Mauro Santinato has been part of the Dream Team for more than one year as Head of Production and Supply Chain, and last week he dedicated some of his time to talk with us.
He has very long and various experience in the production of medical devices. At Gondola, he’s responsible for the entire production chain, including managing our suppliers. Moreover, he’s involved in regulatory and quality activities, such as ensuring the compliance of each production step to current specifications and manufacturing practices. Mauro, furthermore, takes care of elaborating the patients’ feet scan and producing the related insoles for the devices to be used at home by patients, a crucial step that is needed to facilitate usability of the Gondola device and to make sure that the treatment delivered by the device is effective over time.
What is the idea behind the development of the latest version of GONDOLA?
The newest Gondola Home Device is born from a patient need in the first place: when collecting patients’ feedback, we became aware of some difficulties in wearing the device correctly. In addition, previous versions of the device required the presence of a trained caregiver to administer the AMPS therapy correctly. With the new version of the Gondola Home Device, we aimed to enable our patients to be more independent and to improve treatment efficacy over time.
Thanks to the new design, patients can do the therapy alone without any help from caregivers in an effortless way: after an initial configuration session done by a Gondola trained therapy specialists, all patients need to do is to insert their feet in the device while seated and push the start button. The therapy is automatically delivered by the device, takes about two minutes to complete and must be repeated regularly (in most cases two or three times a week) to maintain treatment benefits on an ongoing basis.
As you may know, precision of therapy delivery is one of the key factors to obtain positive treatment outcomes. The stimulation points (the target areas of AMPS stimulation located on the plantar area of the feet) are very small and precise, so it is important for us to be sure that our patients can easily position their feet correctly in the device at every therapy session. For this reason we can say that the design of the insoles is key to deliver the AMPS therapy correctly. Gondola Home Device insoles are made of a material called “EVA”, which is biocompatible, and are manufactured out of a 3D scan of the patient’s feet. The material is soft for a comfortable fit but not floppy because feet must be firmly and precisely positioned into the insoles to allow correct alignment of the stimulation tips with the target points during therapy delivery.
There’s any limitation to the type/size/morphology of foot that Gondola Home can accommodate?
There is no problem for feet up to shoe size 47, as long as all the stimulation points can be reached and stimulated. At Gondola Partner Centers patients have the opportunity to test the AMPS treatment, and therapy professionals scan their feet using a professional 3D scanner mounted on an iPad. Thanks to our R&D advancements, this simple procedure requires less than 20 minutes. Whenever a patient decides to buy a device, the Gondola Partner Center sends me the feet scans, and I elaborate the files to produce the insoles on one of our CNC milling machines.
And, ta-da! Here are the insoles that perfectly match our patient’s feet!
What are you working on currently?
Currently, I’m working on two main projects: fine-tuning the multi-patient device for easier use, and …. struggling to find electronic components!
As a consequence of the Covid pandemic, finding electronic components has become a real problem at the international level.
Currently, one of our priorities is to stock enough components and supplies to ensure continuity in our production in the medium and long term.
Concerning the multi-patient device (Gondola Professional Device), it delivers the very same therapy as the Gondola Home Device, but it allows treating a multiplicity of patients, one after the other, requiring reduced set-up time. It has been developed for Gondola Partner Centers to verify the patients’ response to the treatment before using the Gondola Home Device and for clinical trials.
For long-term therapy, patients need the home version of the Gondola Device so as to be independent of therapists and to receive the treatment easily at their own domicile.
What are your future projects?
One of the strategic projects we are working on is the development and implementation of a remote servicing platform to update device configuration of the Gondola Home Device: correct therapy settings are fundamental to make sure that the AMPS therapy is effective over time, so a regular configuration update (in most cases once or twice a year) is required. Today, patients need to travel to a Gondola Partner Center for regular configuration update service. Our goal is to deliver this service remotely , through a cloud-based system and a remote connection with the home device.
We believe that this further advancement will increase patients’ satisfaction and will unleash new business opportunities for us.
Stay tuned for further news!
