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U.S. and Mexico reach preliminary deal in revised NAFTA agreement

U.S. and Mexico reach preliminary deal in revised NAFTA agreement

NAFTA Rubik's cubeU.S. manufacturers breathed a collective sigh of relief and the stock market jumped more than 200 points at news today that the U.S. and Mexico have reached a preliminary trade deal to replace NAFTA that would benefit both countries. The deal, which President Trump wants to rename the U.S.-Mexico Trade Agreement, gives him a “win” in this particular trade dispute. Inclusion of Canada in the new agreement remains iffy, as it was not present at the table.

According to the New York Times, “many of the most significant changes agreed to by Mexico and the United States simply update the pact to take into account the rise of the internet and the digital economy since the agreement was negotiated. But Mr. Trump’s advisers have also pressed for big alterations to the rules governing automobile manufacturing, in an effort to bring more car production back to the United States from Mexico.”

Qualifying for zero tariffs under the renegotiated agreement would require that car companies “manufacture at least 75% of an automobile’s value in North America,” an increase from 62.5% in the previous trade agreement. “They will also be required to use more local steel, aluminum and auto parts, and have a certain proportion of the car made by workers earning at least $16 an hour, a boon to both the United States and Canada,” said the New York Times article.

Mexico’s automotive and aerospace manufacturing sectors are huge and growing as global companies, particularly from the U.S., have invested in manufacturing plants in that country over the past 30+ years. Foreign companies in Europe and Asia also see Mexico as a conduit for goods to North America as well as Central and South America. Mexico’s manufacturing infrastructure has risen to meet the demand for these companies, including demand for skilled workers through numerous large trade schools in major manufacturing hubs.

While many manufacturing businesses and others in agriculture have had—and still have—their doubts about Trump’s trade policies in an attempt to give the United States a “fair” global playing field, perhaps this proves that U.S. leadership can be tough and win. After all, it involves the “art of the deal.”

Could a New Gut Implant Help Curb Obesity?

Could a New Gut Implant Help Curb Obesity?

BAROnova, a venture backed company developing technologies to treat obesity, said it has submitted a premarket approval (PMA) application to FDA for its TransPyloric Shuttle (TPS) device, a non-surgical treatment option for obese patients.

The TPS device is an intragastric implant that is trans-orally placed into the stomach during a standard endoscopic procedure. The device was designed to reside in the stomach for 12 months before being removed with another endoscopic procedure. During those 12 months, the device works to delay gastric emptying, a frequently used mechanism for weight loss that helps patients feel full much quicker during meals.

“While the device resides in the stomach, it works to slow the passage of food from the stomach into the intestine by intermittently blocking and releasing the pylorus,” says David Thrower, president and CEO of BAROnova. “This is called delayed gastric emptying, which is a known mechanism for weight loss. It helps people feel full more quickly and for a longer period of time when compared to eating without the device. The TPS also does not alter the patient’s anatomy, and therefore preserves future treatment options.”

Thrower said the safety and effectiveness of the device has been evaluated in a multicenter clinical trial called the ENDObesity II study. Now that the study has been completed, the company plans to reveal the clinical findings in November at a week-long conference in Nashville known as Obesity Week — however, the company said the device was evaluated for a 12-month treatment period and demonstrated promising results. Thrower said there could also be the potential for the technology to extend beyond a 12-month period, providing a long-term treatment option unlike anything else currently on the market.

“Longer treatment duration is likely important to patients to help keep the weight off after the device is eventually removed,” Thrower said. “There are currently multiple treatments for obesity, but the most comparable current treatment is with a set of products called balloons from companies like Apollo Endosurgery and Obalon. These devices are generally thin skins delivered into the stomach via the esophagus, which are then inflated into a balloon shape with a gas or fluid. In the U.S., balloons are only approved for up to six months. If approved, we will be the only comparable gastric device in the U.S. approved for 12-month residence in the stomach, which could lead to greater and more durable weight loss for patients.”

