BesTechBlog

Courtesy of Octane

2011-11-03T13:56:00.000-07:00

Congress Rep. Fred Upton blasts FDA's bureaucracy

2011-09-09T12:00:00.000-07:00

Some quotes from his recent article "A defibrillator for American jobs": Overzealous and burdensome regulations — produced right here at home — also play a role in our stubbornly high unemployment rate and lackluster business growth. And What’s producing these potholes for this critical domestic industry? An inhospitable regulatory environment caused by the Food and Drug Administration is a primary culprit.
I couldn't agree more. Good to see that Congress is taking notice.

Discussion over effectiveness of 510(k) process

2011-08-01T09:39:00.000-07:00

An interesting discussion is shaping up about the future of the 510(k) process. The IOM (Institute of Medicine) recommends to chuck the 510(k) process in favor of something else - even if this something is ill-defined. The FDA vigorously defends its sickly child. AdvaMed is scared about the uncertainty facing the industry. Read this article in Fierce Medical Devices, which has several links to more background information.

The FDA's 510(k) report card

2011-07-20T09:48:00.000-07:00

The FDA admits that the average 510(k) review time has increased (to 140 days!) but blames the industry: "FDA data shows that total review time – the time it takes FDA to review an application and for companies to respond to questions that arise during that review – has increased primarily due to companies taking more time to respond to requests for additional information."; see CDRHReports/ucm263385.htm.
From personal experience I know this to be a half-truth. The reason companies need to take more time is that the FDA requires more information than before, and information that was previously not required. So who is the bad guy here?
In my experience, the FDA is making it more and more difficult for the medical device industry to get devices approved, and they're doing this without being upfront, honest and transparent about it.

Kickbacks - read this article

2011-05-23T10:21:00.000-07:00

Once in awhile I come across questions regarding kickbacks and how/how much can we legally compensate professionals who work with us? MassDevice, a New England medical device periodical, gives some good pointers in this article. Worth reading if you have these sorts of questions!

Labeling and photographs in a 510(k) database?

2011-03-16T09:41:00.000-07:00

The FDA is considering to start a publicly accessible database that will contain labeling (user manuals!) and pictures of 510(k) cleared devices. FDA is organizing a "discussion meeting" on April 7th in their offices in MD. Attendance is free after registration. What is your position on this issue? Let me know!

In development: stretchable electronics

2011-03-09T09:44:00.000-08:00

First time I heard about this: NW University and UofI (both in IL) are developing "stretchable" electronics to be used in catheters. See this interesting article about an application for minimally invasive heart surgery. Before you know it, this technology will invade everyday products and gadgets!

Medical device development: an endangered species?

2011-02-28T09:26:00.000-08:00

An article in the StarTribune (Minneapolis-St. Paul) argues that big device companies are spending too much time adding features to existing product lines and too little time developing new technologies. Add to that the unfavorable investment climate for startup companies, and a bleak future for new products emerges.

Yes, the FDA's failures have been all over the news

2011-02-18T09:57:00.000-08:00

But still, I think it is important to post this article about the impact on the US Medical Device industry.

The US is losing its competitive edge...

2011-01-18T08:41:00.000-08:00

An article in the Startribune, Minneapolis, explains a study by PricewatterhouseCoopers, predicting that in the coming decade the US will lose its competitive edge in medical devices to countries such as China, India and Brazil. Why? We don't invest in our future!

510(k) viewed from Italy

2010-12-16T13:07:00.000-08:00

From Italy comes to us Dr. Maria Donawa, who discusses The Evolving US 510(k) Review Process in a well-wrought, interesting article. The FDA's struggles are followed not only here in the US, but all over the world! I'm just crossing my fingers that the FDA won't succumb to the "runaway bureaucracy" syndrome that is so infectious in government circles. Alas, I'm not optimistic...

FDA's registration and listing: opaque and impossible

2010-11-22T10:10:00.000-08:00

I consider myself an "old hand" at registering medical device companies, but I still manage to get myself in trouble. As you probably know, registration must be done on the FDA's website. Recently I tried to register a US subsidiary of a foreign company, and I could not find a way to enter the foreign company's information! Worse, there used to be (albeit in a difficult-to-find place) an email address where one could contact the FDA and get help, but I could not find that anymore! So much for a "customer friendly" and "transparent" FDA.

FDA venturing into medical device design?

