients took either Revlimid or a placebo until their disease progressed.
Among those who received the placebo, half saw their cancer worsen within 778 days, or 25.9 months. By comparison, the median time to progression in the Revlimid group could not be defined because fewer than half the patients had a worsening of their disease at that time.
This represents a 58 percent reduction in the risk of disease progression in the Revlimid group.
Revlimid is a derivative of thalidomide, sold by Celgene as Thalomid. (Reporting by Toni Clarke; editing by Dave Zimmerman and Andre Grenon)
(Contributed by T. Miller, CMR)
Friday, 18 December 2009
Thursday, 17 December 2009
Landmark Islet Cell Transplantation Was A Collaborative Effort
December 15, 2009
Posted: 05:49 PM ET
By Val Willingham
CNN Medical Producer
On November 21, Senior Airman Tre Porfirio was struck in the gut by three high velocity bullets while serving in Afghanistan. Porfirio, from St. Mary's, Georgia, was seriously injured; his entire digestive system was in danger of shutting down. During two operations in combat hospitals, surgeons removed his gallbladder along with portions of his large and small intestines, part of his stomach and a large section of his pancreas.
Porfirio was flown back to the United States immediately after emergency surgery, and taken to Walter Reed Army Medical Center, outside of Washington, D.C.
Col. Craig Shriver, chief of general surgery at Walter Reed, knew he had to remove the airman's remaining pancreas, which was found to be damaged beyond repair. "The optimal procedure at this point was to remove his entire remaining pancreas to prevent further leakage of the pancreatic enzymes and control the bleeding, which could be fatal," said Shriver. "We knew that the procedure would lead to the most severe and life-threatening form of diabetes, which tends to be very brittle and difficult to control in this type of situation.”
In an effort to save Porfirio from severe diabetes, Shriver turned to other surgeons for suggestions. Dr. Rahul Jindal, a transplant surgeon also at Walter Reed, had training and experience in islet cell transplantation, which is considered the best hope for curing diabetes. In islet cell transplantation, the insulin-producing islets are taken from a donor pancreas, treated and then put in the patient's liver where they begin to produce insulin for the body, even if there is no pancreas. In this case, the islet cells would come from Porfirio's own pancreas.
"Isolation and purification of pancreatic islets is a very intricate procedure, which requires a specialized laboratory, and there are only a few such facilities in the United States," said Jindal.
But Jindal knew of the perfect facility for the job; he turned for help to the Diabetes Research Institute at the University of Miami Miller School of Medicine. The director of the institute, Dr. Camillio Ricordi, developed the method for isolating the islet cells from the pancreas and was considered a pioneer in the field. Ricordi immediately agreed to help, noting that he would do "anything to help a wounded warrior."
Doctors at Walter Reed then proceeded to remove the remaining portion of Porfirio’s pancreas, packed it in ice and sent it to Miami.
On Thanksgiving Day, just five days after Porfirio's initial injury, the cell processing team at the Diabetes Research Institute spent six hours performing the islet cell isolation and purification procedure. "More than 220,000 purified islets were then suspended in a specialized cold solution and flown back to Walter Reed,” said Ricordi.
That afternoon, on that very same Thanksgiving Day, the islet cells were injected into Porfirio’s liver with Ricordi and his team coordinating the procedure with surgeons at Walter Reed via an Internet connection, a sort of high-tech telemedicine event.
In the three weeks since being wounded in Afghanistan, Porfirio has undergone 11 surgeries and, according to doctors, is "doing well." In a press conference held Tuesday at Walter Reed Medical Center, surgeons noted that there was evidence of the airman’s islet cells functioning in his liver less than one week after surgery; 15 days after the procedure, the transplanted islet cells were functioning in the normal range. His physicians say as time goes on, the islet cells in the liver will get stronger; when that happens, Porfirio's insulin requirement is expected to decrease. And although he'll still have a form of diabetes, the complication won't be as dangerous and he'll have a better quality of life.
Doctors from both the University of Miami Miller School of Medicine and surgeons at Walter Reed believe this transplantation is the first of its kind in a wounded soldier. They hope the success of the procedure will allow for more cases of islet cell transplantation in military personnel, as more of our fighting men and women return from war with injuries like those of Senior Airman Porfirio.
Posted by: Val Willingham - CNN Medical Producer
Filed under: Health • diabetes (contributed by T. Miller, CMR)
Posted: 05:49 PM ET
By Val Willingham
CNN Medical Producer
On November 21, Senior Airman Tre Porfirio was struck in the gut by three high velocity bullets while serving in Afghanistan. Porfirio, from St. Mary's, Georgia, was seriously injured; his entire digestive system was in danger of shutting down. During two operations in combat hospitals, surgeons removed his gallbladder along with portions of his large and small intestines, part of his stomach and a large section of his pancreas.
Porfirio was flown back to the United States immediately after emergency surgery, and taken to Walter Reed Army Medical Center, outside of Washington, D.C.
Col. Craig Shriver, chief of general surgery at Walter Reed, knew he had to remove the airman's remaining pancreas, which was found to be damaged beyond repair. "The optimal procedure at this point was to remove his entire remaining pancreas to prevent further leakage of the pancreatic enzymes and control the bleeding, which could be fatal," said Shriver. "We knew that the procedure would lead to the most severe and life-threatening form of diabetes, which tends to be very brittle and difficult to control in this type of situation.”
In an effort to save Porfirio from severe diabetes, Shriver turned to other surgeons for suggestions. Dr. Rahul Jindal, a transplant surgeon also at Walter Reed, had training and experience in islet cell transplantation, which is considered the best hope for curing diabetes. In islet cell transplantation, the insulin-producing islets are taken from a donor pancreas, treated and then put in the patient's liver where they begin to produce insulin for the body, even if there is no pancreas. In this case, the islet cells would come from Porfirio's own pancreas.
"Isolation and purification of pancreatic islets is a very intricate procedure, which requires a specialized laboratory, and there are only a few such facilities in the United States," said Jindal.
But Jindal knew of the perfect facility for the job; he turned for help to the Diabetes Research Institute at the University of Miami Miller School of Medicine. The director of the institute, Dr. Camillio Ricordi, developed the method for isolating the islet cells from the pancreas and was considered a pioneer in the field. Ricordi immediately agreed to help, noting that he would do "anything to help a wounded warrior."
Doctors at Walter Reed then proceeded to remove the remaining portion of Porfirio’s pancreas, packed it in ice and sent it to Miami.
On Thanksgiving Day, just five days after Porfirio's initial injury, the cell processing team at the Diabetes Research Institute spent six hours performing the islet cell isolation and purification procedure. "More than 220,000 purified islets were then suspended in a specialized cold solution and flown back to Walter Reed,” said Ricordi.
That afternoon, on that very same Thanksgiving Day, the islet cells were injected into Porfirio’s liver with Ricordi and his team coordinating the procedure with surgeons at Walter Reed via an Internet connection, a sort of high-tech telemedicine event.
In the three weeks since being wounded in Afghanistan, Porfirio has undergone 11 surgeries and, according to doctors, is "doing well." In a press conference held Tuesday at Walter Reed Medical Center, surgeons noted that there was evidence of the airman’s islet cells functioning in his liver less than one week after surgery; 15 days after the procedure, the transplanted islet cells were functioning in the normal range. His physicians say as time goes on, the islet cells in the liver will get stronger; when that happens, Porfirio's insulin requirement is expected to decrease. And although he'll still have a form of diabetes, the complication won't be as dangerous and he'll have a better quality of life.
Doctors from both the University of Miami Miller School of Medicine and surgeons at Walter Reed believe this transplantation is the first of its kind in a wounded soldier. They hope the success of the procedure will allow for more cases of islet cell transplantation in military personnel, as more of our fighting men and women return from war with injuries like those of Senior Airman Porfirio.
Posted by: Val Willingham - CNN Medical Producer
Filed under: Health • diabetes (contributed by T. Miller, CMR)
Sunday, 13 December 2009
New Cancer Therapy Shown to Extend Lives
Spotlight - Breast Cancer
Some women with advanced breast cancer may have a new treatment option. A combination of two drugs that more precisely targets tumors significantly extended the lives of women who had stopped responding to other medicines, doctors reported Friday (11_Dec., 2009). Herceptin and Tykerb aim at a protein, HER-2, that is made in abnormally large quantities in about one-fourth of all breast cancers. Herceptin blocks the protein on the cell's surface; Tykerb does it inside the cell. Patients with advanced breast cancer who took Herceptin with another drug, Tykerb, lived about five months longer than women who took only Tykerb.