According to the company’s PMA application, the device will be indicated for patients with a defined co-morbidity and body mass index (BMI) from 30-34.9. Any other obese patients with a BMI between 35-40 will also be eligible for the implant. With obesity rates continuing to rise in the United States, Thrower said the new TPS device could play a pivotal role for patients who seek non-surgical solutions that can treat obesity. However, technologies like the TPS device are not the only important factor when it comes to treating obesity.

“It’s important to note that technological innovation with devices like the TPS is only one part of the solution,” Thrower said. “Obesity is a huge public health issue in this country, however, very few obesity treatments are covered by insurance. In fact, none of the obesity treatments currently approved in the U.S. are covered by insurance companies. This has to change in order to address this urgent medical need in our society. Otherwise, even though good treatment options like the TPS device may exist, only a very limited number of patients will be able to afford them.”

Thrower said that without regulatory approval, the TPS device remains unavailable to patients for the time being. The company remains optimistic that with recent clinical data, BAROnova will be able to work with FDA to obtain approval and begin to market the device.

Zimmer Biomet's Latest Setback: an FDA Warning Letter

Zimmer Biomet's Latest Setback: an FDA Warning Letter

FDA sent Zimmer Biomet a warning letter in connection with the agency's April inspection of the company's Warsaw North campus. 

The company's quality control problems first cropped up in December 2016 when FDA sent the company a rather long Form 483.  The agency re-inspected the facility in April and made some additional observations, but Zimmer Biomet pushed back on some of those findings. 

"During the 2018 FDA inspection, Zimmer Biomet personnel and the FDA investigators disagreed on some technical [corrective action] topics, (or Zimmer Biomet did not provide sufficient context or explanation), as evidenced by some of the FDA-483 observations," Jeff Gensler, vice president of quality assurance and quality control at Zimmer Biomet, wrote in the company's 98-page response, which is published on its website.

This week, the Warsaw, IN-based company disclosed in an SEC filing that it recently received a warning letter from FDA related to observations stemming from the April inspection. The company said it is in the process of preparing a written response to the letter.

"While the warning letter acknowledges our quality remediation plan and actions we've already taken to address the FDA's inspectional observations, it notes violations that require additional action or explanation," the company noted in the regulatory filing. 

FDA proposed a meeting with the company to discuss corrections. The warning letter does not restrict production or shipment of products from the Warsaw North Campus facility, nor does it require any products to be recalled, the company noted.

Zimmer Biomet said it believes FDA's concerns noted in the warning letter can be resolved without a material impact to the company's financial results. 

Analysts did not seem surprised by the warning letter, given the company's previous two Form 483s.

"The letter is just the latest chapter in [Zimmer Biomet's] ongoing challenges with its legacy Biomet plant," said Mike Matson, a medtech analyst at Needham & Co. "

Could Zimmer Face a Consent Decree?

Matson said the biggest risk from the warning letter in his view is that it elevates the issues in the eyes of FDA. Further elevation of the issues could eventually lead to a consent decree, which is an agreement with FDA that is similar to a court order, he said.

A consent decree can require a company to stop manufacturing non-essential or multi-source products, assign quality assurance responsibilities to a third party, and/or pay fines. Unlike a typical warning letter, a consent decree can have a material impact on a company's fundamentals, Matson explained.

"While we think that the risk of a consent decree has probably increased, we still think it is very unlikely given [Zimmer Biomet's] significant efforts and investments in addressing the Biomet plant issues," Matson said.

Warning letters can delay FDA approvals, but Zimmer Biomet said it does not currently have any PMA applications at FDA.

Plastics packaging supplier Aripack offers anaerobic biogas additive option

Plastics packaging supplier Aripack offers anaerobic biogas additive option

Aripack graphic NEO credit

Packaging supplier Aripack (Brooklyn, NY), announced a partnership with NEO Plastics (Brooklyn), an innovative startup plastics company that offers a new option toward a zero-waste sustainability strategy that addresses the decades-long accumulation of plastics in landfills. The plastics packaging additive from NEO is designed to convert waste in landfills to useful biogas to ultimately produce sustainable clean energy. All packaged products shown in this article contain the NEO additive.

