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Articles from 2019 In May

Medtech Leaders Discuss Snakebite App and Other AI Opportunities

Medtech Leaders Discuss Snakebite App and Other AI Opportunities

At AdvaMed's recent Digital Medtech Conference, held at a conference center nestled inside San Francisco's growing UCSF Mission Bay campus, AdvaMed Chief Strategy Officer Andrew Fish asked for a show of hands: how many of your companies develop products that use artificial intelligence?

About 75% of the crowd raised their hands.

For years, many have looked to AI and machine learning as keys to transforming healthcare, medical devices included. Today, we're seeing real ground broken, especially in diagnostics and software as a medical device (SaMD).

Is AI really ready for prime time in medtech? The panelists in a discussion called "Demystifying AI" discussed the challenges that remain and the opportunities already at work.

Adjust Expectations

In 2017, Stanford researchers developed an algorithm that can recognize skin cancers with an accuracy rate comparable to dermatologists. In some cases, the machine outperformed humans. Should we expect even greater accuracy for medical devices?

The exactness needed for a medtech algorithm depends on intended use, said Sam Surette, regulatory affairs and quality assurance manager for Bay Labs, a San Francisco-based medical technology company that applies AI cardiovascular imaging. Don’t burn out your engineers in a quest for 100% perfection added Pat Baird, senior regulatory specialist and head of global software standards for Philips. Shoot for human-level accuracy first, then aim for slightly better.

Surette said to also watch for false positives and false negatives and to bring in human backup to confirm or deny the machine's numbers. "Something very unique to AI is seeing where humans can act ask risk mitigation for the algorithm," he said in a phone interview after the conference. "Is the output explainable? Can the software explain why it's making this prediction?"

Bay Labs's EchoMD AutoEF software, which received FDA 510(k) clearance in June 2018, calculates left ventricular ejection fraction, but it also provides clips used to make those calculations, Surette said. "In that setting, clinicians don't just get a number. They get the number in the context of video clips, which allows human intelligence to act as a safeguard on AI."

Train to Overcome Bias

AI-based software isn't inherently biased. But the data used to train the device might be. Many types of bias exist: confirmation bias, where the physician gives more weight to evidence that supports his presumed diagnosis; automation bias, where the clinician trusts technology to the exclusion of other evidence; and sample selection bias, which stems from data that doesn't represent the total population, to name a few.

Generally, the panelists recommended developers accommodate all variabilities when feeding data into a device. Mitigate any inadvertent human biases by including a range of genders, ages, ethnicities, shapes, and sizes. Surette describes it as training the algorithm on a sufficient number of low, medium, normal, and high disease states.

The Opportunities Ahead

Dave Saunders, chief technology officer of Galen Robotics, told MD+DI last year that non-real-time applications such as diagnostics, medical image analysis, gene sequencing, drug interaction analysis, and pre-surgical planning have the greatest potential right now.

The panel echoed that statement, noting two products authorized by FDA: iDX-DR, which uses AI to detect eye disease; and, a decision support software that detects suspected strokes.

Panel moderator Yarmela Pavlovic, a partner at Hogan Lovells who focuses her practice on medical devices and diagnostics, cited remote monitoring and at-home monitoring devices as promising opportunities, as they have the potential to keep patients out of the hospital, thus lowering our country's exorbitant healthcare costs.

The panel also discussed AI's potential to bring specialists to rural areas, as well as third world and underdeveloped countries, where experts aren't readily available. African Alliance of Digital Health Networks (African Alliance), for example, works to develop "digitally literate" healthcare workers in Africa. With training and education, more African developers can learn how to use AI to develop technology that will improve public health.

Even technologies such as iDX bring specialist services to people who may not otherwise have access. Designed and tested for use in primary care, iDX-DR can detect signs of diabetic retinopathy. If it detects more than mild eye disease, the physician can then refer patients to an ophthalmologist.

John Daley, vice president of quality assurance, privacy, and security for IBM Watson Health, mentioned an interesting concept for a serious situation—snakebites. About five million snakebites occur globally each year, causing 125,000 deaths. Administering the correct antivenom saves lives, but you have to correctly identify the snake.

Developers are working on an app that would use AI to identify the offending snake from a photo. However, this means a bitten person would have to somehow take a picture of the snake, which may not go well. An alternative method discussed involved an app that tracks the victim using their phone's GPS and then facilitates the arrival of the antivenom via drone. We Robotics has been experimenting with delivering antivenom by drone to small villages in the Amazon Rainforest.

