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Articles from 2017 In January


Interest in connected health devices is growing given the potential for generating and storing meaningful data, but pharmaceutical and medical device companies do face some challenges in development and security. Tony Smith, electronics engineer, specialist medical product manager for DCA Design International Ltd., sees several benefits to connected health devices, so for successful development, he urges healthcare product companies to become aware of all the “risks and rewards” before proceeding with a connected device.He’ll speak at the upcoming Pharmapack conference titled “Why we need to think differently about connectivity” on February 1.

Will Innovation Pay The Price For Immigration Ban?

One Iranian researcher feels trapped in 'big prison called the United States of America' while another Iranian researcher is stuck on the other side, unable to get to Boston to work on precision medicine advancements at a Harvard Medical School lab.

Amanda Pedersen

San Francisco artist Naomi Alessandra created this poster of Samira Asgari to raise awareness of those impacted by President Trump's executive order preventing non-U.S. citizens of seven countries from crossing U.S. boarders. Asgari, an Iranian post-doctorate researcher, is expected to join a Harvard Medical School laboratory but was denied a flight to Boston due to her Iranian nationality.

Samira Asgari is supposed to be in Boston right now, researching cures for tuberculosis at a Harvard Medical School laboratory headed by Soumya Raychaudhuri, a rheumatologist at Brigham and Women's Hospital. Instead, she was turned away at a German airport as a result of an executive order that President Trump has termed a measure of "extreme vetting."

The action blocks citizens of Iran, Iraq, Libya, Somalia, Sudan, Syria, and Yemen from entering the United States for 90 days, even with a valid U.S. visa or green card. It also suspends entry of all refugees for 120 days and bans Syrian refugees indefinitely.

Stories of people like Asgari impacted by the ban inspired a San Francisco artist to put a human touch on the issue. "As an artist, I generally paint people," Naomi Alessandra told Qmed. "I feel that humans can more easily relate to others when there is a face, name, and real-life story attached to a news story."

So when she heard about the ban and decided to take part in protests at San Francisco International Airport, 

Alessandra wanted to her poster do just that--tell a true story about an individual "that was needlessly, unfairly suffering because of this atrocious executive order," she said. "It felt more personal than just writing a slogan on a sign."

First, Alessandra created a poster featuring Asghar Farhadi, whose film "The Salesman" is nominated for an Academy Award for best foreign-language movie, but won't be able to attend the Academy Awards ceremony next month because of the president's executive order. "And that hits at the heart of the matter," she said. "We are losing valuable people and treasured cultural connections through this ban."

Next, Alessandra found out about Samira Asgari, who took to Twitter over the weekend after she was blocked from getting on a flight from Germany to Boston as a result of executive order. "I was pretty excited to join [Raychaudhuri's] lab, but denied boarding due to my Iranian nationality. Feeling safer?" Asgari tweeted.

"Her vivid intelligence and youthful spirit made her an ideal character to paint, as all of that came through in the photos that I found online," Alessandra said. "That she is unable to come and be part of critically important medical research at Harvard is a travesty. Her work is doing good in the world for humanity, and she is shut out because of this inane order that discriminates against her on the basis of her Iranian nationality. It's unconscionable for us to go on as normal when she and so many others cannot be free to do their critically important work."

The artist participated in protests at San Francisco International Airport on Saturday and Sunday, an experience she described as empowering. "It was awesome to see so many out there in a show of support and strength," Alessandra said. "The best part of the days for me were my conversations with Iranian nationals or people with Iranian roots who knew of one or both of the people on my signs. They were moved to see these humans with whom they were familiar, and I was able to hear their specific stories, which gave me greater insight into the situation."

While Asagri is locked out, another immigrant researcher feels locked in. "I'm living in a big prison called the United States of America," said Ehssan Nazockdast, a physicist who specializes in fluid dynamics at New York University.

The Iranian citizen had planned to attend his sister's wedding in Tehran in March, but is now afraid to leave his American wife and children for fear of not being able to come back.

The academic community was quick to react to the executive order over the weekend. In a letter to the Harvard Medical School community, George Daley, the dean of the school, said the impact of the executive order on faculty, students, and staff has the potential to resonate far into the future, "and to alter how we work with colleagues around the globe, and how we care for international patients."

Ivy League schools like Harvard are known for attracting scholars, physicians, and scientists from around the globe. "Collaboration among scholars from throughout the world contributes greatly to positive change in medicine, science, society, and humanity," Daley wrote.