According to the Environmental Protection Agency, “landfill gas (LFG) is a natural byproduct of the decomposition of organic material in landfills. LFG is composed of roughly 50% methane (the primary component of natural gas), 50% carbon dioxide (CO2) and a small amount of non-methane organic compounds.”Aripack NEO flexibles

With the rise of LFG to Energy efforts, including the EPA’s Landfill Methane Outreach Program (LMOP), NEO Plastics support these endeavors by enabling ordinary plastics to provide after-use value. By accelerating the natural process in anaerobic landfills, the NEO organic additive unlocks the energy inherent in plastics to deliver useful biogas to waste facilities that now collect and convert this resource into clean sustainable energy. As part of a Waste to Energy (WTE) strategy, NEO Plastics’s solution in the “ALL IN” fight for a cleaner environment provides an innovative option for brands looking for sustainable packaging solutions.

The company’s organic additives are tested to ASTM standards. NEO Plastics launched in late 2017.

Aripack has been providing custom-made flexible and rigid packaging materials for a wide variety of companies and industries in North America, including food and beverage companies such as Wise, Godiva, Lesser Evil, Ricola, Fruit Bliss, Mayorga Organics Coffee and more.

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“Consumers are becoming more aware of the impact packaging has on our environment and demand a response,” explains Isak Bengiyat, Aripack founder. “Innovation is who we are at Aripack and we believe in providing our customers with options, especially when it comes to the environment. The key is creating practical solutions that add value without disruption, and we believe NEO is that solution.”Aripack Papa coffee pods

“NEO is currently available for use in a wide variety of flexibles and rigid containers,” Bengiyat tells PlasticsToday. “Because this is a new technology, we are educating people and trying to get as many people and brands on board as possible.”

The NEO organic additive can be a liquid or powder and added at to the plastic masterbatch. According to Bengiyat, the material is added to all layers of multilayer constructions.

What’s the benefit to Aripack?

“To offer our customers a new end-to-end solution in innovative packaging and sustainability,” Bengiyat responds. “Consumers can feel good about simply throwing their packaging in the regular trash bin and there is no confusion [about what’s recyclable and what isn’t].”Aripack Maplebrook dairy rigid container

Aripack has featured NEO at Snaxpo and the Specialty Coffee Show and will continue to attend relevant conferences. As with many plastics- and sustainability-related initiatives, Bengiyat points to education as the key challenge and the key opportunity.

“We have submitted press releases and will continue to work in partnership with new brands who incorporate NEO into their packaging,” says Bengiyat. “We have a small social media presence and we have a brand guidelines document that features ways to include the NEO logo on packaging.

“It’s all about getting people to hear and learn about waste to energy and NEO as an option and getting people to believe in this innovative solution.”

Wright Medical Dishes out $435M for Cartiva

Pixabay Wright Medical Dishes out $435M for Cartiva

Wright Medical Group said it has reached an agreement to acquire Alpharetta, GA-based Cartiva for $435 million and the deal is expected to close in 4Q18.

Cartiva is known for its Synthetic Cartilage Implant (SCI) and won FDA approval for the product in 2016. SCI treats arthritis at the base of the great toe is composed of a biocompatible, durable, low-friction organic polymer that functions similarly to natural cartilage and can be implanted in about 35 minutes.

Unlike fusion, Cartiva reduces joint pain without sacrificing the foot’s natural movement and retains mobility and range of motion. Due to a less restrictive rehabilitation protocol, Cartiva patients typically return to function and activities of daily living faster than patients who undergo a fusion procedure. Additional regulatory approvals have been obtained in Canada, Europe, Brazil, Chile, and Australia.

“This transaction accelerates our revenue growth and adds a differentiated PMA-approved technology for a high-volume foot and ankle procedure,” Robert Palmisano, president and CEO of Wright Medical, said during a call discussing the proposed Cartiva acquisition.

