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Reid Supply announces knobs and handles for harsh environments

Reid Supply Company announced today the addition of two new product lines—chrome-plated knobs and chrome-plated handles. The knobs and handles are particularly well-suited for use in harsh weather and laboratory environments, as well as for general applications on machines and equipment whose parts need frequent cleaning cycles for hygienic reasons. They also work very well in general applications on machines and equipment whose parts need frequent cleaning for hygienic reasons, as well as those using water sprays or steam. The chrome-plated surface is resistant to wear, scrapes and shocks. In laboratory tests carried out at ambient temperature (23°C), the chrome-plated surface is resistant to sea water, detergents, acetone, ethyl alcohol, formic acid, chlorine solutions.

The new knobs are glass-fiber reinforced polyamide based (PA) techno-polymer, and chrome-plated with a semi-glossy finish. The five-lobe shape of the lobed knobs offers the operator’s fingers a proper grip and prevents unhealthy residues from depositing thanks to its solid shape without cavities. Moreover the chrome plating makes the surface finish semi-glossy and homogeneous to facilitate cleaning operations.

Richard Nass

Clock Oscillator Provides Tight Temperature Stability in Compact Package

Engineers have frequently faced a dilemma when considering frequency components for medical instrumentation and other applications. A nontemperature-compensated clock oscillator, for instance, carries an affordable price tag but is not capable of very tight temperature stability. In contrast, a temperature-compensated oscillator (TCXO) offers very tight stability, but at a significantly higher cost. Looking to fill this void, Ruby Quartz LLC (Aventura, FL) has introduced the compact COM2-series nontemperature-compensated clock oscillators that feature tight temperature stability at a price point comparable to that of conventional clock oscillators.

Ruby Quartz oscillator
The compact COM2 nontemperature-compensated clock oscillator offers tight stability down to 10 PPM at an affordable price.

Debuting on the market several years ago, the first generation of the COM-series clock oscillators were designed to offer the same temperature stabilities as competing clock oscillators in a significantly smaller footprint. But simple, nontemperature-compensated clock oscillators remained limited, only getting down as far as 20 parts per million (PPM) over a temperature range of approximately -40º to 85ºC, according to Sasha Wolloch, president of Ruby Quartz. If tighter stability was required, he notes, designers would often be forced to employ pricey TCXOs, which typically feature temperature stability of 2.5 PPM and tighter. "The traditional way would probably be to go for [stability performance] overkill with the TCXO and pay for it," Wolloch comments.

Using its compact COM oscillator technology as a building block, Ruby Quartz set out to address this gap in both price and stability performance for frequency components. "Through the usage of a special integrated circuit (IC) and some programming, we are able to reduce the overall stability down to 10 PPM," Wolloch states. "At a more affordable price, [the COM2] has a tighter temperature stability than with a traditional clock but is a bit looser than with a TCXO. And the price is also more [in line with] the price of a clock oscillator than with a TCXO." The company is touting the new technology as the first free-running, nontemperature-compensated clock oscillators with such a tight stability performance over an operating temperature range of -40º to 85ºC in a frequency range of 2.5 to 55 MHz.

Like its predecessor, the COM2 oscillator also boasts an ultracompact package that measures 5.0 × 3.3 mm. Available in high-speed CMOS technology, the oscillator has an operating voltage range of 1.8 to 5 V dc at a maximum of 7.0 mA, depending on the application's frequency and stability requirements. It is RoHS compliant as well.

"This product is ideal for applications in which the designer is concerned about finding the best compromise between price and performance, where a device has to be used at temperatures higher or lower than room temperature," Wolloch says.
 

Friction Between FDA and White House Is Sign of the Times

Is FDA "hopelessly naïve" in trying to ignore the political dimension of its decisions? That's the view of the Obama administration, according to an article by Gardner Harris in the April 2 edition of the New York Times. "White House and the FDA Often at Odds" recounts some of the clashes between the agency and the Obama, Bush and Clinton administrations. A milestone for the current administration happened in the midst of the 2009 effort to craft the Affordable Care Act, writes Harris.

