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By the Numbers: Why Medtech's Customer Base Is Rapidly Shrinking

By the Numbers: Why Medtech's Customer Base Is Rapidly Shrinking

A McKinsey & Co. report shows the level of consolidation and how it will affect the marketplace.  

Arundhati Parmar

Among the headwinds that the medtech industry is facing these days, is a hospital customer base that is rapidly shrinking because of massive consolidation. The infograpic created by MD+DI below is based on a June 2015 report from McKinsey & Co. that shows that between 2008 and 2013 the number of hospital merger deals have been steadily growing. In other words, the number of mergers are growing and so are the number of hospitals involved.

The net result is the number of hospitals available to do business reduces, the remaining merged entities are large and acutely focused on cost.

The report states that these "customers are aggressively changing their models: employing surgeons and fighting to gain a larger share of commercial customers in their regions while becoming even more sophisticated in their procurement capabilities
and cost management." As a result that, physician influence in the hospital is waning.

What's more, the largest hospital systems are accounting for a lion's share of overall expenditures on hospital procedures nationwide.  The infographic below shows how the overall share of spend of the top 150 health systems have been rising since 2007 and how it is projected to grow this year and beyond. 

 [Photo Credit: iStockphoto.com user sgame]

Beware of Bronchoscopes Too?

Beware of Bronchoscopes Too?

Marie Thibault

Duodenoscopes filled headlines this year, in the wake of carbapenem-resistant enterbackteriaceae (CRE) outbreaks at hospitals around the country. Following the cases of infection and in a few instances, death, FDA issued guidance on reprocessing of reusable devices and published extra measures to ensure clean scopes.

But now, FDA is back with a reminder that the vilified duodenoscopes are not the only scopes to worry about getting clean. In a September 17 safety communication, FDA tells healthcare workers, reprocessing staff, and potential patients that there have been a number of reports of infections or contamination from flexible bronchoscopes. Bronchoscopes are used to diagnose respiratory problems.

According to the FDA safety communication, the agency received 109 Medical Device Reports (MDRs) of infection or device contamination about flexible bronchoscopes between January 2010 and June 2015, but that there were 50 MDRs in 2014 alone. This led to more scrutiny of the problem and, as with duodenoscopes, a portion of these incidents “indicate[s] persistent device contamination despite following the manufacturer’s reprocessing instructions.”

FDA writes, “If the [reprocessing] process is not followed meticulously, the flexible bronchoscope can remain contaminated, potentially resulting in infection transmission from one patient to the next.” The agency notes that two items have led to many of the infection and contamination reports:

  • “Failure to meticulously follow manufacturer instructions for reprocessing . . .”
  • “Continued use of devices despite integrity, maintenance and mechanical issues . . .”

The safety communication goes on to detail cleaning and reprocessing recommendations, which seem to be similar to steps advocated in the wake of concerns about duodenoscopes.

The number of reported issues is relatively small, given FDA says there are about 500,000 annual procedures using flexible bronchoscopes in the United States. This also isn’t the first time FDA has mentioned bronchoscopes—the instruments were included in the agency’s final guidance on reprocessing reusable medical devices in March 2015.

Still, there’s no need for potential bronchoscopy patients to panic. FDA believes the risk of infection from reprocessed bronchoscopes may be lower than the infection risk from duodenoscopes and that for most patients, the benefits of bronchoscopy outweigh the risks. 

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference , November 4–5, 2015.

Marie Thibault is the associate editor at MD+DI. Reach her at marie.thibault@ubm.com and on Twitter @medtechmarie 

[Image courtesy of HOLOHOLOLAND/FREEDIGITALPHOTOS.NET]

10 Medtech Recalls that Shocked the Industry—OriGen

10 Medtech Recalls that Shocked the Industry—OriGen

OriGen Biomedical announced a recall in March 2015 for one lot of the OriGen 51 VV13F Reinforced Dual Lumen ECMO Catheters. These catheters are used as part of extracorporeal life support for neonatal and pediatric patients whose hearts and lungs need assistance.