The Netherlands-based company said it expects full-year 2018 Cartiva revenues to be about $35 million, which represents about 50% growth over 2017.

“Cartiva is experiencing rapid commercial adoption currently and we believe we can significantly accelerate that adoption with our large salesforce, which is roughly double the size of Cartiva’s current salesforce,” Palmisano said. “We expect that it will be an excellent door opener for our reps and provide an opportunity to pull through sales of the rest of our foot and ankle portfolio.”

M&A Friendly Environment

There has been a great deal of M&A activity in medtech in 2018. Earlier this month, MD+DI posted a list of what some of the executives for the larger strategics in the industry were saying (during their respective earnings calls) about potential acquisitions.

Boston Scientific was on the list and on average has been picking up nearly a company a month since the beginning of 2018. Some of Boston Scientific’s acquisitions were companies the Marlborough, MA-based firm had invested in previously.

Other companies like DexCom, have targeted smaller tuck-in businesses. The San Diego, CA-based company recently announced it picked up TypeZero (for an undisclosed sum) in an effort to boost its continuous glucose monitoring offerings.

During a panel titled Top Trends in Medtech at MD&M East, an Ernst and Young analyst said it was inevitable that there would be additional mergers this year, because the conditions in the industry were very favorable.

There are also a number of potential attractive M&A companies that could be the target of such acquisitions. MD+DI recently published a report of the top 25 most attractive medtech companies on the M&A radar.

On the flip side, just as there are medtech companies hungry for M&A, there are also a number of firms eager to divest assets. Just take a look at Johnson & Johnson.

The New Brunswick, NJ-based company has been trimming the fat lately and received a $2.7 billion offer from Fortiv for its sterilization unit. The divestiture followed a $2.1 billion offer from Platinum Equity to acquire Johnson & Johnson’s LifeScan blood glucose monitoring business.

10 Disappearing Sedans

Senior technical editor Chuck Murray has been writing about technology for 34 years. He joined Design News in 1987, and has covered electronics, automation, fluid power, and auto.

 

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New Process Solves Light-Curing Issue in 3D-Printed Photo-Polymers

In an effort to improve the process of 3D-printing polymers and fabricating better materials, researchers from the Technical University of Vienna in Austria have developed a new process for developing tailored, more rugged polymers at a high resolution. Their process involves the light-curing aspect in the development of photo-polymers in a 3D-printing process. Light-curing is usually a radical-chain polymerization that splits an initiator into radicals using light energy.

A team led by Robert Liska, a professor at the university, developed an approach for tailored production of what are called methacrylate-based photo-polymers that doesn’t inhibit the curing process—something that has been a persistent issue for these types of polymers, researchers said.

Curing with Light

Many polymer-based coatings, such as varnishes, printing inks, and even tooth fillings, are cured with light. Yet this process, to date, has made it difficult to develop homogenous, tailored polymer networks. Instead, it resulted in brittle photo-polymer materials with limited use in applications such as 3D printing, biomedicine, and microelectronics.

Liska’s team has solved this problem by adding a different material to the mix—an ester-activated vinyl sulfonate ester (EVS). This material, which easily splits off one portion of itself, acts like a chain transfer agent in the light-curing process of methacrylate-based photopolymers.

In light curing, after the radicals are split, they then attack the monomer in the material, such as the C=C double bond in a vinyl group. This forms a new radical that becomes the starting point of a growing polymer network by attacking more monomers and binding to them.

tailored plastic
Researchers from the Technical University of Vienna in Austria have developed a new process for developing tailored, more rugged polymers at a high resolution. (Image source: Technical University of Vienna)

New Method

Newer methods to better control this radical photo-polymerization—as well as the material properties of the products—tend to slow the curing process. This is not the best solution for using these materials in 3D printing, which requires a short irradiation phase to accommodate high spatial resolution and economical production times.