FDA's Vision for Good Machine Learning Practices

Recognizing the potential for AI to transform healthcare, FDA is clarifying its vision for good machine learning practices (GMLP). It mentions GMLP briefly in its AI-focused discussion paper, published last month, and hopes to elaborate on the theme.

Matthew Diamond, MD, PhD, medical officer of FDA's new digital health division, who spoke at the Digital MedTech conference, described GMLP as similar to good manufacturing practices but specifically focused on the challenges presented in machine learning.

GMLP don't exist yet, but Diamond hopes the industry will share its thoughts on what that means. FDA's discussion paper ends with 20 questions for medical device manufacturers and software developers, a few of them centered on GMLP. Diamond encouraged the industry to submit responses to those questions.

FDA has received 41 responses so far. If you'd like to contribute, you'll have to hurry. The deadline for submitting comments is Monday, June 3.

Grail Presents Early Favorable CCGA Data at ASCO

Pixabay Grail Presents Early Favorable CCGA Data at ASCO

Grail has been firing on all cylinders ever since it was spun-out from Illumina three years ago. From massive clinical trials to outrageous financing amounts, the liquid biopsy specialist has not let up on meeting milestones.

The latest milestone from the Menlo Park, CA-based company is fairly positive data from the Circulating Cell-free Genome Atlas (CCGA) study. The massive study is a prospective, observational, longitudinal trial that has completed enrollment of about 15,000 people with and without cancer across 142 sites in the U.S. and Canada.

Grail presented the results during the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.

Results from CCGA show the company’s solution detected a strong signal for 12 deadly cancer types at early stages with a very high specificity of at least 99% (or a false positive rate of 1% or less). In addition, the test identified where the cancer originated in the body (the tissue of origin) with high accuracy.

The company said detection rates for the 12 deadly cancer types ranged from 59% to 86% at early stages (stages I-III). A combined analysis of this group of cancers showed robust detection at early stages (34%, 77%, and 84% at stages I, II, and III, respectively). In addition, a tissue of origin result was provided for 94% of all cancers detected and, of these, the test correctly identified the tissue of origin in 90% of cases.

The 12 pre-specified cancer types included anorectal, colorectal, esophageal, gastric, head and neck, hormone receptor negative breast, liver, lung, ovarian, and pancreatic cancers, as well as multiple myeloma and lymphoid neoplasms. Together, these cancer types account for about 63% of all cancer deaths in the U.S.

“When we set out on this journey, we knew that to be successful, a blood-based screening tool would need to detect the clinically important cancers and not contribute to overdiagnosis of indolent cancers at the earliest stages,” Rick Klausner, MD, Former Director of the National Cancer Institute, and founder and director of Grail, said in a release. “Data being presented at ASCO suggest Grail’s test preferentially detects the most lethal cancers and can detect tumors when they are still localized and amenable to successful treatment. The high detection rate of stage II cancers at 77% in the group of 12 deadly cancers is particularly compelling and supports the potential benefit of our multi-cancer approach.”

Prior to the CCGA results, Grail hit another milestone by being granted Break Through Device Designation by FDA. The designation is for an investigational next-generation sequencing blood test for the early detection of multiple cancer types in individuals 50 or older.

It wasn’t the only milestone in the liquid biopsy space however. Ahead of ASCO, Resolution Bioscience was also granted Breakthrough Device Designation from FDA for a liquid biopsy solution.

Known as the Resolution HRD, the Kirkland, WA-based company said its liquid biopsy test promises to detect sequence variations in key genes related to homologous recombination deficiency for single nucleotide variants, indels, and copy number variants.

AI+AR Equals Altoida’s Alzheimer’s Detection Solution

Pixabay AI+AR Equals Altoida’s Alzheimer’s Detection Solution

Altoida is combining artificial intelligence, machine learning, and augmented reality to help detect Alzheimer’s disease. The Houston, TX-based company has struck a chord with venture capitalists, raising $6.3 million in a series A round.

The financing was led by M Ventures, the corporate venture capital arm of the science and technology company Merck KGaA, Darmstadt, Germany, with participation from Grey Sky Venture Partners, VI Partners AG, Alpana Ventures, and FYRFLY Venture Partners.

The new capital will be used to further expand Altoida's presence worldwide with an immediate focus on commercialization activities in the U.S. and Europe markets.