(from Chicago Tribune/Marilynn Marchione-Associated Press) 12_Dec.,2009
Some women with advanced breast cancer may have a new treatment option. A combination of two drugs that more precisely targets tumors significantly extended the lives of women who had stopped responding to other medicines, doctors reported Friday (11_Dec., 2009). Herceptin and Tykerb aim at a protein, HER-2, that is made in abnormally large quantities in about one-fourth of all breast cancers. Herceptin blocks the protein on the cell's surface; Tykerb does it inside the cell. Patients with advanced breast cancer who took Herceptin with another drug, Tykerb, lived about five months longer than women who took only Tykerb.
(from Chicago Tribune/Marilynn Marchione-Associated Press) 12_Dec.,2009
Tuesday, 17 November 2009
Rich Meelia, President and CEO of medical device maker Covidien details future prospects
Covidien top exec Rich Meelia detailed the near-term outlook for the company on financial cable TV channel CNBC on Nov. 17. The company recently beat earnings estimates and raised their 2010 sales and profit outlooks. Although profits in the latest quarter dipped 85%, the stock price is up 25% in 2009 and the company has made 'significant' investments in high-growth areas since the spin-off from conglomerate Tyco Industries in January, 2007.
Mr. Meelia expects several factors to contribute to Covidien's expected high growth:
- the medical devices segment, which makes up 65% of sales, is driven by surgical procedures which are expected to increase with the aging population.
- although the company acknowledges that it will be affected if President Obama's healthcare reform becomes reality, recent versions of the House bill have lowered the onerous 'device tax' by ~50%.
- the weak U.S. dollar helps Covidien's financials by increasing sales (most of its products are made in the U.S. and sold overseas). The dollar is expected to remain weak for an extended period.
('The Call', CNBC, Nov. 17, 2009)
Mr. Meelia expects several factors to contribute to Covidien's expected high growth:
- the medical devices segment, which makes up 65% of sales, is driven by surgical procedures which are expected to increase with the aging population.
- although the company acknowledges that it will be affected if President Obama's healthcare reform becomes reality, recent versions of the House bill have lowered the onerous 'device tax' by ~50%.
- the weak U.S. dollar helps Covidien's financials by increasing sales (most of its products are made in the U.S. and sold overseas). The dollar is expected to remain weak for an extended period.
('The Call', CNBC, Nov. 17, 2009)
Saturday, 14 November 2009
The Case for Innovation in Medical Technology
On Nov. 13, 2009, Harry Rein, General Partner of Foundation Medical Partners (a venture capital firm specializing in medical opportunities) was interviewed on U.S. financial cable channel CNBC about the future of innovation in the business of medical technology.
Mr. Rein feels that the inclusion of excise taxes on medical technology businesses as anticipated in upcoming U.S. healthcare reform legislation is counter-productive at a time when innovation is crucial to address the highest priorities in healthcare today; 1) better patient outcomes, 2) improved patient access to medical care, and 3) the potential to reduce medical technology costs.
The large number of aging 'baby boomers', who are looking for more healthy time to enjoy leisure and retirement activities, represent an attractive demographic for innovative medical technology companies.
In spite of temporary obstacles like increased taxation via U.S. healthcare reform, Mr. Rein is optimistic that dedication to innovation will continue to be a hallmark of today's medical technology marketplace for the foreseeable future.
('Closing Bell' program, CNBC, Nov. 13, 2009)
Mr. Rein feels that the inclusion of excise taxes on medical technology businesses as anticipated in upcoming U.S. healthcare reform legislation is counter-productive at a time when innovation is crucial to address the highest priorities in healthcare today; 1) better patient outcomes, 2) improved patient access to medical care, and 3) the potential to reduce medical technology costs.
The large number of aging 'baby boomers', who are looking for more healthy time to enjoy leisure and retirement activities, represent an attractive demographic for innovative medical technology companies.
In spite of temporary obstacles like increased taxation via U.S. healthcare reform, Mr. Rein is optimistic that dedication to innovation will continue to be a hallmark of today's medical technology marketplace for the foreseeable future.
('Closing Bell' program, CNBC, Nov. 13, 2009)
Thursday, 12 November 2009
Nanoparticles could go even further
According to a recent article published by sciencedaily.com, (Magnetic Nanoparticles To Simultaneously Diagnose, Monitor And Treat), multifunctional particles based on viral particles such as flu and HIV, are being researched and developed to carry signal-generating sub-molecules and drugs to reach target areas through a safe sprinkling of tiny mNPs and external magnetic forces, creating a medical means to confirm specific ailments and automatically release healing drugs while inside a living system.
While nanoparticles are in themselves not particularly new, "theranostic" (hepatocyte-specific delivery system for improved diagnostics (e.g. enhanced MRI) and therapeutics (e.g. small molecules, DNAs and proteins), molecules could pay a crucial role in developing one-stop tools to simultaneously diagnose, monitor and treat a wide range of common diseases and injuries.
While nanoparticles are in themselves not particularly new, "theranostic" (hepatocyte-specific delivery system for improved diagnostics (e.g. enhanced MRI) and therapeutics (e.g. small molecules, DNAs and proteins), molecules could pay a crucial role in developing one-stop tools to simultaneously diagnose, monitor and treat a wide range of common diseases and injuries.
Change of plans over Industry Tax?
Medical device manufacturers have some positive news in the battle over healthcare reform taxation.
The medical device industry launched an aggressive campaign against the senate finance committee's plans to tax the industry to the tune od $40 billion over 10 years.
Under a compromised version of the House's affordable Health Care for America act released last week, devicemakers would be taxed $27 billion over seven years, beginning in 2013.
Under the House's proposal, the tax would be a 2.5% point-of-sale tax as opposed to an annual assessment based on overall sales. Devicemakers would also be able to deduct the House's tax on their annual corporate tax filings, bringing the net fee to about $20 billion over seven years- this according to Wanda Mobeius, spokeswoman for the devicemaker lobby group Advamed.
While Advamed has praised the House's action, some other voices have been less appreciative of the proposal, including the American Hospital Association, which has raised concerns that the additional tax could be passed on to hospitals and their patients.
However, others have in our view correctly warned that the wrangling over the tax is far from over, indicating that the House discussions may have little impact on the Senate's decision.
From Medicaldeviceguru.com
The medical device industry launched an aggressive campaign against the senate finance committee's plans to tax the industry to the tune od $40 billion over 10 years.
Under a compromised version of the House's affordable Health Care for America act released last week, devicemakers would be taxed $27 billion over seven years, beginning in 2013.
Under the House's proposal, the tax would be a 2.5% point-of-sale tax as opposed to an annual assessment based on overall sales. Devicemakers would also be able to deduct the House's tax on their annual corporate tax filings, bringing the net fee to about $20 billion over seven years- this according to Wanda Mobeius, spokeswoman for the devicemaker lobby group Advamed.
While Advamed has praised the House's action, some other voices have been less appreciative of the proposal, including the American Hospital Association, which has raised concerns that the additional tax could be passed on to hospitals and their patients.
However, others have in our view correctly warned that the wrangling over the tax is far from over, indicating that the House discussions may have little impact on the Senate's decision.
From Medicaldeviceguru.com
Monday, 2 November 2009
Stopping the Spread of Cancer by Using Nano-particle Mediated Drug Delivery
When cancer spreads, this is called metastases and it can be devastating. Metastatic cancer means that the cancer has spread to other parts of the body, including organs like the liver, brain, bones, lungs, etc. Researchers are looking for ways to stop the spread of cancer. Using an integrin-targeted nanoparticle, researchers delivered the chemotherapy doxorubicin to target the blood vessels of the tumor. By using this type of novel targeted approach, scientists have been able to stop the spread of cancer cells. Since tumors rely on blood vessels to survive, the effective use of nanoparticles to deliver drugs may revolutionize cancer treatment. Source: PNAS.org
See www.nanotechbuzz.com ; posted by Dr. Joseph Kim, July 22, 2008
See www.nanotechbuzz.com ; posted by Dr. Joseph Kim, July 22, 2008
MIT and LIMR Announce Nanotech Ovarian Cancer Therapy
Researchers at MIT and the Lankenau Institute for Medical Research (LIMR) have published a paper in the journal Cancer Research suggesting that nanoparticles may be used to deliver a "suicide gene" to combat ovarian cancer.
"The researchers created an 'artificial virus,' a biodegradable polymer that can penetrate the cell and be absorbed by the body, similar to how biodegradable sutures work... the team tested different compounds until they identified a biodegradable polymer that would be a suitable delivery vehicle," according to RedOrbit. "To create the nanoparticle, the polymers were mixed with a gene that produces a modified form of the diphtheria toxin that is only harmful to ovarian cancer cells."
