Posts Tagged ‘medical devices’
The increased use of the internet by healthcare consumers has led to at least two types of medical conversations ironically illustrated by two different online features sharing a name: the “DocTalk” here, in which Arizona kidney specialists share treatment information on smartphones, and another “DocTalk,” where Ontario physician Stuart Foxman discusses such communications issues as the risks of physician’s giving too much information, and the growing irritation among physicians with patients who research conditions and treatments online.
Like it or not, these two “doc talks” are merging. While physicians and other providers are busily keeping up with changing practice parameters, medical literature and patient management (increasingly by computer, smartphone or tablet), patients are trying to keep up, too. WebMD receives more than 40 million hits a month, and anywhere from half to 80% of all Americans have used the internet to research a medical condition or symptoms. Even larger medical providers like Kaiser Permanente encourage the use of websites for gathering medical information. In addition, consumers increasingly have the ability to research and share opinions on their providers through sites like www.vitals.com. Interestingly, the ability of consumers to rate and offer opinions on providers is not growing quite as quickly as other industries, due to reasons we’ll cover in a future post.
If you talk to physicians, many are not thrilled with this new “patient empowerment” reality. Some physicians express frustration with patients coming into their offices apparently under the impression – often false – that they are as informed about their medical condition as their doctors. In addition, a new type of patient, the “cyberchondriac,” believes that his or her condition must be the worst one they read about online. This, of course, is not a new problem; even medical students are warned “When you hear hoofbeats, don’t assume they’re zebras.”
What can physicians do, and how can digital healthcare innovation help them? It’s estimated that two thirds of patients now want doctors to recommend reliable websites to them. Doctors should be able to do more than that, and digital technology should help them:
- Use Google news alerts and other online tools to stay current with the same breaking information that will be read by patients—this will help keep up with consumers but also stay ahead of recent (say, announced that morning) FDA Drug Alerts and other developments.
- Find and recommend patient groups and discussion communities that benefit patients. There are thousands of such groups online, with tens of thousands of patients. Quick searches will result in better exchange of information and satisfied patients. More of this information can be searched and downloaded via smartphones and other digital technology.
- Encourage the use of reliable smartphone apps and online news bulletins, clinical research sites and university medical centers. By steering patients/consumers toward the better-designed and monitored sites, both sides benefit from sharing good information.
The internet has made sharing information easier, and caused empowered consumers to demand more from their doctors. This new world isn’t going away, and medical innovators might be well-served to work closely with doctors—no matter the resistance—to encourage the use of information that separates hoofbeats from zebras.
Do you think physician skepticism of online health information is justified? Or is the online power of consumers helping improve and personalize healthcare? How can technology help steer things in the right direction? Is your medical device or digital health company working on a solution? We’d love to hear your thoughts.
Tags: digital health, healthcare consumers, medical devices, online health information, patient empowerment, personalized healthcare
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We’ve had a lot of discussions about the waves of changes happening in healthcare, thanks to smartphone- and internet-fueled consumer power. In a recent Popper and Company post, Caroline Popper discussed how consumers’ access to information, expectations from the medical profession, focus on wellness (instead of disease) and determination of value are changing the industry.
Dr. Eric Topol, author of The Creative Destruction of Medicine, presented another face of this consumer-driven change; the effects on doctors. In this Medscape video presentation, Dr. Topol suggests that doctors, no longer the sole holder of personal health information, will need to change how they approach their practices as well as their patients.
Consumers are getting health information from many sources. For example, companies like Walgreens are increasing the information content of their consumer interactions. By educating its customers on the data generated by the devices Walgreens sells, patients have more knowledge of their own condition – and a knowledge base that does not start with the physician. Thus, the patient enters the doctor’s office with a more thorough basis of information and more challenging questions. This information base may make physicians uncomfortable, just as direct-to-consumer ads from the pharmaceutical industry have discomforted many. But, as Dr. Topol points out, physicians will continue to have an important role; it’s just going to be a different one.