Altoida said it offers healthcare professionals a novel way to objectively assess cognitive and everyday functions, in the most ecologically valid way, prior to the onset of symptoms. The firm’s digital biomarkers harness advances in technology to detect brain changes early in the disease process, helping to accelerate early diagnosis for better clinical outcomes.

Using an iPad or a Tablet accelerometer, gyroscope and touch screen sensors, Altoida is able to detect "micro-errors" as both a prognostic and diagnostic digital biomarker. The result is that medical professionals are able to detect Alzheimer's disease in patients 62+ years old between six and ten years prior to the onset of symptoms - and before irreversible damage occurs.

The company’s product analyzes visuospatial and executive function during complex activities of daily living through a battery of three tests that ask patients to hide and seek virtual objects in a physical space. Altoida said it has validated its platform and methodology in more than 12 peer-reviewed journal publications and in more than 200 independent studies. It is currently being used in clinics across the US, Europe and Brazil.

In 2019 alone, Alzheimer's disease and other dementias will cost the nation $290 billion. By 2050, these costs could rise as high as $1.1 trillion. Yet, research shows one in three dementia cases are preventable if diagnosed before permanent and irreversible brain damage occurs.

Companies and researchers have been working to detect the disease at an earlier state and help provide better treatment options for patients.

C2N Diagnostics met two major milestones in January with the development of its Alzheimer’s tests. The St. Louis-based company received breakthrough device designation for a brain amyloidosis blood test.

In addition, the firm launched its Plasma Test for Amyloid Risk Screening (PARIS) Study that is evaluating and validating the clinical diagnostic performance of the C2N brain amyloidosis blood test.

Late last year, a team from Brigham and Women’s Hospital announced their results in the development of a test that can detect tau protein. The researchers said the Tau proteins have long been a calling card for Alzheimer’s disease. But the issue is tau occurs as a family of related molecules which have subtly different properties. Investigators took this into consideration and built assays to measure the different forms of tau.

Developing an Alternative to the Snap Fit in Thermoformed Trays

Developing an Alternative to the Snap Fit in Thermoformed Trays
Image of the SEEkeyMD courtesy of SEE Forming LLC

Undercuts are often incorporated into thermoformed trays to hold medical devices with a “snap fit.” But as useful as undercuts can be in securing items within trays, working with them can be “a frustrating process for engineers and clients alike, largely since they can’t be measured, resulting in numerous sample modifications and stretched timelines,” Scott Sadowski, managing director of SEE Forming LLC, told MD+DI. So he and Mark Erickson (engineering director) developed an alternative, drawing on their decades of experience in consumer, food, and medical thermoforming.

“In my 27 years working in engineering and sales, undercuts were my nemesis, and I often thought, ‘There has to be a better way,' ” he said. “I’ve departed many meetings unsure of how to adjust a sample because a consensus could not be reached when searching for the elusive ‘perfect’ snap fit. Some would say the device was ‘too tight;’ others ‘too loose.’ I went through this process so many times with one engineer that he named the process “Goldilocks,” saying, ‘Here we go looking for Goldilocks. Then when we find her, we will lose her and start a new search when we buy the multicavity tool.’ ”

Sadowski said this engineer “was referring to a trend seen often: The customer approves and tests a single cavity with a specific undercut size but adds additional cavities when purchasing a production tool. This makes ejecting more difficult, increases warpage, and decreases run-speed. Manufacturing is then left to mitigate these problems and often reduces the pre-approved undercut size, thus reducing the locking force. (‘Losing Goldilocks again.’) At this point the customer is warned that the plastic flow will be different [fom] the original approved sample. Because the project has had so many delays by this point, the customer often feels pinched for time and is forced to settle for a less-than-ideal snap fit.”

Sadowski was also frustrated with the attribute check process for undercuts. “During this check, a person pushes a device in and out of the snaps and then checks either ‘pass’ or ‘fail.’ This causes wear not only to the test devices, but to the tools as well,” he explained. “When working as an engineer in the thermoforming market, I remade many tools because the undercuts themselves would wear the mold material. The thermoformers I worked for experimented with many other metals and hard coatings but never found a way to stop it. The polling session at HealthPack 2019 revealed 83% of medical device manufacturers (MDM) do not revalidate a package after approval. It’s absurd that the most important feature of a tray can't be (or isn’t) quantitatively measured, is known to wear, and is seldom revalidated.”

An alternative to the snap fit was in order. Sadowski and Erickson developed SEEkeyMD, a packaging system consisting of a thermoformed mold insert and an injection molded plastic key that securely locks a device into a rigid tray and can be released with the push of a finger.