"Unlike chemotherapy, which can destroy both cancer and healthy cells and lead to many adverse effects, this new therapy specifically targets cancer cells and leaves the healthy cells alone," says the Lankenau Institute's Dr. Janet Sawicki. "Our hope is to begin doing clinical trials in patients in the next 18 to 24 months and then potentially tailor this therapy to treat different solid tumor types including pancreatic, prostate, and cervical cancers."
see www.nanotechbuzz.com; posted by Jeff Goldman on August 8, 2009
"The researchers created an 'artificial virus,' a biodegradable polymer that can penetrate the cell and be absorbed by the body, similar to how biodegradable sutures work... the team tested different compounds until they identified a biodegradable polymer that would be a suitable delivery vehicle," according to RedOrbit. "To create the nanoparticle, the polymers were mixed with a gene that produces a modified form of the diphtheria toxin that is only harmful to ovarian cancer cells."
"Unlike chemotherapy, which can destroy both cancer and healthy cells and lead to many adverse effects, this new therapy specifically targets cancer cells and leaves the healthy cells alone," says the Lankenau Institute's Dr. Janet Sawicki. "Our hope is to begin doing clinical trials in patients in the next 18 to 24 months and then potentially tailor this therapy to treat different solid tumor types including pancreatic, prostate, and cervical cancers."
see www.nanotechbuzz.com; posted by Jeff Goldman on August 8, 2009
Why the Mantra of "model early, model often" still resonates in medical device design
Model early. Model often. Sound familiar? To those in product development and manufacturing, it should. It's the age-old cliche that sets the basis for practices surrounding prototyping and production. It is used by both product developers and manufacturers. Prototyping options change rapidly, and new technologies crop up as quickly as old ones become obsolete. But this mantra never goes away.
Anyone can prototype, but to understand the reasons behind it and its suitable methods is truly an art. This is where the practice of "model early, model often" can transform itself into a successful business strategy for some companies and remains simply a well-known motto for others. Those who comprehend why it's a smart--and crucial--step in the product development process set themselves apart from the competition.
The Relationship Between Prototyping and Product Design
Product development used to follow a linear path, with one phase beginning after its predecessor was complete. More often than not, it looked like this: design preparation; prototyping and testing; initial test production; and ramp-up and marketing introduction. The traditional product development process is fine in a market that's fairly stable and predictable, but it's ineffective in most of today's dynamic marketplaces.
In the past, prototyping was viewed as a separate entity that most developers introduced after the initial design phase was complete. In reality, the two are not independent, and each step of the design process includes its own method of creating 3-D artifacts. A different view of how models and prototypes serve a more integrated process is to view it as serving essentially four functions that are intertwined with the various disciplines. Models and prototypes are used for creativity, communications, evaluation and--for the FDA--verification. To further understand the relationship between prototyping and product design, it's best to look at how these fit within the steps of the design phases.
Design is more than creativity, but that's where it starts. Good designers draw creativity from anything and everything. Both the designer walking through the aisles of a local Toys "R" Us or Home Depot looking for ideas--as is frequently done--and the designer in the shop working with "found" objects to simulate basic mechanical actions are tapping into new solutions based on parallels drawn from existing products.
For example, in one project with a client, the firm sought to miniaturize bar code scanners and adapt them to be worn on the forefinger by package handlers. The chassis and basic enclosure were straight-forward, given conventional machined parts, stereolithography apparatuses and urethane castings. But the small plastic clips to hold the adjustable strap on the finger needed to be injection molded in production materials--and there wasn't time for that. However, a walk through the local Wal-Mart led to the discovery of shoulder-strap clips on large-size women's brassieres that were perfect for the project.
From a certain perspective, modeling is just sketching in 3-D. Just as some designers and engineers are most comfortable with a pencil or a seat of CAD, some are best when working in the shop. A sculptor doesn't necessarily see the world the same way that a painter does. And it's easy to jump into CAD too soon, which can lead to a sort of tunnel vision resulting in a "do it and fix it" process. Keeping things open to a variety of approaches using models and prototypes might be best, especially early on.
If a picture is worth a thousand words, then a model or prototype must be worth a million. For all of the creativity that comes from simple sketching, it's always the first model that creates the big "ah ha" (or "oh, crap") for both the design team and, importantly, for the extended team. Designers need to remember that other disciplines do not visualize objects represented in sketches--and even in 3-D CAD--in the same manner. There's also the matter of "scale." The breadbox-size medical products are pretty easy; model a defibrillator or patient monitor one-to-one, and what you see is what you get. But it's usually time and cost effective to make a quarter- or half-scale model of a large clinical analyzer instead of a full-sized model. Even so, it's always good practice to make at least a volumetric, full-sized model to get a sense of scale--and to address human factors issues in a simulated, dynamic setting. Or, at the other extreme, an engineer can get sucked into designing a plastic snap detail in a large CAD image that defies the properties of the materials when prototyped. At this point in the creative process, the models are the best way to preference test a variety of concepts with potential end users and, when the fidelity is high enough, to do preliminary usability testing--all good reasons to model early and model often.
As designs gel into a primary engineering solution, prototypes (both of physical objects and electronic user interfaces) take on the role of tools for evaluation. These may be mechanical/electronic," shake and bake" or (as prescribed to be good practice by the FDA) be used for human factors usability testing in simulated environments of use. This is the critical crossroads for any project. No engineer wants to make major changes at this point in the process, and the management team that sponsors the work doesn't want to hear about delays at this point either. But this is the lowest-risk and least-expensive time to take a hard look at the proposed solution and make sure that it meets the requirements of both the specification and intended use for the instrument or device. The physical models at this point are meant to supplement, but not to replace, other analytical tools such as mold flow and finite element analysis.
The typical crossover point from design and engineering to preproduction tooling and manufacture is in the final engineering phase and verification. Here, prototypes are used to verify that the design inputs match the intended product outputs. It could be as simple as checking tolerances and fits, but more often it allows the designers and engineers to ensure that the product performance meets the specifications. With the availability of prototyping materials that approach production performance, the verification process can assure that final mechanical, thermal, electrical, flammability and other performance requirements will be met as early in the development process as possible. By testing, documenting and correlating the prototype performance to production materials and processes, designers can deliver robust data to support regulatory submissions.
For the developers, there are even more options for prototype resources. Many prototype shops are expanding into low-volume production, and more production manufacturers are offering to help at the prototype end to get their foot in the door early. The most important rule of thumb is, don't go with the low bidders. Saving a couple of bucks on a rapid prototype is being a pound foolish when there are tens or hundreds of thousands of dollars of engineering effort riding on the outcomes.
Models and prototypes are a way to test ideas. Ideas lead to innovation that helps to add top-line growth for customers and help designers to keep from being "commoditized" as service providers. The contract manufacturers that can connect the dots between design/engineering and prototyping/production are most likely to gain a leg up on the competition. Couple that understanding with the familiarity of "model early, model often," and there's a key ingredient for a successful, proven and thriving business practice.
Jack Harkins, president of Farm Design, Inc., co-founded the firm in 1982. He is responsible for Farm's business strategy and is an integral part of the business development team, where he focuses his expertise in cardiology and vascular markets. Jack's true specialties and commitment are in discovering user needs using a wide variety of research methods to determine product specifications. He has led client programs for biomedical start-ups as well as industry leaders such as Schick, Johnson & Johnson and GE Medical. He has recently held positions on the board of advisors of The Design Management Institute and as chair of the Medical Section of the Industrial Designers Society of America. Jack graduated with honors from the Rhode Island School of Design with a BFA and BID in 1976.
Farm is a full-service, FDA- and ISO-compliant product development company with more than 30 years of success in delivering product strategy, technology and development for the medical, laboratory and consumer industries.
Jack Harkins "Why the Mantra of "model early, model often" still resonates in medical device design". Medical Product Outsourcing. FindArticles.com. 02 Nov, 2009. http://findarticles.com/p/articles/mi_hb6159/is_7_6/ai_n28581862/
Anyone can prototype, but to understand the reasons behind it and its suitable methods is truly an art. This is where the practice of "model early, model often" can transform itself into a successful business strategy for some companies and remains simply a well-known motto for others. Those who comprehend why it's a smart--and crucial--step in the product development process set themselves apart from the competition.
The Relationship Between Prototyping and Product Design
Product development used to follow a linear path, with one phase beginning after its predecessor was complete. More often than not, it looked like this: design preparation; prototyping and testing; initial test production; and ramp-up and marketing introduction. The traditional product development process is fine in a market that's fairly stable and predictable, but it's ineffective in most of today's dynamic marketplaces.
