Additive manufacturing is getting attention for its ability to accelerate the product development process.

The most common types of rapid prototyping methods are additive technologies, meaning that the model is built by adding material layer by layer. By contrast, subtractive prototyping methods create a model by removing material, typically by means of standard machining methods such as milling, grinding and drilling.

A rapid prototype originates with a computer model. Typically, this model is fabricated using computer-aided design (CAD). In some cases, where the final product will be custom-made for the patient, the computer model is created from the patient’s CT scan. A prototyping machine reads the computer data and slices it into different layers. The machine then builds the prototype by adding material layer by layer.

Get a list of the most common rapid prototyping and additive manufacturing method from European Medical Device Technology, where Camilla Andersson also discusses important application areas, including advantages for orthopaedic implants.

A bionic arm developed at MIT has an app that gives users more control.

Using the technology with apps also opens up other possibilities Tablets, because they have cameras embedded in them, could enable the bionic arm to be used for remotely based rehab pops up. It also opens up the possiblilty of doing game-based rehab. “This could be used if someone moves x number of degrees, the tablet figures that out and maybe moves like an avatar on a screen, or you build it into a game,” says Stephen Page, PhD, of Ohio State University Medical Center.Traditional rehab is often boring for many patients. “But with game based therapies, patients can lose track of time,” Page says. “And when you have got people with brain injuries, there are sometimes issues with motivation or other factors that may compromise their full participation.” Game-based rehab can become inherently appealing or it can be made more rewarding by adding competitive or social aspect to it."

• China Kangui Holdings. The China-based orthopaedics company continues to grow through its strong product pipeline.
• NuVasive. The acquisition of Impulse Medical could help strengthen NuVasive’s business strategy.
• OrthoFix. The company already surpassed analyst revenue expectations for Q4 2011.

• The outlook for industry recovery looks cautious at best. The trends that we saw throughout last year—dropping procedure volumes and pricing pressures—aren’t going anywhere.
• “Stabilization” is the buzzword in the spine segment. “The ground rules of the spine industry have changed over the past 12-19 months with the government (through FDA and CMS) demanding more data and customers (hospitals and physicians)wanting to pay less for products,” analysts wrote.  

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"My general view is that there’s an interest in robotics and computer assistance, and there’s an interest in personalization. We’re offering something that is addressing current strong trends within the orthopaedic field." --Graeme Brookes, Stanmore Implants

Competition

What's Next 

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As metal-on-metal hip implants continue to be scrutinized, here's the latest from Jim Dickinson in MD+DI's Washington Wrap-Up:

A review of clinical trials, observational studies, and registries produced limited evidence on comparative effectiveness of various hip implant bearing combinations, according to an open source British Medical Journal report by researchers from CDRH and universities in the United States and Australia. “Results do not indicate any advantage to metal-on-metal or ceramic-on-ceramic implants compared with traditional metal-on-polyethylene or ceramic-on-polyethylene bearings,” the study concludes....They say they systematically reviewed the evidence as part of that project to determine the short- and long-term outcomes reported by patients undergoing hip replacement and the rates of revision after using implants with various bearings."

Medical device packaging company DDL is answering industry demand by adding orthopaedic testing to its services (the company previously conducted testing, but capabilities were limited).

The company now has a biaxial tester, which combines tensile and compression with a torque action. In a company release, DDL notes some tests it offers customers:

• ASTM F2193, Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System
• ASTM F1717, Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model
• ASTM F56, Standard Specification and Test Methods for Metallic Bone Staples
• ISO 7206-4, Implants for surgery -- Partial and total hip joint prostheses -- Part 4: Determination of endurance properties and performance of stemmed femoral components
• ISO 14801, Dentistry -- Implants -- Dynamic fatigue test for endosseous dental implants

Dean Tulumaris, president and CEO of Biomedical Structures

• Bifurcated and tapered stent grafts. We don’t play in that arena so we want to work into that.
• Orthopaedic bifurcated and tapered tethers. 
• Heart valves, and minimally invasive cardiac solutions. We will continue to make thin nonwovens for those applications.
• More complex braiding discovery.
• Finer gauge knitting with scaffolds and meshes.

Biomedical textiles are often used as a replacement for structures in the human body.

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Over the next five years, the orthopaedics market in Brazil, India, and China will see a boost from medical tourism, better surgeon training, and growing adoption of certain procedures such as cranio maxillofacial fixation.

A new range of hydroxyapatite (HA) biomaterials have potential new uses in antimicrobial and osteopromotive coatings. They could also be used in the development of bone cements with altered structural features

Calcium phosphate growth after simulated body fluid immersion.

that include toughness, solubility, and porosity. Developed by Ceram, the materials have different biological properties. The company changed the basic chemistry of the material, while keeping its physical structure, by putting different elements into HA.

Related content:

• Surface Manufacturing for Implants
• Advances in Man-Made Materials
• Smart Material Regenerates Bone

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Exactech has voluntarily extended the terms of its DPA with the U.S. Attorney’s Office for the District of New Jersey for three months. The company had entered into the DPA last December following the 2007 investigation into its consulting agreements with orthopaedic surgeons. The extension, which ends on March 8, 2012, gives the independent monitor more time to examine Exactech's compliance system and how it is working. It's important to note that the U.S. Attorney's Office hasn't stated that Exactech has breached the terms of the DPA. 
 
In September, Wright Medical agreed to a 12-month DPA extension.
 
From the archives:

• Oversight of Orthopaedic Device Companies Ends (March 2009)
• Senate Hears Debates Over Payments and Influence (April 2008)
• Zimmer Ends Gift-Giving to Doctors (April 2008)