2010-11-15T11:16:00.000-08:00

What's happening? The FDA announced that they are starting an "External defibrillator improvement initiative" to get industry to improve defibrillators. This is a very interesting development and makes me wonder if we're headed towards government-prescribed "innovation". In my mind this is a slippery slope, and I'd love to hear your comments!

Changes to the 510(k) process - California Healthcare Institute

2010-10-27T10:21:00.000-07:00

The California Healthcare Institute has published a white paper titled "Upcoming changes to the 510(k) Process: New Approval Pathways and the impact on Medical Device Development and innovation", available by clicking on the "white paper" link. Interesting reading!

FDA to rescind 510(k) clearance

2010-10-15T08:49:00.000-07:00

The FDA is taking steps to rescind the 510(k) clearance of a knee implant because they made errors in the original clearance process. Now we finally know they really are bureaucrats, even though they present themselves as being "scientific". Apparently procedure takes precedence over science. This device has so far been used in over 300 cases over a period of 10 years without any complaints. Read this article in the WSJ and don't forget to go to the Comments tab.

OCTANe's Medical Device & Investor Forum

2010-10-14T10:35:00.000-07:00

The annual MDIF will be held this year on 25-26 October in Newport Beach, CA. For more information about the Forum, go to MDIF. Find out who will attend.

FDA's 510(k) process changes: group in Congress is pushing back

2010-10-14T10:16:00.000-07:00

A group of 12 lawmakers from the House of Representatives asked the FDA to delay implementation of five proposed changes to the 510(k) process until the FDA provides more details. They did so in a letter to Dr. Hamburg. See the FDA Law blog for more details.

Small gets smaller and smaller...

2010-10-01T09:57:00.000-07:00

When I went to college, integrated circuits were "small" and decreasing in size rapidly. Nowadays nanotechnologies work with structures only a few tens of nanometers in size, and researchers turn these into baffling technologies! The latest is depositing fluorescent dyes inside living cells! Even if it's way out of your everyday interest, read this article about Quantum dots.

Is vacation a "right" or a "bonus"?

2010-09-29T11:24:00.000-07:00

For Germans (Europeans in general) it's the first, for Americans the second. Read this interesting article about productivity in Germany and the US. As a Dutchman, I can attest that it's true!

Keeping tabs on FDA's performance

2010-09-23T09:53:00.000-07:00

Fortunately, the FDA does that for us, and all we need to do is to access the right webpages to find the information. This is how the FDA describes the program: "FDA-TRACK is a new agency-wide program performance management system that monitors over 100 FDA program offices through key performance measures. These measures are developed by the program offices across the FDA and reported on a monthly basis. Each quarter, monthly performance data is analyzed and senior managers present this data to FDA senior leadership." The FDA Track page can be found at the FDA website. Since I am interested in medical devices, I also look at the CDRH Premarket Dashboard.

FDA gets an F for failure to keep its MDUFMA promises

2010-09-21T11:34:00.000-07:00

Devicemakers: FDA's Performance Not Meeting MDUFMA Commitment
Even though devicemakers are picking up a growing portion of the tab, the FDA is not holding up its end of the bargain — to be interactive, predictable and timely — that it made under the Medical Device User Fee and Modernization Act (MDUFMA). "We're seeing more and more examples where that interactive collaboration ... may be falling short," Mark Leahey, president of the Medical Device Manufacturers Association, said at a MDUFMA reauthorization meeting last week. "As it currently stands right now, I think our members would be hard pressed to support the continuation of this program."
Devices & Diagnostics Letter

Obesity - how about eating less?

2010-09-09T12:23:00.000-07:00

Yes I admit, I'm neither obese nor overweight. But I don't understand why someone who is overweight can't simply eat less? About a decade ago I decided that I needed to lose ten pounds, so I adjusted my diet, lost the ten pounds, and kept them off.

Now sources in the UK are proposing more weight loss surgeries to contain the cost of caring for obese people - is it just me, or is something upside-down here?

Off-label usage

2010-09-09T12:15:00.000-07:00

Off-label usage (of drugs and devices) has long been a hot topic. Companies are forbidden to market off-label uses of their products, and Allergan launched a lawsuit to object to that regulation. Unfortunately, they've dropped that lawsuit, see the excerpt below.