In the past, prototyping was viewed as a separate entity that most developers introduced after the initial design phase was complete. In reality, the two are not independent, and each step of the design process includes its own method of creating 3-D artifacts. A different view of how models and prototypes serve a more integrated process is to view it as serving essentially four functions that are intertwined with the various disciplines. Models and prototypes are used for creativity, communications, evaluation and--for the FDA--verification. To further understand the relationship between prototyping and product design, it's best to look at how these fit within the steps of the design phases.
Design is more than creativity, but that's where it starts. Good designers draw creativity from anything and everything. Both the designer walking through the aisles of a local Toys "R" Us or Home Depot looking for ideas--as is frequently done--and the designer in the shop working with "found" objects to simulate basic mechanical actions are tapping into new solutions based on parallels drawn from existing products.
For example, in one project with a client, the firm sought to miniaturize bar code scanners and adapt them to be worn on the forefinger by package handlers. The chassis and basic enclosure were straight-forward, given conventional machined parts, stereolithography apparatuses and urethane castings. But the small plastic clips to hold the adjustable strap on the finger needed to be injection molded in production materials--and there wasn't time for that. However, a walk through the local Wal-Mart led to the discovery of shoulder-strap clips on large-size women's brassieres that were perfect for the project.
From a certain perspective, modeling is just sketching in 3-D. Just as some designers and engineers are most comfortable with a pencil or a seat of CAD, some are best when working in the shop. A sculptor doesn't necessarily see the world the same way that a painter does. And it's easy to jump into CAD too soon, which can lead to a sort of tunnel vision resulting in a "do it and fix it" process. Keeping things open to a variety of approaches using models and prototypes might be best, especially early on.
If a picture is worth a thousand words, then a model or prototype must be worth a million. For all of the creativity that comes from simple sketching, it's always the first model that creates the big "ah ha" (or "oh, crap") for both the design team and, importantly, for the extended team. Designers need to remember that other disciplines do not visualize objects represented in sketches--and even in 3-D CAD--in the same manner. There's also the matter of "scale." The breadbox-size medical products are pretty easy; model a defibrillator or patient monitor one-to-one, and what you see is what you get. But it's usually time and cost effective to make a quarter- or half-scale model of a large clinical analyzer instead of a full-sized model. Even so, it's always good practice to make at least a volumetric, full-sized model to get a sense of scale--and to address human factors issues in a simulated, dynamic setting. Or, at the other extreme, an engineer can get sucked into designing a plastic snap detail in a large CAD image that defies the properties of the materials when prototyped. At this point in the creative process, the models are the best way to preference test a variety of concepts with potential end users and, when the fidelity is high enough, to do preliminary usability testing--all good reasons to model early and model often.
As designs gel into a primary engineering solution, prototypes (both of physical objects and electronic user interfaces) take on the role of tools for evaluation. These may be mechanical/electronic," shake and bake" or (as prescribed to be good practice by the FDA) be used for human factors usability testing in simulated environments of use. This is the critical crossroads for any project. No engineer wants to make major changes at this point in the process, and the management team that sponsors the work doesn't want to hear about delays at this point either. But this is the lowest-risk and least-expensive time to take a hard look at the proposed solution and make sure that it meets the requirements of both the specification and intended use for the instrument or device. The physical models at this point are meant to supplement, but not to replace, other analytical tools such as mold flow and finite element analysis.
The typical crossover point from design and engineering to preproduction tooling and manufacture is in the final engineering phase and verification. Here, prototypes are used to verify that the design inputs match the intended product outputs. It could be as simple as checking tolerances and fits, but more often it allows the designers and engineers to ensure that the product performance meets the specifications. With the availability of prototyping materials that approach production performance, the verification process can assure that final mechanical, thermal, electrical, flammability and other performance requirements will be met as early in the development process as possible. By testing, documenting and correlating the prototype performance to production materials and processes, designers can deliver robust data to support regulatory submissions.
For the developers, there are even more options for prototype resources. Many prototype shops are expanding into low-volume production, and more production manufacturers are offering to help at the prototype end to get their foot in the door early. The most important rule of thumb is, don't go with the low bidders. Saving a couple of bucks on a rapid prototype is being a pound foolish when there are tens or hundreds of thousands of dollars of engineering effort riding on the outcomes.
Models and prototypes are a way to test ideas. Ideas lead to innovation that helps to add top-line growth for customers and help designers to keep from being "commoditized" as service providers. The contract manufacturers that can connect the dots between design/engineering and prototyping/production are most likely to gain a leg up on the competition. Couple that understanding with the familiarity of "model early, model often," and there's a key ingredient for a successful, proven and thriving business practice.
Jack Harkins, president of Farm Design, Inc., co-founded the firm in 1982. He is responsible for Farm's business strategy and is an integral part of the business development team, where he focuses his expertise in cardiology and vascular markets. Jack's true specialties and commitment are in discovering user needs using a wide variety of research methods to determine product specifications. He has led client programs for biomedical start-ups as well as industry leaders such as Schick, Johnson & Johnson and GE Medical. He has recently held positions on the board of advisors of The Design Management Institute and as chair of the Medical Section of the Industrial Designers Society of America. Jack graduated with honors from the Rhode Island School of Design with a BFA and BID in 1976.
Farm is a full-service, FDA- and ISO-compliant product development company with more than 30 years of success in delivering product strategy, technology and development for the medical, laboratory and consumer industries.
Jack Harkins "Why the Mantra of "model early, model often" still resonates in medical device design". Medical Product Outsourcing. FindArticles.com. 02 Nov, 2009. http://findarticles.com/p/articles/mi_hb6159/is_7_6/ai_n28581862/
'Interesting Times'
There's an oft-quoted ancient Chinese curse that threatens: "May you live in interesting times." The implication is that "uninteresting" times of peace and tranquility are more life enhancing. Some historians claim the saying is more modern in origin and, perhaps, may not even be Chinese. Old and authentic or not, the warning is an interesting one.
Given the current state of the economy (dare we use the dreaded "R"word), some medical device makers--particularly startups and venture capital-backed firms--certainly may feel as if they have begun living in "interesting times."
In 2007, venture capitalists pumped a record $9.1 billion into privately held US biotechnology and medical device companies in hopes of making discoveries they could sell to larger companies or perhaps on Wall Street with an initial public offering (IPO). Biotechnology and medical device companies raised 20% more cash in the United States last year than in 2006, according to a report by accounting firm PricewaterhouseCoopers and the National Venture Capital Association (NVCA).
According to yet another more recent study from PricewaterhouseCoopers and the NVCA, however, the life-sciences sector (biotechnology and medical devices combined) saw a 14% drop in venture capital investing in the second quarter of 2008, with $1.9 billion going into 209 deals (a 9% drop in the number of deals from the first quarter of 2008). This decrease is attributed to declining investment levels in both biotechnology and medical devices.
Christopher Delporte "Interesting times". Medical Product Outsourcing. FindArticles.com. 02 Nov, 2009. http://findarticles.com/p/articles/mi_hb6159/is_7_6/ai_n28581850/
Given the current state of the economy (dare we use the dreaded "R"word), some medical device makers--particularly startups and venture capital-backed firms--certainly may feel as if they have begun living in "interesting times."
In 2007, venture capitalists pumped a record $9.1 billion into privately held US biotechnology and medical device companies in hopes of making discoveries they could sell to larger companies or perhaps on Wall Street with an initial public offering (IPO). Biotechnology and medical device companies raised 20% more cash in the United States last year than in 2006, according to a report by accounting firm PricewaterhouseCoopers and the National Venture Capital Association (NVCA).
According to yet another more recent study from PricewaterhouseCoopers and the NVCA, however, the life-sciences sector (biotechnology and medical devices combined) saw a 14% drop in venture capital investing in the second quarter of 2008, with $1.9 billion going into 209 deals (a 9% drop in the number of deals from the first quarter of 2008). This decrease is attributed to declining investment levels in both biotechnology and medical devices.
Christopher Delporte "Interesting times". Medical Product Outsourcing. FindArticles.com. 02 Nov, 2009. http://findarticles.com/p/articles/mi_hb6159/is_7_6/ai_n28581850/
Wednesday, 21 October 2009
Wall Street Journal's take on medical device industry tax
http://online.wsj.com/article/SB10001424052970204518504574418941379207328.html
Great article from the WSJ on taxation of medical device companies- there has never been a truer statement than the headline- "The Innovation Tax" - or the last sentence. We think this is an unfortunate effect of the U.S. government needing to finance long-overdue healthcare reforms when they are already over-extended with insurance co. and investment bank bailouts, car company rescues, and the sinking U.S. dollar (shall we go on?). We also noted an insightful sentence toward the end of the article, "the device makers simply don't have the same political clout as the other big players, making them an easier mark." AdvaMed is apparently not as politically connected as PhRMA and the likes of Merck, Pfizer, and less diversified pharmaceutical manufacturers that don't derive as much of their revenue from devices and diagnostics. Too much of the U.S. system is rooted in money/profits and influence (i.e, political'connections'.)
