Recent draft polices from the FDA’s Center for Devices and Radiological Health (CDRH) have created concern by industry members that they have been left out of the “network of experts,” a program to supplement the FDA’s existing expertise and to expedite the review process. Despite the fact that the FDA has more than 800 scientists, engineers and clinicians, the agency believes that it is impractical to expect CDRH staff to keep current with so many new and complex technologies surfacing.
The network of experts is designed to be a resource for CDRH, particularly to address questions on emerging and unfamiliar technologies. The outside organizations that are being considered by CDRH for inclusion in the network “…will include professional scientific and medical organizations and academic institutions.” Even though we have not yet heard what organizations the FDA will use in a pilot program to assess their new process, a number of organizations are interested in participating in the program. Industry also would like a seat at the table.
AdvaMed voiced concerns in a written response to the draft policies. The trade organization raised the following issues:
- How will confidential information such as intellectual property and trade secrets be kept confidential? What mechanisms will the FDA deploy to maintain confidentiality?
- When reaching out to experts in a particular area, it is very likely those individuals have been involved in the development and design of a similar device, especially if the technology is new. This brings up the potential for conflict of interest. AdvaMed makes the point that conflict of interest is a concern in industry as it is in academia and that a process for excluding any potential conflicts should be implemented prior to the exchange of information. The organization also points out that academic institutions are often involved in industry-sponsored programs and may have ties that could create a conflict.
- The FDA needs to create a balanced and diverse selection of experts to avoid bias. All stakeholders, including industry, should be allowed to nominate organizations and nominees should include industry scientists. It is preferable that the FDA not select from a pool of experts who are regularly called upon to consult since this may not allow for an objective assessment of a novel device.
- Efficiency and timeliness: There is skepticism that the FDA could provide a rapid turnaround (i.e., two weeks) when engaging the network of experts on a particular topic. Large institutions are not known for making decisions in a rapid and efficient manner.
As life science consultants who represent many companies within the device industry, we are closely monitoring the FDA’s draft policies. It will be interesting to see who will be a part of the network of experts and how they will provide their expertise. We wonder, will CDRH be able to comply with its own rule of conduct for transparency while at the same time maintaining confidential and proprietary information at the review level?
Who do you think should be part of the network of experts? What should the vetting process be? Is there even a need for a network of experts? Please share your thoughts with us here or email me directly at doherty@popperandco.com.
Tags: AdvaMed, cdrh, Center for Devices and Radiological Health, FDA, FDA review process, medical devices, network of experts
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Recently journalists at WSJ and Xconomy interviewed John Lechleiter, Chairman, President & CEO, of Eli Lilly and Company. When I sat down to read Mr. Lechleiter’s interviews, I was prepared to get up from my desk several times to find something more interesting to do thinking the articles were to be somewhat mind-numbing. My expectations were not based on any preconceived notions about Mr. Lechleiter, but rather that I assumed the focus of the interviews would be lamenting the pharmaceutical industry’s problems. Instead I was encouraged by Lechleiter’s dedication and optimism.
It is increasingly easy to criticize big pharma: Fewer truly “new” drugs are developed. It is difficult to understand the economics behind the high costs of certain drugs. After being approved, some drugs go on to be proven ineffective or, sometimes, potentially dangerous.
Yet, while the big pharma industry appears to be lagging in productivity, underperforming from a stock price perspective and reeling from other negative indicators, Mr. Lechleiter remains realistic and – at the same time – confident.
The basis for his confidence? While Xconomy’s Luke Timmerman reported that Mr. Lechleiter stated, “… new medicines just don’t grow on trees,” Lechleiter goes on to say that he places his bet for future R&D successes on research efforts largely driven through Lilly’s own internal investment strategy. He adds to that Lilly’s strategy of working with partners around the world, which has allowed for a greater knowledge base. He also cites that advances in technology in the areas of ‘omics’ and IT have created better and faster tools to exploit pathways and to develop drugs. The underlying cause of disease is being scrutinized, which may lead to multiple drug targets. The time spent in pre-clinical and clinical development may be reduced significantly due to innovative technologies, which may then help move targeted therapies to market.
