What You Missed Last Month (May 2015 Edition- Medical Device & 3D Printing)

June 10, 2015 / by Kapstone Medical / 3 minute read

Additive manufacturing, or 3D Printing, is dominating spring medical device industry headlines, and at halfway through the year, it’s slated to be on the Top 5 list of Kapstone Medical’s most inspiring and thought-provoking topics of 2015.

This past month, from spinal fusion implant firsts in Europe, to the captivating story of three infants’ lives saved by 3D printed medical airway tubes, researchers and healthcare innovators continue to ride the wave of 3D printing, with high production costs and the pace of new materials development as the only perceived industry limitations.

Here are our picks for the top stories you missed in May 2015:

German Patient First to Receive 3D Printed Titanium Spinal Fusion Implant

Spinal fusion surgeries increased by 70 percent in the United States between 2001 and 2011. While those numbers are large in part to an aging American population, advances in additive manufacturing technology will also fuel growth in the future.

A new and developing 3D printing industry continues to produce medical milestones; one of the latest being the first patient to receive a 3D printed titanium spinal fusion implant.

An exacting replication of the German patient’s trabecular bone structure, including nanostructural features, was created in order to achieve the goal of promoting optimal healing and fusion of the patient’s bones. The biomechanical properties of the implant allow for ingrowth into existing bone, which prevents the need for additional bone graft treatment.

Manufactured via laser melting, the titanium implant has up to 80 percent porosity and essentially provides a “scaffolding” that is ideal for growing bone cells and vascular structures.

EOS Imaging Announces CE Mark for kneeEOS, the first 3D Stereo-Radiographic Planning Software for Total Knee Arthroplasty

EOS Imaging now has the CE Mark for kneeEOS, a pioneering 3D Stereo-Radiographic Planning Software for Total Knee Arthroplasty (TKA), based on EOS bi-planar imaging.

The planning suite was recently presented to the 16th European Federation of National Associations of Orthopaedics and Traumatology (EFORT) Congress, May 27-29 in Prague, Czech Republic.

kneeEOS is the second innovative software platform by EOS Images following hipEOS, which was CE marked and FDA cleared in 2014.

The new software allows for surgeons to plan for TKA in a functional weight bearing position, and requires a radiation dose 50 percent to 85 percent less than digital radiology.

Model Prints—Additive Manufacturing Provides an Ideal Way for Doctors to Rehearse Complex Orthopedic Procedures

The greatest surgeon still isn’t perfect—and surgical procedures are not foolproof, either.

Both physicians and their patients desire the best care and clinical outcomes possible. The use of 3D printed orthopedic models allow the experts to better plan their patient’s surgery, resulting in less errors, and less complications.

By printing an exact replica of a patient’s damaged joint, for example, orthopedic surgeons can rehearse for surgery extremely accurately. Techniques can be modified, and strategies can be altered, way before the surgeon and patient ever meet in the operating room.

Again, while technology remains largely cost-prohibitive for large-scale production, it will continue to be in high demand, and pretty soon, the technology will be fundamental to modern medicine.  The article’s prediction? The most successful device manufacturing companies over the next several years will combine addictive manufacturing technology with traditional machining processes to best serve their customers.

3D Printed Device Keeps Very Ill Babies Breathing

One of the most popular and inspiring 3D printing stories for the entire month of May was the viral story of three baby boys whose lives were saved by 3D printing.

The boys, ranging between three months and 16 months old, all suffered from a condition called tracheobronchomalacia, which occurs when airway walls are too weak and collapse during breathing. Because of their life-threatening condition, the children stayed in intensive care for months, were kept under constant ventilation, and required frequent resuscitation.

To save their lives, researchers designed airway splints made of hollow, porous, C-shaped tubes, which essentially prop open the airway passages. The three procedures were risky, but successful, and now, thanks to the 3D printed splints, the boys’ airways have grown and stayed open, and they are essentially cured.

About one child in 2,000 is affected by tracheobronchomalacia. With such a small potential market, like with many medical conditions, there was hardly any real interest in the past in spending money to devise a cure.

The Michigan researchers who designed and fashioned the implants were allowed to go forward by the FDA under its exception for medical emergencies. This cost-effective and feasible new way to treat this deadly condition is continuing to grow, as the researchers are now working with the FDA to create expanded clinical trials.

Are you especially clever at uncovering inspiring medical device, orthopedics, or 3D printing stories? Tweet your article suggestions to @KapstoneMedical during the month of June using #EquipGuideInspire and we may feature you in next month’s blog!

Tags: 3D Printing, Additive Manufacturing, FDA, FDA approval, FDA clearance, innovators, intellectual property strategy, inventors, IP fit, IP services, kapstone, kapstone medical, kneeEOS, medical device, medical device inventors, medical devices, medical emergency, medtech, Model Prints, Monthly Round-Up, Orthopedic, orthopedic surgeons, orthopedic surgery, orthopedics, physician inventors, Product Development, prototyping, Radiography, Regulatory, Regulatory affairs, spinal fusion, titanium implant, TKA, what you missed last month

Kapstone Medical

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