How will physician roles change in this new world? What does it mean for the device or diagnostic? Who bears responsibility for patient/consumer education? Watch Dr. Topol’s video here to learn more, and let us know your thoughts.
Tags: consumer-driven healthcare, Dr. Topol, Eric Topol, healthcare innovation, medical devices, patient education
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There’s a joke that’s often shared by medical students: “What’s the difference between God and a doctor? God doesn’t think he’s a doctor.” Regardless of your spiritual orientation, the line illustrates the lofty perch (and decision-making power) occupied by physicians in today’s healthcare settings. But, as we at Popper and Co. have discussed, a new wave of consumer power may eventually topple this perch.
A recent story in the Wall Street Journal by author Doc Searls, “The Customer as a God,” focused on the growing power of customers using electronic devices for daily communication, shopping and other activities. Most current product development, the article points out, focuses on improving the supply of products to the customer, not involving the customer in making those products. This however, is changing. The story projected a future in which people use their devices to pick out clothes, replace parts for appliances, and shop for products—all unencumbered by invasive marketing tracking methods, corporate service plans, and other systems that, as Searls says, “tend to herd customers as if they were cattle.”
I saw a number of parallels between this view of today’s and tomorrow’s consumer electronics world and the healthcare industry. In the consumer electronics world, internet/wireless service providers determine how the consumer will use devices and control the internet that connects them. Meanwhile, in healthcare, physicians and hospitals “provide” the care that patients are told to accept. Fast forward about 10 years, and the providers are no longer in charge—the consumers are.
Just as in the consumer electronics world, healthcare is not yet completely in the hands of consumers. As digital health pioneer Eric Topol said, the medical establishment is replete with entrenched institutions and individuals resistant to this type of change.
“We are moving away from information asymmetry, ‘Doctor Knows Best,’ to a true democratization of medicine,” he said. “Like in the 1400s with the Gutenberg printing press, people learned to read—that is coming with each individual’s key medical data, like blood pressure, glucose, heart rhythm, displayed on their smartphones.”
While many refer to “personalized medicine” as the treatments and diagnostics that arise from our advancing knowledge of biology to an individual level, the term is starting to mean something else; the consumer demand for treatments that are tailored to their personal needs and aspirations (as well as a tailored treatment for disease).
The “inflection point” of medicine—where portable devices, low-cost genetic screening, and a wealth of accurate online health information all merge to allow a consumer to call the shots—isn’t here yet, but it’s close. Perhaps the ancient Greek writer Homer had it right in The Iliad, where men (and a woman or two) fought alongside the gods.
Do you see the same future of healthcare? How close are we to medicine’s inflection point? What would it take to create a new consumer power? Please share your views with us.
Tags: consumer power, digital health, electronic devices, Eric Topol, future of healthcare, medical devices, mHealth, mobile health
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While securing financing is an important milestone for developing new healthcare technologies, developers need to look beyond this first step and find ways to determine and demonstrate the value of their innovations. And there’s no better place to discuss this crucial issue than in Australia.
Home to 600 medical device companies, Australia ranks as the fourth-largest market in the Asia-Pacific region. I wrote this post last week from the 2012 AusMedTech (Australia Medical Technology) national conference in Sydney after sharing some strategic insights with device executives.
As the device industry continues to grow rapidly, it will be important for technology developers to demonstrate how their products add value to healthcare. No matter where they are located in the world, developers need to:
- Put their product in context right from the beginning:
- Think more about what real problem the invention is trying to solve. This means understanding the state of the industry, standards of care in health provider settings, and how and why the invention should change the status quo.
- Determine how resources would be affected by a new invention. This includes comparing the device’s cost against how much value it provides to the physician and/or to the patient.
- Consider the provider status quo, payor and consumer conditions, and the competitive landscape as they begin development of the product and not just prior to commercialization.
- Align development with current trends:
- Assess how the product meshes with the rise of the power of the consumer in healthcare, and determine how cost constraints at the consumer level as well could threaten the success of the product.