While leading to cautious optimism, these developments may have a synergistic effect for a positive re-design of the pharmaceutical industry. There is hope that the FDA is also seeing that the lights have been turned on and we are living in a new era of real and exciting changes in how drugs will be developed.
Do you share Lechleiter’s cautious optimism? What is your take on the future of big pharma R&D and its partnering efforts with biotechs? Is there one technology that you hang your hat on to truly revolutionize drug development? Please share your thoughts with us below.
Tags: big pharma, clinical development, drug development, drug targeting, Eli Lilly and Company, FDA, John Lechleiter, pharmaceutical companies, Pharmaceuticals
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TEDMED, that health-focused meeting of the minds, is underway in San Diego, and I wanted to share some impressions of the ideas proposed at the conference. This week, there are a lot of very interesting exhibits, thoughtful presentations, and a bright, energetic audience here. And if there was a central theme to this year’s TEDMED, I’d say it was “redefinition;” rephrasing our questions to reflect what we’ve learned about how the natural, social, and physical worlds actually work. I’d like you to chime in; share your thoughts with me on these ideas, or any others!
Here are some of my initial takeaways:
- Dr. David Agus of USC observed that the power of sophisticated diagnostics is needed to produce truly targeted personalized medicine, but wonders if we need to not only redefine diseases such as cancer, but also to find different, more useful definitions of health. In other words, should we focus on defining health, or instead focus on what is meant by disease?
- Ger Brophy of General Electric Healthcare focused on the theme of cancer on a personal basis, rather than on the geography of where the cancer is. As we’ve discussed via this blog, cancer’s traditional definitions based on anatomical location are not keeping up with what we know about the disease – and its many forms – today.
- Juan Enriquez, CEO of Excel Medical Ventures, proposed redefining the U.S. FDA’s role into an entity that facilitates bringing products to market, rather than keeping products from market. That may sound like a stereotypical response to shed all regulations and regulators, but it’s not. Our current FDA is charged with evaluating the risks that are associated with bringing a product to market. But it doesn’t measure what risks are associated with not having a particular product available on the market.
- Eythor Bender proposed a redefinition of paraplegic, using his company’s exoskeleton or “wearable robot” to allow paralysis patients to walk and use their limbs.
An exciting start. And I look forward to reporting more in the days ahead. Please share your thoughts on these ideas, or even what you think TEDMED should be talking about! We look forward to hearing from you.
Tags: cancer, diagnostics, FDA, health conference, health-focused conference, medical conference, personalized medicine, TEDMED, TEDMED 2011
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The U.S. Food & Drug Administration (FDA) likes to trot out the statistic that claims it regulates about $100 billion in biomedical R&D each year: investments made by industry (and government) to create new innovations to treat today’s health challenges. But the agency has been hesitant to address another facet of investments: that they should be predictable. As the late, great economist Paul Samuelson said, “Investments should be like watching paint dry. If you want excitement, take $800 and go to Las Vegas.”
Anybody who’s watched the stock market the last few years knows we would rather live without this kind of excitement. However, the latest documents issued by the FDA – from Research Use Only/Investigational Use Only (RUO/IUO) guidance to LDT to the latest strategy document on boosting innovation (read coverage from Xconomy) – are inconsistent enough to make drug development resemble a Roulette wheel, rather than a science-based, multi-year, multibillion-dollar strategy to develop therapeutics and diagnostics. Even venture capitalists, not known for their risk-averseness, have gone to Congress to demand more predictable responses from the FDA.