What Do You Think?

Amanda Pedersen is Qmed's news editor. Reach her at

[Image credit: Naomi Alessandra] 

New Charges for Ex-Starkey Execs

A superseding indictment adds filing false tax returns to the existing charges faced by former Starkey executives accused of stealing $20 million from the company.  

Nancy Crotti

Two fired executives of hearing aid manufacturer Starkey Laboratories face new charges in a federal embezzlement and fraud case.

The U.S. Department of Justice this week accused former Starkey president Jerry Ruzicka and former chief financial officer Scott Nelson of filing false tax returns. Ruzicka and Nelson were charged in September 2016 with running a complicated conspiracy that stole $20 million from the Eden Prairie, MN, company over nine years.

Don't miss the MD&M West conference and expo, February 7-9, 2017.

Former Starkey human resources senior vice president Larry Miller, as well as two friends of Ruzicka--Jeffrey Taylor, former president of miniature parts supplier Sonion, and Lawrence Hagen, were also charged in the original indictment.

A superseding indictment filed Wednesday charges Nelson with claiming a false tax deduction of $12.9 million on behalf of Starkey for 2013. The deduction covered allegedly fraudulent payments by Starkey subsidiary Northland Hearing of more than $15 million in restricted stock to Ruzicka, Nelson, and to a person identified only as J.L. in the indictment. Ruzicka, Nelson and several others were fired by Starkey in 2015.

The new charges also claim that Ruzicka's actual gross income was "substantially higher" than the $792,693 he claimed in 2011, and the $1,721,089 he claimed in 2015. Nelson is accused of reporting income of $567,979 in 2015, also much lower than his actual income, the indictment says.

The new charges shed additional light on the lengths to which Ruzicka and Nelson went to conceal their misconduct, Starkey spokesman Jon Austin said in an email.

"According to the indictment, one of the false tax returns--used to cover up the timing of payments on a $15 million theft--'had the effect of depriving Starkey of a significant tax benefit' of more than $14 million which our subsidiary could have claimed as a future deduction," Austin added. "The indictment therefore explains how these individuals - in an effort to aid their cover-up - victimized Starkey again by making the company pay more taxes than are owed."

Attorneys for Ruzicka and Nelson did not respond to messages seeking comment.

According to theoriginal indictment, the alleged theft was accomplished through a number of strategies:

  • Ruzicka and Taylor created a fake company called Archer Consulting that that received "commission" payments for supposed sales of hearing aid components from Sonion to Starkey. By 2010 the commission payments were reclassified as "consulting fees," with Starkey paying Archer Consulting $75,000 per month. Ruzicka and Taylor were able to steal $7.65 million through the setup, according to the indictment.  
  • Ruzicka, Taylor, and Hagen controlled two dummy entities called Claris Investments and Archer Acoustics. Taylor falsely told others at Sonion that the two entities were Starkey affiliates, allowing the entities to buy discounted components that could then be sold to other companies at a profit. The scheme pulled in $600,000 in profits. ?
  • Starkey's founder, principal owner, and CEO Bill Austin had created an affiliate called Northland USA in 2002 that acquired and operated retail hearing aid establishments. Ruzicka and Nelson are accused of forging Austin's signature in order to transfer Northland USA's assets to an entity they controlled, called Northland Hearing Centers. Ruzicka and Nelson ended up awarding themselves restricted stock, paying themselves and another individual $15 million to in exchange for terminating the restricted stock grants. ?
  • Ruzicka gave himself and others bonuses, concealing the bonuses from Austin by falsifying compensation reports. ?
  • In 2014, Ruzicka supposedly embezzled $200,000 in "officers insurance," using the funds to pay for his state and federal income taxes. ?
  • Ruzicka, according to the indictment, took the 2011 Jaguar that the company allowed him to use and transferred ownership to himself. ?
  • The indictment also claims that Nelson took $200,000 and used it to buy a condominium where could engage in a secret relationship with a Starkey employee. Nelson also stole $250,000 to restore his investment account after buying a home in Prior Lake, MN. ?

Nancy Crotti is a freelance contributor to Qmed.

[image courtesy of ACTIVEDIA/PIXABAY.COM]

Microscopic ‘Submarines’ Could Treat Stomach Disease

Researchers have designed tiny micromotors that can independently navigate through the stomach neutralizing gastric acid before releasing drugs at a desired pH level.

Kristopher Sturgis

This graphic demonstrates how the tiny submarines work to neutralize gastric acid in the stomach.