According to the company's recall release, this lot of catheters "have the potential for a separation of the clear extension tube from the hub that it is inserted in," which might mean quick action is needed to avoid permanent injury. The catheter's malfunction is associated with one death.

             

[Image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]  

10 Medtech Recalls that Shocked the Industry—HVAD

10 Medtech Recalls that Shocked the Industry—HVAD

HeartWare's HVAD Ventricular Assist Device has been the subject of a number of recent recalls, described in a June 2015 company release. The HVAD is implanted in patients with severe heart failure.

One recall involved an alarm battery failure. This meant that if the HVAD was disconnected from its power sources, the alarm did not sound. According to the FDA recall Web page, there were three injuries and one death reported to be related to this issue.

Another recall involved the HVAD's driveline, which extends from the pump within the patient's body to an external controller and external power. This driveline needs to be handled carefully, because "severe damage or disconnection of the driveline from the controller can cause electrical issues or pump stops that may lead to serious patient injury or death," according to FDA. The agency's recall description states that this flaw was reported to be related to one serious injury and two deaths.

             

[Image courtesy of HEARTWARE, INC.]  

How Philips Is Planning Mobile Health Success

A string of announcements this year show Royal Philips seeking to turn its situation around through major plays in mobile health and overall innovation.

Chris Newmarker

Updated November 24, 2015

One of the world's largest medical device companies has been making moves this year to become a major player in mobile health.

Time will tell whether Royal Philips' strategy will turn its business around. Over the first nine months of 2015, the company's stock was one of the worst performing among large medical device companies. Focus could potentially improve after a planned separation of the company's healthcare and lighting businesses.

Here are seven recent reasons to think that Philips best days are ahead of it when it comes to healthcare:

1. App-based Ultrasound

Philips has also announced a unique ultrasound system called Lumify that plugs into an Android tablet and uses the Philips HealthSuite Digital Platform. The app-based ultrasound Lumify system hit the U.S. market on November 19, with health providers paying an initial subscription rate of $199 per month.

Philips Lumify

Philips' latest ultrasound system takes leverages an Android tablet. As the company's vice president of business segment leader explained in a recent Q&A, the roots of the technology stretch back 12 years.

2. Hosting Medical Data in the Cloud--with Amazon

The company has announced a collaboration with Amazon to link "hundreds of millions of devices and sensors" to the cloud. Cloud-based services, for example, could be used to harvest data gathered from elderly, processing it to identify health problems and potentially dangerous events such as falls. 

3. A Killer App for Diabetics?

Royal Philips, Salesforce, and the Netherlands-based Radboud university medical center think they've hit on a mobile-based app and online community that could greatly help type-1 diabetes patients manage their condition.

Philips diabetes app

"This application will help transform the daily experience that diabetes patients have," says John Wookey, executive vice president at Salesforce, which we describe in the article "Do Philips and Salesforce Have a Killer App for Diabetics?"

4. Transforming Brain Injury Monitoring

Philips and MIT have forged a partnership to potentially transform the way brain injuries are monitored. The fully non-invasive calibration-free, portable technology would monitor intracranial pressure (ICP) through a combination of Philips ultrasound technology and MIT physiological modeling.

Philips Mobile ICP
Philips envisions its mobile ultrasound technology helping to non-invasively determine brain injuries. (Image courtesy of Philips)

5. Personal Health Programs

Philips is planning a series of "personal health programs"  to eventually help people track everything from heart health to back pain, and will each incorporate a package of Philips devices, apps, and the cloud-based Philips HealthSuite Digital Platform.

Philips mobile health
Philips health programs will make use of devices including the Philips watch, which includes a proprietary optical heart rate sensor and accelerometer.  Learn more in our article titled "Philips Is Making a Big Mobile Health Play."