Allergan Drops Suit Challenging FDA’s Off-Label Enforcement
The device industry may have lost its best shot at challenging how the FDA regulates off-label use when Allergan agreed to drop its First Amendment lawsuit seeking the right to tell physicians how to safely use a product off label. The company dropped the suit against the FDA last week as part of a $600 million settlement with the Justice Department over its promotion of Botox for off-label uses. Had Allergan successfully pursued the case, device companies would be able to discuss off-label uses as long as they did so honestly and had safety and efficacy data to support the uses, James Beck, an attorney at Dechert, said.
Devices and Diagnostics Letter

We're from the government, we are here to help you...

2010-09-08T09:41:00.001-07:00

CDRH Touts Proposed 510(k) Changes as Good News for Device Industry
CDRH is trying to sell devicemakers on suggested changes to the 510(k) process, saying the changes would increase regulatory predictability. “It is not our intent to turn the world upside down for device manufacturers,” Christy Foreman, acting director of CDRH’s Office of Device Evaluation, said during an agency webinar last week. CDRH officials promoted the upsides of a Class IIb process for 510(k) devices that are more likely to require additional clinical information, touting it as a step toward global harmonization. Having such harmonization could lead to devices being simultaneously cleared domestically and abroad, CDRH Director Jeffrey Shuren said.
Devices & Diagnostics Letter

Heather Rosecrans to retire later this month

2010-09-06T22:26:00.000-07:00

Director of 510(k) Office Will Retire This Month
A major player in CDRH’s 510(k) process is stepping down just as the agency begins to revamp the device clearance program. Heather Rosecrans, director of CDRH’s 510(k) Office of Device Evaluation, is retiring Sept. 15, FDA spokesman Dick Thompson said. Her departure could be another example of the ongoing turnover at CDRH, John Romans, CEO of BioMedix Vascular Solutions, said, adding that the turnover has resulted in a loss of institutional memory, contributing to the lack of predictability in the clearance process.
Devices & Diagnostics Letter

Hmm, I don't know. I know Ms Rosecrans and she always was rather bureaucratic and inflexible in her dealings with me. Maybe a change would be for the better?

Do you understand this logic?

2010-09-06T22:20:00.000-07:00

Unfortunately I don't subscribe to Devices & Diagnostics Letter, but the excerpt below doesn't make sense! I agree that the current 510(k) process is arbitrary and opaque, but surely that will hurt foreign firms more than US firms, I'd think. What is your opinion?

Lawmakers: Better 510(k) Process Key to Keeping Device Jobs in US
Trying to keep devicemakers, and the jobs they provide, in the U.S., lawmakers are urging the FDA to be more transparent and predictable in its review of 510(k)s. Delays in review times and the agency’s unpredictability in reviewing 510(k)s are hurting U.S. devicemakers trying to compete in the global market, as more countries, including China, require devices to be approved in their home country before granting them marketing authorization. As a result, some devicemakers have moved their headquarters to the EU where they can get more timely marketing approval, Sen. Amy Klobuchar (D-Minn.) said.
Devices & Diagnostics Letter

Cooling therapy for heart attack patients

2010-08-30T10:06:00.000-07:00

I came across a very interesting article in The Vancouver Sun about cooling the body of heart attack victims to increase their chance of survival.

Batteries

2010-08-23T10:34:00.000-07:00

Li-ion batteries have a much higher energy density than most other types of batteries. In addition, their operating temperature range is larger. But now the requirements for these batteries are even notched up higher; see this article in Electronic Design.

More about tubes misconnections

2010-08-23T09:57:00.000-07:00

A week ago I blogged about Luer locks misconnections, and today there was an article in the New York Times about this issue. The author of this article blames the FDA for allowing these situations to continue to exists. International efforts are hindered by politics and probably a lack of focus and/or funding. Oh well...

Al Franken gets involved in the 510(k) process

2010-08-23T09:36:00.000-07:00

Al Franken, the senator from MN, is talking with industry and FDA about the proposed changes to the 510(k) process, see The Hill/Healthwatch blog.

The FDA's 510(k) process, used to clear medical devices for sale in the US, is no longer suited to the sheer volume of new ideas and new technologies developed to help the medical community to diagnose and treat diseases. In one word, the process is broken. However, fixing it is extremely difficult: on one hand it should not become so cumbersome that innovative small and startup companies cannot afford to develop new products; on the other hand the process needs to be robust enough to protect the public's health. I am glad that politicians weigh in and hopefully provide viewpoints that may balance the discussions. But I also think that nobody will "get it right" because there is no one right answer that covers all situations adequately.