The process developed by the Vienna team is different than others for controlling radicals in photo-polymers, as it does not inhibit the curing process, researchers said. They noted that EVS is key to this because of how it works in the radicalization process.

If the growing polymer network attacks EVS instead of the next monomer, an intermediate forms and quickly splits apart to form a terminated polymer chain in the network. It also creates what’s called a highly reactive radical (tosyl radical), which starts a new chain reaction, researchers said. The team published a paper on its work in the journal Angewandte Chemie.

Shorter Chains

The more EVS is added to the material, the shorter the average chain length in the polymer network. Shorter polymer chains remain mobile longer. This means that the process greatly reduces the danger of shrinkage cracks during curing, improving the resolution of the material. Moreover, the polymerization is not inhibited because there are no stable intermediates or reversible reaction steps involved, researchers said.

In the paper, researchers describe how they prepared a scaffold-like sample structure using a methacrylate copolymer, reporting that the resulting material is homogenous and solid, but still elastic and impact-resistant with a high tensile strength. It’s also possible to change the properties of the material to adjust the amount of EVS added. For instance, the material becomes far less brittle once EVS is added, researchers said.

The team believes that its approach paves the way for the ability to use 3D-printed photo-polymers for various applications for which they weren’t well-suited before. Some of those include opportunities in biomedicine, such as shape-memory polymers for tissue growth and tooth fillings, researchers said.

Elizabeth Montalbano is a freelance writer who has written about technology and culture for 20 years. She has lived and worked as a professional journalist in Phoenix, San Francisco, and New York City. In her free time, she enjoys surfing, traveling, music, yoga, and cooking. She currently resides in a village on the southwest coast of Portugal.

 

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Trends in Lithium Electrolytes

The continuing development of lithium ion batteries has resulted in a series of improvements in electrochemical materials. With goals of reduced price, higher specific energy, and improved safety, the electrolyte has come under close scrutiny as an area where improvements can be made. New solvents, new salts, and new additives are providing electrolyte formulations that can help improve battery performance.

Sam Jaffe, the managing director of Cairn ERA, follows the development of lithium ion electrolytes. His company provides market forecasts and strategic information to battery manufacturers and end users. Jaffe will be a speaker at The Battery Show in Novi, Michigan with a talk titled, “Electrolyte: Technology and Marketing Trends,” which takes place on September 11. Sam spoke with Design News about where the electrolyte market is today and what we can expect in the future.

Sam Jaffe
Sam Jaffe, the managing director of Cairn ERA, follows the development of lithium ion electrolytes. (Image source: Cairn ERA)

Organic Solvents

Electrolytes for commercial lithium ion batteries are made up of a mixture of organic solvents and lithium fluoride salts. The purpose of the electrolyte is to allow the mobility of lithium ions between the positive and negative electrodes during charging and discharging. “We will continue to use organic solvents for quite a while. Today, there are no real alternatives,” said Jaffe.

Despite significant improvement in the anode (negative electrode) and cathode (positive electrode) in the past ten years, the electrolytes haven’t changed very much. “Only recently have we seen measurable steps toward investing heavily in electrolyte research,” said Jaffe. “The components have been pretty steady over the last ten years: LiPF6 combined with a cyclic carbonate, a liner carbonate, and a few traditional additives. The additive space has gotten much more sophisticated in the last few years, where every battery manufacturer and electrolyte company has their ‘secret sauce’ for additives,” he added. Jaffe told us that there used to be two or three additives in an electrolyte, but now there can be as many as ten or fifteen different additives.

What’s New

“People have finally realized that the electrolyte, which used to be thought of as a non-working fluid—a medium through which the ions flowed—is actually an intricate part of making a battery. A lot of effort and time has to be put toward getting the electrolyte right if you are going to introduce anything new into the cathode or anode,” Jaffe said. 

“One of the most significant advances of the past few years is high-intensity salt concentrations or ‘solvent in salt.’ They are increasing the ratio of salt to solvent. By mixing with additives, they can dramatically increase the salt amount,” noted Jaffe. The advantages are an acceptance of higher capacity anodes and increased energy capacity because there is more electrochemical active material versus inactive material. “It’s an elaborate three-way balancing act and that’s what makes battery manufacturing hard,” he said.

