Imaginarium, one of India’s largest rapid prototyping and rapid manufacturing services, used 3D printing to produce the prototype of iBreastExam, a new and innovative device used to detect breast cancer. A first batch of 40 devices was then produced using vacumm casting and 50,000 more will now be produced using low volume injection molding.
Breast cancer is the most common type of cancer in women in India and accounts for 15% of cancer in women. It has a high mortality rate due to the lack of awareness and delay in screening and diagnosis. UE LifeSciences developed the iBreastExam concept: a portable, radiation free device used by primary health workers, obstetricians and gynaecologists to identify breast abnormalities in healthy women during a routine health checkup. It enables clinically effective and standardized breast examinations in low-resource setups to detect breast lumps at early stages.
UE LifeSciences initially approached Imaginarium to prototype the device for clinical trials. The prototypes would be used to determine the wear and tear that the device would go through during handling and usage by multiple technicians, doctors, and community health care workers. It would also serve as a sample of the desired aesthetic finish.
The device was split into several parts to make a complete assembly. The outer casings were fabricated in ABS, and had to be aesthetically appealing as well as functional as they held transparent light guides and soft covers for the USB and charging ports. The device was also required to withstand certain radiations and temperatures.
Vacuum Casting was hence selected to roll out the first batch of 40 devices which would give the desired outputs. Transparent, glossy and soft rubber parts were casted in the desired colors and the logo was screen printed.
The feedback and results from the initial batch helped change some critical features and the device was ready for production. Being a medical device with not enough volumes, a low volume injection molding tool was manufactured, which would be good for 50,000 shots enabling Imaginarium to make the parts in FDA approved materials.
The device houses three electronic components; a rechargeable battery, a printed circuit board, and an array of patented FDA approved clear highly sensitive tactile sensors that vibrate at high speeds. iBreastExam has a modular design and the components are easily replaceable.
The final output was assembled and distributed amongst hospitals, doctors, and healthcare workers across 12 countries and they have successfully screened over 2,00,000 women. iBreastExam is not intended to replace mammograms, but to offer an additional level of early screening to women for whom mammograms are largely inaccessible due to finances, location, lack of insurance, young age or other factors.