- Recognize that in every market cost constraints prevail. The new product needs to drive operation efficiency in service delivery and shift the value: cost equation firmly in the direction of value.
I look forward to continuing this conversation and plan to share in a future post my particular view around aligning with current trends. In the meantime, please feel free to share your thoughts here about the Australian medical device industry or about the points I’ve raised in this post.
Tags: 2012 ausmedtech, ausmedtech, australia medical technology conference, device industry, healthcare, medical devices, technology developers
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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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An Interview with AdvaMed Conference Producer Ray Briscuso
In preparation for AdvaMed 2011: The MedTech Conference, we had a unique opportunity to interview Ray Briscuso, President and CEO at Life Sciences Conference Group, LLC. Each year, Briscuso works with the Advanced Medical Technology Association (AdvaMed) to produce one of the most important meetings focused on medical devices and diagnostics, and which brings together more than 1,500 key MedTech executives from companies in every sector of the industry. It is the premier conference, exhibition and partnering event for medical device, diagnostic and health information companies. In the past, internationally respected voices, such as former Presidents George Bush (Sr.) and Bill Clinton, have been featured as plenary speakers.
I am eagerly anticipating September 26-28 when AdvaMed 2011 will be held in Washington, DC. Following are some insights and highlights from our discussion with Ray about how to get the most out of this year’s event:
Q: AdvaMed 2011 promises to be an action-packed three days. What discussions, events, or talks are you most looking forward to this year? What will be 2011’s most pressing issue?
A: I’ll answer that in three parts:
- First, I’m always interested in the CEO Spotlights at the conference. We get some of the top names in the industry that literally sit on a barstool and have conversations with our attendees. This year, look for discussions from industry leaders such as Steve MacMillan, President & CEO, Stryker Corporation; Joe Almeida, President & CEO, Covidien; and Jeff Binder, President & CEO, Biomet, Inc., to name a few.
- Second, I value opportunities to hear from former presidents of the United States. This year we’ve got former President George W. Bush. In the past, Presidents Clinton and Bush (Sr.) have spoken – you could have heard a pin drop during their talks.
- Third, because the global financial situation is contributing to continued turbulence in financial markets, I’m interested in sessions that focus on investment in our industry – everything from venture capital to private banking dollars. I want to learn: What’s happening to the money? Who is getting investments? This is also the answer to what I believe is the most pressing issue to be discussed at the conference overall this year. I expect discussions on economic development incentives to continue to foster the industry within the United States. There is an opportunity to help support, create, and nurture an industry that pays high wages and employs highly skilled people.
Q: As you mentioned, plenary speakers at the AdvaMed Conference are very important and influential people, and this year is no different. What issues will the speakers, including former President George W. Bush and Maryland Governor Martin O’Malley, address? How did they get involved in this year’s event?
A: With respect to Governor O’Malley, we invited him because there is such a large medical technology industry in Maryland; it’s a key part of the O’Malley Administration strategy to get to know the industry and to foster its growth. We saw that and invited him – and we are pleased he is willing to make the trip to Washington. While a lot of Marylanders think about the bioscience medical industry in the state, Maryland is also home to many device and diagnostic companies such as BD and Qiagen.
As for President Bush, his family has a long history of personal experience with medical devices, which helps provide a personal connection for him as a speaker.
The U.S. Secretary of Health and Human Services, Kathleen Sebelius; the FDA Director of the Center for Devices and Radiological Health, Dr. Jeffrey Shuren; and Counselor to the FDA Commissioner John Taylor will also be part of the meeting this year.
Q: In Vitro Diagnostics is a new Program Track at this year’s conference. What should we expect to hear about in this discussion? Why was it added?
A: AdvaMed has been around for more than 35 years. Last year, the association started “AdvaMedDx” to focus solely on the regulatory, payment, and legislative needs of its in vitro diagnostics (IVD) members. AdvaMed is very proud that all 10 major diagnostic manufacturers are members of AdvaMedDx. The members asked us to make sure AdvaMed 2011 was the de facto meeting for AdvaMedDx – and it is. We added a dedicated track and a great deal of other programming specific to the diagnostics industry.
