Why 3-D Printing Hasn't Reached Its Medtech Promise

3-D printing holds all kinds of value, benefits, and possibilities for the global medical device arena. But a new day has not fully dawned for the industry. Here are four reasons why. 

Bart Reitter, QAD

3-D Printing Innovations

7 Radically New 3-D Printing Innovation You Need to Know

The medical device industry has a proven and storied history of innovation. From x-ray tubes and pacemakers, to CT scanners and mobile electrocardiogram monitors, the medical device sector has always embraced innovation with the goal of improving and saving lives. One of the recent trends in that evolution is the concept of additive manufacturing, or 3-D printing. Unlike traditional manufacturing involving machining, additive manufacturing does not remove material from a bare piece of stock. Rather, 3-D printing involves adding successive layers of material to form a 3-D object. This concept is exciting for the industry as it will change the way devices are developed, manufactured and delivered to patients.

When we at QAD (Santa Barbara, CA) speak to our medical device customers from around the world, we hear about the challenges they face and how they are addressing them. Some are concerned about their products becoming commoditized as the line blurs between highly-regulated and consumer devices. Many wonder how to differentiate their solutions among a wide range of competitive offerings from domestic and overseas competitors. Others know that surgeons expect companies to deliver holistic solutions that deliver tangible benefits, and that simple devices which meet single therapeutic needs may no longer suffice. In turn, hospitals expect device manufacturers to focus on how to make the operating room (OR) more efficient and how to improve OR turnover times and usage. The expectation is that new solutions will result in fewer patient visits and less time in the hospital, and reimbursement is often tied to those metrics.

Additive manufacturing can help address some of those challenges and promises to reshape the way device companies bring products to market. 3-D printing allows for rapid prototyping and optimized design of innovative new solutions. Such an approach helps insulate companies against competition and shortens product development lifecycles and time to market. Development and application of devices using 3-D printed anatomical models results in better planning for surgeries, greater physician awareness of device capabilities and limitations, and improved OR efficiency. In addition, the ability to print devices directly from specific patient imaging enables companies to deliver customized devices with improved fit and functionality.

According to the Food and Drug Administration's (FDA's) website, the agency has cleared more than 85 3-D printed medical devices as of December 2015. The applications range from orthopedic implants to surgical instruments and from dental restorations to external prosthetics. In May 2016, the FDA issued a guidance document titled Technical Considerations for Additive Manufactured Devices, and it is assessing the impact of current good manufacturing practice (GMP) regulations on device design and security.

Considering how rapidly manufacturers could make modifications to device designs without major retooling or turnaround times, the appeal of 3-D printing is huge. Further, the operational benefit can be significant. Reductions in capital equipment, inventory, and labor costs, as well as manufacturing cycle times, are all achievable benefits from embracing additive manufacturing. The very real concept of a medical device manufacturer carrying a year's worth of inventory may be a thing of the past as companies can deploy an army of 3-D printers to meet demand. In addition, companies can choose to retain the intellectual property for device design, and outsource the manufacturing to organizations dedicated to printing 3-D devices on a contract basis.

Yet, despite the hype, the excitement about 3-D printing isn't universal, and a new day has not fully dawned on the industry. Here are four reasons why: 

1. Durability Concerns

Several of our customers have expressed reluctance or inability to incorporate the new technology into their processes, and with good reason: some implant manufacturers have expressed concern about the durability of 3-D-printed implants. Titanium alloys have a long and proven record as knee or hip implants, and perfecting a 3-D printed object is no simple task. Many organizations are unwilling to take that risk, and instead, rely on 3-D printing for support devices used during surgery.

2. Customers May Not Always Need It

Hospitals and physicians do not necessarily need custom or on-demand medical devices. Such devices would surely demand a premium in an age when hospitals have little money to spare, to say nothing about the payer perspective and how reimbursement would be handled. Off-the-shelf devices have served the industry for decades, and in many situations, they will be good enough.