6. Bringing Devices into the Mobile Health Mix

Devices Philips is bringing into the personal health programs include the Philips health watch, the Philips upper arm blood pressure monitor, the Philips wrist blood pressure monitor, the Philips body analysis scale, and the Philips ear thermometer.

Philips pressure monitor
The influence of consumer technology can be found in products such as Philips' blood pressure cuff. The company's big mobile health play also includes products such as a weight scale and a thermometer, which can beam data to smartphones.

7. Major Research Partnerships

Philips also has a partnership with the Academic Medical Center (Amsterdam, the Netherlands) for a European multi-center clinical study of a minimally invasive treatment for severe diabetic foot complications. And it recently inked a five-year, $25 million alliance with MIT to further research in its core areas of healthcare and lighting solutions.

Philips is collaborating with MIT
Henk van Houten (right), global head of Philips Research, and MIT Associate Provost Karen Gleason (left) shake hands amid the new Philips-MIT research alliance. Read more in "Philips' Research Boosting Plans Equal 3 Letters: MIT."

Learn more about cutting-edge medical devices at BIOMEDevice San Jose, December 2-3.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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Robotics Firm Sets Its Sights on Wheelchairs and Forklifts

A company known as 5D Robotics wants to bring the field of smart robotics to manufacturing, medical technology, transportation, and other sectors.

Brian Buntz

5D Robotics
5D Robotics' technology could be used to navigate wheelchairs. Image courtesy City of Carlsbad.

5D Robotics' (Carlsbad, CA) navigation technology was originally developed for military applications to detect land mines, but the number of applications of the company's technology could be multitudinous.

The company uses ultra wideband (UWB) tags to navigate, which offer a number of advantages over other technologies used for navigation such as GPS or radar. Compared with GPS, it has far superior precision, capable of navigating a path on an aerial image or map within a centimeter range. GPS, by contrast, sometimes has trouble even directing a car to stay on a single street.

The technology could also be used for warehousing applications as well, where it could potentially eliminate forklift accidents thanks to its ability to "see" around blind corners, according to David Bruemmer, CEO and co-founder of the company. The robot comes equipped with an optical sensor that helps avoid collisions. "The ability to prevent collisions around corners comes from the UWB technology," Bruemmer explains.

In the medical realm, one potential application is its use to offer precise navigation abilities for users of wheelchairs. The company is optimistic about the prospects of the technology to assist with the navigation of wheelchairs as well as cars.

In the video below, the robot can be seen following a skater wearing a vest equipped with sensors.

The original idea behind the robot's navigation technology was for it to help aid in the detection of and marking the coordinates of landmines. The accuracy of its positioning capabilities is an asset here, including its ability to not be thrown off by shadows, dust, and uneven terrain. It can also detect obstacles including people that may be positioned along its path. In this case, it can stop and determine a new route if necessary.  

The robot can also assist soldiers on the battlefield, following behind soldiers or military vehicles carrying supplies in tow.

The fact that this technology has military roots is by no means untypical. There is, in fact, a long history of robotics breakthroughs that have been developed for military applications.

In World War II, the remote-controlled German Goliath miniature robotic tank was used to attack tanks and destroy buildings and bridges. More recently, the U.S. military began to rely heavily on unmanned aerial aircraft to carry out missions.

The medical establishment has also benefited from technology that was originally developed for military applications. The da Vinci robot from Intuitive Surgical was originally designed for use on the battlefield. Powered exoskeletons used in physical therapy such as those made by Ekso Bionics were also originally the result of a DARPA-backed project to upgrade soldier's merely human abilities.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8, 2015.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

Do Philips and Salesforce Have a Killer App for Diabetics?

The idea behind the new app is to put information and community at the fingertips of diabetes patients.

Chris Newmarker

Philips diabetes app
"This application will help transform the daily experience that diabetes patients have," says John Wookey, executive vice president at Salesforce. (Image courtesy of Philips)

Officials at Royal Philips, Salesforce, and the Netherlands-based Radboud university medical center think they've hit on a mobile-based app and online community that could greatly help type 1 diabetes patients manage their condition.