Luer lock misconnections

2010-08-13T09:48:00.000-07:00

Luer locks connect medical tubes such as IV tubes and enteral feeding tubes. Sometimes incompatible tubing sets get inadvertently connected, resulting in patient injury or death.

I thought these problems were solved a long time ago, but the FDA does not seem to think so! The FDA has sent a letter to stakeholders to warn them and to ask industry to make these Luer locks incompatible for systems that should not be interconnected.

Colonoscopy made easy

2010-08-05T09:37:00.000-07:00

If you've ever had a colonoscopy, you'll know that these procedures are inconvenient and sometimes painful. So you'll be happy to know that the FDA has cleared a virtual colonoscope based on CT techniques, made by iCAD in NH. This technology uses CT to find polyps 6mm in size or larger.

Topsy-turvy: Irish investment in the US.

2010-08-05T09:29:00.000-07:00

An Northern-Irish company invests in the US by opening a plant in West Virginia - see this article in the BBC News. Yes, I know Northern Ireland is not the same as the Republic of Ireland, but still one wonders about the timing!

Venture funding up 52% - is there relief in sight for startup companies?

2010-07-26T09:16:00.000-07:00

Venture capital investments in the life sciences industry increased by 52% during the second quarter of 2010 compared with the year-prior quarter, with $2.1 billion going toward 234 deals related to biotech and medical devices, according to the MoneyTree report by the National Venture Capital Association and PricewaterhouseCoopers. See this article.

Higher standards for device approval?

2010-07-21T16:24:00.000-07:00

Group Calls for Higher Standards for Device Clearances, Approvals
The FDA is being pressured from within to adopt device approval standards similar to those used for drugs. Claiming that weaknesses in the agency’s device approval and clearance process have allowed potentially ineffective devices on the market, a recently published article co-authored by Peter Lurie, a senior adviser in the FDA’s Office of Compliance, asks Congress to raise the approval standards for devices to more closely match those required for drugs. Lurie wrote the article as deputy director of Public Citizen’s Health Research Group before FDA Commissioner Margaret Hamburg hired him last year.
Devices & Diagnostics Letter

Get ready for a slower and more demanding FDA

2010-03-25T08:59:00.000-07:00

The FDA has been under fire lately for failures of their oversight processes, and the result is predictable. They're digging in, making the industry pay by demanding more data, more money, and more time. The LA Times has an interesting article about the latest trends.

About OTC (Over The Counter) labeling

2010-03-20T14:09:00.000-07:00

An interesting article about OTC labeling argues that shorter labels increase comprehension and reduce resistance to a product. So, if you need to create an OTC label: short is sweet!

Changes to 510(k) process coming

2010-02-02T10:36:00.000-08:00

The new CDRH Director, Jeffrey Shuren, has announced major changes to the 510(k) process by the end of the FDA's fiscal year, September 30th. However, he has given no indications of what those changes might be; apparently there will be a public meeting later this month, and the changes are not definite yet. If you are interested in the current 510(k) process, check out the FDA's "simplified" essay and enjoy!

No-Questions-Asked 510(k) OTC-clearance received for Abdominal Toner

2010-02-02T10:01:00.000-08:00

One of BesTech's clients, Global Marketing Partners, received OTC-clearance for their abdominal muscle toner. The FDA had no questions or concerns about the 510(k) submission, which reflects very well on the client! They have been very cooperative, made changes to the product at BesTech's request to improve the chance of clearance, and provided all the documentation promptly. Thank you!

510(k) for the Vital Sleep anti-snoring device

2010-01-14T09:46:00.000-08:00

The FDA has recently cleared the Vital Sleep anti-snoring device, manufactured by The Snore Reliever Company from Bronx, NY. BesTech wrote and submitted the application. The process took 109 (calendar) days from submission.

Medical errors tending to our young

2010-01-07T08:30:00.000-08:00

Sometimes oral medications are administered using parenteral syringes, but these may be accidentally connected to an IV line, even though there are systems to prevent that. The Institute for Safe Medication Practices, in an article about this subject, again warns against the practice of using parenteral syringes instead of oral syringes.

MDR's must be filed for adverse events overseas!

2010-01-05T08:34:00.000-08:00

The FDA called a device "misbranded" in a warning letter to an Italian company because the company failed to file MDR's for adverse events that occurred in Europe. The device is also marketed in the US. The company took the position that non-US adverse events would be exempt from MDR reporting, and the FDA took exception to that, saying "The MDR regulation applies to foreign manufacturers whose devices are in commercial distribution in the US. An adverse event that occurs overseas is reportable under the MDR regulation if the device is one that has been cleared for marketing in the US".
Just so you know!