Q: I’m particularly interested in new tools being developed to address inefficiencies in the healthcare system and believe this is a general strategy that will be quite profitable to those companies that execute well. What are your thoughts on this front?
A: In the current budget environment, all parts of the health care industry are being asked to do more with less. Medical technology delivers tremendous patient value so AdvaMed member companies are uniquely situated to help improve value across the continuum of care.
We’ll be educating attendees about proposed government changes. We’ll feature 60 company presentations, many from early-stage companies seeking to address healthcare system inefficiencies. Our members know the importance of medical and economic value in the care setting. This theme will permeate the conference.
Q: AdvaMed conferences bring together people of varied backgrounds with a stake in the MedTech industry. How does this impact the value of the conference?
A: Our conference features investors, seasoned business leaders, and niche service providers with the right experience – we have it all. For attendees, this isn’t about finding a needle in a haystack but rather it’s an efficient way to connect with others who can help them. Like Delta Airlines uses Atlanta as a hub, everyone flies in for our conference and our MedTech Partnering software system allows companies to match needs with skills. It is unique to have such a huge cross-section of the industry, and its senior leadership, represented in one place. We provide efficiencies to small companies who accomplish a lot by attending the MedTech conference.
Q: What advice would you offer first-time attendees for how to make the most out of the conference?
A: The key is to prepare in advance of the conference. Opt-in to the partneringONE® MedTech Partnering system we have as part of the conference. This will open you up to a searchable database to look at anyone else who opted in. You can post a profile, describe your company, and explain your reasons for attending the conference (e.g., to meet with potential strategic partners, to secure funding, to gather regulatory advice). You can search for those who fit your profile and find the right people with which to meet. Look at the schedule in advance and lock down much of your days. During open times, go to a session and introduce yourself to a speaker.
If you don’t plan in advance, you’ll still get your money’s worth, but you are leaving more to chance. Our telephone number is 202-434-7213 and our web address is www.advamed2011.com. Attendees are welcome to call us for more planning tips to ensure you get every ounce of benefit from coming to the conference.
Are you attending this year’s conference? Will your company be participating in MedTech Partnering? I’d be happy to meet up with anyone interested. Please feel free to share your contact information, comments, or your own questions for Ray Briscuso below.
Tags: AdvaMed, AdvaMed 2011, Advanced Medical Technology Association, diagnostics, medical devices, Popper and Co, Ray Briscuso
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In my May 17 blog post, I introduced Dr. Andreas Muehler as one of Popper and Co.’s new strategic advisors. Dr. Muehler brings broad perspectives and business insights, owing in part to his close relationships with established industry leaders in the joint development and commercialization of medical products worldwide. Building upon our last discussion, where I was caught by his enthusiasm as we talked about his past role as CEO for a struggling medical device firm and his experiences positioning products in the global marketplace, I recently talked with Dr. Muehler again to further explore his impressions on the differences between the E.U. and U.S. markets for new life science technologies.
CP: You’ve served within or supported the pharmaceutical and medical device industries in both Europe and the U.S. What do you see as some of the differences?
AM: There are differences in the health care system itself – mainly how you pay for health care delivery, what gets reimbursed, and what control in decision making a physician has in terms of technologies used. For example, the U.S. has good reimbursement for breast biopsies using MRI. In Europe, it’s mainly done with ultrasound because MRI isn’t paid for at all. So in the U.S., technologies are being used when insurance will reimburse for testing and therefore provide a financial benefit to the hospital or physician. In Europe, however, clinical data around a technology is very important in terms of benefit for patient or patient outcome. In Europe, there’s a higher likelihood that good technology, which is backed by good clinical data, will be used when all ducks line up, and the financial benefits to physicians may be less of an overriding issue.
