Medical devices
Safety needles
May/04/10 15:02
I was speaking to someone recently about safety engineered needle technology, and how much has it entered the medical device market. Safety needles are medical devices that retract or protect the needle after use, so that needlestick injuries can be prevented. The consequences of these type injuries are multifold: spread of blood-borne pathogens such as hepatitis, HIV and other viruses and bacteria, lost productivity of the healthcare worker after injury, and economic and psychological costs of prophylactic treatments or, in a worst case scenario, chronic treatments.
In response to both healthcare workers, industry and politicians, several US Federal and State Agencies began to push for adoption of safety needle products by hospitals and other healthcare settings, mostly from late 1990’s through the early 2000’s. For example, NIOSH (the National Institute of Occupational Safety and Health) announced several recommendations for healthcare workers. OSHA (the Occupational Safety and Health Administration) established regulations for healthcare environments regarding needlestick injuries. Congress passed and the President signed into law the Needlestick Safety and Prevention Act that required regulations to prevent needlestick injuries. Read More...
In response to both healthcare workers, industry and politicians, several US Federal and State Agencies began to push for adoption of safety needle products by hospitals and other healthcare settings, mostly from late 1990’s through the early 2000’s. For example, NIOSH (the National Institute of Occupational Safety and Health) announced several recommendations for healthcare workers. OSHA (the Occupational Safety and Health Administration) established regulations for healthcare environments regarding needlestick injuries. Congress passed and the President signed into law the Needlestick Safety and Prevention Act that required regulations to prevent needlestick injuries. Read More...
One of the best
Oct/28/09 00:32
Last week, this blog was named one of the "99 Best Blogs for Pre-Med Students." I started this blog to talk about the medical products industry, of which I have been proud to have been involved for over 25 years. For the past couple of months, I've been busy, so I haven't focused on it as much as I wanted to. I will rectify that situation starting today. I also don't think the quality of my blog meets the standards of others like Respectful Insolence, Science Based Medicine, and The White Coat Underground. But I will try. Read More...
Quality, Mac vs. PC, and my eyes
Oct/27/09 23:52
The largest argument in the internet isn't Obama's healthcare plan, whether the Yankees should lose the World Series, or why does gas cost so much. No, it's Mac vs. PC. Across the internet, it's the argument that gobbles up bandwidth in a never-ending discussion. There are several websites that keep tabs on new technology. They are interesting if you want to read about a new mobile phone or a new rice harvesting robot. But whenever they talk about a new product from Apple or something from Microsoft, there's dozens, if not hundreds, of comments about one or the other. Then it gets personal.
I find these discussions amusing, because the arguments on both sides fall a little flat. Now, this website is hosted on Mac servers. And I wrote and designed this website on a Mac with a Mac-only web design program. So, you might think I'm biased, which I am. I'm not going to get into all the arguments between the two devices, but Windows based computers vastly outsell Macs. Most Mac users tend to very loyal to the brand for a number of valid reasons, including ease-of-use and fewer problems. Most PC users tend to look for lower prices without regards to the brand. However, there is a small, but vocal, group of very technical individuals who are loyal to PC's because they are more adept at maximizing the potential of PC's. I'm not convinced of all of their arguments, but they certainly are. Read More...
I find these discussions amusing, because the arguments on both sides fall a little flat. Now, this website is hosted on Mac servers. And I wrote and designed this website on a Mac with a Mac-only web design program. So, you might think I'm biased, which I am. I'm not going to get into all the arguments between the two devices, but Windows based computers vastly outsell Macs. Most Mac users tend to very loyal to the brand for a number of valid reasons, including ease-of-use and fewer problems. Most PC users tend to look for lower prices without regards to the brand. However, there is a small, but vocal, group of very technical individuals who are loyal to PC's because they are more adept at maximizing the potential of PC's. I'm not convinced of all of their arguments, but they certainly are. Read More...