3. An Expertise Shortage

Currently, finding professionals with expertise to support 3-D printing operations for products that need extreme precision can also prove challenging. Developing expertise in the use of 3-D printers takes time, and there aren't enough experts in the field yet. For the time being, those who want to incorporate 3-D printing find ways to accomplish that. One medical device customer surmised, "We could staff up, train and retain people to do nothing but observe, learn and practice, but we chose to go to a third party because they've got a full warehouse of 3-D printers."

4. Evolving Regulations

Lastly, the regulatory impact of 3D printed devices is still evolving. The FDA recently issued guidance for the manufacturing of 3-D devices, but the approval pathways such as 510(k) and Pre-market Application (PMA) will impact industry acceptance as well. The 510(k) method uses devices that are already on the market to evaluate conformance, and the PMA covers new devices, which, given the expected growth, is the pathway for most 3=D printed devices going forward. The PMA process also requires clinical trials and data to show a device is safe and effective in a large population.

Regardless of the limitations of the technology, the concept is exciting for the medical device industry, as it creates the possibility of new and innovative approaches for developing and manufacturing life-improving and saving devices. With the challenges of implementing 3-D printing in medical device manufacturing, it may take some time before the technology picks up enough momentum to be a "wave," but at the least, we can call the 3-D printing trend a steadily rising tide.

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

How You Can Stay Compliant With UDI

Want a sustainable, extendable UDI program? Here are five reasons why your medical device company needs to implement an Enterprise Labeling Solution.

Laura Johnson, Loftware

UDI Labeling LoftwareWith a goal of improving patient safety, the FDA initially implemented the Unique Device Identification rule in 2013. UDI labeling regulations are being phased in through 2020 in a concerted effort to provide a comprehensive methodology for medical practitioners, caregivers, and patients to identify, track and monitor the safety and efficacy of medical devices. However, as showcased in a recent Qmed article, UDI is presenting some substantial challenges for medical device companies, which are struggling to stay ahead of compliance deadlines.

Compliance with the UDI rule requires a significant investment of time and resources on the part of medical device manufacturers. Just how much, and the return on investment, depends in large part on an understanding of the original intent of the rule. How you and your customers can best utilize UDIs and the insights they generate into your product lifecycle is key. Acknowledging the lack of readiness and the ensuing struggles these companies are facing, the FDA has recently extended the deadline for certain Class II medical devices packaged in convenience kits or non-implantable single use devices.

So the question remains: How can medical device companies achieve value while addressing the challenges of UDI?

Adhering to regulations that define how products are developed, marketed, shipped, and disposed of is essential to avoid fines, retain customers, enter new markets, and in some cases, stay in business. Labeling continues to play a crucial role in meeting evolving standards, especially those like UDI where labeling and identifying parts and packages is critical for consumer's safety.

There is actually a silver lining to the UDI rules going into effect, because a label containing necessary information about a product can be leveraged as it moves through the supply chain. Individualized labels can contain such important information as how the product was made, what it contains, how it should be handled, and how it should be disposed.

In fact, one of the best ways to achieve a sustainable, extendable UDI program is to implement an Enterprise Labeling Solution, which integrates production labeling and business processes to support mission-critical labeling. This dynamic and data-driven approach allows businesses to react to evolving customer, regional, and most importantly, regulatory requirements such as UDI. This approach also ensures consistency across a global supply chain, enabling companies to meet performance and scalability requirements with the flexibility to sustain complex, high volume labeling requirements.  

Enterprise Labeling Solutions enable customers to quickly and efficiently make changes to meet regulatorystandards.   

Here are five things that Enterprise Labeling Solutions can help companies achieve:

1. Simplify the Label Printing Process

Many companies are faced with error-prone manual barcode printing processes and often need to build custom printing applications in an attempt to streamline processes and ensure that users are printing the right labels. Custom applications can enable companies to meet the requirements of a single, ad hoc labeling process, but they quickly become difficult and costly to maintain especially with evolving regulations such as UDI.  The right Enterprise Labeling Solution offers the necessary level of control for data input and enables users to create and manage complex applications dramatically faster and easier by eliminating the need for customers to build their own user interfaces for on-demand label printing.