According to Jaffe, the biggest determining factor in electrolyte cost is the price of the lithium that is used in the salts that are added to the solvents. The price of the solvents have remained fairly constant over the past ten years. The traditional manufacturers from Japan and Korea are recently finding competition from several Chinese manufacturers.

In addition, there are environmental concerns in the manufacturing of electrolytes that come from the use of fluorine. “Any time you use fluorine in an industrial manufacturing process, you end up with environmental concerns,” said Jaffe. This is primarily due to the extreme toxicity of the hydrogen fluoride used to make the LiPF6 salt. Once the salt compound had been synthesized, it is relatively safe to handle.

Growing Production

Jaffe told us the limiting factors for increasing electrolyte production come primarily from the time it takes to bring a plant online to make the materials. “Nobody wants to over-invest in manufacturing capacity, but also, nobody wants to miss the opportunity to be a participant in the battery boom. It’s a five to seven year lead time to build any sort of fluorinated manufacturing process with significant capacity,” he said.

“There is definitely movement in China. Companies have expanded their electrolyte and electrolyte component manufacturing capacities. There’s a lot of activity in the west—both Europe and North America—of companies that have just sat down at the poker table and are being dealt cards, but nobody has laid down their bet yet,” explained Jaffe.

Jaffe has been keeping an eye on solid electrolytes, but doesn’t think that they will be ready for prime time for at least several years. “There will be high-value niche applications within the next five years,” he said, “but they won’t be seen in vehicles for at least five to ten years.” 

Senior Editor Kevin Clemens has been writing about energy, automotive, and transportation topics for more than 30 years. He has masters degrees in Materials Engineering and Environmental Education and a doctorate degree in Mechanical Engineering, specializing in aerodynamics. He has set several world land speed records on electric motorcycles that he built in his workshop.

The Battery Show logoNorth America's Premier Battery Conference.
The Battery Show, Sept. 11-13, 2018, in Novi, MI, will feature a talk from Sam Jaffe from Cairn ERA along with more than 100 other technical discussions covering topics ranging from new battery technologies to thermal management. Register for the event, hosted by Design News’ parent company UBM.

 

Mitsui Chemicals to increase production capacity for performance elastomers

Mitsui Chemicals to increase production capacity for performance elastomers

Mitsui Chemicals wholly-owned subsidiary Mitsui Elastomers Singapore Pte Ltd, is set to raise its production capacity for its Tafmer polyolefin plastomers and elastomers (POEs/POPs). The company will add 25,000 tonnes/year of capacity at its Singapore site, thereby boosting current capacity of 200,000 tonnes/year at two lines to 225,000 tonnes/year, tentatively by July 2020.

Specialty elastomer capacity is being added by Mitsui Chemicals at it production site in Singapore.

Tafmer products are used widely in polypropylene (PP) compound modification in the auto sector. Tafmer is also seeing expanded use in solar panel encapsulants, where it is replacing ethylene vinyl acetate (EVA) resin, as well as impact modification of engineering plastics such as polyamide (PA), and in sports shoe midsoles, where it also replaces EVA resin. Another key application is heat seal applications in packaging.

The auto sector in particular is driving growth in Tafmer demand as tightening environmental regulations spur needs for lightweighting at OEMs. To satisfy this increasing demand, Mitsui Chemicals plans to remove bottlenecks at its existing Tafmer production facilities in Singapore, allowing it to increase production capacity for the elastomer series.

Mitsui Chemicals is also considering additional increases to supply capacity for Tafmer as they look to grow their business further. During a financial briefing in June, company president Tsutomu Tannowa hinted that a new Tafmer plant might be constructed in North America, China, or at the current site in Singapore.