The value of blood-glucose monitoring
May/13/09 09:17
One of the paradigms of managing patients with Type II diabetes includes regular home testing of blood glucose levels using one of the widely available blood glucose monitors. The American Diabetes Association, one of the leading organizations that advocate for and provide information about diabetes, recommends home glucose monitoring for patients who have diabetes and are:
These are probably good recommendations, based on good evidence. Controlling blood glucose in those patients with Type 2 diabetes has strong positive benefits for reducing risks of chronic and acute diseases, such as peripheral artery disease, hypertension, diabetic dyslipidemia, heart attack and stroke.
Recently, a clinical trial published in the British Medical Journal analyzed the medical usefulness of home blood glucose monitoring in patients with Type II diabetes. The trial was well designed enrolling 184 individuals with recently diagnosed type 2 diabetes mellitus. The patients were randomized into two groups: one that utilized a monitor and one that did not. The patients were observed for one year. Read More...
- taking insulin or diabetes pills
- on intensive insulin therapy
- pregnant
- having a hard time controlling your blood glucose levels
- having severe low blood glucose levels or ketones from high blood glucose levels
- having low blood glucose levels without the usual warning signs
These are probably good recommendations, based on good evidence. Controlling blood glucose in those patients with Type 2 diabetes has strong positive benefits for reducing risks of chronic and acute diseases, such as peripheral artery disease, hypertension, diabetic dyslipidemia, heart attack and stroke.
Recently, a clinical trial published in the British Medical Journal analyzed the medical usefulness of home blood glucose monitoring in patients with Type II diabetes. The trial was well designed enrolling 184 individuals with recently diagnosed type 2 diabetes mellitus. The patients were randomized into two groups: one that utilized a monitor and one that did not. The patients were observed for one year. Read More...
Increased FDA scrutiny of medical devices
May/07/09 07:51
In the early 1990’s, Congress directed the US Food and Drug Administration (FDA) to gather more rigorous evidence before a they give approval to manufacturer to market medical devices that were considered the most risky, a category known as Class III devices. The FDA never implemented the law, and several hundred Class III devices were approved by the FDA based on a less rigorous path using a 510(k), which allows the manufacturer to establish that their products are “substantially equivalent” to products marketed before 1976. Early this year, the Government Accounting Office (GAO) issued a report that stated these conclusions about the process:
The recommended that the FDA take immediate steps to issue regulations for all of the Class III devices that were allowed to enter the market through the 510(k) process. They directed the FDA to either reclassify each Class III device into either Class I or Class II (based on scientific evidence only) or require that it remain Class III. Those products that remain in Class III will require a new approval through the Pre-Market Approval (PMA) process, the most stringent for medical devices. Read More...
FDA has stated that eventually all class III devices will require FDA approval through the PMA process and FDA officials reported that the agency is committed to addressing this issue, but the agency has not specified time frames for doing so. Without FDA action, the remaining preamendment class III device types—including device types that FDA identified in 1994 as presenting an unreasonably high risk to public health—may enter the U.S. market through FDA’s less stringent premarket notification process.
The recommended that the FDA take immediate steps to issue regulations for all of the Class III devices that were allowed to enter the market through the 510(k) process. They directed the FDA to either reclassify each Class III device into either Class I or Class II (based on scientific evidence only) or require that it remain Class III. Those products that remain in Class III will require a new approval through the Pre-Market Approval (PMA) process, the most stringent for medical devices. Read More...
Point-of-care diagnostics and the flu
May/04/09 08:51
I am enamored of the point-of-care (POC) diagnostics market. It is clear that these tests bring benefits to patients, physicians and managed care. Influenza A H1N1 (apparently, the pork industry does is not fond of the swine flu label) may open a huge opportunity for rapid testing for flu.
Quidel Corporation (NASDAQ GS: QDEL) manufactures and markets a rapid (less than 10 minutes from swab to results) diagnostic kit for Influenza A and B (and differentiates between the two). As Quidel states, they are not sure if it detects the swine flu strain. The test should be used for any patients that present with influenza symptoms, because a positive result may rule out other types of infections (and should involve contacting a local health department), although a negative result (if the test does not identify the swine flu type) may not rule out the disease. Read More...