"The United States Preventive Services Task Force announced in November [2009] that most women should not get routine mammograms until age 50 because the risks of the X-ray screens and surgical biopsies that often follow outweighed the benefits in younger women, " writes Harris. "Although the task force did not consider cost in its analysis, Republicans charged that its recommendation was the start of health care rationing, an accusation given prominent play on Fox News. “That scared the bejesus out of everybody,” a top F.D.A. official said. The Obama administration became extremely risk averse, fearing further controversies might jeopardize the passage of health care reform, agency and administration officials said. It refused many interview requests for agency officials and scientists until the health law passed."

That is one of the few passages that deal with medical devices—most of the article references food and drug policy—but it's an interesting read nonetheless.

Moving Tissue Engineering to the Next Level by Creating Whole Organs

Moving Tissue Engineering to the Next Level by Creating Whole Organs

For lung cancer patients, lung transplants are similarly hard to come by. In 2007, 6494 U.S. patients were recipients of lung transplants. That same year, lung cancer claimed the lives of 158,683 people in the United States in 2007, according to the CDC. The situation for patients in need of liver, kidney, and pancreas transplants is similarly bleak.

perfusion decellurization
The above image from Miromatrix shows the ability of perfusion decellurazation to preserve structure of a porcine heart. 

Tissue engineering could prove to be an alternative to organ harvesting by enabling the creation of whole organs with vasculature that is intact. Typical tissue engineered products rely on angiogenesis—the body’s own capacity to regrow blood vessels from pre-existing vessels. An example of such a product are tissue scaffolds from porcine or bovine origin that have been completely decellurized. These scaffolds can be implanted in procedures such as hernia repair and breast reconstruction. The body then resorbs them.

While there are tissue-engineered products on the market that are more complex than such scaffolds, they too rely on angionesis, said Ross, who is the vice president of product development of Miromatrix Medical (Eden Prairie, MN).

A Different Approach

To engineer complex tissues, a different approach is needed than the traditional approach, which is is based on isolating cells, growing them in cell culture, and then having a matrix that they are reseeded back onto. “We are still incredibly limited in how revascularized we can create a tissue itself,” Ross said. But to take tissue engineering to the next level to create whole organs and tissues requires that they have a functional vascular network. “From early on in development, one of the first thing that grows and innervates as all of our organs develop is the vascular supply,” Ross said.

Organs, however, are, not surprisingly, complex. And engineering organs from scratch would be a feat. It would require understanding how the organ is composed, including the ratios of collagens, concentrations of the cytokines, thorough understanding of the vascular network, and so forth. “Unfortunately, we don’t understand that yet,” Ross said.

But nature is so good at creating vascularized organs, why not tap into her power to help create them? That is the strategy behind perfusion decellularization. Take an organ with natural vasculature intact, flow a solution through it that only removes the cellular material, leaving the extracellular matrix in its wake. The matrix can then have the organ recipient’s stem cells seeded back onto it.

There is a severe shortage of donated organs in the world. This image, dran from Wikipedia, shows a transplanted heart positioned in the thorax of patient.

The researchers generally use porcine organs because of their similarity to human organs and the fact that harvesting organs from that source offers tighter controls than from human cadavers. “We can get six-month-old swine each and every time, and this technology could still be used for a [human cadaver] but with a cadaver you are going to be getting tissue from 20-year olds all the way to 80 with every disease state in between,” Ross said. “From a quality control standpoint, it is going to be very variable.”

Researchers at Miromatrix have performed this procedure with a porcine heart and then reattached it back up to the vascular supply. Blood was able to flow through the heart because the vascular network is still intact.

The company has also used to process in a number of other organs, including liver, lung, kidney, and pancreas. “We can use this technology for pretty much any vascularized tissue and decellularize it,” Ross said.