The design also enables development of standardized tooling. “The capture-length of the key is seven times longer than traditional undercuts, making more universal trays possible than ever before,” Sadowski explained. “For trays that fit the basic requirements of this innovative system, one key fits all. The elimination of covers, polytubes, and foam inserts significantly reduces shipping and warehousing, while improving risk mitigation.”

The minimum thickness of the base tray is also consistent. “SEE Forming raised the key locks to the highest surface to utilize the thickest/strongest area of the form to hold the key. Using our mold insert, the draw-ratio is always the same, thus the material minimum is predetermined by the selected sheet thickness,” he said. “In contrast, the draw-ratio of a traditional undercut is never the same because the material usage above and below a snap undercut has more linear inches, which causes severe thinning.”

SEE Forming has contracted two companies to manufacture the eight mold inserts for an off-the-shelf item. “We also contracted a Class 7 injection molding company to manufacture the one-size-fits-all SEEkeyMD,” Sadowski explains. “This, too, will be an off-the-shelf item, and we will ship as soon as the order arrives. Initially we thought the MDM would load the keys much like they currently do with covers, polytubes, and foam protectors. However, MDMs are requesting for the keys to be preloaded as it speeds up assembly, eliminates space requirements, and eliminates the need to locate additional products (i.e., covers) from other boxes.”

Sadowski’s team didn’t want to hand-off labor for preloading the keys, so they worked with a couple of automation engineering firms and modified the design so the keys could be nested for a cobot to pick, insert, and retract it in each base tray. “In the redesign, an additional benefit was realized where the keys could be used to replace the stacking lug undercuts of the base trays,” he said.

SEE Forming has tested the design with a number of people. First, the packaging system was shared with a dozen people from the general public who were unfamiliar with medical devices, and Sadowski said they were easily able to release the devices from the trays. Next, the company met with 12 nurses from 8 different hospitals. “All recognized how the device was held, but five simply slid the key back with their finger instead of using the push feature,” he said. “Once the push feature was demonstrated, 100% used it correctly on subsequent packages and preferred it to other packaging methods. At this point we took samples to HealthPack for four additional nurses’ opinions, which brought the same results.

“Demonstrations of SEEkeyMD prove to be well received as innovative and unique to traditional methods,” he continued. “When presented to nurses, they studied it, used it, and then reinstalled and released the device multiple times; their interest peaked. I have yet to see this response with either of the traditional methods; they simply push the packages aside and move on. After about five minutes nurses consistently began discussing where and how SEEkeyMD would be useful in other applications. Many groaned when referring to snap undercuts, and also commented about how much material waste could be reduced by eliminating covers and switching to the new system.”

MDMs concerned about cost may be able to justify the added expense. “If a retainer is of consideration, we simply compare the weight of their current tray to our 1-gram key. Even if three or four keys are needed, the plastic usage will be significantly less,” he said.

He pointed to a potential customer’s case as an example. “One MDM is comparing SEEkeyMDto their current tray/cover project. The cover has a weight of 135 g, which we successfully sampled using four 1-g keys. The plastic reduction of 34X will save over $200K, will eliminate over 20 tons of plastic from the environment, and will eliminate 60 pallets being shipped and warehoused. Furthermore, the cost to install the system using SEEkeyMD is one quarter of a cover forming tool. It’s even easier to compare a polytube or foam insert, by subtracting the cost of our key(s) from the cost of ancillary items. However, the SEEkeyMD benefits are further realized when it is adopted across multiple SKUs, as a better price is realized with more volume.”

Interestingly, the company’s biggest hurdle may not be price, but rather the "diffusion of innovation theory," Sadowski said. “This theory states there is a very small segment called ‘early adapters’ who will become the leaders within an industry. They must have a problem, be aware that they have it, and be actively seeking a solution,” he said. “If one of these three criteria is missing, they will have a difficult time seeing the vision and associated benefits and will miss out on the innovation. This is because it’s easier to associate risk to new ideas.

“Even the best innovations had people and companies that rejected them because they could not see outside of the box of familiarity,” he added. “A great example of this is the bread slicing machine within the food packaging industry. People thought it was unnecessary because the consumer all had knives at home and could cut their own bread. After 16 years of offering the machine to bread companies, people came around to the convenience, safety, and savings of having pre-sliced bread, making “Wonder” known as a leader in the industry.”

