Specificities of active implantable medical device (AIMD) development

The Medi'Nov Connection trade show brings together the key players in the world of medical devices. In addition to the conferences and exhibition hall, a series of flash conferences is organized.

Gilles MANCOSU, Industrialization Manager at Cisteo MEDICAL, will lead one of these conferences on the following topic: the specificities of active implantable medical device development.

Below are the key points of this presentation.

An active implantable medical device (AIMD) generally consists of :

• A casing to ensure the hermeticity of the device
• A battery, rechargeable or not (note that sometimes the device is operated from the outside)
• An electronic board with embedded software
• An antenna for communication and data transfer
• An electrode or component that interacts with the patient and treats the pathology

The challenge lies in achieving the desired performance for each of these blocks, while respecting their compatibility and, of course, patient safety.

In the requirements for design and manufacture, the European MDR 2017/745 regulation specifies in paragraph 19, "particular requirements for active implantable devices :

19.1. Active implantable devices shall be designed and manufactured in such a way as to remove or minimize as far as possible:

(a) risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,

(b) risks connected with medical treatment, in particular those resulting from the use of defibrillators or highfrequency surgical equipment, and

(c) risks which may arise where maintenance and calibration are impossible, including:

• excessive increase of leakage currents,
• ageing of the materials used,
• excessive heat generated by the device,
• decreased accuracy of any measuring or control mechanism

19.2. Active implantable devices shall be designed and manufactured in such a way as to ensure

• if applicable, the compatibility of the devices with the substances they are intended to administer, and
• the reliability of the source of energy

Source: MDR 2017/745, Chapter II

The combination of AIMD components and regulatory requirements should therefore provide a reliable response to the following points:

• Encapsulating the device
• Communicating with the device
• Managing energy
• Guarantee operation (electronics and software)

Each of these points will be discussed in detail at the flash conference on March 27. To take part, please write to us to receive an invitation.

As we saw earlier, the design and manufacture of an active implantable medical device involves mastering a number of parameters.

To support AIMD manufacturers, Cisteo MEDICAL has developed know-how and advantages that are adapted and recognized. These include

• Many cleanroom manufacturing processes :
  • Silicon processing
  • Welding processes (resistance welding, inert gas laser welding, etc.)
  • Micro-assembly of electronic components
  • Overmolded connectors
  • Etc. ...

• Design of the medical device and its test benches can be carried out in-house :
  • Mechanical development,
  • Electronics and software development

• Expertise in development phases :
  • FIH (First In Human)
  • Transfer to production
  • Scale-up

It should also be noted that our scope of ISO 13485 certification now includes active implantable devices, so that we can provide our customers with an ever better response.