 A number of different methods have been explored to recellurize tissue or organs in the procedure. “But the way that has been the most beneficial at this point, which has actually been somewhat of a surprise, is to perfuse the cells back in back through the vasculature.” When introduced in this manner, cells naturally home to their native micro-environment. “If you put in five different cell populations in the heart or the twelve cell populations in the lung, you start to find them [distributed] where you would normally find them [in nature].” This isn’t entirely surprising, Ross explained, because cells are programmed to like certain environments.

Budding Interest 

In the last four years, more than 20 publications and many major universities are investigating the use of the technology. “For the first time, it really enables tissue engineering to the next level. It is the ultimate scaffold. We’ve spent a lot of time characterizing stem cells. We know all of the surface markers, we know all of these populations, now this is a scaffold to try to sort of enable this.”

“A future without organ waiting lists is really possible, I believe.” 

Some of the early feasibility and proof of concept of the technology have been impressive, confirming the technology’s ability to preserve vascular organs’ mechanics, Ross said. In studies at, Massachusetts General Hospital (Boston) have decellurized a rat lung, perfuse cells back into it, and keep that in a bioreactor for 14 days. Afterwards, and transplant it back into a rat model and have it function for 14 days. Similar pancreas studies have also been promising. 

Miromatrix is currently investigating the use of the decellular vascularization to treat liver disorders. At present, the company is working on vascular liver grafts that could be linked up with the liver's native vasculature. 

Once such grafts are on the market, whole organs are likely to follow. 

"A future without organ waiting lists is really possible, I believe," Ross said. 

Brian Buntz is the editor-at-large at UBM Canon's medical group. Follow him on Twitter at @brian_buntz.

Voices of Frustration, Uncertainty in Medtech Election Perspective (Part III)

Advocating for Medtech Causes

Len Czuba's Hot Topic of 2012

Antimicrobials. “When I talk to companies that are developing antimicrobial products, all of a sudden it’s not FDA that they have to worry about, it’s the EPA. The EPA is concerned about what happens to the product after the useful life of the medical device—what happens to the antimicrobials once they get into the waste stream. FDA might be reasonable, but the EPA is not considered reasonable. It’s a new challenge of trying to do business in an environment where we’re now dealing with a different regulatory agency.”
 
Len Czuba is president of Czuba Enterprises Inc.
In the medtech industry, there’s been an increase in polical activism at the local level via state-based trade groups. Thompson cites groups such as Life Sciences Alley, in Minneapolis, and the Indiana Medical Device Manufacturers Council, which have substantially increased their focus on local politics and working with members of Congress, versus traditional FDA regulatory topics. California and Massachusetts are also hotbeds for state and local activity. 
 
Although industry associations AdvaMed and MDMA don’t publicly endorse candidates, they remain active in voicing their concerns of this year’s hot-button issues, namely the device tax, the economy, and investment in R&D, innovation, and job growth. Both associations remain active in working with politicians on a bipartisan level to educate them and the industry about how laws and regulations affect medical device companies and the overall healthcare industry.

Post-Election Hopes

“I think we’ll see some stability happen after the election no matter which way it goes,” Czuba says. “I think with the decision of the Supreme Court—whether the healthcare mandate is [ruled] constitutional—that will allow companies to eventually get rid of this uncertainty that we now face. I hope that if this healthcare bill doesn’t move forward that we continue to work on something that becomes a recrafted version of what we already had in place with public access of healthcare, and make it something that is a shared burden for everyone—not just the people who are paying taxes or have good insurance, but everyone that takes advantage of the system pays into it.”
 
Regardless of the outcome of the election, Bonifacio is advising companies to shift their focus to patient outcomes and cost-efficacy benefits. “The new way that devices, therapies, procedures, and services are going to be evaluated is truly going to be based on patient outcome and the cost to get to that outcome. That’s the one thing that I see as a constant coming out in the future.”