How dense can one get?

2009-12-30T10:52:00.000-08:00

The FDA is warning that scammers impersonate FDA "special agents", see their web entry. Apparently people who have bought drugs over the Internet are threatened and told to wire a "fine" to some offshore bank account. I hope none of my blog readers fall for that! Remember, no matter what, only an US Judge can impose fines, payable to the US Treasury!

FDA opens office in Mexico City

2009-12-15T09:57:00.000-08:00

The FDA has opened an office in Mexico City to help enforce its regulations for food- and medical device safety. "FDA experts in Mexico City will work closely with local industries that ship food and medical products to the United States to improve their understanding of U.S. safety and product quality expectations", said Murray M. Lumpkin, M.D., U.S. FDA Deputy Commissioner for International Programs. See the Press Release.

Changes to the 510(k) process

2009-12-14T11:00:00.000-08:00

In light of recent developments, such as allegations of improper 510(k) clearances instigated by FDA officials, and the removal of Dr. Schultz as head of CDRH, many people expected the FDA to change the 510(k) process drastically. But this may be further off than you think, according to Dr. Jeffrey Shuren acting CDRH director, in an article in the Startribune.

FDA watches your website!

2009-12-02T08:28:00.000-08:00

Recent warning letters declared products "adulterated" (that's not good!) because of unauthorized claims on the manufacturer's website. In particular, you are not allowed to advertise your product for uses that are not covered by the 510(k) clearance or the PMA. For instance, an powered muscle stimulator that was cleared for pain management and massaging may not be advertised for muscle toning or something similar, even though you could possibly get 510(k) clearance for that intended use also. Forewarned is forearmed: be very careful not to go overboard with your website claims because the FDA is watching!

Remote patient monitoring

2009-11-24T08:50:00.000-08:00

In the UK remote patient monitoring seems to work - see this article in Medical DeviceLink. Are there any comparable experiences in the US? Let me know, please!

Advertising of medical devices

2009-11-23T09:32:00.000-08:00

More and more frequently I see reports about the FDA cracking down on off-label advertising, mostly of drugs but also of devices. These are advertisements that recommend the product for use(s) that are not FDA cleared or approved. And you know what – those ads are illegal! Many times advertising executives do not fully understand the regulations and step over the line. The FDA has, in 2004, published a (draft) guidance for "Consumer-Directed Broadcast Advertising of Restricted Devices". This document makes excellent reading on a rainy afternoon, and it contains recommendations from the FDA about what should be in those ads (and what shouldn't). These recommendations contain elements that are also applicable to written advertisements. Note that ads on your webpage are regarded as "broadcast advertising"!

Stents to treat Erectile Dysfunction

2009-11-18T12:27:00.000-08:00

Medtronic is studying the effectiveness of drug-eluting stents for treatment of ED. Read this Medical Device Daily article.

"Fixes" to come to CDRH?

2009-11-17T09:15:00.000-08:00

The FDA Commissioner has pledged to fix the CDRH, in particular the 510(k) process. Read all about it: Medical Device Link

FDA and documentation requirements

2009-11-12T09:20:00.000-08:00

The article below is from FDAnews; unfortunately the complete article is subscription-only. But the summary is clear enough, I think.

Expert: Document Production Essential Part of Inspections
FDA investigators are cracking down on devicemakers that are not able to produce documents during inspections, Elizabeth Troll, a 25-year veteran of the industry, said at a recent FDAnews webinar. The opportunity to get a second chance to correct observations from inspections is more limited now, she said, because investigators have been clear in their expectations.
The GMP Letter

Want to sell you products in Europe? Changes are on the horizon...

2009-11-12T09:10:00.000-08:00

The European MDD that governs CE-marking is getting an update. The Emergo Group has written an newsletter detailing some of those changes and what they may mean to you. Enjoy!

FDA and social media

2009-11-09T10:30:00.000-08:00

The FDA is announcing a public hearing to discuss issues related to the promotion of FDA- regulated medical products (including prescription drugs for humans and animals, prescription biologics, and medical devices) using the Internet and social media tools. Read all about it in the Federal Register. I wonder how that's going to change our lives... more controls?