2. Keep Pace with Evolving Regulations and Standards

In the U.S., there's UDI compliance issues, as well as Title 21 of the Code of Federal Regulations (CFR) Part 11, which provides guidance for electronic records and eSignatures to streamline workflows. Many global companies are looking for a solution that eliminates paper-based approvals and printed first article inspections, which involve endless stacks of paper and require time consuming filing processes and additional warehousing. Instead they are now relying on electronic records that can be easily accessed or linked directly to the electronic batch records. Enterprise Labeling Solutions, which offer workflow and eSignature capabilities provide a new level of visibility and control for managing labels in highly regulated industries and facilitates 21 CFR Part 11 compliance for labeling in the medical device and pharmaceutical companies.

Brush up on your medical device industry know-how at BIOMEDevice San Jose, December 7-8, 2016. 

3. Enter New Markets

Market expansion is essential for success. The faster you can satisfy local language, shipping, and regulatory demands with your labels, the faster you can drive revenue. UDI requirements, which address issues such as traceability, are impacting both U.S. companies and multinationals that market in the U.S.

Utilizing this type of dynamic, data-driven labeling enables companies to rapidly respond to changing regional and international regulatory requirements for labeling, including those mandated by the FDA's UDI Systems. 

4. Automate the Print Process

An automated process allows business users to initiate labeling from the ERP system and eliminate the need to manually input UDI or serial number data. Additionally, an automated process allows companies to achieve significant printing performance gains, allowing labeling to keep up with production. Most importantly, with this type of labeling platform medical device companies are able to initiate print jobs and produce labels anywhere in the global landscape. Labels are based on approved templates, using a common labeling infrastructure.

5. Integrate with Business Processes

A centralized Enterprise Labeling approach allows companies to integrate with their existing ERP, PLM or other validated environments to drive data from "sources of truth," which offers greater control. By using a central database companies can avoid the need to replicate data, which reduces errors and offers improved labeling consistency for deployment to other plants and distribution partners internationally. This ultimately provides a new level of consistency, simplifies troubleshooting and streamlines labeling while adhering to a sustainable UDI program.

Ultimately, labeling is essential to smooth the flow within the medical device supply chain, where problems can arise at any juncture, or may "wait" to manifest in a finished product.How quickly and accurately companies respond to customer requests to meet evolving regulatory requirements such as UDI and respond to unique labeling requirements can mean a huge difference in time to market, customer satisfaction, and cost savings.

To find out more about how Enterprise Labeling can help medical device company's improve labeling practices go to Loftware's medical device page or click on the following link to access Loftware's on-demand webinar "Addressing the Challenges of UDI with Enterprise Labeling" with customer, Greatbatch Medical.

Laura Johnson is a senior account executive for Loftware (Portsmouth, NH). She has over 20 years of expertise working with both pharmaceutical and medical device manufacturers to improve processes and meet regulatory requirements such as serialization, UDI, and secure supply chain.

[Image courtesy of Loftware]

Medtronic Scores a Big Legal Win

A federal judge in Ohio has dismissed hundreds of Infuse bone graft lawsuits, which claimed off-label use of the device.  

Nancy Crotti

Judge gavel

Hundreds of plaintiffs failed to prove that they had a valid claim against Medtronic when it came to alleged off-label use of Infuse bone graft devices, U.S. District Court Judge Timothy S. Black in southern Ohio said in a court order issued last week.

The case involved several hundred patients of Cincinnati orthopedic surgeon Atiq Durrani, who fled the country for Pakistan after his 2013 indictment regarding the procedures.

FDA granted Medtronic a PMA for Infuse in 2002, approving it only for use in a single-level fusion in the L4-S1 region of the lumbar spine via the anterior lumbar interbody fusion procedure and in combination with the LT-Cage.