<< Part II: The Device Tax

Maria Fontanazza is managing editor of MD+DI. Follow her on Twitter @MariaFontanazza.

Voices of Frustration, Uncertainty in Medtech Election Perspective (Part II)

The Device Tax

One provision of the Obama administration’s healthcare reform law has led to one of the most heated debates in the medical device industry. The 2.3% medical device excise tax is scheduled to go into effect next year, and many medical device companies are already taking action in anticipation of the fallout. Stakeholders such as the Medical Device Manufacturers Association (MDMA) and AdvaMed are fighting to repeal the tax, because they believe it will take away from device companies’ bottom lines and thus inhibit the hiring of additional talent or investment in new product development. Many question why the medical device industry has become a target for this kind of revenue raising by government. The tax is expected to raise $20 billion over 10 years.
 
“Although everyone is accepting the fact that it’s fait accompli and are implementing long-term plans to deal with it, they don’t want it to be implemented and not be ready to cover it with their operating costs, says Len Czuba, president of Czuba Enterprises Inc (Lombard, IL). “Everyone, as I have noticed, is controlling spending, hiring, investment in new facilities and new products and new equipment; it just puts a huge damper on the industry.” The uncertainty related to how the device tax, once implemented, truly will affect companies is also putting a damper on those that want to move forward. Device companies, including Stryker, have already blamed the impending tax for forcing them to lay off hundreds of workers.
 
Peter Neumann's Top 3 Healthcare Issues of 2012

1. Budget environment
 
2. Payment reform. “If we really move people off the fee for service model into alternative models—bundle payments, accountable care, etc. that gives the decision makers a much stronger incentive to be cost conscious.”
 
3. Comparative effectiveness research, “and the degree to which we’re going to ramp up evidence generation and synthesis.”
 
Peter Neumann is director of research at the Center for Evaluation of Risk and Health at Tufts Medical Center.
“You can’t continue to have amplified regulation, amplified taxation, a compression of reimbursement threshold from CMS, amplified corporate taxes, and amplified ordinary income taxes, and expect us to continue to have an environment that lends itself well to innovation and job creation,” Buck says. “I don’t buy the argument that the United States government creates jobs; I think entrepreneurs and people create jobs. I also believe that the United States government can do things that can affect whether jobs are easy to create or hard to create.” 
 
NuVasive’s executives are vehemently opposed to the device tax and recently welcomed Mitt Romney to speak out against the tax and other issues during a visit to the company in San Diego. During Romney’s introduction, Alex Lukianov, chairman and CEO of NuVasive, emphasized the challenges faced by the company over the past few years and the curtailment of its ability to innovate due to regulatory burdens. This restriction has prevented the company from hiring as many as 150 people, Lukianov said. “With the medical device tax looming, potentially another 200 jobs would be lost in 2013,” he said at the event. “We need to do everything that we can to push back on these issues, to push back on Obamacare, to repeal it.”
 
In his speech at NuVasive Romney related to the audience by criticizing the long and arduous FDA process and said that while many devices are developed domestically, they are available in Europe much earlier. He called the burdensome regulation and impending device tax an attack on America.
 
“This is not just about the business itself being attacked—bad enough as that is—and the employees who work there being attacked—bad enough as that is— but the entire economy, all of America, slows down, and the proof is what you’re seeing in the current recovery,” Romney said. “The taxation burden and the regulatory burden that the president’s people have put in place has slowed down the recovery and made this the most tepid recovery from a recession that we’ve seen since Hoover.”
 
Romney emphasized that the device tax will not only hurt large companies, but it will also severely inhibit the growth of start-up firms. “Two-thirds of the venture capital that goes into healthcare, in the world, goes into the United States. This is one of the areas where we lead the world, and if we burden this industry by saying there is going to be a tax, even on unprofitable medical device companies—you’re taxed on your sales, not your profit—if you’re a new business starting off, unprofitable every year as you’re trying to grow... What venture capitalist is going to want to invest in an American startup as opposed to a foreign startup?”
 
