Towards clinical use

How to use CamiTK from research prototype to testing in clinical environment?

What is specific in CamiTK compared to other similar framework?

CamiTK provides a Software Development Kit (SDK) and applications in order to support the maturation cycle of your Computer Assisted Medical Interventions Applications or Medical Devices.

Develop your own C++/Python extension directly from the camitk-imp application to quickly design new algorithms or new process in order to shape the concept product.

Once your proof of concept is defined, CamiTK provides another application called the CamiTK action state machine in order to test your prototype over a great number of cases and give it safely into the hands of a end-user.

The maturation cycle of a new medical device using CamiTK and the associated innovation steps is described in this figure:

The maturation cycle of a new medical device using CamiTK and the associated innovation steps

(this figure is greatly inspired by courtesy of MAXITHEC, Grenoble’s Center of Clinical Investigation - Innovative Technonology)

CamiTK can help you during the two first phases of the development of a new CAMI applications or medical devices. It can not only help you to define the product perspectives but it can also support the medical service estimation of your prototype.

Develop your own extensions

Ready to go? These are probably the next steps:

FDA Guidelines / CE normalization for Off-the-Shelf software

(inspired by VTK and ITK guidelines)

CamiTK has to be considered as off-the-shelf (OTS) product for supporting a higher level medical application orproduct. The developer of such applications or products will be responsible for performing the validation process described in FDA published guidelines or CE normalization process for the development of software-related medical devices.

CamiTK is intended to be used as elements in medical applications, those medical applications are the ones that can be subject of an FDA approval / CE normalization. Whoever develop such applications has the responsibility of validating their application in order to demonstrate that it is appropriate for the advertised purpose.

For example, if you develop an application for radiation treatment planning based on CamiTK, it is your responsibility to validate that application. In the process you will have to validate that the use you make of CamiTK satisfies the requirements of your application. You will probably be using a limited set of CamiTK functionalities in such application, therefore what you have to demonstrate is that those specific CamiTK functionalities are behaving as expected in the context of your application.

Note that not only you need to validate the use of CamiTK, but also the use of any other off-the-shelf (OTS) software product used in the development of your application.

That will include things like:

  • Your operating system
  • Your compiler
  • Your OpenGL library/drivers
  • Any other library that your application is linking to
  • Even your processor

Get Support

The CamiTK project team has a long experience in technological transfer of CAMI prototype. Do not hesitate to contact us for advice and support.

CamiTK Software Development and Good Practices

It is worth pointing out that the Software Development Process used to develop the CamiTK project are already following many of the FDA Guidelines / CE normalization for software developement.

In particular CamiTK uses:

How can CamiTK help you?

CamiTK offers a number of tools to simplify the transfert of your technology:

  • definition of software units are at the base of the architecture: all software units are clearly identified within your extension (e.g. algorithms and process are encapsulated in actions, each action has a list of parameter that are named, described and well typed,…)
  • automatic integration test generation: this is one of the most difficult tests to develop and CamiTK provides this automatically.

And much more!

General Guidelines

For details on the FDA Guidelines / CE normalization for development of software for medical devices you must look at the following documents:

See also