Infuse is Medtronic's tradename for its recombinant bone morphogenic protein-2 (rhBMP-2) product, a genetically engineered version of a naturally occurring protein that stimulates bone growth and gives surgeons some control over where that growth occurs. FDA gave limited approval for its use in 2002 as an alternative to conventional spinal fusion to treat degenerative disc disease and open fractures on the tibia, and for some oral and dental procedures, but off-label use of the device became commonplace, with MedPageToday at one point estimating that as much as 80% of Medtronic's Infuse product had been used for off-label applications. (FDA approved using Infuse with two additional indications in December 2015.)

Brush up on your medical device industry knowledge at BIOMEDevice Boston, December 7-8, 2016.

Some of the plaintiffs in the cases against Medtronic that were dismissed last week were implanted with Infuse without the LT-Cage, according to court papers. Some were subjected to a posterior surgical approach. Others had Infuse implanted in multiple levels of the spine, and some had it implanted in their cervical or thoracic spines.

The law does not prohibit such off-label uses, Black wrote. Plaintiffs did not provide enough details when it came to what was wrong with the device, and maintaining they had no access to such information did not entitle them to obtaining it through the lawsuits, he added. The court also found that the PMA covered both the bone-growth component and the cage, even when used separately.

"Several courts throughout the country have examined this exact issue and have held that 'the FDA established specific federal requirements for the Infuse Device, even when the Infuse Protein is used alone,'" Black wrote. He also said that Ohio state law did not supersede federal law, and that even if Medtronic reported adverse events related to Infuse to FDA, the agency is not required by law to make those public.

The judge also took the plaintiffs to task for essentially talking out of both sides of their collective mouth. They alternately argued that Durrani, acting as Medtronic's agent, had committed fraud because he knew of the risks of using Infuse and did not convey those risks to the patients. They also argued that Medtronic committed fraud because it did not tell Durrani of those risks, Black wrote. 

Cincinnati-based West Chester Hospital and its parent company, UC Health, agreed in October 2015 to pay $4.1 million to settle allegations that West Chester Hospital violated the False Claims Act by billing federal healthcare programs for costs associated with medically unnecessary spinal surgeries performed between 2009 and 2013 by Durrani.

The Star Tribune of Minneapolis reported in April that Medtronic failed to alert FDA to more than 1000 adverse events related to Infuse between 2006 and 2008. Medtronic has been mired with lawsuits and Senate probes over Infuse, whose use has been hotly debated among the medical and legal communities.

Company employees discovered the adverse events--including four deaths--in a retrospective chart review of Infuse, but shut down the study in spring 2008 without reporting them to FDA, the Star Tribune said. Most of those employees have since left the company, leaving current officials befuddled by the failure to report.

Nancy Crotti is a contributor to Qmed.

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[Image courtesy of Salvatore Vuono on FreeDigitalPhotos.net]

What Apple Really Wants to Do With HealthKit

Collecting data is one thing. Using it to improve healthcare worldwide is another.

Maureen Kingsley

Apple Health

Apple wants to take its HealthKit software platform to the next level, from simply collecting health and fitness data to analyzing it, interpreting it, and using it to advise users and healthcare providers, reports Bloomberg, citing people familiar with Apple's plans.

HealthKit, launched in September 2014, is Apple's developer framework that collects data from various iOS-friendly health and fitness apps and displays it to users through Apple's Health app, which was first made available on the iOS 8 operating system. HealthKit also makes it possible for its member apps to share user information with each other.

In recent years, Bloomberg reports, healthcare specialists recruited by Apple have been developing improved electronic-health-record software for actually putting all of that collected data to work for users and care providers, ultimately to offer wellness and medical advice and assist in diagnoses.

A beefed-up version of HealthKit, with the help of better electronic-health-record software, could potentially address two outstanding concerns that remain inadequately addressed: transferring health data reliably and securely among databases at various hospitals and doctors' offices, and helping providers to quickly access and analyze "salient information from mountains of data," the report states.

To this end, Apple earlier this year bought three-year-old Silicon-Valley startup Gliimpse Inc., a firm founded by Anil Sethi (now director of Apple Health) that has created software that pulls electronic health records from different databases and in different formats, then stores them in one place.