Quidel Corporation (NASDAQ GS: QDEL) manufactures and markets a rapid (less than 10 minutes from swab to results) diagnostic kit for Influenza A and B (and differentiates between the two). As Quidel states, they are not sure if it detects the swine flu strain. The test should be used for any patients that present with influenza symptoms, because a positive result may rule out other types of infections (and should involve contacting a local health department), although a negative result (if the test does not identify the swine flu type) may not rule out the disease. Read More...
First iPhone application for medicine
Apr/16/09 07:29
I receive a lot of announcements of new medical products through various trade journals and email alerts. I read most of them, just to see what’s coming out of product pipelines of various medical products companies. Since I’m more of a technology person, I enjoy innovative devices that fill a need in the market. As I’ve said before, I think it’s critical that medical device and equipment companies bring products to the market that improve user ergonomics, reduce errors, and are easy-to-use. Read More...
Scientific medicine and Big Pharma
Apr/08/09 08:42
I keep reading across the blogosphere that Big Pharma (for the sake of this discussion, defined as all medical products companies, including ones that don’t manufacture or market pharmaceuticals) somehow blocks either positive or negative results to further their profits. The accusations come from a wide variety of sources, some of the more vocal being the anti-science proponents, such as the anti-vaccination movement. Utilizing an ad hominem argument of personalizing the issues and then attacking the motives or character of others, usually those who dispute the claims made by pseudoscience. Read More...
Strength of the medical products industry
Mar/30/09 09:11
There continues to be quite a bit of anecdotal data that the medical products industry, including medical device, biotechnology, and pharmaceutical sectors of the industry, is healthy and employment is running counter to the recession. I do not have definitive evidence why hiring is strong in this industry, but the assumption must be that most medical products companies are flush with cash, have products ready for launch in the next year, or are building staff in advance of an upswing in the economy. It could be all of the above. As discussed previously, the medical products industry is currently undervalued, especially if the predicted decrease in unemployment and improvement in the economy occurs late in 2010.
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Designing better medical products
Mar/22/09 11:35
I am an early adopter of any new technology, not only because I like new gadgets, but because I always expect the newer technology will have improved quality, power, and ease-of-use. Sometimes, I am quite pleased with the results, my iPhone from Apple being one of the better examples. More often than not, I find myself quite disappointed.
Without intending to be an uncritical fan of Apple (you can find those discussions in several other locations on the web), there are real reasons that the iPhone is simply the best cell phone on the market. First, it holds a good sampling of my music collection, eliminating one other device to carry with me. And that music is transferred to my iPhone by simply the most elegant piece of software I’ve ever used: iTunes. I hear people tell me that they can get music on their phones, but it takes work. I have no time to figure out arcane programming steps to get music on some other device. The music simply gets onto my iPhone, I can access it. That’s the ballgame for me.
Second, I have downloaded and installed onto my iPhone dozens of Apps, which are the programs for the iPhone. I have games, access to sports scores real time, business news, stock prices, maps, movies, Kindle books (this is a whole story in itself), and an amazing program that listens to music and identifies it (and it’s free). Using iTunes, I can buy the apps (many are free, but you still have to “purchase” them) at the iTunes store, and upload them to my iPhone. At its essence, iPhone has made my life easier. Read More...
Without intending to be an uncritical fan of Apple (you can find those discussions in several other locations on the web), there are real reasons that the iPhone is simply the best cell phone on the market. First, it holds a good sampling of my music collection, eliminating one other device to carry with me. And that music is transferred to my iPhone by simply the most elegant piece of software I’ve ever used: iTunes. I hear people tell me that they can get music on their phones, but it takes work. I have no time to figure out arcane programming steps to get music on some other device. The music simply gets onto my iPhone, I can access it. That’s the ballgame for me.
Second, I have downloaded and installed onto my iPhone dozens of Apps, which are the programs for the iPhone. I have games, access to sports scores real time, business news, stock prices, maps, movies, Kindle books (this is a whole story in itself), and an amazing program that listens to music and identifies it (and it’s free). Using iTunes, I can buy the apps (many are free, but you still have to “purchase” them) at the iTunes store, and upload them to my iPhone. At its essence, iPhone has made my life easier. Read More...
