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Articles from 2019 In February


New $500k Grant Awarded for Research Program Exploring 3D Printing Technologies

New $500k Grant Awarded for Research Program Exploring 3D Printing Technologies
Brent Nowak, executive director at the applied Medical Device Institute (aMDI), which will explore the use of 3D printing for final medical device manufacturing.

A new research grant has been awarded to Grand Valley State University in Michigan that aims to fund the research efforts of both students and faculty as they explore 3D printing techniques used in the manufacturing of medical device technologies. The research grant will pair university students and faculty with two community partners on a two-and-a-half year collaborative research program that will explore 3D additive manufacturing for medical devices.

More than a dozen graduate and undergraduate students from Grand Valley State University will be joining a team of researchers from the applied Medical Device Institute (aMDI) and MediSurge to collaborate on the project. A state-of-the-art Carbon 3D printer has been installed in aMDI’s incubator space at the university’s Cook-DeVos Center for Health Sciences to help the team explore the process of 3D additive manufacturing.

“3D Additive Manufacturing (3DAM) has matured since its early inception in the 20th century,” said Brent Nowak, executive director at aMDI. “Advances in microelectronics, polymer chemistry and materials, software tools and design, and system design have resulted in a range of 3DAM methods. Collectively, these advances enable a greater precision, higher production rates, and lower waste. We are seeing, we believe, the advent of a new manufacturing tool beyond what is known as a 3D prototyping tool. Our focus in applied research at aMDI is to understand the crossover where the value of proposition for 3DAM production is greater than that of traditional manufacturing methods.”

Nowak said that 3DAM could soon be the gold standard in medical device manufacturing, especially with its ability to fabricate complex geometries that current manufacturing techniques cannot. While there are a variety of factors that will determine the future of 3DAM as a manufacturing tool, such as the type of medical device and whether it’s a polymer- or metal-based design, 3DAM does offer certain manufacturing possibilities that current technologies simply do not.

“Imagine today a small- or medium-sized business considering the investment in 3DAM as an additional tool to their current manufacturing capabilities,” Nowak said. “Beyond the ability of 3DAM to fabricate complex geometries by no other means, there are other factors that our work will address around the decision to contract out or even build internal 3DAM capabilities.”

These other factors, according to Nowak, include cost of entry, cost of operations, how to train and staff engineers and technicians, and other important factors. While the two-and-a-half year study may not be able to address all of these questions, they do hope that they will be able to contribute to the broader understanding. And to be able to explore these questions with university students contributing to the research is one of the biggest perks, according to Nowak.

“Graduate and undergraduate students in this program are immersed in a real-world, project-based study that requires in-depth analysis of engineering, manufacturing, and business elements,” he said. “There is nothing more educational, no greater learning than applying theory. I’m not sure where the definition originated, but there is a gap — a distance between invention and innovation. The invention is an idea realized, and innovation is a marketable product for the betterment of humankind. The students are innovating as they learn about the elements of cost, manufacturing, and regulatory impacts that are needed to realize a product. A good design is more than just a technical solution. These are the students that will be best prepared to lead industry, whether in medical devices, consumer products, aviation, or other applications of 3DAM. This program will develop, retain, and attract talent to this field and to manufacturing in general.”

Is Medtech Ready for an On-Demand Manufacturing Model?

Is Medtech Ready for an On-Demand Manufacturing Model?
Protolabs's CNC machining manufacturing floor. All images courtesy of Protolabs.

Manufacturing has traditionally been a lengthy process from initial design to finished part. And given regulations, medical device manufacturing has been cast as a pretty conservative one. But industry’s use of stock component offerings and the rise of industrial-grade 3D printing could be propelling medtech toward an on-demand approach to manufacturing.