Could the FDA be showing signs—finally—that it is aware it needs to change its stripes? In its recent “Driving Medical Innovation” strategy document, the agency outlines a number of steps to streamline clinical trials for critical treatments, encourage more external input in policy-making, review policies and regulations for unnecessary obstacles, and train its staff to keep up on fast-breaking innovations in biotechnology. All of these are good things—we especially like the new small business liaison program and fellowships for young entrepreneurs. And the tentative list of Entrepreneurs in Residence looks impressive.
Like all of us who work in life science, the FDA faces many challenges, not the least of which is keeping up on new technology. While the agency has always acknowledged its dual roles as regulator and facilitator of innovative products, it now appears to be taking some realistic steps to embrace its latter role. If the reforms result in a more predictable, faster regulatory process, while maintaining safety obligations, then biopharmaceutical companies, investors, patients, health care providers and the U.S. economy can all win. Without the gambling.
What do you think of these FDA reforms? Will recent actions help create a clearer pathway for therapeutics innovation? Is there a broader opportunity for post-market surveillance, especially in assessing diagnostics? We look forward to learning your thoughts.
Tags: assessing diagnostics, biopharmaceuticals, biotechnology, FDA, FDA reforms, therapeutics
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A recent article posted by Luke Timmerman of Xconomy.com paints a bleak picture for the state of biotech investment. He explains that the general public no longer views biotech as worthy of the almighty buzz factor, i.e., the magazine cover stories and TV morning shows so important to the elusive independent investor. He suggests that the biotechnology industry may never capture the public’s imagination again, a strong assertion considering the amazing things happening in genomic research, companion diagnostics, medical technology, telemedicine and other parts of the sector. But is the buzz factor the only thing that matters in an age of consumer empowerment? What about the equally powerful phenomenon of simply going viral?
In some ways Mr. Timmerman’s article, in which he speaks of investor excitement for TECHnology versus BIOTECHnology, may not present a fair comparison. Facebook and LinkedIn do not have an entity like the Food & Drug Administration (FDA) that sends years of data to the trashcan more frequently than it approves a product for use. Nor do many technologies reckon with the complex reimbursement issues faced by products utilized within the healthcare system.
Clearly, the pathway to popularity and acceptance for a Linkedin is different from the pathway for a new clinical assay. Adoption of a new test or device is a challenge because it has to captivate a group of specialists (i.e., physicians) rather than the general public or patients themselves. Hence, Mr. Timmerman may be off in his analogy unless the general public becomes the primary audience that needs to be convinced the test is useful—changing the paradigm in which physicians play the directors in medical decision-making.
With all that said, I do believe the consumer is going to move the adoption of medical technology forward using tools like the iPhone. My kids have no idea what life is like without mobile phones, for example. Just as they understand that much of life is accessible with their phones, they will likely want to use the power of their handheld devices to request a test or to influence the direction of their own health care.
Consumer driven health care is what will capture the public’s imagination. What are your thoughts about the power that consumer demand will play in future biotech investment? Share them here.
Tags: biotech, biotech investment, biotechnology, clinical assays, consumer empowerment, FDA, luke timmerman, technology, xconomy
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Berkeley HeartLab’s experience with its KIF6 StatinCheckTM highlights the discrepancies between how well a test is marketed versus its clinical utility.
In 2008, the assay KIF6 StatinCheck genotype test was introduced as a laboratory developed test. More than 250,000 tests, with a price tag of about $100 each, have now been performed. In December of 2010, Celera (Berkeley HeartLab’s parent company) submitted a pre-market approval application to the U.S. Food & Drug Administration (FDA) based on several studies. These studies suggested a relationship between carriers of the KIF6 gene and an increased risk of coronary heart disease (CHD) and statin response.
The Berkeley HeartLab states the test’s clinical value on its website as follows:
KIF6 genotyping provides significant information beyond traditional risk factors to help with the identification of patients at risk for CHD events and the personalization of their treatment. Kinesin-like protein 6 (KIF6) is a protein involved in intracellular transport. A single nucleotide polymorphism (SNP) of KIF6 (719 Arg) has been shown to predict increased coronary heart disease (CHD) risk and event reduction during statin therapy.