CP: When it comes to launching a new technology, can you tell us more about some of the pros and cons for each geographic locale?
AM: The advantage of Europe for marketing a new technology is that physicians are free (in particular in the hospital setting) to choose their technology if they believe it has a benefit. In Germany, for example, there is a general pricing reimbursement system in hospitals through which the hospitals receive a lump sum payment for a patient with a certain diagnosis but are basically free to use any products and technologies as they see fit. The hurdle to get into market is less as long as you have good clinical data. In the U.S., however, physicians are more open to trying new technology even without clinical data, which can be good for companies. Physicians in the U.S. are also very open to use of electronic patient records (EPR); whereas in Europe, physicians are not as convinced that EPR makes a difference and have more concerns around patient privacy.
CP: What’s different today than five years ago in terms of health technology adoption?
AM: On both sides of the Atlantic, there’s an increase in need for good clinical data for adoption of new devices, in part because of financial pressures on the systems themselves. To successfully market your device, the importance of large-scale clinical data has grown if you want market penetration of your product. In the past, a small clinical observation was sometimes enough to get adoption of your device. Now physicians ask for clinical outcome data and payers and hospitals ask for pharmaco-economic data.
CP: What will be different five years in the future?
AM: The pendulum swings back and forth. The U.S. will realize that a lot of innovation in medical devices will go to Europe because of current restrictions within the FDA’s 510K process. If good examples of important medical breakthrough technologies emerge in Europe that America doesn’t have access to, I believe some new processes will evolve that will allow medical technologies to get approved quicker in the U.S. One such example is hearing implants. Countries like Austria and Germany had in the past instituted mandatory routine hearing tests for babies, and, if needed, paid routinely for hearing implants while the children were still quite young. As a result, most educational facilities for children with hearing disabilities in Austria and Germany actually closed since implanted children undergo an almost normal linguistic development. In the U.S., hearing implants aren’t yet available as widely because they are seen as expensive for the healthcare system and by payers, even if they save more than their share of costs down the road by removing special educational requirements. If this continues, the industry should lobby to politicians and changes may occur in the regulatory process. Then, hearing implants will likely be made more widely available. By the way, the European policy for early hearing tests and hearing implants produced a market leader in hearing implants that is located in Austria.
There are important insights here, especially the need to track the level of clinical research attached to a product as it’s introduced to the E.U. market. It’s also important to note how receptive the European medical community is to new technologies introduced from the U.S. We’ll continue to focus on this important topic, and to share additional insights from Dr. Muehler and our second advisor, Dr. Mills.
We welcome your thoughts on the importance of clinical data in selling medical technologies and how the pendulum of restrictions continues to swing. Where do you think we are now in the U.S. as far as restrictions and our ability to sell in the E.U.? Share your thoughts below.
Tags: Dr. Andreas Muehler, health technology, life science, life science technologies, medical devices
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Sometimes, between the hotel room, the lectures, the networking, the power lunches and the data consumption at a conference, you’re on the plane home before you have time to reflect upon why you attended in the first place. I’m excited to be heading to the 18th International Molecular Medicine Tri-Conference in San Francisco this week—and I’m setting out my reasons for going this year beforehand.
I always look forward to this conference because of its balanced range of life science topics, including those with technical, scientific, business, strategy, regulatory and reimbursement slants. Within this balanced range of topics, the Tri-Con uses a channel structure to help attendees “tune in” where they can get the biggest bang for their buck. I’m excited to learn more about the following specifics within each channel:
- Diagnostics—Rapid changes are taking place on the diagnostics stage this year. Personally, I’m interested in molecular diagnostics, personalized diagnostics, cancer markers and circulating tumor cells (CTCs). I’ll be tuning in to discussions on the adoption and integration of the next generation of sequencing, companion diagnostics and the use of/characterization of CTCs.
- Drug discovery & development–Here, sessions promise updates on translational science, including the use of biomarker technology to support drug development.