Delivering drugs to the stomach could become a much easier task thanks to a new study out of the UC San Diego Jacobs School of Engineering where nanoengineering professors have designed a new microscopic "submarine" drug carrier that can navigate the harsh, acidic conditions of the stomach. The tiny micromotors were designed to speed independently through the stomach using gastric acid as fuel and neutralizing it, before releasing a drug payload once the desired pH is reached.

The micromotors are tiny magnesium spheres only 20 micrometers in size that are coated with a nanolayer of gold. Embedded in the micromotors is a pH sensitive polymer designed to release the drugs when a certain pH level activates the polymer.

In their most recent study, the group was able to embed the polymer coating with a dye known as rhodamine 6G as a model payload. The magnesium spheres were placed on a glass support during the coating process, where a tiny individual spot on the core of the sphere was left uncoated. In this uncoated spot, an electrochemical reaction occurs that consumes protons and forms magnesium ions that release tiny bubbles of hydrogen gas.

These bubbles are what propel the tiny submarines through the stomach, while at the same time neutralizing the gastric acid. After less than 20 minutes in the stomach, the surrounding environment reaches a neutral pH value, whereupon the polymer dissolves and releases the drug payload. The micromotors are entirely biocompatible so they can dissolve naturally into the body, and researchers say that normal pH value is re-established in the stomach within 24 hours.

We have seen something similar in the past when it comes to polymer materiasl designed to respond to pH levels in the stomach. In 2015 researchers from MIT designed a pH-responsive polymer gel that could be used to coat capsules and aid in drug deliveries to the stomach. The polymer gel was designed to be used in combination with drug delivery systems to enable orally-administered drugs with extended-release capabilities.

However this new method aims to not only provide a drug delivery system that can release drugs with more precision, but it also the first design that makes use of gastric acid rather than fighting against it. Gastric acid is produced in the stomach to protect from pathogens and promote digestion, but it can break down orally administered pH-sensitive drugs before they reach their desired destination. Some of these drugs can be coated with proton pump inhibitors that can block the production of gastric acid, but over time this can lead to headaches, diarrhea, and other harmful side effects.

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For years coating drugs with gastric-resistant substances has been used as a workaround for some of these issues, but it doesn't solve the problem for drugs that need to be activated in the stomach itself. These new microscopic submarines help address all of these issues by navigating to the stomach using gastric acid as fuel before releasing its payload.

As they move forward with their research, the nanoengineers from UC San Diego hope that this new technique can be used to address many of these longstanding issues in a simple-to-use drug delivery method. The group believes the method could soon be used to treat stomach ulcers, as well as a variety of different bacterial infections in the stomach. In time, the group aims to refine the method so that it can be used to treat virtually any stomach disease that responds to acid-sensitive drugs.

Kristopher Sturgis is a contributor to Qmed.

[image courtesy of WILEY ACADEMICS]

Medtech Analyst Predicts M&A Will Keep On Rolling

Canaccord Genuity analyst Jason Mills predicted that medtech's M&A roll will continue to gain speed over the next two to three years.

Canaccord Genuity analyst Jason Mills predicted that medtech's M&A roll will continue to gain speed over the next two to three years.

Thick Like Thieves: The Global Specter of Medical Device IP Theft

Thick Like Thieves: The Global Specter of Medical Device IP Theft

Theft of intellectual property is a real threat in the medical device industry, and cybersecurity is only the first step to protecting precious IP.

Bart Reitter

When we speak with our medical device customers around the world, one of the issues foremost in their minds is the potential for intellectual property (IP) theft. In an industry so heavily dependent on innovation, device companies go to great lengths to safeguard their competitive advantages as each passing year brings new rivals, novel solutions, and greater potential for theft. Whether entering a new market, incorporating connected products to their existing solutions or expanding their distribution network, IP concerns are ever present.

It's a valid concern, as the economic damage of IP theft is estimated at over $300 billion per year. This total includes software piracy, counterfeiting, trademark violations, and other forms of purloined IP. A significant amount of theft comes from China, according to the IP Commission Report, as well as from other countries that lack judicial infrastructure to enforce existing laws. In addition, there have been some cases of government-sponsored efforts to acquire trade secrets in order to facilitate economic growth. The exact figures for each industry and type of theft are hard to estimate because many companies are reluctant to report instances, due to concerns about the effect on valuations or stock prices. One thing is certain: medical device companies need a multi-faceted approach to protect their IP.