However, what started as a test to better identify persons at risk for CHD and help predict which patients should receive statin therapy has now become engulfed by studies disproving the link between the KIF6 gene and risk of CHD.
In October of 2010 a meta-analysis reported in the Journal of the American College of Cardiology refuted the utility of the test. Other studies have followed suit along with researchers and physicians voicing concerns over the lack of clinical utility.
Further adding fuel to the unfavorable articles that appear to be eroding the success of the test, the FDA denied the company pre-market approval for the assay because clinical data and peer reviewed publications submitted did not sufficiently support the safety and efficacy of the test.
Some of the key issues stem from the lack of analytical and clinical validity as well as clinical utility. For example, investigators within the Health Protection Study stated concern that the test could do more harm than good for those without the gene who may not receive statin therapy when in fact they should be treated.
This case clearly exemplifies the discrepancies between how well a test is marketed versus the clinical utility of the test. Perhaps the block in the road may be the impetus for Celera or others currently developing a similar test to create better tests. Ultimately, clinical utility is and should be the value driver for a diagnostic test.
Do you agree? Are there other examples that point to the imbalance between marketing means and clinical utility? Please share your thoughts below.
Tags: Berkely HeartLab, Celera, CHD, coronary heart disease, FDA, genotype, genotype test, KIF6 gene, KIF6 StatinCheck
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Medscape.com reporter Emma Hitt wrote yesterday, “A U.S. Food and Drug Administration advisory committee has agreed that direct-to-consumer (DTC) clinical genetic tests should have more oversight from the U.S. Food and Drug Administration (FDA).”
The recommendation came after the FDA’s Molecular and Clinical Genetics Panel of the Medical Devices Advisory Committee met for two days in Washington, DC. The Panel discussed several issues – from potential risks of incorrect results for DTC testing performed without medical counseling to claims associated with various DTC genetic tests.
We’ve long been interested in this subject area and we followed some of the live coverage of the panel via Twitter posts from the likes of @RDGene @aliciaault @likesky3 @genomicslawyer and @dgmacarthur using the hashtag #FDADTC. Subsequently, we read perspectives surrounding the Panel’s deliberations via blog posts by @dnalawyer and @dgmacarthur, which you may want to check out.
Here, Ken Walz and I offer our own point/counterpoint take on a letter the American Medical Association wrote to the FDA Panel in which the Association called for strict regulation of DTC testing.
The AMA wrote in its letter: “The AMA has consistently supported efforts to realize the full potential of personalized medicine and the great promise it offers to the delivery of individualized care that meets the particular needs of each patient. However, we have concerns that the unfettered and unregulated growth of genetic tests marketed directly to consumers will have a significant adverse impact on consumers and undermine the physician-patient relationship. In many cases, it also represents the unauthorized practice of medicine.”
Point/counterpoint:
CAROLINE: We need to balance access to information with adequate background on how to use the information. The data resulting from DTC testing is often difficult to interpret even by trained professionals, let alone by a consumer. However, increased demand for and access to information is an unstoppable trend. The FDA should establish processes to regulate the analytical performance of DTC tests. Meanwhile, professional medical organizations should engage in (and take some responsibility for) consumer education.
KEN: The AMA is painting with a very broad brush as it characterizes DTC genetics companies and how those companies do (or do not) inform consumers. The AMA view seems to be that consumers/patients cannot be expected to make informed use of the results of these tests. However, any visitor to the 23andMe site cannot help but notice the extensive disclaimers imploring customers to seek qualified medical advice before acting on their results. These disclaimers seem more than sufficient.
The idea that we need to protect consumers/patients from knowledge of their genome is a paternalistic attitude that is out of sync with the rapid advances in technology that enable that knowledge. The physician/patient relationship that the AMA says it seeks to protect will only be undermined to the extent that physicians are less knowledgeable than their patients – a situation that can be prevented by the physician becoming and staying knowledgeable about new medical technologies.
