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Bone Bioprinting Breakthrough

    Arrow  back3-D Printed Bone Trinity

Researchers at the AMBER material science center at Trinity College Dublin in Ireland have created a process to support larger and more complex 3-D printing of bone material.

Instead of outright printing bone, the AMBER team's bioprinting involved depositing different biomaterials and adult stem cells to engineer cartilage templates matching the shape of a segment within the spine. A cartilage templates was able to mature  over time into a fully functional bone organ with its own blood vessels.

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See Tim Lew of AxoGen discuss, "Advances in 3-D Printing Capabilities for Medical Device Development," at BIOMEDevice San Jose, December 7-8, 2016.

[Image courtesy of AMBER material science center at Trinity College Dublin]

Creating the Octobot

    Arrow  backOctobot Wyss

3-D printing enabled Harvard researchers to create the "octobot," an octopus-inspired robot that is entirely made of soft materials and powered by chemical reactions controlled by microfluidics.

"In fields where a gentle touch is more important than a rigid grasp, we believe soft robots will emerge as the winner. Soft robotic grippers are already being used to handle undersea structures in scientific research. One can easily envision soft robots being used to handle fragile objects such as crops, or even living beings. Internal medicine and wearable devices are also likely areas for future soft robots," Michael Wehner, postdoctoral fellow at Harvard's  Wyss Institute and co-first author on the work, recently told Qmed

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See Tim Lew of AxoGen discuss, "Advances in 3-D Printing Capabilities for Medical Device Development," at BIOMEDevice San Jose, December 7-8, 2016.

[Image courtesy of Harvard University's Wyss Institute]

A Better Bioprinter

    Arrow  backRegenova

Researchers at Indiana University-Purdue University Indianapolis (IUPUI) and Johns Hopkins University are using a bioprinter that preserves cells better than the traditional scaffold 3-D printing technique, according to a reportin TechRepublic.

The  robotic 3-D printer is called the Regenova. Made by Tokyo-based Cyfuse Biomedical, Regenova places groups of cells called spheroids in fine needle arrays, following pre-designed 3-D data. The cells then bond and fuse into tissue.

The Regenova can print tubular body parts, such as veins and arteries, the report said. The IUPUI researchers are working on tissue engineering and regenerative medicine projects in vascular and musculoskeletal biology, dermatology, ophthalmology, and cancer, according to a university statement.

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See Tim Lew of AxoGen discuss, "Advances in 3-D Printing Capabilities for Medical Device Development," at BIOMEDevice San Jose, December 7-8, 2016.

[Image courtesy of Cyfuse]

4-D Printing Gets More Sophisticated

    Arrow  back4-D Printing Harvard

Harvard University researchers have come closer to unleashing the potential of 4-D printing, which involves materials that transform and assemble themselves. (Imagine an implantable medical device that assembles and deploys itself inside the human body.)

Researchers at Harvard's Wyss Institute for Biologically Inspired Engineering devised a mathematical model that determines how a 4-D object must be printed to achieve prescribed, changeable shapes. The model drew inspiration from the way that plants in nature are able to change shape over time in response to stimuli in their environment.

"We have now gone beyond integrating form and function to create transformable architectures," Jennifer Lewis, senior author on the study, said in a statement. 

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See Tim Lew of AxoGen discuss, "Advances in 3-D Printing Capabilities for Medical Device Development," at BIOMEDevice San Jose, December 7-8, 2016.

[Image courtesy of Harvard University's Wyss Institute]

Custom-Built 3-D Printers Enabling Innovation

    Arrow  backMcAlpine 3-D Printer University of Minnesota

3-D printing breakthroughs--such as the creation of implantable bioprinted tissues--are becoming increasingly possible because researchers are creating custom 3-D printers that are far more complex than what is presently commercially available.

McAlpine Nerve Regeneration GuideThink custom-built 3-D printers that create with multiple materials from the nanoscale to the macroscale--enabling significant medical device innovation in the process. Pioneers in the field include Michael McAlpine, PhD, at the University of Minnesota, Jennifer Lewis, ScD, at Harvard University, and Anthony Atala, MD, at the Wake Forest Institute for Regenerative Medicine.

McAlpine, for example, was able to use a custom-built 3-D printer to improve a rat's walking ability. McAlpine and his research colleagues used a 3-D scanner to reverse engineer the structure of the rat's sciatic nerve, and then 3-D print a silicone regeneration guide (shown on the right) that also had 3D-printed chemical cues to promote both motor and sensory nerve regeneration. Implantation of the guide in the rat provided a proof-of-concept that such guides could promote nerve regeneration. McAlpine envisions such guides someday being made of bioabsorbable materials, enabling nerve regeneration that is usually rare among people suffering from nerve damage.