Learn about "Merging Product Data: What's Next After the Acquisition Closes" at MD&M West in Anaheim, CA, February 7-9.

Theft via hacking has become a real threat for IP-driven industries. In 2014, medical device giants, Medtronic, St. Jude, and Boston Scientific, were all infiltrated. These attacks did not result in any compromised patient information, suggesting the aim was stealing intellectual property. That same year, for the first time, known state actors were charged for hacking, according to the Department of Justice. The defendants allegedly conspired to steal information from U.S. companies that would benefit their competitors in China, including some Chinese state-owned enterprises. In 2015, the Obama administration made a pact with the Chinese government to reduce the amount of hacking. This curtailed activity from China to U.S. companies, but resulted in an increase from China into other countries, according to reports from cybersecurity leader FireEye.

These cases suggest that IP cyber threats are a major source of concern, not only from established competitors or agents working on behalf of foreign entities, but also from within. As recently as last year, the FBI indicted a man of stealing secrets from Covidien and Edwards Life Sciences. According to news reports, he allegedly stole more than 10 trade secrets on medical devices, and cost millions in research and development while employed by the companies. His alleged approach was to download documents from a work computer, and then send them to his personal email account, with the intent of establishing his own company in China.

A similar case in 2014 involved an Indian national who worked for CR Bard, and later Becton, Dickinson (BD). According to the FBI, through his work at Bard and BD, he was able to steal secret information related to the companies' products, including Bard's development of the first implantable port used for power injection of drugs throughout the body. He also had access to secret information related to a self-administered disposable pen injector still under development by BD, but not yet available for commercial sale.

The approach in this case was similar, in that he downloaded product information from company computers and forwarded it to his personal email accounts. He downloaded approximately 8000 files, enough information to mass produce BD's new pen injector. His hard drives were discovered in a rental car and a hotel room where he stayed while planning to move back to India, according to the FBI.

Theft of trade secrets by employees isn't limited to foreign nationals. In 2015, a former St. Jude vice president was charged with stealing trade secrets in Minnesota. After being put on administrative leave by St. Jude for allegedly misappropriating more than $10,000 via a corporate credit card, he allegedly downloaded onto personal devices more than 4600 work files, including St. Jude's highly-sensitive 2014-2018 strategic plan, marketing planning documents, and new medical device concepts.

These cases illustrate the fact that medical device manufacturers need to take precautions to defend themselves from all types of IP theft. Focusing on cybersecurity without taking precautions to guard against internal theft would be like locking your front door, and leaving your back door wide open. In truth, cybersecurity is only the first step to protecting precious IP.

Companies also need procedures for identifying and securing sensitive data or information, especially if they have complex supply chains that could render that data vulnerable. It's not uncommon for organizations to have documents, patents, design drawings, and other confidential data reside across multiple servers or computers that are accessed by dozens or hundreds of employees, each of which is a potential point of risk. There are a number of commercially-available data protection solutions to ensure corporate IP safeguarding policies are enforced.

Personnel screening is critical as well, and should include performing background investigations on anyone hired for positions that involve proprietary information. Organizations can also add independently-validated integrity tests to their hiring processes. These are personality assessments, administered electronically in the employee application process, that measure traits such as conscientiousness and emotional stability. Another way to prevent theft is to run credit checks on employees before they are hired to ensure they don't have dire financial situations that could push them to steal.

Whatever strategy is chosen, IP security and protection should be foremost in the minds of medical device executives. Their very future could depend on it.

Bart Reitter is the director of life sciences at Santa Barbara, Calif.-based manufacturing enterprise resource planning (ERP) software company QAD, Inc. (NASDAQ: QADA) (NASDAQ: QADB). He can be reached at


Alere Refuses To Fold On Abbott Deal

Alere still isn't ready to fold, but Abbott is long past ready to walk away from the $5.8 billion deal the two companies agreed to a year ago.

Amanda Pedersen

In business, as in life, it's important to "know when to fold 'em," as Kenny Rogers put it in his 1978 hit "The Gambler."

But that advice isn't always easy to follow, especially when there's a $5.8 billion deal at stake.

Keep track of who's buying, selling, and spinning off with our list of medtech mergers and acquisitions of 2016!

Alere CEO Namal Nawana reassured investors this week that the company remains "highly confident" that its merger with Abbott will close according to the terms of the agreement the two companies signed nearly a year ago.