The system will be available under pilot release by the end of the year, Philips announced this week. The idea is to give diabetes easy daily access and shareability when it comes to both their own personal health data from devices such as wireless glucose meters and activity monitors--and clinical data from their health providers.

This Is How Philips Wants to Innovate Its Way to Success

It is but the latest in a string of major moves that Philips has been making to turn around its performance and place itself at the forefront of mobile health. Philips says it plans to introduce similar systems to the diabetes app to address other chronic conditions.

To create the diabetes system, Philips and the researchers at Raboud took advantage of the Salesforce App Cloud and Salesforce's "tremendous capability to bring people together with technology," Jeroen Tas, CEO of Philips Healthcare Informatics Solutions and Services, says in a video accompanying the announcement.

"This application will help transform the daily experience that diabetes patients have," John Wookey, executive vice president at Salesforce, said in the video.

"We really wanted to create an ecosystem that put the patients in control," Lucien Engelen, director of the REshape Center at Radboudumc, said Thursday at the Dreamforce 2015 conference in San Francisco.

Besides the shared information, diabetics can get coaching guidance at home and on the go through the mobile app. The app connects to a secure online community where enrolled patients and healthcare professionals can interact via private messaging or shared posts--staying within a healthcare organization's clinical guidelines. Patients are able to get feedback from their doctors and other health professionals, using the combined data. They can also share their experiences with fellow patients, clinicians and caregivers.

On top of the Salesforce App Cloud, the system also takes advantage of Philips' cloud-based HealthSuite digital platform.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8.

Chris Newmarker is senior editor of Qmed and MPMN. Follow him on Twitter at @newmarker.

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The Value of Digital Health — Q.E.D.

The Value of Digital Health — Q.E.D.

Arundhati Parmar

Digital health is cool, no questions about that.

But does it actually work? 

One startup is aiming to answer that very question akin to a mathematical problem that is solved with a conclusive proof or  Q.E.D. -- quad erat demonstrandum.

Evidation Health -- the name is a mash up of evidence, data and validation -- based in Menlo Park, California, takes a 21st Century approach to the more traditional clinical research organization. Evidation's goal is not only to design and run studies that pull clinical data, behavioral data and contextual data, but also to leverage those to arrive at a quantifiable result of the value of digital health technologies. 

Learn more about "Using Connected Populations and Data Analytics to Quantify Outcomes for Digital Health Products," at BIOMEDevice San Jose, December 7-8.

This is important at a time when payers are closely scrutinizing new technologies. But it is especially important for digital health technologies given that the category wants to usher in a new paradigm of care but the market is still unsure of how to reimburse them.  

"I agree with you that there is a big question around incentive structures and reimbursement pathways in digital health," said Deborah Kilpatrick, CEO of Evidation Health in a recent interview with MD+DI. "Where I think we can play an important role is in the definition of very clear clinical benefit and very clear economic benefit because no matter what product class you look at in 2015 and beyond, whether its molecular diagnostics or imaging diagnostics, or a new biotech injectable or pill, no matter what you look at, there is no scenario where clinical impact, economic impact are no longer important."

Evidation employees have the right mix of consumer technology, web analytics and Big Data analytics expertise combined with the classic medtech, biotech and pharma world expertise to be able to pull this off, Kilpatrick believes.

"We come from this very mashed up set of worlds that allows us to be pretty competitive in what we are offering because we can come at problems with radically different viewpoints [that] are neither pure healthcare nor pure digital," she explained.

Other CROs also perform health economics studies and outcomes research, but Kilpatrick contends that there is more to validating a technology and quantifying it.

"What I say we do better than anybody else is the quantification of outcomes on the basis of medical data, behavioral data and contextual data," she said.

Evidation was formed in December 2014 as a joint venture between GE Ventures and Stanford Healthcare, but didn't come out of stealth mode until March. Currently, the company's customers are health plans, digital health companies and pharma companies. Sometimes large providers considering running pilot programs may also approach the startup.