Could Apple be taking a stab at solving medtech's EMR interoperability problem? It kind of seems that way.

Brush up on your connected health know-how at BIOMEDevice San Jose, December 7-8, 2016. 

Apple's ResearchKit framework, too, seeks to change the "information silos" model of patient-data storage to one of shareable, accessible data from across the world, and leverage it to benefit medical research.

Apple also continues developing new apps for the Apple Watch, particularly those related to wellness, according to Bloomberg's sources. One such app helps users track sleep patterns; another "gauges fitness levels by measuring the time taken for the heart rate to fall from its peak to resting level." Apple does currently have a Watch app that measures heart rate, but that app does not analyze or interpret the data in any way.

The latest report is in line with Apple's high interest in continuing its push into mobile and connected healthcare. This summer, the company published guidelines for mobile medical app (MMA) developers that take steps toward addressing the unique safety, privacy, and regulatory concerns of MMAs

Maureen Kingsley is a contributor to Qmed

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[Apple Health image courtesy of Apple]

Former Starkey President Pleads Not Guilty to Theft

Jerry Ruzicka and three other defendants in the case pleaded not guilty to charges that they fleeced the hearing aid manufacturer and its main owner out of $20 million over a nine-year period.

Chris Newmarker

Jerry Ruzicka
Jerry Ruzicka

A December trial date has been set in federal court in Minneapolis for four of the five men accused of stealing from hearing aid maker Starkey and its principal owner and CEO Bill Austin. 

Former Starkey president Jerry Ruzicka, the company's former human resources senior vice president Larry Miller, and two friends of Ruzicka--Jeffrey Taylor, former president of miniature parts supplier Sonion, and Lawrence Hagen--pleaded not guilty in U.S. District Court on Friday. Absent was the fifth defendant in the case, former chief financial officer Scott Nelson.

Ruzicka's lawyer John Conard told the Star Tribune of Minneapolis that the case rests on the false premise Austin did not know what was going on in his own company. A Starkey spokesman described Conard's claim as absurd. 

Charges in the case range from everything from making financial transactions related to fraud proceedings to conspiring to commit money laundering, wire fraud, and mail fraud. 

The indictment claims Ruzicka and the other defendants stole from the company between 2006 and September 2015, when Ruzicka and scores of other employees at the company were fired. According to prosecutors, the alleged theft was accomplished through a number of strategies, which mostly shifted company money to sham entities. (Though, Ruzicka supposedly got creative with the sale of his company-issued Jaguar.)

Starkey operates 21 facilities and conducts business in more than 100 markets worldwide. It lists its employee numbers in the 1001 to 5000 range on LinkedIn. The 52-year-old company develops, manufactures, and distributes hearing aids through the Audibel, NuEar, MicroTech, AudioSync, and original Starkey brands.

Discover more about medical device innovation at BIOMEDevice San Jose, December 7-8, 2016.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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BD to Spend $100 Million on Nebraska Syringe Plant

Becton, Dickinson and Co. plans to expand its ability to manufacture insulin syringes at the factory.

Chris Newmarker

BD Holdrege Plant
BD's Holdrege, NE, plant. (Image courtesy of BD)

BD recently announced a $100 million investment in new technology and manufacturing equipment at its Holdrege, NE, insulin syringes plant.

The goal is to expand capacity to make syringes at the factory. BD already makes more than 2 billion insulin syringes annually. That comes to more than 250,000 syringes per hour.

"About 40 percent of people with diabetes who inject insulin use syringes as part of their diabetes management regimen," Ken Miller, worldwide president of diabetes care for BD, said in a news release. "This investment will provide benefits to this diabetes population and underscores our commitment to supply high-quality, industry-leading insulin syringes to patients." 

BD started out in Holdrege 50 years ago in 1966, with a 12,000 square foot building with 66 associates. The plant is now 350,000 square feet, with more than 650 associates manufacturing 20 different BD products.

The new investment will increase production capacity, but it will not necessarily mean additional employees, a BD spokesperson told the Omaha World-Herald.