More reaction to medical sector taxation reform
Yesterday morning saw representatives from several Minnesota medical technology companies, a VC company and even a couple of patients gather at Plymouth City Hall to protest against the $40 Billion tax on medical device firms, proposed as part of the Senate Finance Committee's health care reform bill.
Minnesota, as highlighted previously on this blog, is a key area for medical device companies, with somewhere in the region of 200 companies listed as being located there, and employing around 20000 people.
Rumours of a possible additional tax for medical device companies is causing considerable concern because of the potential impact on research and development, jobs and manufacturing as companies try to cut costs. Rumours around the tax have already begun to impact VC funding to small companies, impacting innovation. These companies are not just the lifeblood of the larger medical companies who frequently acquire clever start ups, but in the long term they are the lifeblood for patients laying their hopes on improved medical advance to cure diseases. Increasing taxes will increase costs or stifle development.
We hope that the mounting concerns are heard and acted upon. Extraordinary developments continue to be made by medical device companies all of the time, and without the small start ups, innovation in the sector will be strongly impacted. Taxing the innovation and creativity taking place in U.S. device and diagnostics companies is counter-productive from nearly every perspective. How would the tax apply to a larger healthcare company which receives a minority of its revenues from devices/diagnostics? Would it be exempt? Would the tax apply on a pro rata basis? Anyone know?
Tuesday, 20 October 2009
Company Focus: CeloNova Bio Sciences
Spoke yesterday with Teresa Wilson, Director of Strategic Analysis at CeloNova in Newman Georgia about the company's product, Embozene Colour Advanced Microspheres. CeloNova is involved in producing microspheres for embolization, an increasingly used technique in the field of Interventional oncology, both for the treatment of tumours or areas of unwanted bleeding, whereby Interventional Radiologists or specially trained physicians inject drugs or radiation into a blood vessel to target affected areas.
CeloNova is not alone- their key competitors in producing microspheres are BioCompatibles, Biosphere Medical and Boston Scientific, but where CeloNova differentiates itself is in being the first company to offer colour-coded microspheres to allow the doctor conducting the procedure to clearly see which calibration of tiny microsphere is being used, thus offering strong benefits in terms of patient safety, but also to help with the speed of the procedure, thus minimising possible radiation exposure time.
The use of microspheres to treat cancers has come about as doctors and researchers looked for targeted solutions that would allow the cancer itself to be destroyed whilst allowing the healthy tissue around the cancer to remain undamaged. Furthermore, because the threat to healthy tissue is reduced, higher doses of radiation or drugs can be applied to the tumour.
CeloNova has been in the press a couple of times in recent weeks, firstly when Dr Franco Orsi and his colleagues at the European Institute of Oncology concluded that the company's small, highly calibrated Embozene Microspheres were better than other products for the treatment of liver cancer and metastases. The EIO team has developed a technique to cut off the blood supply deep within the tumour bed of primary and metastatic liver tumours, leading to effective tumour control and reduced recurrence of tumours without thr use of chemotherapy drugs. The team highlighted that "The dimension and shape of embolic particles seem to be the most important characteristics for this aim".
This week the company also announced that it had received BSI approval for an expansion of the list of medical indications for which Embozene Microspheres can be used, as well as the addition of a tenth size of the product. In Europe, Embozene Microspheres are now approved for the treatment of liver cancer, uterine fibroids, tumour of the head, neck, torso and skeletal system, for bleeding and trauma, and for reducing pre operative bleeding throughout the body with the exception of the central nervous system.
Theresa also mentioned that the product has been piloted for use in cardiovascular procedures involving overactive heart muscles.
I asked Theresa about the challenges of interventional oncology gaining more mainstream acceptance, and she highlighted the continuing issue of "medical turf wars", that there are huge levels of competition between medical specialities and that the referral is always tricky to work out. This may be a specifically US problems- CMR has had discussions with a number of interventional radiologists in the UK, and the patients seem to be referred quite equally by phyisicans- as one told me "there are more than enough to go around".
Again, the U.S. system allows for, if not encourages, specialist physicians to 'market' themselves and their practices with the goal of maximizing their personal gain from their expertise; the 'entrepreneurial model'.For other innovators in the microsphere area, see Dr. Naomi Halas, Rice University, Houston, TX at http://www.ece.rice.edu/~halas/.
CeloNova is not alone- their key competitors in producing microspheres are BioCompatibles, Biosphere Medical and Boston Scientific, but where CeloNova differentiates itself is in being the first company to offer colour-coded microspheres to allow the doctor conducting the procedure to clearly see which calibration of tiny microsphere is being used, thus offering strong benefits in terms of patient safety, but also to help with the speed of the procedure, thus minimising possible radiation exposure time.
The use of microspheres to treat cancers has come about as doctors and researchers looked for targeted solutions that would allow the cancer itself to be destroyed whilst allowing the healthy tissue around the cancer to remain undamaged. Furthermore, because the threat to healthy tissue is reduced, higher doses of radiation or drugs can be applied to the tumour.
CeloNova has been in the press a couple of times in recent weeks, firstly when Dr Franco Orsi and his colleagues at the European Institute of Oncology concluded that the company's small, highly calibrated Embozene Microspheres were better than other products for the treatment of liver cancer and metastases. The EIO team has developed a technique to cut off the blood supply deep within the tumour bed of primary and metastatic liver tumours, leading to effective tumour control and reduced recurrence of tumours without thr use of chemotherapy drugs. The team highlighted that "The dimension and shape of embolic particles seem to be the most important characteristics for this aim".
This week the company also announced that it had received BSI approval for an expansion of the list of medical indications for which Embozene Microspheres can be used, as well as the addition of a tenth size of the product. In Europe, Embozene Microspheres are now approved for the treatment of liver cancer, uterine fibroids, tumour of the head, neck, torso and skeletal system, for bleeding and trauma, and for reducing pre operative bleeding throughout the body with the exception of the central nervous system.
Theresa also mentioned that the product has been piloted for use in cardiovascular procedures involving overactive heart muscles.
I asked Theresa about the challenges of interventional oncology gaining more mainstream acceptance, and she highlighted the continuing issue of "medical turf wars", that there are huge levels of competition between medical specialities and that the referral is always tricky to work out. This may be a specifically US problems- CMR has had discussions with a number of interventional radiologists in the UK, and the patients seem to be referred quite equally by phyisicans- as one told me "there are more than enough to go around".
Again, the U.S. system allows for, if not encourages, specialist physicians to 'market' themselves and their practices with the goal of maximizing their personal gain from their expertise; the 'entrepreneurial model'.For other innovators in the microsphere area, see Dr. Naomi Halas, Rice University, Houston, TX at http://www.ece.rice.edu/~halas/.
Monday, 19 October 2009
Is Minimally invasive prostate surgery riskier?
Interesting article in Medical News Today about possible complications surrounding robotically assisted prostate surgery and whether despite the fact that it offers patients improved short term recovery, it can actually create long term genitourinary complications. It would bhe interesting to hear further reaction from medical professional about this-Intuitive Surgical the key player in robotically assisted surgery has already come back to say that in 800 previous studies on robot-assisted prostate surgery, the overwhelming majority have shown superior results, while other medics have advised that the Medicare billing codes used to extrapolate data for the study don't necessarily reflect between robotically-assisted and other forms of MIRP.
Thoughts and views on this would be welcome- highlights and link to the full article below:
While it is accepted that minimally invasive surgery cuts post operative recovery time and shortens hospital stays, research from the US has highlighted the possiblity of complications for patients following minimally invasive procedures to treat prostate surgery. These possible complications include erectile disfunction and incontinence.
The research was the work of Dr Jim C Hu, from the division of Urolic surgery and the Center for Surgery and Public Health at Bringham and women's hospital Boston.
The research suggests that there has been a rapid rise in minimally invasive radical prostectomy (MIRP), particularly robot assisted procedures, from 1% of all radical prostectomies in 2001 to 40% in 2006, and this despite the lack of data on outcomes when compared with open retropublic radical prostectomy (RRP), the more conventional prostate treatment.
For the study, Dr Hu and his team assessed the surgical outcomes of MIRP versus RRP in nearly 9000 men with prostate cancer, nearly 2000 of the men had MIRP, the others had RRP. The data they used came from US Surveillance, epidemiology, and end results medicare-linked data.