"The best examples of who pays us are the health plans, the digital health companies pharmaceutical companies that are wanting to test something in a given population," Kilpatrick says. 

Humana is a customer but Kilpatrick declined to be more specific about what projects Evidation Health is conducting on the recently acquired insurer's behalf. She is also mum on who else the startup's customers are.

But Kilpatrick did offer an example of how nimble and thorough and definite its analytics engine and recruiting capabilities can be. Back in May, Fitbit, the consumer fitness wearable company filed to go public and made certain usage and marketing claims around how active and engaged its uers were. Online news company BuzzFeed approached Evidation Health to see if the startup could validate those claims.

"So within 72 hours we designed a study, deployed a study and got back [the results] - we are talking about thousands and thousands and thousands of consumers - where we basically said 'Yeah, we agree that their claims are what is going on in the marketplace.'" Kilpatrick explained.

The study was done using Evidation Health's AchieveMint platform, a website that allows users to earn rewards with the health and fitness apps they already own and use. The results were reported through BuzzFeed, which did not sponsor the study.

"Could you imagine another time where you are being asked to this in 72 hours, and you can deploy a study among 20,000 people and 6,000 people enroll and participate and have it done ..." she asked rhetorically.

The Fitbit example was for a consumer application but that same capability can be leveraged for medical technologies to arrive at a clear result related to how valuable digital health technologies across various therapeutic areas are.

"We believe that value is based upon clinical impact and economic impact and what we are able to do now which we were never able to do before is measure patient behavior 24/7," she said. Couple that with medical data and contextual data, [and we can] redefine what clinical and economic benefit mean."

Arundhati Parmar is senior editor at MD+DI. Reach her at arundhati.parmar@ubm.com and on Twitter @aparmarbb 

 [Photo Credit: iStockphoto.com user mediaphotos]

The Technologies That Are Helping Paralyzed People Walk

In the past couple of years, there have been a number of technological breakthroughs that have enabled paralyzed people to walk again with support.

Brian Buntz

It may be early yet, but there have been a number of recent advances to give paralyzed people hope that they may one day regain feeling in their limbs--and even walk. There have already been a handful of patients who have, after years or paralysis, taken a stand and in some cases walked without support.

Consider the case of Darek Fidyka, a Polish man who was paralyzed from the chest down from a severe knife wound in 2010 who, as the BBC reported, is able to walk after transplanting cells from his nasal cavity into the spinal cord. The patient reports regaining some sense of feeling in his extremities after the procedure.

In the United States, there have also been several advances at the University of Louisville, the California Institute of Technology, and UCLA using neurostimulation to help paralyzed patients regain movement. Last year, a spinal stimulator originally designed for pain treatment was used to help four patients regain some control of their legs. And more recently, UCLA has had similar results with a noninvasive approach to stimulate the spine.

Also this year, there have been news reports about the use of robotic exoskeleton technologies melded with electrical stimulation therapy. A great example Mark Pollock, who was able to walk using the technologies after being paralyzed for four years.

To learn more about advances in this area, Qmed reached out to Nick Terrafranca, CEO of NeuroRecovery Technologies (Monarch Beach, CA), who is collaborating with the the three aforementioned universities to develop unique spinal cord neuromodulator technologies.

Qmed: What are the main kinds of technologies currently available that are promising for people who are paralyzed?

Mark Pollock
Mark Pollock, who had been paralyzed for four years, was able to stand and walk using electrical stimulation and an Ekso Bionics exoskeleton. Image from Mark Pollock.

Nick Terrafranca: Current technologies to help paralyzed individuals walk can be broken down into three categories: powered devices, non-powered devices, and cell-based therapies. In the category of powered devices you have robotic exoskeleton systems such as those by Ekso and ReWalk. These motorized robotic support systems for the most part allow the paralyzed patient to gain the ability to ambulate under the power of the robotic apparatus, with little to no movement being generated by the user themselves. While these devices provide the patient the ability to ambulate and stand upright, our scientific team at UCLA, in a limited study and scientific review, has observed that they do not provide much long term or sustained benefit toward reversing muscle atrophy or regaining function.