Although predictions vary on what affect the election will have on the device tax, substantial changes in the White House or on Capitol Hill could create a bigger opening to repeal the device tax.
 
However, not everyone in the industry thinks the tax is as great of a concern as the state of FDA. “I would rather see more rationalized decision making at the FDA level than worry about the tax,” Adam Elsesser, CEO of Penumbra (Alameda, CA), said in a recent MD+DI article. In addition, he doesn’t believe that venture capitalists are basing their decisions on the tax.
 
“Companies need to develop a strategy that makes sense as they look at globalization of the product and the workforce,” says Jim Prutow, PRTM director in the Health Care Group at PricewaterhouseCoopers. “The device tax is one element in thinking through that strategy, but I don’t see where companies are going ahead and driving their decision making solely based on the tax. I think there’s a bit of a wait-and-see attitude about what is going to happen with this device tax.”
 

<< Part I: Frustration

Part III: Post-Election Hopes >>

 
 Maria Fontanazza is managing editor of MD+DI. Follow her on Twitter @MariaFontanazza.

Tiny Cyberplasm Robot Could Detect Illness

Putting medical diagnostic devices right into your body has been a growing trend and now a team of American and UK researchers is taking their own crack at it—and they’re taking their cue directly from nature.
 
In a project that will take place over the next few years, a team of researchers jointly backed by the American National Science Foundation and the UK’s Engineering and Physical Sciences Research Council have set out to create what they have dubbed Cyberplasm, a sort of living robot that will have electronic visual and olfactory sensors modeled after animal cells as well as artificial muscles that will be powered by glucose. Scientists are looking to model Cyberplasm after the sea lamprey (aka the vampire fish), a parasitic fish native to the Atlantic ocean that nonetheless has a simple nervous system that is both easy to mimic and provides excellent knowledge of the creature’s surrounding. In a press release, Dr. Daniel Frankel of Newcastle University, who is leading the UK-based team says, "Nothing matches a living creature's natural ability to see and smell its environment and therefore to collect data on what's going on around it.”
 
By mimicking the sea lamprey, scientists are seeking to eventually develop a nano-robot capable of navigating its way through the human body and detecting a variety of diseases.
  
So what’s a sea lamprey look like, you ask? Check out the video below to see one in action. Now imagine one swimming inside of you…you’re welcome.
 

 
 

Voices of Frustration, Uncertainty in Medtech Election Perspective (Part I)

Manufacturers want the government to foster a business-friendly environment that encourages growth, investment, and innovation. However, many stakeholders say the government is stifling these critical areas and are frustrated with the partisan approach taken by both Democrats and Republicans. The lack of an ability to find common ground regarding certain policies and the all-or-nothing approach to major decisions such as healthcare reform, has resulted in a battle over world views rather than key issues.

"The regulatory environment has gotten so arduous with all the validations and the way that a Class I, II or III device behaves in the marketplace. We’re not helping introduce healthcare reformation through innovation, we’re constraining it." --Toby Buck, chairman and CEO, Paragon Medical
“The ability to sit down and develop sensible policy inevitably through compromise on both sides just doesn’t seem to be happening anymore,” says Bradley Merrill Thompson, shareholder at Epstein Becker Green (Washington, DC). “It discourages people from getting involved, and it keeps good people from having any desire to go to Washington because the environment is so poisonous and not designed to get the will of the people done.”
 
The lack of compromise has also resulted in a much more cynical opinion of how the role of President of the United States does or does not affect the medical device industry.
 
