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Articles from 2013 In April


Getting the Most Out of Medical Device Failure Analysis

Medical device failure can be disastrous if not properly analyzed to determine what happened that caused the device or device component to not work as intended. There can be various reasons a device or material could fail in the field as the recent article, "Five Common Causes of Medical Device Failure," discusses. To determine what the actual cause is for a given failure, in-depth testing must be performed by an experienced laboratory with expertise in examining failures. This article will look at a recent failure analysis project solved by Impact Analytical (Midland, MI) and will discuss how the failure was solved and some steps the company can take in the future to avoid the issue from reoccurring. The company will not be named in order to maintain confidentiality.

A medical device company had oral brushes used in endoscopic procedures and was experiencing issues with new brushes they had manufactured. The old brushes had never exhibited issues but the new brush sheathes were kinking and they needed to understand fast what was going on so they could fix the problem and move forward.

With any failure analysis project, it is important not to jump to a conclusion that you may believe is the issue. Sound analytical data must be examined in order to accurately pinpoint a cause. For this case, a variety of analytical techniques were performed in conjunction with each other to examine multiple aspects of the brush and brush material to cover all the bases and not miss any key facts that could change the verdict. Both the good and bad brush sheath material were examined for tensile strength to compare stiffness and modulus, Fourier transform infrared spectroscopy (FT-IR) for chemical structure comparison and material characterization, scanning electron microscopy (SEM) for physical fiber characterization and material characterization, differential scanning calorimetry (DSC) for crystallinity and compositional comparison, compression testing and lastly, optical microscopy for visual examinations of the failed kinked surface. Each analysis alone is like a piece to a puzzle. It is not until data is collected for each analysis and interpreted that the whole picture of the failure comes together.

Key observations of the brush sheath properties included different sheath wall thickness, cut-end deformation from the manufacturing process that resulted in a dimension diameter change, deformation of the sheath in the packaging, and a lower compressive force required to produce kinks in the sheath walls versus a good performing sheath. Testing suggested the materials exhibited only slight differences by FT-IR and thermal analysis (DSC), leaving material processing as the culprit.

When switching vendors for raw materials or components that go into your end product it is a good idea to have independent third-party testing done as a quality check for the new material in use. Even though the raw material you are ordering may be the same, different vendors can sometimes have different specs. More importantly, even though materials are specified to be the same, the material processing and tool quality can result in fabricated product differences. It's important to verify the properties of your new material or product to ensure it will behave the same as the one you are replacing. Unfortunately, not all failures can be outright avoided but by taking steps to ensure the quality of your starting materials, the likelihood of a failure in the field can be greatly diminished.

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 --Lisa Grasel is the marketing leader at Impact Analytical (Midland, MI)
 

Another Classification Kerfuffle at FDA

Another Classification Kerfuffle at FDA

In the 2012 FDA Safety and Innovation Act enacted last summer, FDA managed to persuade Congress give it new administrative-order authority over the classification of devices that were grandfathered in the pre-1976 Medical Device Amendments. Now, the agency’s effort in replacing notice-and-comment rulemaking with administrative order authority has produced three targets. 

EPI has been unsuccessful getting FDA to downgrade its Alpha-Stim electrotherapy device to Class II. Now FDA may require PMA, based on "not enough" information.

In the first week of April 2013, FDA published an incredibly dense 10-page Federal Register notice, proposing to order the reclassification of three Class III pre-amendments devices to require PMA or notice of completion of product development protocol.

These devices are the sorbent hemoperfusion devices for the treatment of hepatic coma and metabolic disturbances; the cranial electrotherapy stimulator (CES) for the treatment of depression, anxiety and insomnia; and the transilluminator for breast evaluation.

Only the directly affected companies and their lawyers were able to follow the notice, and then only after multiple readings. Industry stalwart Washington guardians, Advamed, and MDMA said not a word about it.

One of the directly affected companies swiftly expressed concern that for 14 months, CDRH has failed to correct an erroneous official position that its devices present a safety risk.

The company, Mineral Wells, TX-based Electromedical Products International (EPI) has been trying to convince the center that its CES device, Alpha-Stim, does not belong in Class III where the 1976 statute arbitrarily placed it pending future FDA reclassification. The April 4 notice represents FDA’s third attempt since 1993 to assert status for CES devices, each of the prior two being frustrated by company resistance.