In the category of non-powered robotic or prosthetic systems several are under development by scientific and commercial groups around the world. These non-motorized bracing systems demand more patient interaction, therefore in theory will result in some gains such as in trunk stability, muscle strength, and lessening bone loss or improving bone density (hardening).

Qmed: What about in the future?

Terrafranca: What the future holds is probably a hybrid between the two, a system which in the beginning provides or performs most of the work for the patient and later on as recovery is realized provides little to no movement and simply support.

Patient injuries vary as well as their ability to recover, so there will be a need for each one of these different devices to one degree or another.

Qmed: What is the most important goal for these technologies?

Terrafranca: Ultimately the goal would be to provide a device and/or treatment that will lead to the rehabilitation of an individual to the point where they can ambulate on their own with the use of little to no adjunctive walking aid. However, this will take some time to achieve and will more than likely involve use of a combination of therapies in series or together, such as robotics, neuromodulation, pharmaceuticals, and even stem cells.

Qmed: What can you share about NeuroRecovery's work in this area?

Terrafranca: To contribute to this effort we at NeuroRecovery have on our drawing board a system to help paralyzed individuals regain the ability to walk, but unfortunately it is in the rough prototype stage of development and years away from an attempt to making it a commercial product.

Learn more about cutting-edge medical devices at MD&M Philadelphia, October 7-8, 2015.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

Psst! Industry Has Taken over FDA

Psst! Industry Has Taken over FDA

Is Robert Califf, nominated to be FDA commissioner, too close to industry?

Jim Dickinson

By nominating cardiologist Robert M. Califf to be FDA’s next commissioner, the Obama Administration has taken a giant step away from the agency’s traditional avoidance of even the suspicion of coziness with the industries it regulates.

This is a good thing, even though shocking to the traditionalists. It owns up to the reality that FDA is now beholden to its regulated industries who have quietly “come inside” its decision-making processes to an extent that has never been publicly admitted.

Just six years ago, the industry-at-arm’s-length tradition held sway—as it had throughout FDA’s history—when Califf was passed over in Obama’s hunt for a commissioner.

The reason? The Duke University researcher of numerous drug industry clinical trials was then viewed as being too close to the pharmaceutical industry—the same reason that had for decades kept other similarly situated candidates from being chosen to lead the world’s premier health regulatory agency. New York health commissioner Margaret Hamburg was chosen instead.

Actually, her selection wasn’t the pure-as-the-driven-snow alternative to Califf that it seemed at the time. A month after being sworn in she had to recuse herself from the agency’s 2009 rulemaking on dental amalgam safety due to her prior board membership at the country’s largest amalgam distributor, Henry Schein, and divest substantial income from that and other FDA-regulated companies.

Hamburg wasn’t the first FDA commissioner to be embarrassed by being too close to regulated industry. Before her, former commissioner Andrew von Eschenbach was publicly criticized by congressional investigators over his choice of a pharmaceutical industry PR firm, Shaw Science Partners, to develop an FDA Web site for consumers about drug ads and for removing an employee without sufficient cause based on a drug company’s complaints.

And before him, former commissioner Lester Crawford was found to have concealed his ownership of stock in regulated companies while in office and agreed to pay a $50,000 fine instead of going to jail.

These sorts of distractions from FDA’s mission not only consume taxpayer dollars as they are investigated and resolved, but they detract from what has often been called the “FDA gold standard” and actually contribute to public distrust of government.

Califf’s nomination, if it isn’t stalled by political gamesmanship on Capitol Hill, offers an opportunity for public examination of the diverse ways regulated industry can and does influence FDA decision-making.

Stockholding in regulated industry is clearly prohibited by conflict of interest laws, so he will have to divest any stocks in such companies that he and his immediate family possess.