Sadowski said SEE Forming is already “finding applications where engineering needs device security, corporate agendas mandate sustainability, and quality is requiring quantitative measurements to reduce risk. The benefits of this innovative system speak for itself. It’s also just a matter of time before the “risk of innovating” is outweighed by the risk of failing to realize the benefits incurred through the cost savings, plastic reduction, risk mitigation, shipping and warehouse storage, elimination of ancillary products, improved device security, speed-to-market, and standardized tooling,” he said. “When was the last time you bought a loaf of bread that wasn’t sliced?”

What Are 20 of the Top Tech Companies Paying Engineers?

Rob Spiegel has covered automation and control for 19 years, 17 of them for Design News. Other topics he has covered include supply chain technology, alternative energy, and cyber security. For 10 years, he was owner and publisher of the food magazine Chile Pepper.


Drive World with ESC Launches in Silicon Valley

This summer (August 27-29), Drive World Conference & Expo launches in Silicon Valley with North America's largest embedded systems event, Embedded Systems Conference (ESC). The inaugural three-day showcase brings together the brightest minds across the automotive electronics and embedded systems industries who are looking to shape the technology of tomorrow.
Will you be there to help engineer this shift? Register today!


10 Green Principles For EV Sustainability

As electrification begins to spread across the transportation sector, the way in which battery systems are developed, manufactured, used, and recycled has a significant effect on the scale of their environmental impact. Growth from just a few percent today to more than 40% of the new vehicle market within the next 10-20 years means that there is a need for a “comprehensive set of recommendations to guide mobile battery deployment and technological development from an environmental perspective.” That was the rationale behind the creation of ten “Green Principles” that were developed by researchers at the University of Michigan’s School for Environment and Sustainability under sponsorship from the national nonprofit Responsible Battery Coalition (RBC).

“We’ve seen rapid growth in electric vehicles in the last few years, and recent projections that EV growth will increase exponentially in the next decade, so the publication of these guiding principles is both timely and highly relevant,” said Steve Christensen, executive director of RBC in a news release.

EVs require different battery considerations than do stationary grid applications. UM researchers have developed “Green Principles” for both applications. (Image source: University of Michigan)

Every Part of the Lifecycle

A team led by Dr. Gregory A. Keoleian, director of the University of Michigan Center for Sustainable Systems and a member of the RBC Scientific Advisory Board, developed the “Green Principles for Vehicle Energy Storage,” which define best practices for minimizing the environmental impact of EV batteries. Drs. Maryam Arbabzadeh and Geoffrey M. Lewis conducted the research with Dr. Keoleian.

“As we look at the full lifecycle of EV batteries – from initial raw materials extraction all the way through end-of-life – it is important to examine all aspects, including how and where charging will occur, maximizing overall performance and ensuring proper recycling,” Keoleian said. The principles were published in an article in the Journal of Energy Storage on May 25. The principles are similar to those previously established by the University of Michigan stationary grid battery applications and are valid for both emerging battery technologies such as lithium-ion, and also the stewardship of existing lead-acid batteries.

Through a close interaction with diverse stakeholders that included battery manufacturers, suppliers, OEMs, recyclers, and ANL and a careful review of existing literature on design, operation, and end-of-life of mobile battery systems, the research team was able to condense the information to the current ten principles. The team understood that the principles are not immutable and that there will often need to be tradeoffs between principles as electrification continues to develop. They have however produced a set of principles that can guide analysis and inform decisions on development and deployment of battery systems for mobile applications.

Key parameters, such as type of chemistry, influences battery cycle life and thermal stability, which ultimately sustainability. Degradation of battery capacity during charging and use can result in a reduction in round-trip efficiency and environmental performance. (Image source: Center for Sustainable Systems, adapted from Figure 1 in Arbabzadeh, Lewis, Keoleian J. Energy Storage (2019))

These are the 10 Principles

The ten principles, as stated in “Green principles for responsible battery management in mobile applications” in volume 24 of the Journal of Energy Storage ( are as follows:

Principle #1: Choose battery chemistry to minimize life cycle environmental impact

Develop and select battery chemistry that enhances operational and broader life cycle performance, which ultimately drives sustainability.

Principle #2: Minimize production burden per energy service

Minimize the production burden per energy service provided by the battery system. Production burden includes material production, manufacturing, and associated infrastructure.

Principle #3: Minimize consumptive use of critical and scarce materials

Design and production of batteries should minimize the consumptive use of scarce and critical materials, since depletion of materials can constrain continued deployment of these systems.