Annie Cashman, global segment manager/business development-medical for Protolabs, an on-demand, quick-turn contract manufacturer, believes most of the medical industry is using an on-demand business model today in some fashion. “Look at companies like Qosina or any distributor that simply buys parts and keeps them in inventory for any engineer to procure and put into his or her design. The customer doesn’t have a minimum-order quantity, which is a version of on-demand manufacturing (ODM) that has been around for many years,” she told MD+DI.

Today, advances in medtech prototyping are driving new manufacturing capabilities. When it comes to prototyping, Cashman said, “There are many changes, but the main one is the adoption of additive manufacturing in terms of materials and services offered. And additive manufacturing technologies are developing rapidly. For example, at Protolabs, we offer five different 3D printing processes. This technology has enabled medtech companies to prototype parts much faster and sometimes more cost effectively than injection molding a part. That being said, we have seen a huge uptick in our CNC machining services, and I believe that is because speed is still the number-one driver for prototyping, especially when you are working with a pre-revenue customer that is not yet to market.”

On-demand manufacturing “involves all of the same processes that we use for our prototyping services,” continued Cashman. “There are different options as far as secondary operations that we can offer or different pricing models that may be more attractive to customers. This depends on what they are trying to achieve with their project and when they are using Protolabs in their product development cycle.”

Above: Direct Metal Laser Sintering (DMLS) parts right off the printer. 

Timelines could shorten significantly in on-demand approaches. “The game-changing technology that is starting to get traction and where we fit is that we can make a custom part that’s unique to one specific customer’s needs and have a part in that customer’s hands in hours for CNC machining, and days for a molded, printed, or sheet metal part,” said Cashman. “That is truly transformational, and as companies like Protolabs continue to offer more to the regulated industries for production, we believe it could revolutionize manufacturing in those industries—medical, aerospace, and auto, for example.”

Additive manufacturing offers specific benefits. “3DP enables products to get to market faster and to have improved designs through increased design iterations,” said Cashman. In addition, “3DP can produce parts with complex geometries and organic shapes, perfect for unique or customized applications.” Such capabilities could benefit the medical device industry in particular, as “nothing is more customized than the human body,” she added.

Protolabs augments such on-demand production with digital manufacturing, a “technology-enabled, automated approach to manufacturing,” Cashman told MD+DI. “Through our ecommerce portal, once a customer uploads a 3D CAD file, our system analyzes it and delivers design for manufacturability (DFM) feedback and a pricing quote within a few hours. This system enables designers and engineers to rapidly iterate their product designs. The ability to provide feedback in hours and parts in days is a game changer for the manufacturing industry. It enables real-time inventory monitoring, which allows companies to master their whole production line and intervene when it is necessary to adapt the product to the changing market.”

Above: A stereolithography microfluidics part. 

Such a “digital” approach could serve medtech companies as “we apply this digital thread across multiple services [such as] 3D printing, CNC machining, injection molding, and sheet metal fabrication,” she said. “If a customer were using a traditional method, which would most likely involve sending a part drawing to an engineer at the receiving company, just the quote alone could take days or weeks to send back depending on availability and capacity of the quoting team on the receiving end. Once the quote is generated and accepted in the traditional format, a company then has to manually block time in its schedule for the mold or part to be built. By comparison, Protolabs’ proprietary software creates a digital thread that seamlessly runs from upload to quoting to scheduling to production, which creates efficiencies that are not possible without it.”

There are some implementation challenges in terms of using 3D printing for market-ready components or finished devices. “I still believe the largest barrier to entry is the lack of clinical data in the additive space,” said Cashman. “Also, very few 3D printing materials are USP Class VI compatible, and few 3D printing shops are ISO 13485 compliant. We are ISO 9001, which is good for prototypes and some end-use applications. The FDA regulations are only about a year old and are still evolving.”

On-demand manufacturing is also driving the need for new skills. “I visit many customers that tell us one of the most important skills any new engineer must have is they need to have a fundamental understanding of how to design for digital manufacturing,” she said.

Above: An injection-molded part.