 

 

 

Here's What MD+DI Readers Said About The Bleeding Edge

Here's What MD+DI Readers Said About The Bleeding Edge

As part of MD+DI's coverage last week of the Netflix documentary, The Bleeding Edge, we asked readers for feedback on the film and its assessment of the medical device industry. A total of 62 respondents took the three-question survey. 

1. The Bleeding Edge claims that FDA's 510(k) process, reportedly the most popular way medical devices reach the U.S. market, doesn’t require the submission of as much safety data as does the premarket approval (PMA) process. Do you believe this is a fair depiction?

Of the 62 respondents who answered this question, 48 (77.42%) said yes, and just 14 (22.58%) said no. Additionally, 25 respondents chose to explain their answer. Those comments include the following, selected to represent the full range of viewpoints:

"FDA requires evidence that any device will be clinically safe (and also effective). In the case of a 510(k), a predicate is submitted by the applicant and judged by FDA as a comparison to the device seeking marketing approval. The collective data supplied for both the predicate and the new device are judged by FDA for sufficient evidence that the new sought device will be safe. The preponderance of evidence necessary for a PMA device or a 510(k) device may be considered the same, it's just a matter of whether there's a predicate to start from. 1976 was the baseline for which predicates began. However, that was 42 years ago."

"Since its introduction in 1976, the 510(k) path for medical device approval has been perverted into a means of getting products out faster with as little regard for patient safety as possible. This is because safety testing costs time and money in the short term, even though it can cost far more in the long term. 'Never time to do it right, but always time to do it over' ... or just stop selling it if it doesn't work out, has become a feeding frenzy of medical device firms. I personally have left companies because of this obsessive attitude."

"The 510(k) process is one that measures substantial equivalence to a predicate device. The purpose of the information submitted, therefore, is to show equivalence, not safety. In addition, there is no guarantee that the predicate device is safe because there is no check for recalls or adverse event history for that predicate."

"It is true, but just in the cases where the safety of the device has been proven before, that's why you don't have to show all the evidence again. It must be important to consider that this predicate device shouldn't [have] been withdrawn previously from the market or had a series of adverse events."

"The film misrepresents the regulatory process as it seems the filmmakers themselves don't understand the process."

"That is somewhat due to the devices that are cleared via a 510(k) are lower risk than those requiring a PMA."

"I have worked for a company that was under 510(k) and then went through the PMA approval process. PMA definitely requires more safety testing and data, but in my opinion, it's still not enough. Biocompatibility studies are key, and they are not performed for long periods of time. A product could pass 510(k) requirements (or even PMA requirements for that matter), but the issue with the device won't show up for months or years after the device is used/implanted."

"A 510(k) is 'the most popular' pathway to clearance because most medical devices are classified as Class II or lower. Class II devices (those cleared through 510k) are a lower risk product by nature. They shouldn't have the same documentation burden as a Class III device (PMA)."

"Companies aren't using "grandfathered" predicates anymore. That is ridiculous to imply. The process is robust and appropriate."

"Predicate device relationships are abused. There are products approved that have very little relationship to predicates stated. Design control and design histories are laxly reviewed. You cannot add quality at the end of development it has to be continuous during development. You also can't test quality into products. The agile methods are the worst thing to happen to device development since snake oil."

2. Please select any of the following suggestions that you believe could reduce risks to patients:

A total of 58 respondents selected one or more of the listed choices, and 22 respondents provided further comment. Select comments appear below the appropriate suggestion.

This question received a total of 58 responses and four skips.

  • Overhaul the regulatory process to require more upfront safety data for 510(k) submissions – 31 (53.45%)

"Without an overhaul, it would help if surgeons and hospitals did their homework regarding device safety. Too much is taken for granted by healthcare providers and they mostly get their info from the industry. If we had publicly accessible registries, like they do in other countries, it would help. In the meantime, providers can check with UK or Australian registries if they want to see the record."

  • Require longer postmarket surveillance studies on the safety of 510(k) cleared products – 35 (60.34%)

"Longer postmarket surveillance studies (more than three years) should be the norm for Class III and anything implanted."