Medical Device Guru Group

2009-11-03T21:20:00.000-08:00

I'm a member of the Medical Device Guru group on LinkedIn, but I never knew that this group has its own website! Check it out if you're interested at http://www.medicaldeviceguru.com

Misconnections between IV's and enteral feeding tubes

2009-11-03T12:41:00.000-08:00

A small step by an infusion pump manufacturing might reduce the danger of misconnections. See this Morningstar article.

New FDA import computer system.

2009-10-30T10:32:00.000-07:00

The FDA will this fiscal year implement a new computer system for importing of FDA-regulated goods, including medical devices. The system is called PREDICT and relies heavily on the completeness and accuracy of the data provided by the importer. For instance, the foreign manufacturer and the foreign exporter must be known to the FDA through their registration numbers. Of course, so must the importer and the device. Read the FDA's presentation PREDICT.pdf.

Tax incentives in Canada

2009-10-29T09:52:00.000-07:00

I recently attended a seminar by Canadian government representatives detailing tax incentives given to companies who are willing to invest in Canada. These incentives are substantial (but too complex to repeat here). A new medical device company is apparently "hooked" as read in The Chronicle Journal.

CDRH's document developments

2009-10-29T09:44:00.000-07:00

CDRH has published a list of documents that they will be developing this (fiscal) year. Typically, these documents will be open for public comment before they're finalized, so if you are interested, check it out!

How about some good news?

2009-10-29T09:36:00.000-07:00

Angels are investing in more companies this year, with health care/medical devices receiving 28% of total investments, according to the Pittsburgh Business Times. Congrats!

"Device Tax"

2009-10-29T08:35:00.000-07:00

I must admit that I have not followed the details of the "medical device tax" in the various proposals for healthcare reform. Medical Device Link posted this article about a new proposal to halve that tax. How is this going to work out? One thing seems to be certain: the industry will have to pay more for what exactly??? Ever since the FDA got the first MDUFMA approved (instituting fees for services we don't want but are mandated by law) the idea of industry sectors to pay for oversight seems to gain more and more traction. As long as the US controls the biggest medical device market in the world, that'll work, but has nobody noticed how much that position is eroding?

Warning letters for lack of MDR procedures

2009-10-28T13:47:00.000-07:00

The FDA wrote warning letters to 16 laser eye centers (probably all under the same ownership) throughout the country for the lack of written MDR procedures. The MDR procedures are part of 21CFR803, whereas the Quality System Regulation (QSR) is codified in 21CFR820; that might be a reason that the MDR procedures are often overlooked. In my experience, the FDA is now actively checking for those procedures, but a few years ago they were not that keen. So make sure that you have these MDR procedures!

Neither pretty nor pink: musings on cancer

2009-10-28T13:15:00.000-07:00

I want to share this article with you, not because it has anything to do with BesTech (or Regulatory Affairs) but because the author has an interesting take on how our society treats "cancer" in general. I picked it up from Medical Device Daily Perspectives, and couldn't find a link to the article so I just copied and pasted the whole thing.