“In a lot of quarters, there’s a fair amount of disinterest or ambivalence towards the presidential election,” Thompson says. “Who sits in the president’s office does directly impact other issues that people care about—just not so much the issues that impact the success or failure of the device industry. FDA doesn’t change radically each time the president changes or each time there’s a change in the party in control of Congress. Even with FDA changes in commissioner, it takes a long time for that to impact FDA regulation on a day-to-day basis.”
 
Regardless of who wins the election, the healthcare industry is facing a constrained budget environment, and much of its fate depends on economic growth, says Peter Neumann, ScD, director of research at the Center for Evaluation of Risk and Health. The center is located at the Institute for Clinical Research and Health Policy Studies at Tufts Medical Center. “Everyone in the device industry is going to have to think harder about the evidence they bring to the marketplace,” Neumann says. “There may be more regulatory oversight, [and] more reimbursement oversight or infrastructure with the Democrats than with the Republicans, possibly, and more decentralization with the Republicans.”
 
The industry appears to be fairly evenly split in its choice for president. In an online poll conducted by MD+DI in March, President Obama edged out Mitt Romney by less than 50 votes.
Many conservatives support Mitt Romney as the best alternative to Obama, citing his business experience with Bain Capital in the private equity industry as a positive for the device industry. Toby Buck, chairman and CEO of Paragon Medical (Pierceton, IN), says reelecting President Obama would be a big negative. He doesn’t think the current administration truly understands how the medical device industry works. “This administration simply doesn’t extend a level of deference or sensitivity to what this industry needs to operate effectively and demonstrate a high level of functional efficacy as it relates to innovation or product introduction,” Buck says. 
 
However, in a Q&A with MD+DI, Josh Makower, MD, praises President Obama’s focus on innovation and manufacturing exports, which he says are “central components of the medtech industry.”  

Healthcare Reform

In a recent report by PricewaterhouseCoopers Health Research Institute respondents (consumers) ranked healthcare as the second most important election issue, next to job creation.
 
The fate of the Patient Protection and Affordable Care Act will most likely have to wait until June, when the Supreme Court is expected to announce its ruling on the constitutionality of the bill. The Democrats love it, the Republicans hate it, and in the meantime, the device industry is trying to anticipate the affect that the 2700-page law will have on innovation, regulation, and patient care.
 
“The way our healthcare system works today, I wouldn’t say it’s broken; it just costs too much, so we have to get cost out of the game,” Buck says. “For those individuals who don’t have coverage, we’ve got to find a way to extend deference to those who are less fortunate. How that manifests in legislation is different from what is presently contemplated.”
 
Although healthcare reform is a heated debate and a largely divided issue, President Obama is being given credit for pushing this front-and-center dialogue about the need for change in the healthcare industry. “Change has to occur. We cannot continue to see the rate of healthcare inflation moving at three, four, [or] five times that of the rest of the economy,” says Mark Bonifacio, founder of Bonifacio Consulting (Natick, MA). “It’s not sustainable, and it’s going to head for a crash at some point.”

Part II: The Device Tax >>

Brad Thompson's Hot Topic of 2012: Medicare Reimbursement

"We've had significant cutbacks in diagnostics and the amount of the fee schedule changes that would be available for compensating laboratory test providers, and indirectly, and manufacturers of equipment. The recent decisions to cut back payment in that area stand to have a profound impact on our ability to get innovative diagnostics to market. People are very concerned and it’s influencing product development decisions and what products will be offered in light of those changes."

Brad Thompson is a shareholder at Epstein Becker Green

Maria Fontanazza is managing editor of MD+DI. Follow her on Twitter @MariaFontanazza.

Pilot: Just Say ‘No’ to User Fees!

It’s time for the medical device industry to “just say 'no'” to device user fees. So says longtime medical device attorney and former FDA director of medical device compliance Larry R. Pilot.

Writing in an online FDA Webview commentary, Pilot picked up from recent Senate Health, Education, Labor and Pensions Committee testimony by CDRH director Jeffrey Shuren who, when asked about the benefit of user fees when approval and clearance times are up substantially since 2009, glibly answered: “If you just throw money at it, you won’t solve it.”