Initially, FDA tried to assert on the basis of literature reviews that CES devices had a risk of causing potentially lethal seizures, but at a February 10, 2012 Neurological Devices Panel meeting, industry experts were able to show that the literature had been misinterpreted by FDA. Only two seizures had ever been reported, and these occurred before use of a CES device.

FDA ultimately dropped this justification for keeping CES devices in Class III but continued to insist that not enough was known about the devices’ safety and effectiveness to down-classify them into Class II, as their manufacturers wanted.
“Not enough known,” however, is not among the statutory definitions qualifying a device for Class III and mandating approval of a PMA, but this isn’t stopping FDA from forging ahead.

In its April 4 proposed order, the agency lists four “risks to health” from CES devices:

  • Possible worsening of the condition being treated if the device is not effective.
  • Skin irritation that may be caused.
  • Reported cases of post-treatment headaches.
  • Unknown adverse effects that potentially may occur from electrical stimulation of the brain.

Citing glowing reports from military experience with more than 1200 Alpha-Stim devices since 2005, EPI board chairman, Daniel L. Kirsch told FDA after the proposed order was published that his device does not meet the statutory requirements for Class III.

“The only manner in which FDA might argue that CES devices meet the Class III definition,” Kirsch wrote, “is if it were to assert that CES devices provide an ‘unreasonable risk of illness or injury.’” However, EPI has shown “that CES devices are safe with no unreasonable risk of injury or illness.”

Kirsch cited that from 2007 to 2011 there were approximately 8,200,000 treatments administered using EPI’s Alpha-Stim device. Among these, the only adverse events reported were 11 skin irritation events, two instances of tinnitus, one claim of panic attack, and one case of a patient’s tongue turning black (which was later found to have been due to an over-the-counter medication)—all adding up to an incident rate of .00018%.

Increasing FDA’s administrative authority, especially when done in a way that eliminates a more open process like public notice-and-comment rulemaking, is a troubling concept.

In its deeply obscured essence, the notice represents a power grab by FDA. In one fell swoop, FDASIA replaced notice-and-comment rulemaking. For decades the agency had blamed this process for inhibiting the agency’s ability to complete the required reclassification of all preamendments devices. However, as demonstrated by the CES example, FDASIA also allows FDA to hold hostage in Class III, those devices that might be candidates for down-classification.

A Hyman Phelps & McNamara legal analysis on FDASIA’s passage predicted the possibility of difficulties with recalssification. “CDRH’s perspective is that, as a result, it could now take longer to down-classify certain devices. The industry representative on the panel acknowledged that in urging Congress to require a panel prior to reclassification, industry was concerned about up-classification, and perhaps had not considered the impact on down-classifying devices.” 

Further, the report noted that CDRH “seemed unsure about how the new law will affect the progress made to date on reclassifying some of the Class III devices for which FDA has not yet called for PMAs. CDRH indicated that progress would likely be stalled, and panels would need to be called. It is not clear whether the law was intended to have this type of retroactive effect.”

Jim Dickinson writes the Washington Wrap-Up Column for MD+DI. 

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Age Plays A Big Role in Surgeries Overall and Specifically in Certain Types of Surgical Procedures (infographic)

This interesting infographic from CompHealth shows who is undergoing a surgical procedure and for what. Age plays a role of course. 

For instance, 80.5 percent of people undergoing a coronary angioplasty or an atherectomy are between 75 and 84 years old. Read on for some interesting nuggets of data regarding the 48 million surgeries that are performed in the U.S.

Surgeries by Age Group - An infographic by the team at Top Surgeries Graphic - CompHealth

By Arundhati Parmar, Senior Editor, MD+DI

 

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Edible Biosensor Could Be Used for a Range of Patient-Monitoring Applications

The ingestible biosensor would be no larger than an ordinary medication tablet.

Last year, the FDA approved Proteus Digital Health's ingestible biosensor for monitoring drug compliance. The technology blurred the line between the world of pharmaceuticals and medical devices in the way that no medical device had before. Unlike combination products such as drug-eluting stents, the device illustrates the convergence of sensors, apps, and wireless technologies exemplified by the consumer devices such as smartphone and tablets. And the swallowable Proteus biosensor is able to offer that functionality in a computing system made out of ingredients found in food: silicon, copper, and magnesium. The biosensor powers itself in a manner similar to a potato battery.

As digital health commenter David Lee Scher, MD notes, the Proteus device "provides a firm foundation for development of offshoot technologies." Now, researchers at Carnegie Mellon University are making good on that prediction by developing another edible electronic medical device. The degradable device, which is no larger than a common pill, makes use of an inexpensive non-toxic sodium-ion battery.