Neither pretty nor pink: musings on cancer
By ROXANNA GUILFORD-BLAKE
Medical Device Daily Contributing Writer
This is not the column I had planned. But I've had reason to think a lot about cancer lately. The older I get, the more friends I have who are coping with it.
But while the reality of cancer reminds me of how devastating it can be, the marketing of breast cancer suggests it's a mere inconvenience – and a sweetly empowering one at that.
Perhaps because it's Breast Cancer Awareness Month, I'm encountering all sorts of efforts to make breast cancer pretty or noble or sexy. It isn't. Breast cancer has killed one friend and inflicted misery on several others.
Attempts to "perkify" breast cancer with pink ribbons, pink tops on yogurt, pink magnetic ribbons, pink ad nauseam can distract us from this: Cancer is an ugly, insidious disease.
In the interest of full disclosure, many of my breast-cancer survivor friends do wear the ribbons. And they have every right to do so – and if they asked me to, I'd don one. But breast cancer has become a marketing tool. Everyone wants a piece of the action, and breast cancer moves merchandise. (I don't even have time to address the latest trend – sex appeal. Newsweek blogger Kate Dailey asks "Sexy Breast–Cancer Ads: Provocative or Patronizing?" My answer: Yes – and hell, yes.)
I'm not the first curmudgeon to be pinked off at the whole thing. Barbara Ehrenreich tackled this almost a decade ago, after her own battle with breast cancer. Her essay "Welcome to Cancerland" excoriates all things pink and perky. She writes: "In the harshest judgment, the breast-cancer cult serves as an accomplice in global poisoning – normalizing cancer, prettying it up, even presenting it, perversely, as a positive and enviable experience."
Declawing cancer
I can't help thinking Ehrenreich is right. We may be raising awareness – and even money – but we're also declawing cancer. Especially breast cancer.
I don't object to cause marketing. It can raise awareness of all sorts of issues. And I suppose if you're going to buy yogurt, choosing the one with pink top does some tiny bit of good – you're tossing a few pennies toward research. (Just keep in mind that, regardless of what you buy, most companies have a cap on what they will contribute. The Breast Cancer Action's "Think Before You Pink" campaign offers questions to ask before buying pink.)
Of course, making a big, warm-and-fuzzy deal over breast cancer does raise awareness, which promotes increased screening, which decreases the mortality rates, right?
Maybe.
Maybe not.
New – controversial – questions are emerging about screening for breast (and prostate) cancer. In summarizing a JAMA commentary, New York Times' Gina Kolata suggests researchers noted that early detection of cancers thought incurable should lead to a decline in late–stage incidence. That's true, she says, for colon and cervical cancers – but not for cancers of the breast and prostate cancer.
Pink and green
What is true is that raising awareness raises money for research and treatment.
This is the tricky part: I do not begrudge breast cancer one cent of its funding or one second of its coverage. And pitting one disease against another is a nasty, no-win business. But breast cancer does receive a disproportionate amount of attention. Perhaps rather than shining a spotlight on one or two cancers, we need to flood the entire stage with light?
Look at how we treat lung cancer: According to Lung Cancer Alliancedata, it kills more people than all the other major cancers combined. This year, it's expected to kill nearly twice as many women as breast cancer. But it only receives a fraction of the funding. (Some of that is due to the "they brought it on themselves" mentality. But more than 60% of new lung cancer patients are former smokers – or people who never smoked at all. In fact, 20% of women being diagnosed now with lung cancer have never smoked.)
Esophageal and pancreatic cancers also have high mortality rates and limited funding. In May, CBS reported that cancers receiving the most funding are seeing the steepest declines. And – perhaps not coincidentally – some of the fastest growing cancers are those with little publicity or funding.
Breast cancer has a high survival rate. That makes it an attractive investment and provides a strong cadre of advocates. Low survival rates for pancreatic and lung cancer mean there aren't lot of folks left to do the lobbying.
Not a popularity contest
I realize my position is unrealistic: Don't take money from breast cancer; just provide adequate funding for all those other cancers. So be it. I am deeply uncomfortable with the notion that somehow, breast cancer is more palatable – and fundable – because it's prettily packaged.
I do want to "save the ta-tas," as one campaign so elegantly puts it. But I'm far more interested in saving lives, regardless of the cancer type. I want to see technology advance to the point where cancer is merely an inconvenience. Sweet or otherwise.

Preemption: a blessing or a curse?

2009-10-27T18:07:00.000-07:00

A Minnesota judge dismissed a lawsuit against Medtronic over defective defribillator leads because the FDA had approved the leads. The argument is, that if the FDA approves a product, it's approved under Federal law, which would preempt State law. See this article in Mass Device for details.

What is your opinion, is this kind of ruling "good" or "bad"? Obviously, the families of the over 100 patients who died as a result of the bad leads won't be overly joyed. On the other hand, medical device companies now find an (unlikely) ally in the FDA: if a product has inherent defects but is approved anyway, the company goes scott-free. I think there is something wrong with this picture, although I admit that sometimes it is difficult for a company to test a product exhaustively enough to prevent all failures. But then, I've been around long enough to know that companies have a tendency to stick their head in the sand with product "issues" that might affect the bottom line.

Follow your SOP's!

2009-10-26T10:18:00.000-07:00

Every week some unfortunate company in the US receives a warning letter from the FDA for not having or not following procedures. Today I picked up this report, which is all too common. The lesson: have procedures, follow them!!

Warning: Devicemaker Can't Prove It Reviewed Sterility Results
Connecticut-based devicemaker Gaven Medical has received an FDA warning letter for manufacturing violations related to its Punctur-Guard winged sets for blood collection. The FDA maintains there is no documentation showing the company reviewed sterility results for one lot of the device prior to its distribution, according to the June 26 letter recently posted to its website. The letter stems from an inspection conducted April 27 through May 8.
The GMP Letter

Want to live "forever"?

