Tsunami Medical s.r.l with its latest generation implantable products was the protagonist of the inaugural event of the Medical Devices Virtual Talks of JSB Solutions.
Founded in 1997 in the heart of the Biomedical Valley, near Modena, the company is now a leader in the technological innovation of spinal surgery, with a main focus on medical solutions made using the technology of 3D printing titanium. A professional reality that has 20 years of experience in the design and production of high quality medical devices, with an international calibre distribution.
With the new Regulation on Medical Devices (EU 2017/745), all products of Tsunami Medical will pass from class IIB to class III with the exception of some, such as screws, bars and devices with battery and engine, which will remain in class IIB.
Q&A: Questions from JSB Solutions to Tsunami Medical
1. Has it been difficult to develop a production line validation for such special products? “Yes, because we were among the first in Italy with the first intersomatic cage produced in 2011. The biggest obstacle was to convince the certifying body that the predicated MD considered was comparable to ours despite the technology used to produce it was different (3D technology vs traditional technology)”
2. Are there any particular issues you are working on for ISO: 13485/2016? What are you most concerned about? “We hope it will be harmonized throughout the year to get an idea of what the qualitative system will be to deal with the MDR (MDR Certification. Clinical follow-up/ management validation). The risk could be to disadvantage small companies (Italian and not) where technological innovation is made, because a start-up will hardly have the economic and financial opportunities to manage a clinical analysis even for products of class I/Is. In addition, the processes of renewal/ obtaining certification will be more complicated given the difficulty in finding clinical evidence of products”
3. How do you deal with requests from different countries? “Tsunami Medical relies on several local distributors both for the commercial part and for the support in the field of product registration in different countries. The documentary core is the same for all countries but specific documents are added. Italy is the most complicated country from the point of view of bureaucracy, all products must be registered with the Ministry of Health even if they are not sold in Italy this process lengthens the time”
4. How do you combine the production of customised products with standard products? “For standard products (“in stock”) you make the drawing in CAD and then you go to production. For customized products we use dedicated platforms in which the CT scans are loaded and then we do the simulation with the doctor. Once you get the doctor’s okay you move on to production. For this type of products it is necessary to develop a strong collaboration with the doctor; it is less complicated from a certification point of view because the responsibilities are more of the doctor than of the manufacturer”
Our focus on the classification of medical devices
The classification of a medical device must necessarily take place upstream of the project because according to the class, all the requirements, guidelines and regulations to be respected will be defined.
The classes of medical devices are defined and framed on the basis of 22 specific rules, including their purpose, their risk of use, the duration of exposure, invasiveness and energy:
- destination: Primary medical device use
- duration of use: continuous duration of a medical device for each use
- invasiveness: type of penetration of the medical device
- energy: any device whose operation depends on a source of energy other than that generated by the human body for that purpose or gravity
*The information shown in the graph relates to generic cases. It is recommended to carefully evaluate the specific characteristics of your device before classification.