The U.S. FDA apporves the world's first single unit-audio processor.

According to a press release from Med-El, the compact design of the product combines the microphone, battery pack, and coil into a single externally-worn processor, and can be used with all Med-El cochlear implants.

With the FDA approval of the Rondo, MED-EL cochlear implant users will now have the option of selecting the first-ever audio processor without an ear hook and separate coil and cable. The processor attaches magnetically to the internal implant component; a variety of magnet strengths are available, ranging from soft to standard, strong and super strong.
 
Rondo is based on the OPUS audio processor platform, and features the same signature Maestro System software technologies including FineHearing, a built-in telecoil, and Automatic Sound Management.  Med-El's exclusive FineTuner remote control is used to adjust program, volume, sensitivity and a variety of other listening parameters. 
 
“The Rondo audio processor is an exciting addition to MED-EL’s wide portfolio of implant system solutions that provide our candidates with options to fit their unique hearing loss situation and lifestyle,” said Richard Collette, president and CEO, Med-El Corp. USA. “We are thrilled to be able to offer this revolutionary single-unit processor to our cochlear implant users, because it makes the external equipment even less noticeable.”
 
The Rondo will be available in four colors: Anthracite, Nordic Grey, Crème, and Ebony.  Med-El USA plans to launch the processor in the Spring of 2013.

A new auto-injector concept has been designed by innovative product development firm Cambridge Consultants in a bid to ease the trauma for women undergoing fertility treatment. The piOna device has been developed to help patients who need regular injections of progesterone in oil (PiO). The daily intra-muscular injections are often the most dreaded and stressful part of the IVF process as they involve a large and long needle and typically take the patient more than a minute to administer due to the viscosity of the oil.

Progesterone supplements are a vital part of fertility treatment as the hormone helps sustain the pregnancy to full term. The supplements usually take the form of pills or suppositories. But in some cases women need higher doses of the hormone – which involves regular self-administered injections. The intimidating and complex nature of the injections, however, means some patients cannot administer the PiO properly or delay or miss injections, which can lower the success rate of the fertility treatment.

The PiO injections involve warming the oil to make it less viscous and then using a syringe fitted with a 22-gage (1.5") needle to inject the progesterone deep into the muscle. Patients often find it difficult to find the right angle, speed and temperature to ensure correct and painless drug delivery.

The new auto-injector concept guides the patient though the injection process – with audible, visual and tactile signals at each stage and the needle hidden from view – reducing the injection duration by up to 30%. The piOna device automatically warms the oil to the optimum temperature, and its ergonomic and intuitive design makes it easy to hold and use – even for awkward posterior injections. Once the device has made contact with the skin, only a small downward pressure is required to trigger the auto-injection. The technology could also be used for other viscous drugs that need to be self-injected.

As well as being faster and easier to use, the new piOna device could help reduce the amount of swelling and additional side effects around the injected area that patients have to endure. By automating the temperature and injection speed of the PiO, it will help the solution dissipate when it enters the body.

“Fertility treatment is a very stressful and difficult process for a woman to go through and – after discussions with fertility nurses – we felt it was important to tackle the usability issues of self-administered PiO injections," says Lai Chiu Tang, senior industrial designer at Cambridge Co. "Providing women with the confidence to administer a drug dosage without fear of unnecessary pain and stress will open doors to this technology platform being used in all manner of drug delivery. Improving the user experience will help women all over the world to gain access to health opportunities which were previously perceived to be unobtainable.”

One of Boston Medical Center's IVF affiliates – the Reproductive Science Center – handles more than 2,800 assisted reproduction cycles per year.  “Every one of our patients takes progesterone as part of their infertility treatment,” said Wendy Kuohung, MD, associate professor of obstetrics and gynecology at Boston University School of Medicine, whose practice sites include the Reproductive Science Center and the Boston Medical Center. “There are various methods to administer progesterone and, in certain situations such as frozen embryo transfer cycles, intramuscular injection is still considered the most effective route of delivery. 

“Patients may self-administer up to 70 injections during the course of treatment. Already burdened by the stress of infertility, our patients universally find the current manual injection method difficult, painful and anxiety-provoking. After seeing this auto-injector prototype, I have to say that I'm impressed as I believe any innovation in this area will be a great benefit to my patients.”
 

Officials at

Roche

announce  the U.S. market availability of the Elecsys HE4 assay, an FDA approved test used in monitoring patients with ovarian cancer. The HE4 test is used as an aid in monitoring the recurrence or progressive disease in patients with epithelial ovarian cancer.

Studies like K Huhtinen et al show that HE4 shows a high specificity to ovarian cancer over that of CA 125 alone. Both HE4 and CA 125 together, rather than either of them alone, provides a more accurate tool for differential diagnosis of patients with ovarian cancer and ovarian endometriotic cysts from healthy subjects.

"As a leader in oncology, Roche is committed to providing reliable tests that will enable physicians to deliver the best possible care to their patients," says Randy Pritchard, vice president of marketing at Roche Diagnostics Corporation. "The addition of the Elecsys HE4 assay further strengthens our tumor biomarker menu and means healthcare providers now have another tool to give them greater confidence in monitoring patients with ovarian cancer."

High end in the tool industry frequently goes hand in hand with ultra-high precision and minimum diameters nowadays.