The biosensor developed at Carnegie Mellon makes use of a shape-memory alloy that enables it to expand once inside of the body. The ingestible biosensor could fuel drug-delivery systems or biosensors. In the former case, it could be used to deliver large protein molecules via the small intestine.

The biosensor could also serve as a platform to power electronics in various other medical devices. Similar to the Proteus smart pill, the device is made of biocompatible materials found in the human diet. Specifically, it makes use of a sodium-ion electrochemcal cell and flexible polymer electrodes. The device's battery has a lifespan of approximately one hour. It is expected to be expelled from the body within 18-24 hours after ingestion.

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

Device Tax, Fundraising Advice, Managing Growth and Eyeing Asia Mark Topics at Minneapolis Device Conference (slideshow)

At the inaugural 10x Medical Device Conference in Minneapolis, Monday, topics ranged from the medical device tax to how to look for capital in a tight funding environment, as well as strategies for rapid growth and ways to enter the Asian market.

Senator Amy Klobuchar (D-MN) and Rep. Erik Paulsen (R-MN) expressed their hope in getting the device tax repealed as part of a broader conversation about tax reform. Klobuchar said that is a great improvement from the "blank stares" she received from her colleagues when she first began to talk about a repeal of the 2.3 percent device tax.

John Eckberg, a spokesman for Cook Medical, declared that the company has shelved plans to build five factories in the U.S. because of the burden of the device tax.

In discussing how to creatively fund startups, Jim Buck, CEO of Mardil Medical, said he went overseas to Malaysia when fundraising efforts in the U.S. did not pan out.

Achieving high growth was another topic of discussion, and NuVasive's Stephan Ogilvie, VP of Corporate Development, said that the company made the strategic decision to build a distributor network who would exclusively sell NuVasive products. That very expensive decision led the firm to become a $700 million company. NuVasive is now looking to ramp up in international markets.

Looking beyond U.S. markets is key to device company growth given the demand there and how flat U.S. markets are. Ames Gross, founder and president of medical consulting firm Pacific Bridge Medical, said relationship-building is key in Asia. He said that is not a matter of having one meal at a restaurant in your partner's country. It takes time and requires cultural sensitivity on the part of the American company seeking to do business in Asia.

View a slideshow here (click on Show Info to see comments the speakers made.)

-- By Arundhati Parmar, Senior Editor, MD+DI

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In the Hunt for Capital, Don't Lose Your Head if A VC Shows Interest

This CEO of a Medical Device Firm Hasn't Drawn a Salary in Six Months

In the Hunt for Capital, Don't Lose Your Head if A VC Shows Interest

In the Hunt for Capital, Don't Lose Your Head if A VC Shows Interest

Joe Bjorklund, CEO of Insituvue

Imagine that you have been trying to raise money for a long time, but have been disappointed.

You believe you have an innovative product and money is the only thing that is preventing you from finalizing design and getting your 510(k). You are not drawing a salary because you want to save every penny and send a message to investors about how you believe in the product.Then a trusted source introduces you to a VC firm that appears to be really interested.

Get excited, but don't lose your head. And most importantly, don't forget to do your due diligence. That's the advice that Joe Bjorklund, CEO of Insituvue in Pittsburgh, gives following an experience that left a bad taste in his mouth. Bjorklund was speaking to an audience at the 10x Medical Device Conference in Minneapolis, Monday.

Bjorklund is living the situation described above as he tries to bring to market a vein illuminator that he believes can help physicians guide a needle into the arm of a patient without having to use traditional imaging techniques that aren't user friendly.

Last year, he was introduced to a northeast VC firm. He won't name the company or the venture partner involved.

"The venture firm was all hot to talk to us," Bjorklund told the audience.

He was told that a relative of the VC would be attending the meeting as well. At the meeting to which Bjorklund and Insituvue co-founders flew, the VC partner spent 30 minutes talking before leaving them with his relative for an hour and a half.

It turned out that the relative was actually the VC's brother who had a distribution business and wanted access to Insituvue's products when they would be ready to be sold.

"We were open to a distribution agreement, but only with investment," Bjorklund said, in an interview later.

But the VC wasn't interested in investing. He was only looking to help his brother out.

"We didn't do our due diligence, we didn't put two and two together," he said. "Shame on us. Your really need to ask, 'What is their business? Do we fit in their paradigm at all?"