Principle #4: Maximize battery round-trip efficiency

Maximize battery round-trip efficiency to minimize energy losses during vehicle charging and operation.

Principle #5: Maximize battery energy density to reduce vehicle operational energy

Design battery storage with maximum energy density to minimize mass-related fuel consumption.

Principle #6: Design and operate battery systems to maximize service life and limit degradation

Use charging patterns that minimize degradation by preserving battery capacity and round-trip efficiency. Temperature also impacts degradation.

Principle #7: Minimize hazardous material exposure, emissions and ensure safety

Exposure to, and emission of, hazardous materials should be minimized during production, use (operation and service), and end-of-life stages of the battery system in order to provide a safe environment for communities, workers, and users.

Principle #8: Market, deploy, and charge electric vehicles in cleaner grids

Charge EVs with cleaner electricity to lower life cycle emissions. Any grid-vehicle interaction should result in lower emissions, and cause minimum battery degradation.

Principle #9: Choose powertrain and vehicle types to maximize life cycle environmental benefits

Increasing degree of electrification from ICEV to PHEV to BEV should result in lower life cycle emissions, depending on the grid mix.

Principle #10: Design for end-of-life and material recovery

“Circular economy” end-of-life approaches (reuse, remanufacturing, and recycling) can significantly reduce environmental impacts and global demand for extracted materials.

How They Should Be Used

“These principles define and develop a solid approach to properly managing the next generation of mobile battery technologies,” RBC’s Steve Christensen told Design News. “Now we’ll continue our work with the university in 2019 to provide more specific guidance to limit battery degradation, including recommended consumer practices for optimizing battery life in electric vehicles and other consumer devices, such as mobile phones, laptop computers and cordless power tools.”

The findings behind the 10 green principles also lend themselves to educational campaigns associated with EV charging strategies to extend battery life and minimize emissions, Christensen told us. In addition, the focus on design for end-of-life and material recovery, battery round-trip efficiency, and comparisons of battery chemistries can be used by battery manufacturers and EV OEMs in minimizing the lifecycle environmental impacts.

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.


Drive World with ESC Launches in Silicon Valley

This summer (August 27-29), Drive World Conference & Expo launches in Silicon Valley with North America's largest embedded systems event, Embedded Systems Conference (ESC). The inaugural three-day showcase brings together the brightest minds across the automotive electronics and embedded systems industries who are looking to shape the technology of tomorrow.
Will you be there to help engineer this shift? Register today!


Renault, Fiat Chrysler Could Reap Product Development Benefits from Merger

A proposed merger between Fiat Chrysler and Renault would produce benefits in the area of product development, especially through the sharing of vehicle platforms and cooperation in research, experts said this week.

The merger, which would create the third largest automaker in the world, would build on the strengths of each company. Renault is one of the biggest producers of electric cars in Europe, where Fiat Chrysler’s electrification efforts have been weak. And Chrysler, with its big SUVs and pickups, provides strength in the US, where Fiat and Renault are virtually non-existent. “This is a merger where each one is bringing different things to the table,” noted Sam Abuelsamid, principal analyst at Navigant Research. “Where one has weakness, the other has strength. It’s a deal that potentially makes a lot of sense.”

Renault’s Zoe is one of the best-selling electric cars in Europe, whereas Fiat Chrysler has little or no electric presence in Europe. (Image source: Renault)

It makes sense because of scale, experts say. The ability to share would potentially enable the big new company to cut costs in the design of engines, transmissions, brakes, power electronics, electric motors, hybrid components, and many other parts. That’s especially important now, because car companies are currently being pushed by air-quality and fuel-efficiency regulations to invest heavily in technologies that are not yet producing revenue. Those technologies include highly-efficient internal combustion engines and electric car batteries, among others.

Moreover, most OEMs are now spending hundreds of millions of dollars, or even billions of dollars, on self-driving car technologies, which also produce no revenue.

“There’s a certain amount of development costs involved in doing these technologies, and it’s easier to spread it out over a larger number of vehicles,” Mike Ramsey, senior director and automotive analyst for Gartner, Inc., told Design News. “So by combining these two medium-sized players, you get one very large player.”

Indeed, the resulting company would be huge, with annual production of approximately nine million cars and trucks. In terms of overall size, it would rank behind Volkswagen AG and Toyota Motor Co., but ahead of General Motors. Moreover, if joined by Nissan Motor Co. Ltd., which is currently in an alliance with Renault, it could become the biggest automaker in the world.