In its letter to FDA, the AMA wrote that it is necessary for DTC genetic testing to “be carried out under the personal supervision of a qualified health care professional” and that “individuals interested in obtaining genetic testing access” should be steered “to qualified health care professionals for further information.”
Point/counterpoint:
CAROLINE: I don’t think a qualified professional should always be a mandatory component for execution of a DTC genetic test. Rather, manufacturers and testing companies need to try and provide information, however complex and nuanced, in a manner that the consumer can use. This doesn’t need to be all that different than when a consumer buys a new laptop. He or she doesn’t need to be a technology expert, but should be able to absorb basic information and to consult with a technician when certain offerings require advanced levels of knowledge. Furthermore, when it comes to DTC genetic testing, it is only in the last year or two that physicians-in-training have begun to truly be taught about how to interpret these tests…so existing generations of physicians may not know more than the average consumer.
KEN: I don’t think these tests need to be carried out under medical supervision. As for directing interested consumers/patients to a qualified health care professional for more information, while this shouldn’t be a requirement, many DTC testing companies will make this suggestion to consumers/patients as the market develops and matures. We may even see some of the DTC companies offer this as part of their service.
The AMA wrote, “We encourage this [FDA] Panel to make a recommendation that the FDA work with the U.S. Federal Trade Commission to require that DTC companies include all relevant information regarding capabilities and limitations of the tests directly to consumers who utilize their services as well as on their websites and in other literature advertising the tests.”
Point/counterpoint:
CAROLINE: I agree with this statement. It’s appropriate for a regulatory agency to ensure that good information is available in a manner that is most easily digested by consumers.
KEN: I think that there should be regulatory oversight, but only to the extent necessary to ensure that the tests are run properly and the results are accurate. Note that this only pertains to the test itself not to the clinical interpretation of the test results. I would be in favor of a requirement that companies demonstrate technical competence and disclose proof of this competence in their marketing materials.
In closing, here are our respective thoughts on how DTC genetic tests should be used, by whom, and where they can make a difference in health care.
Point/counterpoint:
CAROLINE: They should be available to and accessed by everyone, as desired, except for insurance companies.
KEN: DTC tests should be used by anyone interested in gaining greater awareness of his or her personal genetic characteristics for any reason. Obviously the information should remain private and not permitted to be used against an individual in any context.
The biggest impact of DTC tests at the moment is in the area of prevention and wellness as better-informed individuals may make healthier choices and decisions with respect to diet, exercise, and lifestyle than they would have in the absence of knowing their genetic characteristics and predispositions.
There’s obviously quite a lot of room for debate around the issue of DTC genetic testing and the potential for FDA regulation of how these tests are given and interpreted. Please add your thoughts below and share with us your take on these issues.
Tags: DNA, DTC, DTC genetics, FDA, fda regulations, food and drug administrations, genetic tests, genetics, personal genomics
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“Relieves, helps, aids, protects, reduces, may help to slow…”
Fill in the blank for many products (particularly those labeled nutraceuticals or cosmeceuticals) whose marketers some times “claim” that they can do all or some of the above.
These claims can be dangerous, as shown by a recent report in FDA’s Medwatch. The report provided public notification of an “undeclared drug ingredient” in Fruta Planta, a dietary supplement imported from outside the United States. The FDA had received multiple reports of adverse events associated with the use of the product, which included cardiac events and, in one case, death.
There is an increase in consumer focus on health and wellness due to the growth of the population over the age of 65, the rising costs of healthcare, and an interest in preventive natural treatments that extend beyond traditional medicine. Also, alternative treatments are easily accessible without a prescription at local stores (grocery or pharmacy), from alternative health providers, or via the Internet. The demand for such products is growing, but with that demand comes added pressure for U.S. governmental regulation.