New FDA Commissioner
Mar/13/09 11:08
On March 11, President Obama appointed Margaret A. Hamburg, MD to be the new FDA Commissioner. She has a substantial educational background including an MD degree from Harvard and training in neuropharmacology. She has had long public service at the U.S. Office of Disease Prevention and Health Promotion, the National Institute of Allergy and Infectious Diseases at NIH, where her work focused on AIDS research, and Health Commissioner for New York City. President Clinton selected her in 1997 to be assistant secretary for policy and evaluation at the U.S. Department of Health and Human Services. Not only does she have a background in healthcare policy, medical research, and the bureaucracy that controls both, she has experience with industry, sitting on the Board of Directors of Henry Schein. Read More...
Successful Marketing Management
Mar/12/09 19:47
I haven’t done an entry in about a week, because I have been focused on a consulting assignment on pricing strategies in a couple of medical device segments. Interestingly, it was for a large investment banking firm. In this down-market, research into medical companies, because they are spending more time analyzing the fundamentals of these corporations.
Part of my assignment was to give a one day training session on how manufactured products get to the market. Trying to condense 20 years of knowledge in this industry down to a six hour Powerpoint presentation (yes, too long, but they didn’t have 20 years to get up to speed) is challenging, but it was critical to their understanding of the medical products market.
I often relate a story about the medical products market whenever I am interviewing someone for a marketing position in this industry which helps define the almost every challenge for product marketing managers in this business. There are over 50,000 medical products companies in the United States (probably more, but it’s hard to obtain exact data). If each one of those companies sent a sales representative into a physician’s office, surgery center or hospital, there would be no time for patients. Since the primary (but hardly exclusive) method for marketing a medical product is through the sales process–new product introductions are especially sales critical. Read More...
Part of my assignment was to give a one day training session on how manufactured products get to the market. Trying to condense 20 years of knowledge in this industry down to a six hour Powerpoint presentation (yes, too long, but they didn’t have 20 years to get up to speed) is challenging, but it was critical to their understanding of the medical products market.
I often relate a story about the medical products market whenever I am interviewing someone for a marketing position in this industry which helps define the almost every challenge for product marketing managers in this business. There are over 50,000 medical products companies in the United States (probably more, but it’s hard to obtain exact data). If each one of those companies sent a sales representative into a physician’s office, surgery center or hospital, there would be no time for patients. Since the primary (but hardly exclusive) method for marketing a medical product is through the sales process–new product introductions are especially sales critical. Read More...
The recession and the medical industry
Feb/23/09 15:12
I have been in numerous positions within the pharmaceutical, biotechnology and medical device industries over the past 20 years. The one paradigm upon which we all relied during those years was very simple: “the medical industry was recession-proof.” In fact, way back in 2008, medical products stocks, including Big Pharma and medical device manufacturers, were considered safe locations to invest during a economic downturns. Industry analysts, executives, and investors believed that people would continue to buy medical services, who would then buy all of the products from table paper to expensive capital equipment.
Current speculation seems to reinforce the old paradigm. A recent article published in Tech Journal South offers up the following optimistic forecasts:
Current speculation seems to reinforce the old paradigm. A recent article published in Tech Journal South offers up the following optimistic forecasts:
- M&A activity will increase significantly.
- Biotech stocks will outperform the rest of the market (which shouldn’t be hard given the continued implosion of stock values)
- Most investors consider biotech undervalued
- Most expect biotech to rebound either this year or next
Ethics and medical sales
Feb/20/09 13:28
While searching for information on another blog entry of mine, I came across a story where a Stryker sales representative in Ohio pled guilty to felony “misbranding of a medical device.” As an executive and manager in the medical device and pharmaceutical markets, my rules were quite explicit to all sales people--do not violate applicable regulations and laws for marketing medical product. Stryker has a similar statement on its website (though I cannot know if they placed it there after the criminal actions, but most ethical companies have the policy in place). Read More...