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See Tim Lew of AxoGen discuss, "Advances in 3-D Printing Capabilities for Medical Device Development," at BIOMEDevice San Jose, December 7-8, 2016.

[Image of custom-built 3-D printer at the University of Minnesota taken by Chris Newmarker/Qmed. Nerve regeneration guide photo courtesy of Michael McAlpine/University of Minnesota]

Printing Replacement Tissue for People

    Arrow  back3-D Bioprinting Wake Forest Ear

Regenerative medicine scientists at Wake Forest Baptist Medical Center announced in February that they have created a custom-designed 3-D printer able to bioprint sophisticated ear, bone, and muscle structures.

The tissue structures printed at Wake Forest had the right size, strength, and function for use in humans. And they were able to mature into functional tissue with a system of blood vessels after being implanted inside animals.

Anthony Atala, MD, director of the Wake Forest Institute for Regenerative Medicine, described the novel tissue and organ printer as an important advance in the field.

"It can fabricate stable, human-scale tissue of any shape. With further development, this technology could potentially be used to print living tissue and organ structures for surgical implantation," Atala said in a news release

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See Tim Lew of AxoGen discuss, "Advances in 3-D Printing Capabilities for Medical Device Development," at BIOMEDevice San Jose, December 7-8, 2016.

[Image courtesy of Wake Forest Baptist Medical Center]

7 Radically New 3-D Printing Innovations

    3-D Printing Innovations

It is so much more than a prototyping tool these days. Here are seven examples of 3-D printing technology that could revolutionize the medical device industry.

Chris Newmarker

3-D printing is already used for prototyping, surgical models, and prosthetics in the medical device industry. But major medtech companies are now embracing additive manufacturing to use it for much more.

Stryker, for example,is creating a 3-D printing plant in Cork, Ireland after enjoying some success with 3-D printed ortho implants. Johnson & Johnson has forged 3-D printing partnerships with companies including Hewlett Packard, as well as Google-backed Carbon and its high-speed CLIP (Continuous Liquid Interface Production) process in which objects quickly rise out of ultra high-performance urethanes.

Researchers are meanwhile developing 3-D printing technologies that could be even more disruptive in the medical device space.  Derek Mathers, R&D director at Worrell Design (Minneapolis), wishes the device industry had better mechanisms for adoption of the some of the 3-D printing processes presently stuck in the laboratory.

"There needs to be a better bridge to get that out of a research environment and commercialize in a medical device and pharmaceutical environment," Mathers says.

Here are seven 3-D printing research innovations that are especially worth noting.

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See Tim Lew of AxoGen discuss, "Advances in 3-D Printing Capabilities for Medical Device Development," at BIOMEDevice San Jose, December 7-8, 2016.

New 'Smart’ Needle Could Improve Diagnoses

Researchers create a new smart needle technology equipped with electrodes that can guide physicians to specific areas of the body, and send alerts when the needle approaches sensitive nerves.

Kristopher Sturgis

Injeq IQ-Needle tipA new tool, known as the Injeq IQ-Needle, has been developed by researchers at Tampere University Hospital in Finland to help doctors locate and draw spinal fluid from patients without damaging the delicate surrounding tissue, according to GE Reports.

The device was designed to provide a novel tool for use on infants suffering from neonatal meningitis, a condition that has become one of the leading causes of infant mortality in the western world.

For tiny infants, collecting spinal fluid is the most efficient way to obtain an early diagnosis for neonatal meningitis, but the procedure can be as difficult as it is dangerous. Typically doctors will use computer tomography or ultrasound to help guide the needle in lumbar puncture procedures, but neither scan is perfectly accurate, which can lead to additional procedures and punctures.

This new technology comes equipped with electrodes that can guide physicians to the appropriate spot, and send an alert when the tip of the needle contacts the spinal fluid. It can also alert the physician if the needle comes close to any sensitive nerves in the surrounding area -- providing doctors with a tool that is both safer and more accurate. Injeq, the Finnish medical device startup company that developed the technology, recently partnered with GE to further the technology, and create other tissue-identifying needles for spinal taps and cancer biopsies.

"The most urgent clinical need is in neonatal puncture," Injeq CEO Kai Kronström told GE Reports this week. "The study is in its early stage, but everything looks good so far."