- Biologics–This is a vast topic, but I’m especially interested in discussions on the study and use of stem cells. I’ll be looking to learn more about the applications of stem cells to support drug testing and for use as therapeutics.
- Cancer–For this channel, I’ll be focusing on sessions related to companion diagnostics, stratification of patient populations (including predictive and prognostic markers), and recent developments in pathway-driven or targeted drugs (a.k.a., personalized medicine).
- Informatics–Within this area of focus, I’ll watch for updates on methods to analyze integrated data types, workflow management and more.
The integration of each of these channels (which include more than 250 presentations), the focus throughout on industry-changing and trendsetting technologies, and the quality of keynote presenters is what distinguishes Tri-Con from other industry events. It also doesn’t hurt that more than 70 scientific posters will be displayed and that the exhibit hall is packed with vendors that present their latest products and technology (often in a manner that enables you to dig in and understand the role of the product/technology in the R&D process).
In addition to all of the educational aspects of the conference, I’m also looking forward to meeting thought leaders in many of the disciplines, and to connecting with Popper and Company clients and colleagues who will be attending.
If you’ll be there, please comment below or drop me a note, and let’s plan to connect. If you’re not attending, but are interested in any of the channels above, I hope you’ll tune back into our blog for my follow up piece post conference. As for now, I’m leaving on a jet plane…
Tags: 18th international molecular tri-conference, biologics, cancer markers, ctcs, diagnostics, drug discovery, Health Care, informatics, life sciences, medical devices, personalized diagnostics, tri-con
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“I looked in the Yellow Pages. ‘Furniture Movers’ we’ve got; ‘Strange Phenomenon’, there’s no listing.” – Diane in Poltergeist
I had to laugh at one of last week’s headlines on the Daily Scan from Genome Web. It was titled, “They’re Baaaaaack!” Before reading the article, I imagined it had something to do with the Poltergeist series of movies where chaos and unexplained phenomena occur – objects careening through the air along with visitations from old and terrifying ghosts. But when I read the article, it had to do with the revisiting of the direct-to-consumer genetic (DTC) tests rather than some type of paranormal activity. Not exactly a poltergeist but nevertheless a phenomenom that 1) won’t go away, 2) is somewhat chaotic, and 3) is worth following.
From March 8-9, 2011, the Molecular and Clinical Genetics Panel of the FDA’s Medical Devices Advisory Committee will host a public meeting. The group will take comments and make recommendations on DTC tests. Several issues are on the agenda with the focus on the risk and benefits of such tests and the potential availability to consumers without a physician’s prescription.
Proponents of DTC tests believe that consumers who wish to purchase and take the tests should have easy access to information about their genetic makeup. Such access, the proponents argue, would allow consumers to make informed decisions with regard to such things as whether they are carriers of a certain genetic disease, have a predisposition to develop a particular cancer, or whether they will respond to a particular medical treatment. In essence, information obtained from DTC tests would empower consumers to take control of their own health.
Those who are uneasy about the risks related to DTCs are concerned about test results being misinterpreted and acted upon in the absence of other important substantiating information. They argue that physicians play an important role as gatekeepers of medical information.
Developers of DTC tests are another category of influence on this issue. They play a role in helping to shape the debate around the level of scientific evidence needed to support the test claims.
In the movie Poltergeist, the character Marty explains: “Poltergeist disturbances are fairly short duration. Perhaps a couple of months. Hauntings can go on for years.”
We may not know until months after the Advisory Committee meeting whether we are dealing with a poltergeist or a haunting when it comes to the phenomena of DTC genetic tests, but we do know “they are here” and they will make an impact on the future of healthcare.
Where do you come down on this issue? Are the tests important for consumer empowerment or do physicians need to be involved via the traditional prescribing process? What role should developers play in setting standards for scientific evidence? What should be the FDA’s role in this process? Please share your thoughts with us.
Tags: DTC Genetic Tests, fda's medical devices advisory committee, medical devices, molecular and clinical genetics, patti doherty, poltergeist and DNA
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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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