Results showed that over the study period, MIRP use went up by nearly five fold, from 9.2 % in 2003 to 43.2 % iin 2006-7. The study found that short term, MIRP offered good patient benefits such as shorter hospital stays, lower risk of postoperative respiratory complications, lower risk of miscellaneous surgical complications and lower likelihood of needing blood transfusions, while long term, men undergoing MIRP vs RRP experienced more genitourinary complications 4.7 % vs 2.1% and were more often diagnosed as having incontinence and erectile disfunction.
For full details of this story see http://medicalnewstoday.com/printerfriendlynews.php?newsid=167322
CMR wonders if there is a danger of confusing the robotic-assisted prostatectomies, other procedures included under 'minimally invasive radical prostatectomy', and surgical techniques, such as 'nerve-sparing' surgery designed to minimize erectile problems and other-post surgical complications?The preponderance of scientific evidence to this point suggests that robotic-assisted surgery does have financial advantages to the hospital/clinic/physicians' practice using it, i.e. less blood loss, shorter recuperations, fewer post-surgical clinical complications, all designed to facilitate faster patient movement through the operating suite to maximize revenue. While these advantages suggest a benefit to the patient as well, it seems that more study is indicated on the incidence of two specific complications and their psycho-social, as well as economic, implications for the patient's ultimate satisfaction with the procedure.
Thoughts and views on this would be welcome- highlights and link to the full article below:
While it is accepted that minimally invasive surgery cuts post operative recovery time and shortens hospital stays, research from the US has highlighted the possiblity of complications for patients following minimally invasive procedures to treat prostate surgery. These possible complications include erectile disfunction and incontinence.
The research was the work of Dr Jim C Hu, from the division of Urolic surgery and the Center for Surgery and Public Health at Bringham and women's hospital Boston.
The research suggests that there has been a rapid rise in minimally invasive radical prostectomy (MIRP), particularly robot assisted procedures, from 1% of all radical prostectomies in 2001 to 40% in 2006, and this despite the lack of data on outcomes when compared with open retropublic radical prostectomy (RRP), the more conventional prostate treatment.
For the study, Dr Hu and his team assessed the surgical outcomes of MIRP versus RRP in nearly 9000 men with prostate cancer, nearly 2000 of the men had MIRP, the others had RRP. The data they used came from US Surveillance, epidemiology, and end results medicare-linked data.
Results showed that over the study period, MIRP use went up by nearly five fold, from 9.2 % in 2003 to 43.2 % iin 2006-7. The study found that short term, MIRP offered good patient benefits such as shorter hospital stays, lower risk of postoperative respiratory complications, lower risk of miscellaneous surgical complications and lower likelihood of needing blood transfusions, while long term, men undergoing MIRP vs RRP experienced more genitourinary complications 4.7 % vs 2.1% and were more often diagnosed as having incontinence and erectile disfunction.
For full details of this story see http://medicalnewstoday.com/printerfriendlynews.php?newsid=167322
CMR wonders if there is a danger of confusing the robotic-assisted prostatectomies, other procedures included under 'minimally invasive radical prostatectomy', and surgical techniques, such as 'nerve-sparing' surgery designed to minimize erectile problems and other-post surgical complications?The preponderance of scientific evidence to this point suggests that robotic-assisted surgery does have financial advantages to the hospital/clinic/physicians' practice using it, i.e. less blood loss, shorter recuperations, fewer post-surgical clinical complications, all designed to facilitate faster patient movement through the operating suite to maximize revenue. While these advantages suggest a benefit to the patient as well, it seems that more study is indicated on the incidence of two specific complications and their psycho-social, as well as economic, implications for the patient's ultimate satisfaction with the procedure.
Tuesday, 13 October 2009
ATS Medical receives CE Mark for Cryoablation Probe
A good bit of news today about ATM medical receiving a CE mark for its Cryomaze 10-S Surgical Cryoablation probe aimed at treatment of cardiac arrhythmias. This is a nice example of a company directly responding to the preferences of surgeons in creating a product that makes awkward procedures easier.
The product provides a more controlled stiffness than the current Cryomaze probe, and increased support through the length addresses the desire of some surgeons for more probe leverage to access hard to reach areas.
The device was first used by Professor Mohr a globally renowned thought leader within the cardiac surgery community, who highlighted the benefots of using the device in minimally invasive procedures.
The company highlighted the product as its response to request from cardiac arrhythmia surgeons for a more substantial cryoablation instrument
It is good to see companies listening and being so reactive to medical communities' needs.
The product provides a more controlled stiffness than the current Cryomaze probe, and increased support through the length addresses the desire of some surgeons for more probe leverage to access hard to reach areas.
The device was first used by Professor Mohr a globally renowned thought leader within the cardiac surgery community, who highlighted the benefots of using the device in minimally invasive procedures.
The company highlighted the product as its response to request from cardiac arrhythmia surgeons for a more substantial cryoablation instrument
It is good to see companies listening and being so reactive to medical communities' needs.
Medical device startups are taking a recessionary hit
While the big boys in the medical device sector are weathering the recessionary storm, the innovative medical device start-ups have struggled with adverse finanical conditions according to a report released today by Ernst and Young. US and European medical technology companies saw total industry financing drop by 38% in 2008. The US has been particularly badly hit.
The big players are performing well, but their new life blood, the types of tiny companies producing compelling device innovations that they acquire in order to keep growing, are struggling. Mergers and acquisitions, usually the only way these companies can make a return for their investors, showed a strong decline in 2008, down 41 % from the previous year.
A sobering thought for an industry which in the US particularly is facing new goverment reform and taxation threats.
However, there is reason to be positive; medical advance will always be needed, and the Ernst and Young report does highlight some key regions for medical device technology that are still thriving; California, Massachusetts and Minnessota are major hubs for medical device innovation, with strong support from a population of skilled scientists, access to capital, and a robust network of support institutions such as hospitals and universities.
The big players are performing well, but their new life blood, the types of tiny companies producing compelling device innovations that they acquire in order to keep growing, are struggling. Mergers and acquisitions, usually the only way these companies can make a return for their investors, showed a strong decline in 2008, down 41 % from the previous year.
A sobering thought for an industry which in the US particularly is facing new goverment reform and taxation threats.
However, there is reason to be positive; medical advance will always be needed, and the Ernst and Young report does highlight some key regions for medical device technology that are still thriving; California, Massachusetts and Minnessota are major hubs for medical device innovation, with strong support from a population of skilled scientists, access to capital, and a robust network of support institutions such as hospitals and universities.
Monday, 12 October 2009
Is embolisation actually a better treatment for uterine fibroids?
Uterine fibroids are a very common disease amongst women. Approximately 30 % are affected, and symptoms may include heavy menstrual bleeding, bowel obstruction, pain, and pressure on the bladder.
Usually, fibroid removal requires hysterectomy or a myomectomy, (In the UK, it is estimated that gynaecologists perform some 12,000 hysterectomies due to fibroid disease every year), but both are invasive treatments and hysterectomy is clearly not suitable for anyone still planning a family. Uterine Artery Embolisation (UAE) can offer treatment for fibroid disease, but is currently only widely practiced in the USA, UK and France, and many women in Europe still do not have widespread access to this procedure. A quick scan of the web reveals why- there has been little conclusive proof about its effectiveness, notably long term.
However, the results of two randomized studies comparing the results of hysterectomy and embolisation in treating uterine fibroids were presented at the last CIRSE meeting in Rome in September. Both the Dutch EMMY trial and the Scottish REST study were performed independently, and both show a similar quality of life for patients following both the surgical and the embolisation procedures. The EMMY study also showed that this was maintained after a two year follow up period.
This is the first time results indicating the success of UAE have been proved in randomized studies, and there is now scientific proof that embolisation is an effective alternative to hysterectomy. Both studies even went further, revealing that embolisation procedures are almost 40 % cheaper than the surgical option.
These trials represent another siginificant step in cementing interventional radiology treatment as a viable and mainstream alternative in procedures where surgery may not be an option, and can offer a less invasive and even more cost effective alternative.
Uterine fibroids can also be an obstacle to successful conception and child-bearing and, as such, along with endometriosis, are of interest to gynecologists and reproductive endocrinologists, as well as interventional radiologists.
For those women for whom surgery is not an option, a non-invasive alternative is available in the form of injections of a Gn-RH agonist, such as Lupron Depot, which down-regulates production of estrogen and shrinks fibroids. Although effective, critics point out that loss of estrogen produces some undesirable side-effects, such as 'hot flashes', mood swings, and vaginal dryness, but these effects can be successfully managed in many patients by low doses of progesterone.These study results, together with a large body of clinical evidence from the U.S. show that UAE is a viable option for treatment of uterine fibroids in women for whom radical surgery and medications are not options.