3D printing is enabling new innovators to step into the medical device market, such as doctors or other clinicians. “We often have surgeons making their own surgical tools that will potentially commercialize in to the market,” she said. “3D printing lowers the barrier of entry for surgeons with good ideas to bring their ideas to reality.”

When asked whether medical devices will one day be printed closer to the point of care, Cashman said they are already seeing this in dental. “Many industries are looking to simplify supply chains and move to a distributed model – they also want to look to suppliers with the capacity and expertise to help them. However, the expertise to run such a wide variety of geometries/machine maintenance/material handling could prove to be a challenge.”

FDA Cautions Against the Off Label Use of Surgical Robotics

FDA Cautions Against the Off Label Use of Surgical Robotics

Off-label use medical device use is a tricky subject and one that has been at the center of many heated debates. It is strictly against the law for manufacturers to promote their products for off-label use, however, physicians have the discretion to use a device in an off-label manner if such use might be beneficial to the patient.

One area where this practice has become particularly touchy is robotically-assisted surgery. FDA issued a safety note Thursday to doctors and patients urging caution when using robotically-assisted surgical devices for mastectomy and other cancer-related surgeries.

“... We are warning patients and providers that the use of robotically-assisted surgical devices for any cancer-related surgery has not been granted marketing authorization by the agency, and therefore the survival benefits to patients, when compared to traditional surgery, have not been established,” said Terri Cornelison, MD, PhD, assistant director for the health of women in FDA’s Center for Devices and Radiological Health.

Cornelison said the agency is aware of scientific literature reporting that surgeons have been using robotically-assisted surgical devices for off-label uses.

"We want doctors and patients to be aware of the lack of evidence of safety and effectiveness for these uses so they can make better-informed decisions about their cancer treatment and care," he said.

The agency also noted that there have been reports of poor outcomes for patients, including one limited report that describes a potentially lower rate of long-term survival of long-term survival when surgeons and hospital systems use robotically-assisted surgical devices instead of traditional surgery for a hysterectomy in cases of cervical cancer.

FDA also said physicians should complete the appropriate training for the specific robotically-assisted surgical procedures performed. Doctors also should discuss the benefits, risks, and alternative procedure options with their patients to make informed treatment decisions, the agency said. Patients should ask their doctors about training, experience, and outcomes related to the use of robotically-assisted surgery, FDA said.

A Pill, That’s a Device, That Delivers a Drug!

Courtesy of Rani Therapeutics A Pill, That’s a Device, That Delivers a Drug!

Rani Therapeutics just achieved one of its most significant milestones since it was spun out of InCube Lab in 2012. The San Jose, CA-based company just finished conducting the first human study of its “robotic capsule” set to replace injections. Previously the device, which administers a pharmaceutical through a digestible pill, had been tested in more than 100 animal models.

The human study was conducted at a Clinical Research Organization (CRO) in Texas under the Investigational Review Board (IRB) approval. There were two sub-groups, one cohort was fed and another fasted. Each subject swallowed a drug-free version of the RaniPill capsule.

Rani Therapeutics said results revealed no sensation of the capsule inflating or deploying, and the successful passing of the remnants. The RaniPill capsule was well-tolerated by both male and female adult subjects of similar BMI with no adverse events. The study showed similar intestinal deployment times for both fasted and fed subjects, indicating that food does not impact the RaniPill capsule's performance.

“We’re now preparing for our second in-human study, but this time with a drug,” Mir Imran, Rani's Chairman and CEO, told MD+DI. “That will happen within the next several months and we’re very excited about it. This will be another major milestone for the company and it will pave the way for us to start doing regulatory development in the U.S. and Europe.”

Insulin will be placed in the RaniPill for the next human study.