Harnessing Sensors and Data Management

Sensors and data management are changing the game when it comes to medtech product development. Learn how to use these tools to create your next winning innovation at MD&M Minneapolis on September 22. Qmed readers get 20% off with promo code Qmed16.

Smart needle solutions have become a recent novel solution for physicians to help ensure patient safety and improve needle puncture procedures. Over the summer, Graham Reynolds, vice president of pharmaceutical delivery systems at West Pharmaceutical Services Inc., said that there are a variety of new smart needles and syringes on the horizon. These smart needle and syringe technologies will not only make puncture procedures safer, but should also improve the accuracy and efficiency of procedures going forward.

Kronström also noted that traditional needle procedures that use computer tomography to guide the needle involves exposing the patient to radiation, and can also result in false negatives--which can require patients to repeat the procedure. These kinds of delays can put off cancer treatments for weeks, and can require patients to remain in the hospital due to risks associated with the procedure if the surrounding tissue becomes damaged or bleeds.

Ultimately Kronström and his colleagues hope that this new technology can help eliminate most of these risks, and improve the entire diagnostic process. He even says the technology can be refined to help identify the presence of tumors in real time in other places like the liver. Eventually, the smart needle technology could be used to replace things like computer tomography scans and act as a complementary tool along with ultrasound technologies.

As they move forward with their research, the group hopes to continue to explore the technology as a means to identify the nature of tissues during puncture procedures, and provide diagnostic results in real time. In time, the Injeq IQ-Needle could become the gold standard for collecting spinal fluid, and perhaps other delicate puncture procedures as well.

Kristopher Sturgis is a contributor to Qmed.

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[Image of Injeq IQ-Needle tip courtesy of Injeq]

Medtronic Scores New Cardio Device Approvals

The medical device giant recently won U.S. FDA approval of what it touts as the first drug-coated balloon treatment for in-stent restenosis, and Medtronic's Reveal LINQ insertable cardiac monitor ICM system has won approval from Japanese regulators.

Chris Newmarker

IN.PACT Admiral Medtronic
Illustration of the IN.PACT Admiral (Image courtesy of Medtronic)

Medtronic this week announced new cardio device regulatory approvals in the U.S. and Japan. 

In the U.S., FDA has approved IN.PACT Admiral drug-coated balloon for the treatment of in-stent restenosis in peripheral artery disease patients. Medronic says the approval marks the first time a drug-coated balloon has been approved in the U.S. for such a use. 

"We are experiencing a paradigm shift in treating patients with complex [peripheral artery disease]," said John Laird, MD, interventional cardiologist at U.C. Davis Medical Center and co-principal investigator for the IN.PACT SFA trial of the balloon. "Until now physicians have had limited treatment options to address patients with [in-stent restenosis]. The FDA's approval of IN.PACT Admiral DCB allows us to treat patients with a durable, proven, and safe technology."
In-stent restenosis, which takes place when plaque forms around an implanted stent, takes place in up to two-fifths of all stents placed in the superficial femoral artery, according to Medtronic. 
Also this week, Medtronic announced that Japanese regulators have approved Medtronic's Reveal Linq insertable cardiac monitor ICM system. About the size of a AAA battery, the Linq is placed in a 1 cm incision on the left side of the chest and helps physicians quickly and accurately diagnose irregular heartbeats. Medtronic launched Linq in 2014 after it won FDA clearance and CE Mark. The Linq has already proved itself to be a cardio device sales booster for Medtronic.

Structural Heart Opportunities and Challenges

TAVR and TMVR are among the hottest technologies in medtech right now. Learn what it takes to innovate in the structural heart space at the MD&M Minneapolis conference on September 21. Qmed readers get 20% off with promo code Qmed16..

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

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High-Paying Device Sectors

High Pay--Digital/Mobile Health, Diabetes, Anesthesia Equipment, Orthopedics, Combination Devices, & In Vitro Diagnostics

Those professionals working in the relatively new field of digital health and mobile health earn a median salary of $118,630.

Employees concentrating on diabetes tech make a median salary of $119,000

Medtech employees who said they work on anesthesia equipment reported a median salary of $120,000.

Orthopedics is another device sector where employees said they earn $120,000 in median pay.

Working on products that combine devices, drugs, and/or biologics? Professionals in the combination device space earn a median salary of $122,000.

In vitro diagnostics employees earn a median of $123,500

Want more? Check out our free Medtech Salary Survey report, with breakdowns by job description.