Overall, Franklin Lake, NJ-based BD is a major Nebraska employer, with 2500 workers in four manufacturing facilities--one each in Holdrege and Broken Bow and two in Columbus.

Discover more about medical device innovation at BIOMEDevice San Jose, December 7-8, 2016.

Chris Newmarker is senior editor of Qmed. Follow him on Twitter at @newmarker.

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DIYers See Opportunity in EpiPen Price Hike Fiasco

At least two enterprising DIYers have been touting their own low-cost epinephrine injectors in the wake of EpiPen maker Mylan's price hike controversy.

Maureen Kingsley

EpiPencil Michael Laufer
Michael Laufer holds up an "EpiPencil." [Image courtesy of Michael Laufer]

A mathematics PhD and a Minnesota physician are among those who have taken it upon themselves to design alternatives to Mylan's EpiPen, a lifesaving device for severe allergy sufferers that has been mired in controversy because of huge price hikes. 

Michael Laufer, a graduate student in the mathematics PhD program at City University of New York, has created a so-called "EpiPen hack" dubbed EpiPencil from low-cost and relatively-easy-to-obtain materials. Laufer's device combines an off-the-shelf needle injector marketed to diabetics with a syringe loaded with the correct dose of epinephrine.

During a recent interview with The Parallax, Laufer demonstrated assembly and operation of his DIY EpiPencil device. Laufer was able to load the syringe within 3 minutes, assemble the auto injector, and then provide himself with a 0.3 mm injection of saline, according to The Parallax. 

Ambitious (and cost-savings-motivated) souls wishing to construct their own EpiPencil at home according to Laufer's instructions would need to buy the auto-injector, syringes, needles, and epinephrine (via doctor prescription) separately. Laufer's website provides links to each of the components, except the drug itself, epinephrine.

Next, the individual would load the syringe with the correct dose of epinephrine--again, based on a doctor's prescription--and screw together the auto-injector.

Laufer estimates that those following his instructions would pay roughly $35 to fully assemble each EpiPencil, versus the hundreds of dollars it costs for an EpiPen two-pack. EpiPen's maker, Mylan, has been taking a great deal of flack because the cost of an EpiPen two-pack has risen from $100 in 2007 to $600 in 2016. The company's damage control has included offering coupons and launching a generic version to reduce the cost to $300.

While Laufer's EpiPencil is certainly low-cost and seemingly easy to assemble and use, it is also worth noting that it is not being assembled amid regulated mass production in an FDA-registered facility. There are legitimate questions, then, regarding the device's sterility (or lack thereof), reliability, and safety in a life-or-death anaphylaxis situation. 

The AllergyStop device (Image courtesy of AllergyStop)

Taking the FDA Route

Douglas McMahon, a practicing physician at the Allergy and Asthma Center of Minnesota in Eagan, has also created an EpiPen alternative, the AllergyStop device. In contrast to Laufer, however, McMahon is not encouraging patients and caregivers to build his device themselves; rather, he is attempting to gain FDA clearance to make and market the product in the United States. In a recent Fortune article McMahon estimates the cost of his device would be around $50.

The AllergyStop device features patient-specific needle lengths and epinephrine doses based on patient BMI, according to McMahon's website. The device case is described as "palm sized" and contains a compartment for antihistamine medication for less-severe allergic reactions. As of midday, September 23, 2016, McMahon's Indiegogo fundraiser was at about $10,300, with a flexible goal of $200,000.

"Overall, AllergyStop is an inexpensive device due to the low cost of epinephrine," the Indiegogo page reads. "However, completing quality testing and gaining FDA approval for AllergyStop is expensive." 

Learn the latest about creating connected health devices at BIOMEDevice San Jose, December 7-8, 2016.

Mylan Responds

For its part, EpiPen marketer Mylan stands by its product's regulatory approval, prescription-only status, and safety record. 

"EpiPen Auto-Injector is a complex prescription product designed to administer epinephrine, the only first-line treatment for anaphylaxis, quickly and properly in an emergency situation...The more than 15 critical component parts in this device must work every time without fail," the company told Qmed in a shared statement.

