Objet Prototypes Cut Time to Medical Trials

By Susan Smith

An Ivivi device prototype, printed in hours on Objet Geometries’ Eden 350 3D printer.

Products developed for medical clinical trials require that prototypes look and feel like the real thing. That’s no easy task when the device originates with a complex design.

  Ivivi Technologies of Montvale, NJ, designs noninvasive, nonpharmacologic electrotherapeutic devices to treat many conditions such as osteoarthritis and injured tissue by way of electromagnetics. Ivivi is a small company of 25 employees, five of whom are engineers. With a multi-disciplinary background in electronics, mechanical,  software, design, materials, production, and regulatory engineering, the engineering team enables Ivivi to create a medical device from initial concept to commercialization, all in-house.

  The Ivivi SofPulse is a patented device that uses pulsed electromagnetic field (PEMF) technology to generate a micro-current in injured tissues, jump-starting the natural electrochemical processes in the body. Electrotherapy is a new area of medical study that is being undertaken by some of the most esteemed scientists in the emerging field of electrotherapeutics.

  The technology addresses health on a cellular level, as the electromagnetic response is inherent in all cells. Ivivi describes greater efficiency in aiding the activity of healthy cells. As with dominos, tapping the first one sets off a chain of events that affects the other cells. The Ivivi signal helps to stimulate the natural chain of events that may be impaired in a diseased state, thereby aiding the body’s own healing response.

The Ivivi Palermo model electronic therapy prototype, currently in clinical trials for the treatment of pain from osteoarthritis of the knee. At right is a diagram showing how thePalermo is to be worn by the user.

The SofPulse, which can be worn over clothing, was developed with the help of the Eden 350, a 3D printing system from Objet Geometries of Israel. The Objet machine enabled Ivivi to put its product into clinical testing very quickly by rapidly printing the exterior case for the machines.

  According to Andre DiMino, chief technical officer of Ivivi Technologies, the Objet system allows engineers to produce a prototype unit of the company’s noninvasive electronic therapy devices to be used in clinical trial. These trials often involve runs of 80 to 100 units to go to patients for their feedback. Ivivi contracts with a university and specifies that they would like 80 patients tested, 40 with the active device and 40 with non-working mockups or placebo devices. Ivivi then manufactures units made with the Objet Eden 350, installs the electronics, and hands them over to the trial team to conduct the study. The majority of the company’s devices are battery operated.

“Patients can actually use it and it feels like a product that was made through injection molding,” says DiMino.

Original prototypes of the Ivivi Torino model production unit were developed using thecompany’s Objet 3D printing system.

Prior to acquiring the Objet 3D printer a year ago, Ivivi produced conceptual drawings, then sent them out for stereolithography (SLA) prototyping. The process provided a good representation of what the model would be like, but it was a time-consuming one because if any changes had to be made, Ivivi would have to redraw the model, send it back out, and then wait for a prototype to come back. It could take weeks in between the changes. The parts were expensive and could only be procured one at a time.

  Further, DiMino said prototypes produced via SLA did not have the finish and feel of the final product. “We wanted to bring ]a process] in house,” he says, “that would allow us to have a much faster development cycle, which would cut the time down. But also, if we got something that looked good, we wanted to take it to the next step and actually put it into the hands of users for clinical testing,  which is what we can do with Objet.”

  According to DiMino, a big change occurred when the company purchased the Objet Eden 350 system, because designers can produce their own prototypes. “If they looked good it was also very similar to what a final injection-molded piece would be like so we could then produce multiple copies of it,” says DiMino. “Once that was approved, we could then produce 20-100 units and put them directly into clinical trials, so it shortened the development process tremendously.

“We’re not losing weeks, and sending it out for third-party fees,” he explains. After the initial cost of the system, the cost of materials used by the Objet system are now the company’s only costs related to prototyping. A change request made on Thursday can result in new units to ship to customers by Monday. “To be able to have a workable unit on a desktop within 48 hours is a dramatic change.”

  In terms of materials, DiMino says Objet supplies a number of different materials ranging from soft flexible materials to hard materials that are “just like” injection-molded polystyrene. Some of the products Ivivi creates have a soft “over-mold” and the interior case will be made out of a harder material in which the electronics are contained. A softer piece will be printed to the inside of the outer case to create a cushiony feel when placed against the body.

A custom jig — printed on the Objet system — for finishing Ivivi clinical trial devices.

Ivivi is currently testing the electrotherapeutic unit designed for osteoarthritis of the knee. It produced the housing, a round shape that forms around the knee, and then put a velcro strap on the back. The electronics are embedded into the housing. The button and window areas, which contain display lights, are also produced on the Objet machine. The only parts not made by the Eden 350 are the circuit boards and circuitry, says DiMino.

  Other uses for the Objet system include making various tools and fixtures needed in the manufacturing process. Ivivi used to have the fixtures machined by a machine shop, but now they can make the tool themselves. The Objet machine is used at 60 percent of its capacity, but DiMino says he thinks the company will fill that time up within the next six months.

  DiMino has been involved in the medical device industry for more than two decades. “Looking back,” he says, “if I knew then what I know now, the decision to utilize rapid prototyping and the Objet system would be one of the easiest of my career.

“The Objet has easily cut five to six weeks off our clinical trial, and that’s a very conservative estimate. The machine has basically paid for itself in less than a year.” The additional savings being realized by being able to develop new prototypes and make product modifications rapidly have not yet been quantified.

More Info:
Ivivi Technologies
Montvale, NJ

Objet Geometries
Rehovot, Israel

Susan Smith is a contributing editor for Desktop Engineering magazine. Send e-mail about this article to [email protected].