“If you combine the part-sharing and development agreements that Nissan brings right now, you would have one very, very large player,” Ramsey said. But Nissan’s ultimate role in the potential merger is unknown, Ramsey added.

Combining Strengths

Whether Nissan joins or not, however, electric vehicles are expected to play a key role in the merger. Renault’s all-electric Zoe is currently one of the best-selling EVs in Europe, while Fiat Chrysler has virtually no electric presence in Europe. Recent news reports indicate that Fiat Chrysler paid nearly $2 billion in zero-emission vehicle credits to Tesla to meet its electric car obligations in Europe. That’s not a method it wants to repeat going forward, experts said.

“One area where the two companies are complementary is in electric vehicles,” Abuelsamid said. “So by combining, they can leverage what Renault has already done in electrification.”

Fiat Chrysler, meanwhile, would bring US profitability to the new company, largely due to the popularity of its internal-combustion-engine-based pickups and big SUVs. “Chrysler would be the healthy part of the business right now,” Ramsey said. “But it survives on one oddball market. The US market is a total oddity. We have giant SUVs, whereas nowhere else has them. And we have huge pickup trucks that get sold nowhere else.”

The resulting company would therefore be an assembly of pieces, each well-suited to certain global geographies. It would be a major player in South America and Europe, thanks to vehicles built by Renault and Fiat, Ramsey said. And it would have a profitable presence in the US, as a result of Chrysler SUVs and Ram pickups.

p>Still, the merger is far from being a slam-dunk business success, Ramsey said. Historically, mergers haven’t always been profitable, with participants often struggling to integrate vehicle architectures, components, and CAD systems, as well as non-technical elements, such as accounting systems, human resources, and even e-mail.

“There will be cost savings, for sure, but they won’t happen overnight,” Ramsey told us. “The problem is that mergers on paper are very different than mergers in reality.”

Senior technical editor Chuck Murray has been writing about technology for 35 years. He joined Design News in 1987, and has covered electronics, automation, fluid power, and auto.

Drive World with ESC Launches in Silicon Valley

This summer (August 27-29), Drive World Conference & Expo launches in Silicon Valley with North America's largest embedded systems event, Embedded Systems Conference (ESC). The inaugural three-day showcase brings together the brightest minds across the automotive electronics and embedded systems industries who are looking to shape the technology of tomorrow.
Will you be there to help engineer this shift? Register today

SyncThink’s Marketing Claims Raise Questions

SyncThink’s Marketing Claims Raise Questions
A recent MD+DI story raised concern among readers regarding the marketing claims made by SyncThink for its Eye-Sync technology.

Editor's Note: To address any reader confusion, we have revised the headline of this article (and that of the earlier article, now entitled Premier Lacrosse League Adopts Eye-Sync as Part of Concussion Management Protocol) and have supplemented the text below concerning the FDA breakthrough device designation and the relevance of FDA's direct-to-consumer warnings. We have posted the reader comments we received after publishing the first story in the comments section of that story.

A story MD+DI published this week about the Premier Lacrosse League (PLL) adopting SyncThink's eye-tracking system into its concussion management protocol drew criticism from several readers (some of whom may be competitors). We take all reader feedback seriously and pride ourselves on accuracy in reporting so we took a closer look at the issue and reached out to the company for comment. Here is what we learned:

  • FDA cleared the Eye-Sync platform in March 2016 for recording, viewing, and analyzing eye movements to help clinicians identify visual tracking impairment.
  • SyncThink's marketing practices landed the company in hot water in 2017. According to this FDA warning letter to the company, SyncThink was promoting the Eye-Sync device for cognitive assessment/testing of concussions and head trauma, including in injured athletes and soldiers, which FDA said would constitute a major change or modification to the device's intended use.
  • As previously reported, FDA granted SyncThink a breakthrough device designation in February 2019 for Eye-Sync. As a point of clarification for our readers, FDA's breakthrough device designation program allows companies to have more frequent and less formal interactions with senior FDA reviewers. The program is intended to expedite the development and review process of a particular device. It does not in and of itself, however, mean the device is approved or cleared for the desired indication.
  • FDA warned the public in April 2019 not to use devices or apps marketed to consumers that claim to help assess, diagnose, or manage head injuries.  However, in describing the role of Eye-Sync in at least one athletic program, Doug Appleton, SVP Business Development at SyncThink, has stated in a press release that The Premier Lacrosse League (PLL) is “backing up their ‘We the Players’ motto by bringing cutting-edge technology like Eye-Sync to their sidelines to help their medical staff assess and manage potential concussions and most importantly, ensure their players safe return to the field.” In a follow up statement to MD+DI, a spokesperson for SyncThink said that the Eye-Sync platform “must be used with a clinician. We do not market to consumers for purchase and we don’t claim to assess concussions.”
  • FDA has dedicated a page on its website to devices that are legally marketed for the assessment of head injury. SyncThink's device is not on that list.