Perhaps, Pilot suggested, Shuren recalled the “testimony of two small device companies in Florida during his May 5, 2011 ‘town hall’ meeting. For them, the payment of user fees was a considerable and harmful expense.”

Puzzling over the industry’s conflicting lack of both benefit from and outrage over user fees after 10 years experience with them, Pilot suggested that “there never was a problem that could be solved through the payment of user fees.”

He also noted that “what may have been good for the relatively large and profitable pharmaceutical manufacturers would not be good for the much larger numbers of small and developing start-up device manufacturers, many of whom are reportedly moving to more hospitable countries which do not have user fees.”

Pilot’s commentary recalled that the industry had initially—and successfully—opposed Democratic efforts on Capitol Hill to persuade it to follow the brand-name pharmaceutical industry in accepting user fees. The new Republican majority in the House, led by Virginia’s Thomas Bliley, conducted significant investigations into CDRH leading to meaningful regulatory reforms and the 1997 FDA Modernization Act.

The Medical Device Manufacturers Association (MDMA), Pilot wrote, “continued its opposition to user fees, because there were no facts, studies, evidence, etc. to support the need for them or any realistic expectation that user fees would solve any apparent problems. This was a sound and thoughtful approach to every reasonable discussion about user fees.”

That all changed in 2002, according to Pilot, when influential Republican senator Orrin Hatch told MDMA’s 10th annual meeting “the user fee train had ‘left the station’ and passage was inevitable. This was a disappointing surprise to many in the audience. The even greater surprise later was that leadership of the MDMA boarded the user fee regulatory train that was headed for inevitable disaster. It was wrong of the MDMA to support user fees and abandon a fundamental purpose of its existence to represent interests of the smaller, entrepreneurial members.”

“If you just throw money at it, you won’t solve it.”

Pilot’s commentary called on industry to “simply say 'no!'” to user fees, rather than accept the recently announced “FDA/industry” MDUFA agreement, “the product of a ‘go along to get along’ / ‘inside the beltway’ mentality.”

“For starters,” Pilot went on, “if very large and affluent device manufacturers want to join the pharmaceutical manufacturers (many are both) in support of making large, maybe larger, NDA/PMA user fee contributions for applications, try this as an experiment for the next five years. Relieve all the remainder of those who now are burdened by every present user fee and the administrative expenses incurred by both industry and the FDA/CDRH.

“For nearly a century, the activities of the FDA and its predecessors were supported primarily by taxpayers and all derived a benefit from the services provided by the FDA. Shuren is correct in his belief that throwing money at it won’t solve problems. Better management of resources by the FDA, greater accountability through responsible oversight, and a more creative approach to application of private enterprise resources and intelligence are realistic options.

Behind the Curtain of an Incredibly Successful Medical Device Entrepreneur | Medical Device Podcast

One of the best ways ambitious achievers can find an edge within their industry is to listen and learn from the experiences of others who have succeeded in their field. And there is certainly no disputing the incredible success of medical device entrepreneur and investor Rudy Mazzocchi, who is currently the CEO of Elenza.

Rudy's incredibly impressive medtech career includes obtaining more than 50 patents, as well as founding or co-founding 11 companies across several medical specialties including cardiology, oncology, orthopedics, neurosurgery, and embryonic stem-cell development. His latest achievement: Rudy authored a controversial medical thriller titled 'Equity of Evil' which draws on his own industry experiences.

Hopefully you'll be inspired through this interview with Rudy Mazzocchi. Better yet, apply your newfound inspiration in order to become the next lynchpin within your company!

Listen to the "Behind the Curtain of an Incredibly Successful Medical Device Entrepreneur" podcast (right click and select "Save Link As" to download the podcast).

Download the PDF action points of the "Behind the Curtain of an Incredibly Successful Medical Device Entrepreneur" podcast.