Within this product area, there are claims of improved health, wellbeing, reduced risk of disease, increased energy and vitality, and prevention of the inevitable aging process. All of which are huge temptations for consumers.
There is also increasing federal surveillance of products that make claims indicating they could potentially be drugs, in which case they would fall under FDA’s new drug application purview. Claims for skincare products such as “rejuvenates, repairs or restructures” or “molecules absorb and expand, exerting upward pressure to ‘lift’ wrinkles upward” could be considered drug claims, as well.
To define these terms:
- Nutraceutical (The combination of the words “nutrition” and “pharmaceutical”):a food or a food product used to prevent or treat a condition.
- Cosmeceutical (The combination of the words “cosmetics” and “pharmaceutical”): an organically active product that alleges to be medically beneficial. Cosmeceutical only refers to products that are applied topically (balms, creams, ointments) and not ingested. Cosmeceuticals may also have nutraceuticals as part of the ingredient list.
Under the broad categories of nutraceuticals and cosmeceuticals are an array of terms such as nutrigenetics, nutrigenomics, nutricosmetics, functional food, nutrification, dietary supplements, and functional beauty.
Some of the ingredients in these products come from sources such as herbs, teas, fruits, and essential oils and are increasingly labeled “organic,” “all natural” or “ethical.”
Chemicals used in cosmeceuticals and nutraceuticals may be extracted from food products such as antioxidants (as found in red wine), probiotics (as found in yogurt), prebiotics (as found in onions and garlic), and Omega-3 fatty acids (as found in fish or algae sources).
Typically, nutraceuticals are not regulated in the same way as a pharmaceutical but there are industry standards put forth by organizations such as the American Nutraceutical Association, which works with the FDA to help assure a product is safe. Cosmetics fall under the FDCA (Food and Drug Cosmetic Act), but cosmeceuticals are not covered by the FDCA. Clinical evidence of nutraceutical products differs widely—some have been tested with scientific rigor similar to pharmaceuticals and can demonstrate benefit and others have minimal evidence to substantiate their claims.
There is increasing concern over the claims and mislabeling made by companies whichmislead and potentially harm the consumer. Sometimes foreign and domestic products do not indicate how much or what ingredient(s) are actually in the product. Not until there are reports of unexpected side effects from taking the product does it come to the attention of the public.
Manufacturers of nutraceuticals and cosmeceuticals may benefit from accurate disclosure of ingredients, inspections of manufacturing plants, and development of better guidelines on product claims. These requirements would help to prevent contaminated products from reaching the consumer and better inform the consumer about product ingredients. The addition of new technologies in bioanalytic testing to detect tainted products or significantly elevated amounts of a potentially dangerous ingredient will be critical to these growing markets.
So what happens now that nutraceuticals and cosmeceuticals are becoming more commonplace? Will regulation guidelines become more distinct? The first step might be standardizing definitions of these two new words because each one is viewed by the FDA as more like a dietary supplement than a pharmaceutical.
What do you think about this topic? Do you take nutraceuticals or use cosmeceuticals? Do you believe their claims? Should the FDA regulate these classes of products? Please share your thoughts here.
Tags: ana, cosmeceuticals, cosmetics, dietary supplements, FDA, fdca, nutraceuticals, patti doherty, regulation
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On January 19, the FDA’s Center for Devices and Radiological Health (CDRH) announced its action plan to address deficiencies of the 510(k) program. As the program exists today, some have argued that there’s a lack of clarity, efficiency and speed in the process. With that in mind, there’s been a push by industry, patient advocates and other critical stakeholders for significant change. Needless to say, the FDA has a tough balancing act to perform in this space.
For context, here’s a current definition of the 510(k) program from the FDA website:
“Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.”
In the past, the process associated with this program has created delays for companies to market their devices while at the same time it has protected the public from devices that perhaps were not quite ready to market.