  • Eliminate the 510(k) process – 5 (8.62%)

"The 510(K) process is totally flawed and should be eliminated. All devices should go through a full approval, having nothing to do with being similar to an existing device."

  • Bar FDA staff from joining industry or vice versa –16 (27.59%)

"Bar medical device companies from the regulatory process making, and forbid lobbying in Washington."

  • Bar doctors from accepting compensation from medical device companies –30 (51.72%)

"Doctors who are in the employ of industry should not practice. This is a serious conflict of interest."

  • No regulatory changes are needed –5 (8.62%)

"Reducing risks to patients could be taken to the extreme point of view that no intervention is ever allowed. Our regulatory system has to use a reasonable approach to balancing risk versus benefit."

"However, some sort of maintenance of 510k's should be required. Recalled or devices that aren't marketed anymore shouldn't be allowed to be predicates for other devices. Consider a re-registration process for 510k devices like CE mark. Perhaps once every 5 years?"

  • Other

"Examples in the documentary (mesh, cobalt in implants) indicated inadequate biocompatibility or clinical studies. Depending on the situation, more is needed here. Perhaps introduce a mandatory pre-sub process?"

3. What lessons can be learned from this documentary?

"Tons of lessons: 1 - when an [adverse event] surfaces, don't rationalize it, don't brush it under the rug, use proper risk management to figure out what happened and correct it - the way the aviation industry does. 2 - Don't succumb to the greed that pervades the industry today. Timelines for product pipelines are based as much on making money as they are on helping patients with needed technology. I know: I've spent 40 years as a serial entrepreneur in this industry. 3 - Do let people know that the scenarios in this film are the exception to what is a very good (note that I didn't say excellent) safety record over the past 40 years. Don't hide from the debate - engage objectively and openly."

"Never treat a reported adverse event lightly. Some are inevitable as nothing is ever perfect, but [an adverse] event affects a person that could have been close to you. We are working in this industry because it is different, and it is different because what we do has an impact on patients' lives."

"I have three implants for different reasons. Being a biomedical engineer, I searched for my physicians and selected them on their background and track record. I also went to a reputable medical facility for my procedures, as well as researched the devices themselves. I used to think this was a bit overkill. Not anymore. And, with the Internet and the ease of obtaining information, I say there is little to no excuse for not doing this yourself before you go for medical treatment. If you don't feel you are able, get someone you trust involved to do it for you. Do not rely on TV and/or radio commercials, or go to someone only because you know them or are connected to them only personally."

"The presentation was very one-sided, but they did bring out some issues that we need to address. We know that our regulatory process is sufficient for the 510(k) pathway, but we need to respect the process and not try to get around it. We also need to police our industry more and make sure that the 'snake oil' approach is not tolerated."

"It's easy to tell the difference between a smear piece and a documentary when only one side of the story is told and the details that are shown are inflammatory. I agreed with many things in the film, but overall felt it was an unfair depiction. I don't label it a documentary.

"The FDA medical device approval process requires a complete overhaul. This will become more important as technology development surges forward. We cannot leave regulations as they were set up in the past when it comes to safety and effectiveness for a device."

"There are issues with the medical device process for sure. But what's the answer? Doing exhaustive testing for 10 years before a medical device is considered 'safe'? The company would go out of business. Right now, the best thing we have is a risk/benefit analysis where a company has to prove that the benefits to the public health greatly outweigh the risks. This documentary highlighted a few bad cases where the process failed the public. But for most medical devices, this doesn't happen. And the public is better off with them in the market.

"Is it really a documentary as Roger Moore makes, or was it just another Netflix program to boost viewership?"

"There is certainly room for improvement in the medical device industry and regulation space. That said, it is a very complex network of stakeholders, processes, and procedures. In order to improve, all stakeholders (FDA, device companies, patients, and doctors) must work together acknowledging that they have at least one common mission- and that is improving patient care. Silos and fingerpointing will not help us drive positive change."