Waltham, MA-based Alere said the European Commission recently cleared the acquisition, which Nawana said marked "a significant milestone" toward completing the transaction.

But Illinois-based Abbott is still doing everything it legally can to walk away. The company filed a complaint in early December to terminate the deal, citing "numerous damaging business developments" that made Alere a less valuable asset.

"We continue to work through the steps necessary to gain regulatory approvals, as is required, but Alere clearly is not the company we agreed to buy and [we] look forward to showing why that constitutes a material adverse event in court," Scott Stoffel, an Abbott spokesperson, told Qmed on Friday.

Abbott initially agreed to acquire Alere for $56 a share in late January 2016. Alere makes diagnostics for infectious diseases, including HIV, dengue fever, tuberculosis, and malaria. But Abbott's enthusiasm for Alere didn't last long.

Alere revealed in March that it had received a grand jury subpoena from the U.S. Department of Justice related to its sales practices for 2013 through 2015 in Asia, Africa, and Latin America, and to matters related to the U.S. Foreign Corrupt Practices Act. A few weeks later, Abbott offered to pay Alere between $30 million and $50 million to kill the deal, but Alere's directors declined. 

Alere also delayed filing its 2015 annual report until August last year, citing "material weaknesses" in its internal control over financial reporting for 2014 and 2015. Then, when it seemed as though Abbott may have been dragging its feet to secure regulatory clearances necessary for the merger, Alere took Abbott to court to compel the company to uphold its end of the deal.

Amanda Pedersen is Qmed's news editor. Reach her at

[Image courtesy of Pixabay]

Helping Our Population Age Better—with Manufacturing

Helping Our Population Age Better—with Manufacturing

Here's how manufacturing can help the medtech industry meet the growing health demands of baby boomers.

Todd Nelson

With aging baby boomers leading the way, older Americans will outnumber children in this country in less than two decades, according to U.S. Census Bureau projections.

Those age 65 and older will overtake the number and percentage of those under age 18 by 2035 as the population of older Americans will more than double, from 46 million today to more than 98 million by 2060. In addition, those age 65 and older are living longer, working longer, and more educated than past generations. Simply put, "boomers will not get old," as demographer, author, futurist (and boomer himself) Kenneth W. Gronbach has declared.

This mask gasket is made of liquid silicone rubber. Medical device designers often turn to LSR because it's biocompatible, so LSR parts work well for products that have skin contact.

Baby boomers seeking to stave off their own mortality will create what Gronbach terms "20 years of overwhelming demand for health care" as they age. That's because boomers, while generally healthier than their parents' generation, also are more likely to be obese, have diabetes or high blood pressure, and be less active than younger age groups, among other health concerns. Although their quest for a fountain of youth may not pan out, boomers and the growing number of older Americans will succeed in helping to reshape healthcare.

Becoming 'Agile Innovators'

Along with the aging population, the rise of consumer-driven care, payers' increasing focus on value-based reimbursement, and health systems' continuing interest in outpatient services and home care are among factors driving significant change in the healthcare industry. Medical technology companies that adapt to these trends will find enormous opportunities to grow and thrive, as Boston Consulting Group wrote in its recent article, "Medtech companies need to transform while times are still good."             

One step in that direction is shifting product portfolios to target aging patients who are increasingly sedentary and dealing with chronic diseases. Medtech companies need to become "agile innovators," leveraging new development paths. "To make tangible progress on an innovation agenda, medtech companies need to iterate more quickly, take calculated risks, and get comfortable with the notion of failing fast," the consultants' report said.

Rapid Manufacturing Can Help

Medtech companies can get an assist in that regard from rapidmanufacturing companies that can help them prototype and develop medical devices, home care products, and prosthetics for the senior market.

Manufacturing partners with the ability to offer design feedback in a matter of hours and deliver parts within days can shorten the development cycle and get products through testing and on to the market quickly and efficiently. Also of value are suppliers with expertise in processes such as rapid overmolding--a form of injection molding that adds soft-touch grips and other benefits to products including toothbrushes, surgical instruments, and prosthetic fingers--and industrial 3-D printing of such parts as hip replacements and cranial implants.

The "additive bionic human" on display at last fall's International Manufacturing Technology Show in Chicago featured 3-D-printed implants and body parts, including tracheal implants, dental implants, and ribs, legs, joints, and hands that could help improve and extend the lives of older patients and others.

