A COMPLETE 360° SOLUTION! From innovation to delivery, our development methodology includes all the steps required to bring the product from an idea to serial production at the highest standards.
Tsafrir Kolatt, CEO of Fertigo Medical Ltd., talks about working with us and the company’s product:
“The success of a product development project largely depends on the project manager you work with. Avi Keiton, head of the medical field in Aran’s Development and Manufacturing Division, provided us with excellent support, demonstrated expertise and knowledge on the subject, and showed great care for the project’s success.
Aran has development and manufacturing capabilities under one roof, a significant advantage when a product development process starts from low levels of finishing and progresses and evolves to final development, with close support from the team and the required capabilities that may change during product development.
Aran has a deep familiarity with working under stringent standards in medical device development and a commitment to working with regulators according to required standards, which is a critical advantage.
The transition from development to production is natural because Aran has the capabilities to produce models for clinical trials and then for finished product manufacturing. Transitions between manufacturing processes are minimal even when there’s a need to move between different production environments. For example: different environmental conditions (clean room).
It’s advisable to align expectations, define timelines and pricing in advance. Define project boundaries upfront and establish the understanding that there will be a certain degree of changes along the way due to regulatory constraints and strict work procedures. If all this is coordinated in advance, delays and disappointments are avoided.
The product developed by Fertigo is a new product of its kind that doesn’t exist in the market! The company has developed a tiny microscope (endoscope) inserted into the patient’s body to examine the tissue structure of the uterine lining down to its smallest details. A computerized system analyzes these small details to indicate the condition of the tissue. In fact, this is a virtual biopsy.
The diagnosis is performed in real-time without the need to collect a sample for biopsy. The first (but far from the only) use of the system is in the field of fertility medicine. During an In Vitro Fertilization (IVF) treatment cycle, the system recommends to the treating physicians the best timing for returning the fertilized eggs to the uterus. The system, which combines hardware and software, will allow the implantation of fertilized eggs in the uterine wall, a critical stage for the success of the process. From there, the path is paved for the development of a normal pregnancy and the birth of a healthy baby. The system is expected to increase the success rates of fertility treatments by two times or more.”