According to a statement made by Jeffrey Shuren, Director of the CDRH, the FDA’s action plan is expected to create a transparent pathway through the 510(k) process to build “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly.”
Some history behind the changes – in 2009, two committees were established to address the concerns expressed by industry, consumers, and healthcare providers about the impediments to the 510(k) program. Namely, some stakeholders criticized the 510(k) program for being unpredictable, inconsistent, and opaque. As a result, some argued, medical device developers have begun to look outside of the U.S. to further develop and market their device in “better” regulatory markets.
The two committees established in 2009 are the 510(k) Working Group and the Task Force on the Utilization of Science in Regulatory Decision Making. In addition, the Institute of Medicine is also independently reviewing the 510(k) program and making recommendations.
The general public also had the opportunity to provide input into the recommendations, either in writing or through public meetings. Consumers, healthcare professionals, patient advocates, industry, third party payors, venture capitalists, academicians, legal counsel, and other stakeholders were among the groups that provided comments to the FDA.
After receiving feedback from the public, the working groups made more than 50 recommendations for improvement of the 510(k) program. From the larger list of recommendations, 25 actions were developed into the action plan.
In my opinion, some of the most significant action plan recommendations include:
- Streamlining the de novo process
- Clarifying when to provide clinical data
- Clarifying and consolidating the concepts of “indication for use” and “intended use”
- Providing supplemental guidance on pre-IDE meetings and the 510(k) process
- Creating a network of experts to review new medical device technologies
The agency has a tall order to fill and needs to make changes that will provide a scientifically based, efficient, and expeditious program to bring new devices and tests to market while at the same time assuring consumers and patients who use those devices that they are safe, effective, and economical.
What is your reaction to the FDA’s action plan? Have the right steps been addressed? What is missing? Share your thoughts here.
Update: Yesterday, the FDA announced that it would be reviewing cutting-edge medical devices through its newly proposed “Innovative Pathway,” a program intended to accelerate the time it usually takes to review truly innovative new devices. Only a few devices will be reviewed per year due to limited resources at the FDA. The program is subject to public comment at a meeting set up for March 15, 2011.
However, the Agency is still faced with the fact that the majority of medical devices are innovative but they may not be revolutionizing in terms of changing patient care — a current feature of the proposed pathway. Thus, most devices reviewed by the Agency would not go through the Innovative Pathway as currently defined.
We’ll continue to watch this unfold and to keep you updated!
Tags: 510(k), cdrh, de novo process, FDA, healthcare providers, institute of medicine, jeffrey shuren, medical devices, pmn, premarket notification, task force on the utilization of science, working group
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Danaher Corporation (NYSE:DHR) announced today (see San Francisco Chronicle story here) that it has entered into an agreement with Beckman Coulter, Inc. (NYSE: BEC) to acquire Beckman for approximately $6.8 billion. When the acquisition is complete, Beckman will become part of Danaher’s Life Sciences and Diagnostics business segment.
This is yet another example of the diagnostics landscape’s rapid upheaval in which different players will clearly be dominating and leading the industry.
The diagnostics industry shake up is in full swing: As we wrote recently, sequencing technology (one critical part of the Dx space) is changing at an earth-shattering speed and today’s announcement is evidence of what is happening on the market level. Need more evidence? Check out this post by Xconomy’s Luke Timmerman on “diagnostics warming up.”
There’s little doubt that established diagnostics players will have interesting strategic responses to all of this change as they move to shore up their product positions and to maintain their channel franchises.
In all, it’s a great time to be in diagnostics and a broader variety of partnering and exit opportunities are emerging for small, innovative diagnostic companies. We’ll be writing about other diagnostics and device industry trends and changes in our blog (including a post later this week on the FDA’s recently announced 510(k) action plan). We’d love to hear what you think (so please leave a comment below) and we hope you’ll continue to read our views here.
Tags: beckman coulter, biotech, Caroline Popper, danaher corporation, devices, FDA, life sciences, sequencing
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