The RaniPill capsule has a special enteric coating that protects itself in the acidic environment of the stomach. When the capsule moves into the intestine and pH levels rise, the enteric coating dissolves and a chemical reaction takes place which inflates a balloon. The pressure in the balloon pushes the dissolvable microneedle filled with the drug into the intestinal wall. The uptake of the drug is immediate due to the highly vascularized intestinal wall. Because there are no sharp pain receptors in the intestine, the injection is painless. By comparison, subcutaneous injections can be painful, especially when patients have to inject themselves chronically.

The RaniPill capsule uses no metal, springs or other elements that the body cannot easily absorb or pass quickly. The company's more than 100 preclinical studies, including the testing of more than 1,000 capsules in animal models, and its recent human study, have shown that large animals and humans are able to pass the remnants of the RaniPill capsule within one to four days.

“There is no precedent for this product,” Imran said. “It’s not like there are five other products like this, that we can draw on for a regulatory or clinical path for our product. This is the first in its category.”

The idea of pill-like devices isn’t a new one, however most of these technologies have tremendously different applications than the RaniPill.

Given Imaging was well known for its pill cam technology – used for the detection of colon polyps in patients for whom a complete evaluation of the colon isn’t technically possible. The company received FDA clearance for the technology in 2014. Given Imaging was eventually acquired by Covidien for $860 million. The Dublin-based company was then picked up by Medtronic in one of the largest medtech deals to date.

Proteus Digital Health developed and received FDA clearance for a digestible sensor to help improve medical adherence. In 2017 FDA signed off on Abilify Mycite, a drug-device combination product comprisded of Otsuka’s oral aripiprazole tablets that have been embedded with Proteus’ Ingestible Event Marker (IEM) sensor.

Abilify is mostly prescribed for complex patient populations such as those with serious mental illnesses like schizophrenia, bipolar disorder, depression, and Tourette syndrome.

Supplier Stories for the Week of February 24

GenX Medical has been awarded an ISO 13485:2016 Management System certificate by SRI Quality System Registrar for manufacturing medical-grade extrusions intended for use in medical components. GenX Medical specializes in micro-bore tubing, bioresorbable extrusions, multi-lumen tubing, and other extrusions."We are pleased to acknowledge that GenX Medical LLC has demonstrated effective implementation of a management system," stated Edward L. Maschmeier, SRI's associate vice president, certification, in a news release issued by GenX Medical. "ISO 13485:2016 certification provides evidence to customers, suppliers, employees, and their community of their commitment to producing a quality product (service) and providing customer satisfaction.”GenX Medical can ship custom tubing within only 5-7 business days, and it designs and manufactures its own tooling dedicated to a client’s application, ensuring that the physical properties are customizable, repeatable, and predictable between various lots, the company reported in the release. “We truly believe that great business is done by building great relationships with our customers, our suppliers, and our employees, “ stated Tyler Ware, president, in the release. “Those core values contribute to the significant growth we have seen over the last few years.”The company had moved to a larger facility at in Chattanooga, TN, in August 2018. Equipped with a controlled white room, the location has electrical utilities and additional space for future expansion.[Image courtesy of GENX MEDICAL]Editor's Note: If you have news you’d like to submit for potential inclusion in future weekly roundups, please send a press release and any related images to daphne.allen@ubm.com with the subject line “Supplier Stories.”

Abbott Offers up Rapid Influenza Diagnostic

Abbott Laboratories said its latest rapid influenza diagnostic test has been granted waived status under CLIA by FDA.

The Abbott Park, IL-based company’s BiaxNow Influenza A&B Card 2 is for use with the Digival diagnostic reader (formerly Alere Reader). Recall, Abbott acquired Alere for $5.3 billion in 2017.

The prevalence of influenza in the U.S. is both high in incident and costly. The burden of influenza is estimated to be 9 million to 36 million cases per year. Influenza and its complications cause as many as 140,000-710,000 hospitalizations and 12,000-56,000 deaths annually. The disease also poses a significant economic burden including medical care expenses and loss of productivity.

Rapid influenza diagnosis can help guide appropriate treatment decisions so that antivirals can be prescribed, and antibiotics withheld, as needed.