“It must also be possible to produce such tools quickly and cost-effectively. Otherwise, a medium-sized company such as ours cannot survive on the market,” says Georg Eckerle from InovaTools.

With high-precision grinding machines produced in Switzerland, InovaTools can meet all requirements in an optimum manner.

Very first GrindSmart a Success

Eckerle came into contact with Rollomatic for the first time in 2002, as he was searching for a grinding machine for tools with diameters of less than 1mm. He was therefore looking around to see what sort of grinding machines were available: “I’m a mechanical engineer myself so I have an extremely in-depth knowledge of the subject. During my research, it quickly became clear to me that there are vast machines with long travel distances. And then you have the special Rollomatic kinematics!” He realized that the Swiss grinding machines had a design-related advantage in their small diameters: “There is nothing better out there!”

His contact with the company came about through Dieter Furtwengler, head of sales at Rollomatic Germany. “Mr. Furtwengler introduced us to the GrindSmart 620XS, but warned straight away that the machine’s precision can only be incorporated into the tool with correspondingly precise, cylindrically ground carbide rods,” says Eckerle. “After a few tests with standard carbide rods, we discovered that he was right!”

A ShapeSmart NP4 cylindrical grinding machine, also produced by Rollomatic, was an ideal addition. After that, things happened quickly, and now there are eight GrindSmart 620/628XS, one GrindSmart Nano6 and four cylindrical grinding machines in operation at InovaTools.

Rollomatic: From Tool to Grinding Machine

Rollomatic started in the early 1950s as a manufacturer of micro tools. “I worked in tool production myself in the 1980s,” says Rollomatic CEO Michel Rollier. “Even back then, we used to manufacture our own machines and systems. That is why I understand how a machine must be designed for it to be popular with manufacturers.”

And so the design of the machines is based on experience of what is crucial in micro tool production. On the one hand, there are the space requirements: Production floor space is expensive, which is why the company tries to keep the machines small and compact. “There are two reasons for this: Long travel distances take a great deal more time and result in considerable heat development. The compact design of Rollomatic machines reduces both of these factors. They have everything in them, from the cooling system to the oil supply,” says Eckerle.

Precision and Dimensional Accuracy: A Fixed Requirement

Precision and process reliability combined with high dimensional accuracy within defined position and form tolerances are tremendously important in micro tool production. The challenge is nothing less than to manufacture a tool at as low a cost as possible. “Both the raw material and the quality of the grinding machine enter into the equation here,” says Eckerle. For example, how safely can it work without any operator intervention? This is a very important factor as our machines are in operation seven days a week.”

Even during weekend operation, an operator is only on site twice a day to equip the Rollomatic machines and measure the tools. “This is only possible with machines that offer perfection and work without any faults,” says Eckerle.

A smooth workflow is possible as Rollomatic machines are based on a shared software and control system. The training courses required are held in Le Landeron and make the operators ready to meet any challenge. “The finer points are explained in follow-up training courses on site under production conditions,” says Furtwengler.

GrindSmart Nano6 – An Expert in Ultra-Small Diameters

With Project Future, InovaTools embarked on far-reaching restructuring of its production conditions in 2011 in order to meet the heavy demand for high-performance tools. “For this reason, we purchased the new machines with a view toward achieving more cost-effective production and combined them to create special production lines. Our Rollomatic Line, for example, is intended for tools with diameters of up to 5mm,” explains Eckerle.

This is where the GrindSmart Nano6 for diameters at the limit comes into play. Three of its six axes are hydrostatic. This allows it to achieve optimum damping, which is an absolute necessity when creating the very smallest of tools. Excellent surface qualities in a tolerance range of 0.003mm are the result. “The precision that can be achieved also influences our tool design,” says Eckerle. “We are only able to produce our PrimeLine or the Edition Diamant because we use Rollomatic machines in these diameter ranges.”

Optimization Suggestions from Real-World Experience

Despite all the expertise regarding the design and production of grinding machines that Rollomatic unites in its company, feedback from salespeople, technicians, and customers is also important. “We collect this information and then try to incorporate it into ongoing series production,” says Michel Rollier. “However, it’s the great ideas that give rise to new models. Naturally, the users would prefer it if the machine could do everything on its own. With each new software release, we try to program complex tools in a simple manner so that we can get that bit closer to achieving this vision.”

“The Wizard tool in our VirtualGrind Pro software provides assistance in designing tools rapidly,” says Furtwengler. “Manufacturers program new tools independently using additional modules; these are not included in the templates delivered.”

Technologies with a Future

The trend towards ever smaller diameters shows no signs of abating. “A few weeks ago, we successfully ground 0.02mm ball nose end mills as a test. However, conventional geometries below this size are not so easy to achieve.”

In order to create more opportunities for tool manufacturers, Rollomatic will soon be offering the LaserSmart system. This can be used to process ultra-hard materials as well, such as CBN, PKD, or CVD diamond with a laser.

“Thanks to our machinery, we are well positioned to meet the challenges of the future,” says Eckerle, summing up. “Thanks to the reliability and precision of the Rollomatic machines, we can expand our tool range, particularly in the field of micro cutting, in an optimum way.”

For further information, call Damien Wunderlin at 41.32.752.1700, or email him at d.wunderlin@rollomatic.ch.