Usually, fibroid removal requires hysterectomy or a myomectomy, (In the UK, it is estimated that gynaecologists perform some 12,000 hysterectomies due to fibroid disease every year), but both are invasive treatments and hysterectomy is clearly not suitable for anyone still planning a family. Uterine Artery Embolisation (UAE) can offer treatment for fibroid disease, but is currently only widely practiced in the USA, UK and France, and many women in Europe still do not have widespread access to this procedure. A quick scan of the web reveals why- there has been little conclusive proof about its effectiveness, notably long term.
However, the results of two randomized studies comparing the results of hysterectomy and embolisation in treating uterine fibroids were presented at the last CIRSE meeting in Rome in September. Both the Dutch EMMY trial and the Scottish REST study were performed independently, and both show a similar quality of life for patients following both the surgical and the embolisation procedures. The EMMY study also showed that this was maintained after a two year follow up period.
This is the first time results indicating the success of UAE have been proved in randomized studies, and there is now scientific proof that embolisation is an effective alternative to hysterectomy. Both studies even went further, revealing that embolisation procedures are almost 40 % cheaper than the surgical option.
These trials represent another siginificant step in cementing interventional radiology treatment as a viable and mainstream alternative in procedures where surgery may not be an option, and can offer a less invasive and even more cost effective alternative.
Uterine fibroids can also be an obstacle to successful conception and child-bearing and, as such, along with endometriosis, are of interest to gynecologists and reproductive endocrinologists, as well as interventional radiologists.
For those women for whom surgery is not an option, a non-invasive alternative is available in the form of injections of a Gn-RH agonist, such as Lupron Depot, which down-regulates production of estrogen and shrinks fibroids. Although effective, critics point out that loss of estrogen produces some undesirable side-effects, such as 'hot flashes', mood swings, and vaginal dryness, but these effects can be successfully managed in many patients by low doses of progesterone.These study results, together with a large body of clinical evidence from the U.S. show that UAE is a viable option for treatment of uterine fibroids in women for whom radical surgery and medications are not options.
Interventional radiology gains some solid recognition
Is interventional radiology just a useful thing to be able to do as part of a "bigger job"?
According to CIRSE, ESR and SIR, the many practising interventional radiologists worldwide, cardiologists and oncologists using IR techniques, the patients whose lives have been extended, made easier or saved because they might not have been able to undergo regular surgery, interventional radiology is categorically an important medical division in its own right...and now UEMS, the European Union of Medical Specialists has chosen to agree. On 25th April the UEMS council vote overwhelmingly went in favour of establishing a division of Interventional Radiology.
Interest in interventional radiology continues to grow. Many non-radiologists may think of IR as a collection of peripheral vascular interventional procedures, but actually its breadth is considerable, covering non-vascular interventions (biliary, gastrointestinal and urinary) and increasingly gaining interest for its use in oncology with procedures such as embolization and tumour ablation.
Interventional radiology in our mind is the use of imaging simply to conduct pinhole surgery, both in treatment and diagnostics. IR allows patients to recover faster, and in many cases to undergo considerably less traumatic surgery. IR can offer a last piece of hope for some patients where other treatments have failed.
With a positive vote on the establishment of an IR division within the UEMS Radiology section, IR has finally been recognised as a medical speciality in Europe, and interventional radiologists as distinct medical specialists. The next step will be the national implementation of this decision.
The decision is important not just in terms of a long deserved status, but in achieving significant goals, such as the establishment of a European training curriculum for IR, a European IR skill certification and quality standardisation. A good solid foundation for a highly valuable discipline.
According to CIRSE, ESR and SIR, the many practising interventional radiologists worldwide, cardiologists and oncologists using IR techniques, the patients whose lives have been extended, made easier or saved because they might not have been able to undergo regular surgery, interventional radiology is categorically an important medical division in its own right...and now UEMS, the European Union of Medical Specialists has chosen to agree. On 25th April the UEMS council vote overwhelmingly went in favour of establishing a division of Interventional Radiology.
Interest in interventional radiology continues to grow. Many non-radiologists may think of IR as a collection of peripheral vascular interventional procedures, but actually its breadth is considerable, covering non-vascular interventions (biliary, gastrointestinal and urinary) and increasingly gaining interest for its use in oncology with procedures such as embolization and tumour ablation.
Interventional radiology in our mind is the use of imaging simply to conduct pinhole surgery, both in treatment and diagnostics. IR allows patients to recover faster, and in many cases to undergo considerably less traumatic surgery. IR can offer a last piece of hope for some patients where other treatments have failed.
With a positive vote on the establishment of an IR division within the UEMS Radiology section, IR has finally been recognised as a medical speciality in Europe, and interventional radiologists as distinct medical specialists. The next step will be the national implementation of this decision.
The decision is important not just in terms of a long deserved status, but in achieving significant goals, such as the establishment of a European training curriculum for IR, a European IR skill certification and quality standardisation. A good solid foundation for a highly valuable discipline.
Interventional radiology used to treat blood clots
A trial for the catheter-based treatment of deep vein thrombosis will evaluate the use of clot-dissolving drugs in conjunction with clot removal devices to prevent post- thrombotic syndrome (PTS) in patients with DVT.
PTS causes permanent damage to the veins, resulting in debilitating chronic leg pain, swelling, fatigue and ulcers. About 25% of patients currently develop PTS when being treated with blood thinners alone, which did not dissolve the existing clot. Preliminary studies have indicated that interventional clot-busting treatments can remove clots and have strong potential to prevent PTS.
The $10 million trial, ATTRACT, will be funded by the NHLBI and may fundamentally alter the way that DVT is treated in the USA, moving interventional radiology to the core of DVT treatment. ATTRACT ( Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) is a multicenter randomized trial that will establish whether PTS can be definitively prevented with the use of interventional techniques.
If the trials prove to be successful, this is important news both in preventing PTS but also in the considerably greater use of interventional techniques in DVT.
PTS causes permanent damage to the veins, resulting in debilitating chronic leg pain, swelling, fatigue and ulcers. About 25% of patients currently develop PTS when being treated with blood thinners alone, which did not dissolve the existing clot. Preliminary studies have indicated that interventional clot-busting treatments can remove clots and have strong potential to prevent PTS.
The $10 million trial, ATTRACT, will be funded by the NHLBI and may fundamentally alter the way that DVT is treated in the USA, moving interventional radiology to the core of DVT treatment. ATTRACT ( Acute Venous Thrombosis: Thrombus Removal with Adjunctive Catheter-Directed Thrombolysis) is a multicenter randomized trial that will establish whether PTS can be definitively prevented with the use of interventional techniques.
If the trials prove to be successful, this is important news both in preventing PTS but also in the considerably greater use of interventional techniques in DVT.
One step closer to simple and portable tuberculosis tests for the developing world
Googling tuberculosis reveals some shocking statistics- one third of the world's population has been affected with the illness, and new infections occur at a rate of one per second. The proportion of people in the general population who become sick with tuberculosis each year is stable or falling worldwide but, because of population growth, the absolute number of new cases is still increasing.
TB remains the seventh leading cause of death worldwide, killing more than 1.5 million people annually. 90% of people carrying TB have "latent" infections, and have no symptoms. The 10% of people who go on to develop full-blown TB infect, on average, another 10-15 people per year.
There is therefore a critical need to detect latent TB infection, particularly in the developing world.
A group of researchers at Colorado State University (CSU) have demonstrated a new way to use light to detect traces of TB bacteria in fluids. The researchers have developed a technique that can sensitively detect different molecular markets indicating a TB infection. The test would be cheap to use and no more difficult to administer than a pregnancy test, making it ideal for use in the developing world.
TB is curable after a lengthy course of antibiotics. The basic strategy of the WHO's efforts to curb the spread of TB worldwide is to simply find the people infected and give them the antibiotics to cure the disease. Currently however, finding the people infected is difficult, particularly those infected with latent symptoms. The CSU development could go a long way to helping detect these people, but it could be some time before it is widely available, as it will need to undergo significant clinical trial testing.
TB remains the seventh leading cause of death worldwide, killing more than 1.5 million people annually. 90% of people carrying TB have "latent" infections, and have no symptoms. The 10% of people who go on to develop full-blown TB infect, on average, another 10-15 people per year.
There is therefore a critical need to detect latent TB infection, particularly in the developing world.
A group of researchers at Colorado State University (CSU) have demonstrated a new way to use light to detect traces of TB bacteria in fluids. The researchers have developed a technique that can sensitively detect different molecular markets indicating a TB infection. The test would be cheap to use and no more difficult to administer than a pregnancy test, making it ideal for use in the developing world.