Abbott said the BinaxNOW Influenza A & B Card 2 test provides an advancement in lateral-flow testing technology. The card can be easily used by healthcare staff in physician offices and hospitals. The card is placed in the camera-based DIGIVAL diagnostic reader for result interpretation, which removes subjectivity and provides consistency in reading. In addition, the instrument helps with quality control management and can be connected to the hospital information system. As a Class II assay, the BinaxNOW Influenza A & B Card 2 complies with the FDA's new reclassification requirements for RIDTs.

Shockwave Looks to Go Public with $75M IPO

Pixabay Shockwave Looks to Go Public with $75M IPO

Shockwave Medical could raise $75 million in its initial public offering. Earlier this week, the Santa Clara, CA-based company priced the offering and said it plans to sell five million shares for between $14 and $16 in the IPO.

Shockwave Medical is developing a technology that uses pressure from sonic waves to treat calcium deposits in the circulatory system. The treatment enables arteries to expand under low pressure and become more compliant.

The company has secured regulatory nods for its technologies but is working on gaining approvals for the treatment of coronary artery disease (CAD).

“We are undertaking ongoing clinical trials of our C2 catheter intended to support a PMA in the U.S. and a Shonin submission in Japan for the treatment of CAD,” Shockwave Medical said in a prospectus filing. “We anticipate having final data from these ongoing clinical trials intended to support a U.S. launch of our C2 catheter in the first half of 2021 and a Japan launch in the second half of 2021.”

The company said it plans to trade on the Nasdaq with the symbol of "SWAV."

News of the IPO follows Abiomed investing $15 million in Shockwave Medical. In addition, the Danvers, MA-based company said it would work with Shockwave on a training and education program in the U.S. and Germany focused on the benefits of complementary use of their respective technologies.

Drug-Delivery Devices Celebrated at Pharmapack Europe

Drug-Delivery Devices Celebrated at Pharmapack Europe

Drug-delivery devices were honored in both the Exhibitor Innovations and Health Products categories in the awards program held February 7 during Pharmapack Europe 2019. Here are the device-related winners:

Exhibitor Innovations: Best Innovation in Drug Delivery Device

  • Connected Health Platform by Phillips-Medisize
  • Cartridge-based wearable device by Stevanato Group

Health Products: Patient-Centric Design Award

  • Excilor 2-in-1 Wart Treatment by Medical Brands, co-developer: Vemedia

Pharmapack Europe Brand Director Silvia Forroova said the winners “showcased a wide range of industry-changing discoveries in the field of drug delivery, packaging, and automation.”

Two exhibitors were honored with the Best Innovation in Drug Delivery Device awards.

Phillips-Medisize was honored for its Connected Health Platform (CHP), depicted below in a patient app.

The cloud-based CHP offers drug-delivery device developers and pharmaceutical companies a medical device data system platform that could help reduce risk, cost, and time to market for connected health solutions, the company shared in a press release last October. “Our CHP further demonstrates our commitment to creating innovative solutions for our customers. This allows clients to quickly change or fine-tune reports without the need for costly, time-consuming software development,” said Matt Jennings, CEO and President, Phillips-Medisize, in the release. “By offering our platform as a service (PaaS), we’re responsible for data security, management and storage. That gives our customers the freedom to focus on what they do best – creating connected health solutions that provide better patient experiences and facilitate improved patient outcomes.” 

Stevanato Group was honored with a ‘Best Innovation in Drug Delivery Device’ award for its cartridge-based wearable device, shown below.

Stevanato's cartridge-based wearable device is offered as alternative to traditional pen-injectors, the company reported on its Web site.  The device consists of a discreet disposable pod and a handheld user interface and controller; when the controller is placed over the pod, the pod delivers the needed dose. The device can deliver subcutaneous or intramuscular injections. The company described ideal applications as those that would need at least 2 injections/day or slow injection times. 

