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)
Tuesday, 17 November 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/
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