TB is curable after a lengthy course of antibiotics. The basic strategy of the WHO's efforts to curb the spread of TB worldwide is to simply find the people infected and give them the antibiotics to cure the disease. Currently however, finding the people infected is difficult, particularly those infected with latent symptoms. The CSU development could go a long way to helping detect these people, but it could be some time before it is widely available, as it will need to undergo significant clinical trial testing.
Diabetes and Obesity Rates Soar
Shockingly, according to Diabetes UK, the number of people diagnosed with diabetes in the UK has risen by more than 145 000 in the last year. Latest data from GP surgeries shows that there are now more than 2.6 million people with diabetes in the UK, coupled with a staggering 5.2 million patients now regostered as obese. In basic terms, obesity now affects almost 9 percent of the UK population, and this is just the known cases.
The link between diabetes and obesity and the impact on the heart is well enough documented that most people should understand the risks, but the link between obesity, diabetes and very serious complications such as risk of lower limb amputation, severe eyesight problems and kidney damage may be less well known.
While ultimately patients need to help themselves by keepingtheir diabetes under control with sensible eating and exercise, how can device companies operating in diabetes help beyond improving tools such metering and pumps?
CMR believes there is room for further help with improving education to reinforce messages about these very grave risks, and to help patients to further manage their diabetes to bring it under control and reduce the chances of serious illness.
Diabetes UK also highlighted that almost 90% of people with diabetes in the UK have never received structured diabetes education, which is the key to improved self-management of the condition. In the USA, a recent medicare study also highlighted the importance of diabetes education in reducing health care costs.
Seems to us that there is an opportunity here for vendors to both aid patients and health care systems whilst building valuable brand perception.
The link between diabetes and obesity and the impact on the heart is well enough documented that most people should understand the risks, but the link between obesity, diabetes and very serious complications such as risk of lower limb amputation, severe eyesight problems and kidney damage may be less well known.
While ultimately patients need to help themselves by keepingtheir diabetes under control with sensible eating and exercise, how can device companies operating in diabetes help beyond improving tools such metering and pumps?
CMR believes there is room for further help with improving education to reinforce messages about these very grave risks, and to help patients to further manage their diabetes to bring it under control and reduce the chances of serious illness.
Diabetes UK also highlighted that almost 90% of people with diabetes in the UK have never received structured diabetes education, which is the key to improved self-management of the condition. In the USA, a recent medicare study also highlighted the importance of diabetes education in reducing health care costs.
Seems to us that there is an opportunity here for vendors to both aid patients and health care systems whilst building valuable brand perception.
Cleveland Clinic's top 10 medical innovations for 2010
A search of the web this morning yielded an interesting article whereby the top 10 medical innovations for next year have been unveiled by Cleveland Clinic at its 2009 Medical innovation summit. Devices highlighted range from treatments for sleep related breathing disorders to those aimed at helping patients with Parkinsons Disease to improve motor function.
10. Whole-Slide Imaging for Management of Digital Data In Pathology: A technology for creating digital pathology slides with excellent image quality that can be viewed, stored, streamed over the Internet, and analyzed on a computer
.9. Devices for Occluding Left Atrial Appendage to Reduce Stroke Risk: Device alternatives to long-term warfarin use that can prevent clots from developing in patients with atrial fibrillation
.8. Oral Thrombopoeitin (TPO) Receptor Agonist That Stimulates Platelet Production: A recently approved drug that stimulates production of cells in bone marrow that form platelet cells in the blood
.7. Outpatient Diagnosis of Sleep-Related Breathing Disorders: Self-contained, reliable, at-home sleep-monitoring devices for screening, diagnosing, and treatment assessment of sleep-related breathing disorders
.6. Forced Exercise To Improve Motor Function in Patients With Parkinson's: Pedaling at 90 RPMs on a tandem bike to dramatically improve motor functioning of patients with Parkinson's disease.
5. Fertility Preservation Through Oocyte Cryopreservation: A rapidly-improving technology that allows eggs of a healthy woman to be safely frozen and stored, ready to be thawed and fertilized at a later date
.4. Non-Vitamin K Antagonist Oral Anticoagulants: Predictable and well-tolerated alternatives to the oral anticoagulant warfarin that provide a more convenient -- and safe -- way for patients to dose themselves and prevent blood-clot formation
.3. Continuous-Flow Ventricular Assist Devices: Tiny 3-ounce devices surgically attached alongside the heart that quietly and effectively take over the pumping ability of the heart
.2. Low-Volume, Low-Pressure Tracheal Tube Cuff To Reduce Ventilator-Associated Pneumonia: A device that dramatically reduces the risk of ventilator-associated pneumonia and death in the hospital ICU by providing continuous effective airway seals
.1. Bone Conduction of Sound For Single-Sided Deafness: A new non-surgical, removable hearing and communication device designed to imperceptibly transmit sound via the teeth to help people with single-sided deafness.
Four major criteria served as the basis for qualifying and selecting the Top 10 Medical Innovations. Nominated innovations were required to:
Have significant potential for short-term clinical impact (either a major improvement in patient benefit or an improved function that enhances healthcare delivery).
Have a high probability of success.
Be on the market or close to being introduced.
Have sufficient data available to support its nomination.
10. Whole-Slide Imaging for Management of Digital Data In Pathology: A technology for creating digital pathology slides with excellent image quality that can be viewed, stored, streamed over the Internet, and analyzed on a computer
.9. Devices for Occluding Left Atrial Appendage to Reduce Stroke Risk: Device alternatives to long-term warfarin use that can prevent clots from developing in patients with atrial fibrillation
.8. Oral Thrombopoeitin (TPO) Receptor Agonist That Stimulates Platelet Production: A recently approved drug that stimulates production of cells in bone marrow that form platelet cells in the blood
.7. Outpatient Diagnosis of Sleep-Related Breathing Disorders: Self-contained, reliable, at-home sleep-monitoring devices for screening, diagnosing, and treatment assessment of sleep-related breathing disorders
.6. Forced Exercise To Improve Motor Function in Patients With Parkinson's: Pedaling at 90 RPMs on a tandem bike to dramatically improve motor functioning of patients with Parkinson's disease.
5. Fertility Preservation Through Oocyte Cryopreservation: A rapidly-improving technology that allows eggs of a healthy woman to be safely frozen and stored, ready to be thawed and fertilized at a later date
.4. Non-Vitamin K Antagonist Oral Anticoagulants: Predictable and well-tolerated alternatives to the oral anticoagulant warfarin that provide a more convenient -- and safe -- way for patients to dose themselves and prevent blood-clot formation
.3. Continuous-Flow Ventricular Assist Devices: Tiny 3-ounce devices surgically attached alongside the heart that quietly and effectively take over the pumping ability of the heart
.2. Low-Volume, Low-Pressure Tracheal Tube Cuff To Reduce Ventilator-Associated Pneumonia: A device that dramatically reduces the risk of ventilator-associated pneumonia and death in the hospital ICU by providing continuous effective airway seals
.1. Bone Conduction of Sound For Single-Sided Deafness: A new non-surgical, removable hearing and communication device designed to imperceptibly transmit sound via the teeth to help people with single-sided deafness.
Four major criteria served as the basis for qualifying and selecting the Top 10 Medical Innovations. Nominated innovations were required to:
Have significant potential for short-term clinical impact (either a major improvement in patient benefit or an improved function that enhances healthcare delivery).
Have a high probability of success.
Be on the market or close to being introduced.
Have sufficient data available to support its nomination.
Friday, 9 October 2009
This week the team has been discussing our plans for a multi client study on the area of interventional radiology. Why did we pick this area? Well, what is appealing about it is that IR techniques can often be applied where conventional surgery fails, so for those patients who may be unable to go through open surgery to correct a problem such as a vascular blockage, can be treated through pinhole surgery instead. The recovery time for the patient is considerably shorter than through traditional surgery.
The team were also interested to learn that techniques such as stenting that started out as an interventional radiology technique are now mainstream in areas such as cardiology.
But is there any growth in IR and why is it particularly interesting? Well at the moment, there seems to be a movement to "recognise" IR more, not necessarily pulling it out of the radiology department and into its own right, but certainly giving the speciality more of an identity of its own, and giving more doctors the impetus to train as IR specialists. Secondly, interventional oncology does seem to be a growth area, and a significant one too, as using techniques such as RF ablation to target tumours and burn the tumour away offer benefits both in terms of treating patients who may previously have been untreatable, but also in terms of reaching tumours that may previously have been unreachable due to location and shortening recovery times.
We're going to be talking to companies involved in producing products for this sector as well as interventional radiologists involved in treating tumours. More information on this fascinating area coming up soon.
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