2009-10-23T08:28:00.000-07:00

I found this interesting article on Medical Device Link about research into regenerative therapies that may help people to regenerate body parts that are damaged or worn out. Do you think that'll be applicable to the human brain also?? And if one were able to regenerate one's brain, would that change one's personality?

FDA's "reduction of paperwork"...

2009-10-23T08:18:00.000-07:00

I can't help but being skeptical when the FDA announces another initiative to reduce paperwork. This time it's about collection of information from third party QSR inspectors; see http://edocket.access.gpo.gov/2009/E9-25395.htm. The weird part of these "initiatives" is that they are always accompanied by a mountain of paperwork...

Isn't there another way to curb bureaucracy's appetite for red tape? Please, politicians, step up to the plate and help society to be more effective and less wasteful. We're strangling our own industries by adding more and more rules but forgetting to delete old ones and streamlining processes that are based on 50- or 100-year-old business models.

More power cord failure details

2009-10-20T06:39:00.000-07:00

The FDA has already published a detailed report on the power cord failure reported yesterday. You can find the report here.

Power cords are sparking unrest

2009-10-19T15:10:00.000-07:00

It seemed surreal to me that something as banal as power cords would cause the FDA to issue a warning, but here it is! Some power cords used with medical devices seem to be unsafe, and the FDA has issued a warning on their website. Happy reading!

GMP for Combination Products

2009-10-16T12:38:00.000-07:00

QMN Weekly Bulletin wrote:

Proposed Rule for Combo Products Offers Streamlined GMP Option
Makers of components in co-packaged or single-entity combination products would have two options for showing compliance with quality system requirements for devices and cGMPs for drugs or biologics under a new proposed rule.

For co-packaged or single-entity combination products, the rule proposes that companies demonstrate compliance with all cGMP regulations for each part of the product. Alternatively, companies could develop written procedures for a "streamlined system," which could show compliance with the regulations for either devices or drugs plus certain provisions of the rules for the other component.

"What will be critical for industry to do is to document their revised manufacturing procedures to assure they are fulfilling the supplementary requirements and be able to provide objective evidence of compliance," Steven Niedelman, senior consultant with Crowell & Moring, said. Comments are due by Dec. 22.
The GMP Letter

Small business scams in California

2009-10-14T08:48:00.000-07:00

Have you received (a) letter(s) about LLC's and S-Corps needing to file various reports with the State? If so, you're not alone. There are scams out there offering to file these reports for you at an outrageous cost. Read Jan Norman's article about this issue at scams.

Design Control

2009-10-13T21:28:00.000-07:00

The attached article by Master Control (a manufacturer of medical device quality control software) is a good reference for companies that design medical devices. In particular, if your quality system is weak, you may want to read this. Keep in mind that quality control procedures are not "computer dependent" in the sense that you need a computer software system to comply with the FDA's requirements. In fact, BesTech offers a comprehensive FDA-compliant quality control system that includes design control. This system is paper-based, keeping the cost low. Read Quality By Design and also check out BesTech's download page for additional information on Design Control.

FDA Warning letters

2009-10-12T12:02:00.000-07:00

One of my client's distributors recently got a warning letter from the FDA for illegal claims on his websites. If you advertise your medical device for intended uses that are not included in your 510(k) clearance, your device is "adulterated". The FDA has an array of sanctions available that they can impose, from just "clean up your act" to "recall all products". Things get worse, of course, if your device causes unsafe situations or patient injuries. The FDA is very active researching websites and advertising materials for exaggerated claims, but many of these FDA investigations result from competitors or unhappy customers complaining. So be careful!

OCRA's new website

2009-10-11T06:45:00.000-07:00

OCRA, the Orange County Regulatory Affairs Discussion Group, has recently revamped its website. This organization is more than a "Discussion Group": there are now 716 members! OCRA organizes many meetings throughout the year, with a joint FDA-OCRA meeting usually scheduled for June. Check out the OCRA website

FY 2010 registration with the FDA

2009-10-10T15:52:00.000-07:00

Yes, it's that time again, and you probably know all about it already: between now and the end of the year, all medical device companies must renew their registration. Not only that, but also pay the new and increased fee of $2,004. The FDA has completely overhauled its website, and it looks different but has not improved. Most of the bookmarks you have collected over the years don't work anymore. Compatibility with any other browser but Internet Explorer for Windows is non-existing. Our taxdollars hard at work!

The FDA found it necessary to publish a 12-page guidance of how to register your company - not a moment too soon, seeing how complex that process has become! Check it out at FDA's website.

Enjoy!