Ultimately, combining these manufacturing techniques with the principles of human factors engineering to improve safety and effectiveness of devices can help med tech companies accelerate development and get to approval and market more quickly with products offering the feel, aesthetics, usability, and other characteristics that appeal to consumers and clinicians.

Home Healthcare Settings

Shown are three samples of parts made with rapid overmolding, a form of injection molding that adds soft-touch grips and other benefits to products used in health care.

Elderly consumers and professional caregivers are increasingly using medical technologies and devices in home settings as hospital stays shorten, outpatient treatment grows, and seniors seek to maintain independence. Examples range from syringes and assistive devices such as walkers to complex devices such as ventilators and infusion pumps. Diabetes, high blood pressure, and other chronic conditions to which the elderly are susceptible require regular use of monitoring devices. All of this is driving a market for personal or self-care devices that is estimated to reach a projected $19.6 billion globally in 2019, dominated by North America.

Seniors also are among those with a growing need for prosthetics, attributed largely to what many term the diabetes epidemic. Diabetes is the leading cause of limb loss in the United States, accounting for more than 65,000 amputations yearly. The number of people living with limb loss, with diabetes contributing greatly to the increase, is projected to double by 2050. An estimated 33% of Americans will have diabetes by then, according to numbers from the Amputee Coalition.

A Surging Market

The 106 million Americans age 50 and older will spend $30 billion on health and wellness between 2014 and 2019, according to an AARP report. The opportunities in this market include developing products and services that will help seniors stay active; monitor vital signs; provide emergency detection and response services; and manage medication, diet, and nutrition.

Medical device firms, of course, are already well aware of the rise of the senior market, said Shannon Clark, CEO of San Jose-based UserWise Consulting, which aims to help companies design safe and effective medical devices.

"The aging population is presenting one of the greatest business opportunities in the medical device industry at the moment," Clark said. "Companies and start-ups in the bay area and around the nation that I'm talking to, they're all talking about serving that population."

Medical device  companies would do well to apply human factors engineering principles to the design of a product, Clark said. FDA defines human factors engineering, also known as usability engineering, as the application of human skills and abilities to medical device design, including mechanical and software interfaces, displays, controls, packaging labels, instructions, and training. The agency's new formal guidance on human factors engineering puts greater responsibility on medical device companies to design devices "to maximize the likelihood that new medical devices will be safe and effective for the intended users, uses, and use environments."

In addition to those elements, Clark advised designers to consider the tasks users will have to undertake and the sequence and combination of steps necessary to use the device.

Beyond medical device makers, pharmaceutical companies are also recognizing this surging market and getting into medical device design, putting more investment and effort into developing drug-delivery devices that are less intrusive and easier to self administer.

A Closely Watched Market

FDA is keeping a close eye on device makers for the aging population, especially monitoring the way in which companies include and observe seniors in usability testing, Clark said.

"The FDA is really cracking down on high-risk populations, especially the elderly, and making sure that companies are doing their due diligence in watching end users use the device beginning to finish in an uninterrupted manner," Clark said.

Federal regulations, Clark pointed out, require design validation to ensure that devices meet defined user needs and intended uses.

"It is a regulatory requirement in the Code of Federal Regulations that a device manufacturer must define the intended use of the device and the actual needs of the user or patient and then prove through a final usability study or validation testing that the user is able to achieve safe and effective use of the product," Clark said.

High Risk, High Reward

For medtech companies, incremental improvements aren't good enough in today's fierce competition, the Boston Consulting Group study found. While the double-digit growth of the early 2000s marked "the gold age for med tech," sales gains have leveled off at around 4%. The strongest innovators in medtech--those that put more R&D money on big bets--outperformed competitors, another study found.

"The innovation model in medtech is more high risk, high reward than ever before, but companies that get it right will reap the benefits of strong pricing and growth in market share," the study said.

Because of the size and growth of the aging population, device designers need to understand that a greater share of that R&D investment will go to products for that group, said Jeff Schipper, global industry manager at Proto Labs, a Minnesota-based digital manufacturing company that specializes in 3-D printing, machining, and injection molding.

Manufacturing partners that can produce multiple iterations of the same product in parallel, so multiple iterations can undergo testing and even user trials at the same time, can help med tech companies reduce their risk by arriving at the best product design sooner. That can help them gain a first-mover advantage in the market and also can produce options that may be more cost effective to manufacture.

"This is the part of the market that because it's growing, companies should be capitalizing on," Schipper said. "There's going to be a lot more opportunity in the next five to 10 years to support things in this area because it has the largest market potential. Everyone is aware this is the big target to chase, so speed to market and getting the product that's going to be adopted the best are critical."