"We appreciate your concern based on reader feedback," SyncThink said in a statement provided to MD+DI on Thursday. "The Eye-Sync platform that’s being implemented with the PLL clinicians as a part of the PLL’s concussion management protocol is FDA cleared for recording, viewing, and analyzing eye movements in support of identifying visual tracking impairments, and received breakthrough device designation recognizing that the technology has the potential to solve an important unmet need for providing objective measurements to aid in the assessment of concussion. We’ve presented our technology accurately in the press release in that the league clinicians will use Eye-Sync with a clinician to evaluate baselines and in-game assessments."

Here are a few devices MD+DI has previously covered that have received FDA clearance or approval for a concussion or traumatic brain injury:

Banyan Biomarkers' blood-based Banyan Brain Trauma Indicator test.

The Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT) and ImPACT Pediatric devices from Pittsburgh, PA-based ImPACT Applications. The ImPACT devices are computerized tools used to test a person's cognitive function after a possible concussion.

Oculogica's EyeBox concussion test, designed to remove some of the guesswork from concussion assessment. This test does not rely on a baseline measurement for comparison.

Resolution Bioscience Granted Breakthrough Device Designation from FDA

Pixabay Resolution Bioscience Granted Breakthrough Device Designation from FDA

Resolution Bioscience is the latest in a long line of firms that has been granted breakthrough device designation from FDA. The Kirkland, WA-based company received the designation for its qualitative in vitro diagnostic.

Known as the Resolution HRD, the company’s liquid biopsy test promises to detect sequence variations in key genes related to homologous recombination deficiency (HRD) for single nucleotide variants, indels, and copy number variants.

“This designation is really helpful because it allows us to have more frequent and less formal interactions with more senior people at FDA,” Mark Li, Resolution Bioscience CEO, told MD+DI. “This will expedite our development, review, and hopeful approval of the assay.”

Resolution Bioscience plans to seek approval for the Resolution HRD assay as a companion diagnostic. If approved, the Resolution HRD assay could be the first assay to detect gene deletions from cell-free DNA (cfDNA) and differentiate between single copy and biallelic (homozygous) gene deletions through a simple blood draw.

The assay would also detect biallelic loss of function through a combination of a deleterious mutation and a heterozygous deletion in the same gene.

“We’ve been working on this particular assay for three years now,” Li said. “[The assay is focused] on detecting gene deletions from blood. What most of the liquid biopsy field is struggling to do is copy number amplifications. Gene deletion is a much subtler mutation to detect. We’re basically trying to detect the absence of a signal in a highly noisy background.”

With the liquid biopsy space booming the competition can get pretty fierce. Data will be key in evaluating the effectiveness of the liquid biopsy offerings.

Recently researchers from Diana-Faber Cancer Institute presented data at the 2019 American Association of Cancer Research Annual Meeting from a study that compared Resolution Bioscience’s technology to Guardant Health’s Guardant360 test.

Results revealed that Resolution Bioscience’s assay was able to detect nearly twice as many gene fusion mutations with significantly higher allele frequencies than the Guardant360 test.

Supplier Stories for the Week of May 26

Aptar Pharma reports that its patented Freepod® nasal spray device with GlaxoSmithKline’s Otrivin® has received a Medical & Pharma category award at the World Packaging Organization (WPO) 2019 WorldStar Packaging Awards ceremony, which took place on May 15, 2019, in Prague.The drug-delivery device was recognized by the WorldStar Awards jury for its sustainability impact. The Freepod is delivered as a single component to the GlaxoSmithKline factory, resulting in 20% fewer CO2 emissions per shipping pallet owing to improved packaging, according to GlaxoSmithKline.“We congratulate GlaxoSmithKline on this prestigious WorldStar Packaging Award win," said Howard Burnett, Aptar Pharma Vice-President Global Account Management, in a news release. "At Aptar Pharma, we’re very proud that our patented Freepod technology has been recognized with GlaxoSmithKline’s Otrivin® as a deserving winner in the Medical & Pharma category of the WorldStar Packaging Award.”[Image courtesy of APTAR PHARMA]