But what do you do about the more subtle forms of influence that may flow from long-held personal relationships and intellectual sympathies developed over years of research assignments with regulated companies?

As the public charges against both von Eschenbach and Hamburg indicated, the issue of at least subliminal pro-company biases in an FDA commissioner is a real one, and something that is not easily addressed by passing a law against it.

No matter how sincere a commissioner might be—and Hamburg was—in divesting him or herself from all potential appearances of possible conflicts of interest before taking on the job, suspicions will linger in the minds of people and groups ready to provoke investigations that cost taxpayer dollars.

That is exactly what seems to be developing in the case of Califf’s nomination.

In a press release, Public Citizen said the Senate should reject it because of Califf’s close ties with industry over the years. “During his tenure at Duke University, Califf racked up a long history of extensive financial ties to multiple drug and medical device companies, including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck Sharp & Dohme and Sanofi-Aventis, to name a few,” the group said. “Strikingly, no FDA commissioner has had such close financial relationships with industries regulated by the agency prior to being appointed.”

Public Citizen argued that Califf’s appointment would “accelerate a decades-long trend in which agency leadership too often makes decisions that are aligned more with the interests of industry, rather than those of public health and patients. The Senate should reject Califf and demand that the president nominate someone who has not been so closely connected to FDA-regulated industries and is therefore better suited to protect public health.”

Echoing similar concerns, National Center for Health Research president Diana Zuckerman said Califf could have a bias toward industry after working in tandem with companies that funded clinical research at Duke.

When Califf joined the agency last February as deputy commissioner for medical products and tobacco—a step widely seen as grooming him to become commissioner—Zuckerman told Time that his “interdependent relationships” may bring into question his “objectivity and distance.” In the Time article, she pointed out that research has shown that scientists may unknowingly be swayed by their industry relationships.

And such credibility- and prestige-shaking suspicions aren’t confined to choosing FDA commissioners. They are also present in the statute-sanctioned user fee process, where accusations occasionally are made that FDA employee attitudes toward sponsors have been made less skeptical and objective in a user fee-influenced internal culture evoking a “he who pays the piper calls the tune” syndrome, at least subconsciously.

Indeed, there have been complaints by FDA whistleblowers in the recent past that managers have encouraged reviewers to regard device sponsors as the agency’s “customers.”

Building “customer satisfaction” has become official CDRH policy, albeit perhaps not in those exact words. It may not be a huge step from that objective to the well-worn mantra from the world of everyday normal commerce: “The customer is always right.”

The inroads industry has made at FDA are not always viewed with apprehension, however.

Califf’s nomination was welcomed enthusiastically by Francis Collins, the director of FDA’s sister agency, the National Institutes of Health. He told The Wall Street Journal he has worked with Califf for years, and called it “a fantastic nomination. . . . I hope that Congress will respond quickly . . . He has such a wealth of experience in how to do research.”

And Friends of Cancer Research chair Ellen Sigal strongly supported the nomination, saying in a statement that her organization looks forward to working with Califf on “vital issues that directly impact patients’ lives.” Sigal said that with Califf’s “diverse background, and his exemplary knowledge of clinical and translational medicine, he will continue to improve the FDA's drug approval process while ensuring that patients are receiving the safest and most effective treatments as quickly as possible.”

FDA’s independence from the industries it regulates has throughout its 109-year history been largely taken for granted.

That has changed in recent years, obscured by the agency’s growing penchant for secrecy in its internal administrative deliberations and communications with individual product sponsors.

The Califf confirmation process in the Senate, with its arena of contestants for and against, is likely to cast a spotlight on how much of FDA’s thinking has been taken over by industry influence.

Jim Dickinson is MD+DI's contributing editor. 

Want to catch up on the latest in medical device innovation? Register for the MD&M Minneapolis conference , November 4–5, 2015.


[Image courtesy of XEDOS4/FREEDIGITALPHOTOS.NET]