Industry Examples

Medtech companies are interested in developing wearable and remote monitoring devices for blood pressure and other conditions, said Timothy Press, Midwest sales manager for Kraiburg TPE Corp., a Georgia-based thermoplastic elastomer compounding company. Materials that are resistant to skin oils and maintain a silky surface and soft touch work well in those applications.

The process begins with understanding what the customer wants the material to accomplish, focusing on design inputs such as skin contact, blood contact, contact duration, and colors and what cleaning or sterilization products a device will undergo.

"The earlier that we're involved in that process with customers, especially in medical applications, and the earlier that we understand what they're looking to accomplish, the more efficient we can be in helping that customer attain cost targets and eliminate concerns down the road as far as testing or any modifications," Press said.

During the usability engineering process, asking seniors about hearing or visual impairments or conditions that would affect their ability to handle the product, such as rheumatoid arthritis, can help identify design inadequacies and lead to design improvements, Clark said.

One example is redundant feedback systems in handheld devices such as auto-injectors, with visual and audio feedback confirming that the injection is taking place in cases where audio feedback alone may not be loud enough for older users. The overmolding process can add tactile feedback that will help an elderly user hold a device correctly and find the on-off button more easily, Clark said. Overmolding also can offer a visual indication of a device's function and use.

"Labels and words printed on medical devices tend to be very ineffective in helping users use the product properly," Clark said. "What overmolding and a thoughtful form design could accomplish might be the same effect but much more powerful by communicating visually what a user needs to do. You need to make it even more obvious for elderly users."

Todd Nelson is a writer for Proto Labs.


‘Smart’ Inhaler System Improves Patient Outcomes in Study

Smartinhaler, a "smart" personal medication monitoring system from Adherium Ltd., has shown effectiveness in reducing hospital admissions over a 12-month independent, randomized controlled trial involving children with poorly controlled asthma. The study was conducted at Sheffield Children's Hospital in the UK, and the results were published online in the peer-reviewed medical journal Thorax.

The Smartinhaler system consists of connected sensor devices that fit discretely onto medication inhalers; apps that connect to the device and monitor medication adherence, usage, dosage, and provide patient reminders; and software for analysis of patient and medication usage data by caregivers, reported Garth Sutherland, CEO of New Zealand-based Adherium.

"The Bluetooth-enabled Smartinhaler medication sensors wrap around patients' existing inhalers and automatically send usage data to their smartphone," Sutherland explained. "The Smartinhaler app enables the patient and health care professionals to track medication adherence, set daily reminders, and discover insights into their medication usage. The Smartinhaler app enables real-time reporting, monitoring, data storage and analysis of inhaler use."

The app can work with one or more Smartinhaler devices on multiple inhalers, and it provides a view of medication usage patterns as well as the ability to set audio visual reminders on the Smartinhaler device itself to help ensure no doses are missed, he added.

Smartinhaler performs the following functions: it records the time and date of inhaler use, independent of patient action; it transmits patient usage data to a mobile device and into the Adherium cloud-based servers; and it alerts and reminds patient about the medication. "The dedicated health professional, with patient consent, can also access the data to review patient progress," Sutherland said.

To monitor dosing behavior from month to month and identify any trends that could signal a poor outcome, patients (via their smartphone app) and their physicians (via the portal) can see drug usage on a simple dashboard, he added.

After use, Smartinhaler can be removed from the empty inhaler and then attached to the new one. Smartinhaler does not mechanically impact drug delivery or dose counters from the existing inhaler in any way, Sutherland added.

Smartinhaler is drug/brand agnostic, says Sutherland. "Adherium tailors different Smartinhaler devices for each partner pharmaceutical company's proprietary dry powder or pressurized metered dose inhaler," he said. "This allows pharmaceutical companies to supply the Smartinhaler devices directly to patients and be confident that they can only be used with that company's product."

Adherium has become the exclusive smart inhaler partner for AstraZeneca with 10-year global supply and development agreement.

Adherium believes Smartinhaler can address the problem of medication nonadherence in chronic respiratory conditions. "An estimated 300 million people worldwide suffer from asthma, with 250,000 annual deaths attributed to the disease, and almost all of these deaths are avoidable. The U.S. Centers for Disease Control estimate there are 25.5 million asthmatics and 6.8 million people with COPD in the US," Sutherland said.

