In this article we will explain the most important steps on how to obtain a medical device, focusing on the last steps, those of the packaging of the medical device and the sterilization of the medical device.

how is a medical device born? The packaging

There are various phases that lead to the production of a medical device: it starts with the evaluation of the feasibility by the technical office, up to the actual manufacturing, finishing and control phases.
After the checks and washing, the product is sent for packaging according to validated procedures.

For sterile products, clean rooms are the department where this operation takes place. In this phase, the primary packaging takes place (blisters, tyvek bags or vacuum bags) which guarantees perfect sealing
against external pollutants.

The packaging work is perfected with the labeling and the insertion of the blisters in the special boxes that are protected from dust by a transparent heat-shrink film. Even this phase, as often happens in the medical
field, automation is reduced to a minimum.

Partly because the volumes do not exist to allow an investment in automation and partly because the human eye and attention in the medical field are still considered a plus today.

how is a medical device born? The Sterilization

After being vacuum-sealed and packed, medical components will continue their journey towards the last step that separates them from the operating room: the sterilization.

Due to their caracheristics, some components are not sold in blisters or bags, but loose. These kind of components are generally used in the kits that surgeons have at their disposal during the operation. Only
during operationm, in fact, surgeons can select themost suitable components according to the type of operation.

Usually these are screws or plates, used in trauma. These kits, supplied in special autoclavable metal containers, are sterilized after each use.