-- By Arundhati Parmar, Senior Editor, MD+DI

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Doctor's Incomes Are Up, and Orthopedic Surgeons Earn the Most

  • HIV/infectious disease specialists, $170,000 . Up 12% since 2011.
  • Pediatricians, $173,000. Up 7% since 2011.
  • Family practice doctors, $175,000. Up 5% since 2011. 

And now for some surprises: Only half of respondents would choose medicine as a career again. And only 41% would choose the same specialty. About 52% feel they are unfairly compensated for their work. Even among those highly-paid orthopedists, only 37% would chose the job again.

It might be that the physicians are feeling the pressure as they move into a new era of healthcare reform. They don't get to spend enough time with patients, or are forced to relearn surgical procedures becuase of Accountable Care Organizations, or Hospital Groups taking brand power away. 

These practitioners will need medtech support as we move forward. The Orthotec  will be held June 5-6. During the event, Kevin R. Stone will provide the end-user’s perspective on orthopedic technologies

Heather Thompson is editor-in-chief of MD+DI. 

MD+DI Podcast: Designing The World's First Bionic Eye

In our latest podcast, MD+DI speaks with Robert Greenberg, CEO and founder of Second Sight, creators of the Argus II Retinal Prosthesis System. The Argus II has recently received FDA approval and will be available later in 2013. Greenberg talks about the over 20 years of development that lead to the creation of the world's first bionic eye, overcoming regulatory hurdles, and how creating the implant was like submerging a TV into the ocean and having it still work.

Greenberg will also be speaking at MD&M East in a Medtech Innovate Seminar. 

CLICK HERE to listen to the podcast

This CEO of a Medical Device Firm Hasn't Drawn a Salary in Six Months

Joe Bjorklund, CEO of Insituvue

Pittsburgh-based Insituvue has developed what its CEO feels is a novel vascular access device that can help doctors know what exactly they are doing when they are sticking a needle in a patient.

Insituvue has developed a handheld imaging device based on ultrasound technology that reflects the internal image of a patient's arm or other body part onto a reflective mirror thereby providing an accurate picture of the anatomy within. That contrasts with current ultrasound tools where the doctor has to look up and see a magnified image, and then look down to guide the needle.

The Sonic Flashlight, on the other hand, is a visual guide to a doctor inserting a needle in a patient that provides an accurate reflection of scale at the location where the doctor is trying to insert a needle. The image is reflected on the mirror and appears to float just beneath the skin whereby the doctors can see the veins clearly. As the company website proclaims, with the Sonic Flashlight, it' s like the doctor has X-ray vision.

The Sonic Flashlight vein illuminator

The problem is while hospitals and doctors are interested in the device, VCs think the company's needs - $2 million to $4 million - is too paltry to warrant attention, said CEO Joe Bjorklund, at an interview at the 10X Medical Device Conference in Minneapolis.

Roughly three years after being founded in 2010, the company has run out of money and has basically four to six months left before it shuts down. 

"Unless you are developing something really sexy, the VC firms aren't interested," he said of his experience trying to raise capital in the last 18 months.

Insituvue hasn't conducted any clinical trials, but the company has done a phantom study that pit the Sonic Flashlight against conventional ultrasonography

Despite the miserable experience fundraising Bjorklund is hopeful. A northeast VC fund is close to raising $100 million and Insituvue is the no. 1 on the investment list.

"If we weren't confident of raising capital we would have shut the company down" he declares. "We do it not because we like it, but because it sends a message to investors." 

"We" includes the two founders of Insituvue who also have gone without a salary for half a year.

The device, Bjorklund believes, will play particularly well under the changes wrought the Affordable Care Act.

"We have a device that we think can very directly affect the infection rates" something that hospitals are very keen to reduce.

That's of course if it survives the next four to six months. After all, Insituvue has already had one episode of being left hanging at the altar by a VC firm that committed $3 million, before it diverted the funds elsewhere Bjorklund noted. But he believes that Insituvue will get the Series A funding it is looking for from a northeast VC firm trying to raise $100 million.

"We're the no. 1 investment listed and they are using our company as an example to raise money for the fund," he said. 

If Bjorkluns is successful is raising the capital, Insituvue can move to finalize the design of the product and file for a 510(k) at the end of the year. 

Here is a video of the product that was licensed from the University of Pittsburgh where the technology was invented.

-- By Arundhati Parmar, Senior, Editor, MD+DI

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