For Kablooe Design, creating devices that transform the medical industry is not a new endeavor. Nearly seventy-five percent of the product design firm’s creations are medical devices. Kablooe, located in Minneapolis, Minnesota, has worked with some of the nation’s largest medical technology companies creating medical device prototypes that have changed the way patients are treated, significantly improving the quality of life for thousands of people.
Recently a medical technology company approached Kablooe for assistance in the development of a device that would radically transform the treatment of Benign Prostatic Hyperplasia (BPH). BPH is commonly known as enlarged prostate and is estimated to affect ninety percent of men by age eighty-five. The most common surgical procedure used to treat BPH is Transurethral Resection of the Prostate (TURP). This invasive procedure can leave many patients with bleeding, scarring and the need for a short hospital stay. Post-procedure patients often require a urinary catheter for an extensive period of time – some never regain regular urinary function again.
The new device would offer patients a minimally invasive procedure; no cutting, no bleeding. By design, it would allow physicians to inject steam vapor into the prostate causing the prostate to shrink and return patients to normal urinary function within a matter of hours.
Kablooe’s task was to design a tool for surgeons to use during the delivery of the therapy. Kablooe had to invent many mechanical functions for this device; including a saline flush function, a vapor delivery function, a needle deploy and retract function, a drain function, a video adapter function and a rotation mechanism. Kablooe had to mechanically design, invent, and discover how all these functions were going to work in a handheld tool connected to a generator unit.
Kablooe needed a prototyping method that would allow them to make design changes fast, but could also produce a durable plastic enclosure that houses complex computer and motor components. The Kablooe designers estimated they would need seven to ten iterations to get the design perfected. And they knew they would be required to perform product feasibility testing for the FDA.
With all this in mind, it would not have been feasible to spend the hundreds of thousands of dollars to make traditional injection molded tooling on early designs, only to find that changes would have to be made.
According to Tom Kramer, president of Kablooe Design, “The device is very complicated. It has RF energy generators, computer circuit boards, and power transformers. It is a very complex geometry that will need to be tested for EMI (electromechanical interference) and against UL (Underwriters Laboratories) standards prior to manufacturing.”
The designers at Kablooe knew traditional tooling and injection molding would also be far too costly and time consuming. Kablooe decided to produce FDM parts with ABS plastics through Stratasys Direct Manufacturing because the plastic had to endure complex and heavy components being screwed and mounted into the device. It had to be strong enough for drop testing while also maintaining a level of aesthetic appeal. Because FDM models are made from the same tough thermoplastics used in injection molding, they are able to withstand rigorous testing. If Kablooe had chosen other prototyping methods like SLA, their model would have cracked or even shattered during testing.
Ordering FDM models through Stratasys Direct Manufacturing during the medical device prototyping process saved a minimum of $250,000.00 and 12 weeks of time versus going to tooling and production. Kablooe was able to print a model, test the mechanics and human factors of the device, quickly make changes and reprint the model with improvements. For example, Kablooe discovered through feedback from physicians and technicians that operators preferred a pistol shaped grip and tweaked the design and print to accommodate.
Printing these parts through Stratasys Direct Manufacturing was a cost effective way for Kablooe to make changes without going through tooling and then testing. And with Stratasys Direct Manufacturing, Kablooe didn’t have to invest in capital equipment. They only paid for the units they printed.
“A device of this nature must not only meet the needs of patients, doctors, hospital administration staffs, the FDA and other regulatory bodies, but its design and creation must be timely and cost effective as a worthy investment for the creating company. Stratasys’ FDM technology allows us to create these devices in a timely and cost effective manner, and in essence, is helping us transform the medical industry,” says Tom Kramer, President, Kablooe Design.