The Excilor 2-in-1 Wart treatment (shown below) by Medical Brands was recognized in the Health Product category with the Patient-Centric Design Award.

Co-developed by Vemedia, Excilor 2-in-1 Wart combines cryo and acid treatments into a single device, providing faster treatment time and fewer applications, Pharmapack shared.

Please click here to see other Pharmapack Award winners recognized for their pharma packaging achievements.

Pharmapack Europe 2020 will be held February 5-6, 2020.

How Devices Could Tackle Migraine Pain

A recent survey found a significant underutilization of non-drug treatment options for migraine among female patients and healthcare providers.A total of 1,005 adult females (ages 18 to 60) who have been diagnosed with migraines were surveyed about their experiences with migraine treatments, management of their symptoms, the impact of migraines on their quality of life, and knowledge of non-drug treatment options. Additionally, 402 healthcare professionals were surveyed about migraine treatments they use for patients, their perceptions of migraine patients, and their familiarity with the role of the vagus nerve in treating migraines.The survey, sponsored by bioelectronic medicine company electroCore and completed in partnership with HealthyWomen, showed that only 18% of patients are completely satisfied with their current migraine treatment, yet only 8% of healthcare providers say they have treated patients with a non-drug therapy.Perhaps even more telling is the fact that the survey revealed 86% of female migraine patients say they would be willing to try non-drug treatment options, while only 28% of healthcare providers said their patients would be willing to try non-drug treatments. These findings reveal a crucial knowledge gap between patients’ satisfaction and providers’ perceived patient satisfaction with commonly prescribed migraine treatments, as well as a lack of knowledge about non-drug migraine treatments."The survey is a clear indication from the marketplace that there are a considerable amount of demand and folks out there that are looking for non-drug alternatives to manage pain conditions, especially migraine and cluster headache," electroCore CEO Frank Amato told MD+DI.Current medications available to patients who suffer from migraines or cluster headache are inadequate in their efficacy, Amato said, and a lot of them have side effects or contraindications for cardiovascular events."Folks are just dissatisfied with the current treatment options," he said.In the following slides, we highlight several devices, including electroCore's gammaCore Sapphire, that are either on the market or in development to tackle migraine and/or cluster headache.

So, When is the GE Healthcare IPO Happening?

Pixabay So, When is the GE Healthcare IPO Happening?

Don’t look for General Electric to spin out its healthcare unit just yet. The Boston, MA-based company said an IPO for its healthcare business was going to be put on hold while it sells of its pharmaceutical unit to Danaher for $21 billion.

During an interview with CNBC, General Electric’s chairman and CEO said that an IPO of for GE Healthcare in 2019 is “unlikely at this point.”

The firm made waves in June of 2018, when it announced it would spin out GE Healthcare. During that time, the company said the IPO could occur sometime this year. The reason behind the move was it would give the company a chance to get back to its roots and focus on aviation, power, and renewable energy.

General Electric’s plans called for it to sell about 20% of the health business and spin off the rest to its shareholders. The healthcare unit has long been a bright spot for General Electric. In 2018, GE Healthcare generated about $19 billion in revenue with $3.4 billion in profit.

General Electric isn’t the only company that has been in the process of restructuring and divesting businesses. Shortly after the company announced the healthcare spin out, Bovie Medical revealed a plan to sell its electrosurgical offerings to Specialty Surgical Instrumentation, a subsidiary of Symmetry Surgical, for $97 million.

Johnson & Johnson has been very active in shedding off units in the past few years.

In early 2017, the New Brunswick, NJ-based company made a huge splash when it was announced it was selling its Codman Neurosurgery Business to Integra Lifesciences for $1.05 billion. J&J had then announced plans to shut down Animas Corp., which once provided insulin pumps to 90,000 patients. J&J said those insulin pump users would have the option to transfer over to Medtronic pumps.

The company capped off its divestitures by selling off its LifeScan Diabetes unit to Platinum Equity for $2.1 billion.