The Sheffield study "showed unequivocal independent evidence that digital monitoring impacts clinical outcomes, not just medication adherence, in children with poorly controlled asthma," Sutherland said, pointing to these achievements:

  • Five-fold reduction in hospitalizations observed in patients using Smartinhaler.
  • Smartinhaler use resulted in sustained increase in medication adherence and significant reduction in asthma exacerbations.
  • Days off school and doctor visits reduced.
  • Clinical benefits increased over time, particularly at nine and 12 months.

"These benefits, particularly the reduced number of hospitalizations, make a clear, cost-saving argument for introducing Smartinhaler into standard practice, which can easily be done without disruption to the patient's medication, routine, or care plan. With this data, Adherium can now offer healthcare providers, payers and insurers a cost-effective way of improving chronic respiratory care," he said.

Adherium has FDA 510(k) clearance to market Smartinhaler in the United States as well as CE Marks for its devices and software in major markets, including EU, Canada, Australia, New Zealand,and China."The Smartinhaler platform has been used in over 30 countries, in more than 65 projects (clinical, device validation or other) and has peer reviewed journal articles resulting from 14 studies," Sutherland said.

Automation, Zero-Defects Philosophy Behind New Drug-Delivery Components Plant

Datwyler Sealing Solutions's Middletown, DE, facility will produce vial and syringe components when it opens next year.

Datwyler Sealing Solutions has broken ground on a new facility for producing specialty coated rubber components for drug-delivery devices. The Middletown, DE, facility will produce the company's Omniflex family of vial and syringe components following to its own rigorous FirstLine standards, which employ ultra-modern cleanroom technology, automated production cells, fully automated camera inspection, and a specialty washing process.

Datwyler will highlight the new facility and its components for injectable packaging, drug delivery systems, and diagnostic applications at the upcoming MD&M West 2017 expo February 7-9 in Anaheim, CA. These include serum and lyophilization stoppers and plungers in custom designs.

The Middletown plant will employ lean-manufacturing, zero-defect, and Quality by Design philosophies, explained David Clark, vice president of operations, Americas. Many of its systems will be very similar to those in place at Datwyler's Belgium location, which currently produces the Omniflex coated products line. These components are 100% spray coated with a specialty fluoropolymerthat eases performance and eliminates the need for siliconization, he explains.

Datwyler will also introduce several upgrades to its Omniflex production with the new plant. "In Belgium, we don't always use camera inspection for all products," Clark said. "But in the United States, we'll offer 100% inspection, normally right before the packaging system." Such inspection can capture a higher number of defects, yielding higher quality levels.

The new plant will also offer the ability to steam sterilize components for ready-to-use products, he added.

Automation will play a central role in production. "Automated ingredient weighing will be used during the mixing process, and as the bricks exit the mixing lines, they will be picked automatically and placed into compression lines," Clark said. "Compression presses are not typically automated, but some will be in our new plant. This allows us to produce more products, and quality will be better." Automation use will also depend upon customer volumes, he added.

"Our new plant will be designed to offer customers options," Clark said. "We've been visiting a number of our customers to ask them what they need, and we've been incorporating those needs into our plans. They've been asking for flexibility in order quantities, for instance, and we'll offer that with our new plant."

Middletown is close to Datwyler's customers throughout the mid-Atlantic region, as well as to its plant in Pensauken, NJ, which produces pharma-grade components.

Instead of expanding this plant, Datwyler elected to invest $102 million in building a new one to institute its FirstLine approach. Datwyler describes this approach as maintaining a fully integrated good manufacturing practice environment that exceeds the most stringent quality standards of the European and U.S. regulatory authorities. FirstLine facilities are certified to ISO 15378.

Clark added that the FirstLine approach "is equipped to minimize the risk of human interaction to prevent any particulate and biological contamination. Datwyler's FirstLine manufacturing supports the pharmaceutical industry in the pursuit of safety through reduced endotoxin, bioburden levels, and particulate levels--both visible and sub-visible."

Production in Middletown is expected to begin in the first half of 2018, and it will ramp up to first provide local supply for U.S.-based customers and then serve other markets, Clark said.

Datwyler is also investing in a new facility in India, which will then allow the company to offer locally produced FirstLine components in Europe, the United States, and Asia.

With Middletown, Datwyler will produce one billion components per year in the United States, a company spokesperson told Qmed.

Daphne Allen is executive editor of Pharmaceutical and Medical Packaging News and a contributor to Qmed. Reach her at