Mylan's CEO, Heather Bresch, testified before Congress this week, explaining, among other things, that the company's profit per Epi-Pen two-pack sold is about $100. Regarding that figure, Marianne Udow-Phillips, director of the University of Michigan's nonpartisan Center for Healthcare Research and Transformation, was quoted in USA Today as saying, "Taking [Bresch's] $50 per EpiPen at face value, I would describe that as a very good [profit] margin on a product where we know the drug itself costs something like $1 and the device was developed long before Mylan bought it. It is likely that the R&D cost for this device was recovered long ago. Whether a continuing profit margin of $50 per device is 'reasonable' or not is a judgment question."

Last month, Mylan announced it would launch the first generic version of the EpiPen auto-injector at a list price of $300 per two-pack carton, and double eligibility for its patient-assistance program.

Maureen Kingsley is a contributor to Qmed

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Trump Versus Clinton: Medical R&D

Hillary Clinton

Clinton has said she will support investing in science and technology research and development, as well as in technology transfer. She has also pledged to improve the patent system to reward innovators, and ensure an effective copyright system that protects creative content, while unlocking access to orphan works and promoting open-licensing arrangements for materials supported by federal grant funding. She also said she will affirm strong consumer protection values without stifling innovation.

Donald Trump

Trump has said that what he hears about the National Institutes of Health is "terrible."

He also told Science Debate that although he's committed to balancing the federal budget, investing in healthcare, science, engineering, and "other areas that will make the lives of Americans better, safer, and more prosperous" should remain a priority.

Election got you grumpy? This antique medtech will make you happy it's 2016>>

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[Trump portrait by Michael Vadon, CC BY-SA 2.0. Clinton portrait by Gage Skidmore, CC BY-SA 3.0.]

Trump Versus Clinton: Reforming Medicare/Medicaid

Donald Trump

Trump has promised to "preserve Medicare for future generations," and to "review basic options for Medicaid and work with states to ensure that those who want healthcare coverage can have it."

He would also administer Medicaid money to the states in the form of block grants, removing "federal overhead." States would have incentives to seek out and eliminate Medicaid fraud, waste, and abuse, he said.

Trump has also said he would take care of low-income people "maybe through concepts of Medicare," according to the website On the Issues. He also pledged to save Social Security, Medicare, and Medicaid "without cutting it to the bone" at the Iowa Freedom Summit in 2015, according to the Des Moines Register.

Hillary Clinton

Clinton has pledged to support allowing people over 55 years of age to buy into Medicare. And she wants to explore cost-effective ways to make more healthcare providers eligible for telehealth reimbursement under Medicare and other programs, including federally qualified health centers and rural health clinics. She would also work with governors to expand Medicaid in every state, and make enrollment through Medicaid and the Affordable Care Act easier. She would also expand reimbursement systems for collaborative care models in Medicare and Medicaid, and has pledged to increase state compliance with Medicaid compliance for children with developmental disabilities, including autism.

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[Trump portrait by Michael Vadon, CC BY-SA 2.0. Clinton portrait by Gage Skidmore, CC BY-SA 3.0.]

Trump Versus Clinton: Obamacare

Hillary Clinton

Clinton has taken a strong stance against repealing the Affordable Care Act, and has pledged to expand taxpayer-funded health insurance, pushed by Vermont Sen. Bernie Sanders as the "public option." According to CNN, Clinton has supported a public option for health insurance for years.

Donald Trump

Trump says that he would "ask Congress to immediately deliver a full repeal of Obamacare" and would work with Congress on passing reforms based on free-market principles to "broaden healthcare access, make healthcare more affordable and improve the quality of the care available to all Americans." Trump has also promised to modify existing law that inhibits the sale of health insurance across state lines, review basic options for Medicaid, and work with states to ensure that those who want healthcare coverage can have it.

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[Trump portrait by Michael Vadon, CC BY-SA 2.0. Clinton portrait by Gage Skidmore, CC BY-SA 3.0.]