Pre-clinical testing with SMART.sim

From supply requirements to safe application: In the development and approval of novel medical devices, preclinical evaluation to test safety, function and suitability for use is of great importance.

In our test laboratory, ideas mature into safe medical products. The application of novel medical technology is always carefully analysed and planned in dialogue with all parties involved (sponsor, investigators, laboratory personnel, external service providers) and with regard to the specific reason for the trial.

Essential for a successful review process - the carefully planned application in a multimodal simulation process, still in the realistic environment of a certified test laboratory. Use the concentrated peace and quiet ufor undisturbed research and development, surrounded by excellent medical technology and perfect equipment.

The company is DIN EN ISO 9001:2008 certified. Please feel free to compare us with other service providers.

Resilient - the project management

From needs assessment to implementation - quality assured processes: Professional project management is our key to success. The company has all the necessary structural, logistical and personnel resources to successfully and on schedule handle all requirements that are the subject of preclinical trials. Our employees, like those of our external partners, are suitably qualified and are planned and deployed at an early stage in accordance with known requirements.

Our external partners are reliably involved via appropriate framework agreements, always from the planning stage to the realisation of the respective projects. Cooperation in the projects is regularly evaluated according to proven standards.Because the complexity of the respective service varies with each new project, we invest in advance in the establishment of resilient service chains.

A reliable cooperationof the individual actors will only satisfy the clients of the respective projects if this project work always functions reliably and successfully, even when dealing with the usual variances and imponderables.

All-encompassing - the analysis

No testing plan without careful day-to-day- and risk analysis The concept of multi-modal simulation provides a framework for the analysis and verification of the visual, acoustic, embodied and spatial aspects of direct interaction and accompanying communication in the application of the medical device. As is well known, this involves a very complex interaction between the trained user, the medical device and the patient.

Tyically, the multi-modality simulation in the context of pre-clinical testing is carried out in four phases:

1. 1. It begins with a retrospective analysis of the typical procedures in the application of the medical device to be tested in its immediate purpose, which is usually at the beginning of every new or further development of a medical device.

2. 2.With the profound understanding of risk analysis on the typical modalities of interaction between user, medical device and patient and the knowledge of the normative requirements in the approval process, prerequisites are given for the development of a test plan for early, preclinical application.

Versatile - the applications

SMART.sim - Multimodality Simulation as a recipe for success: "See one, do one, teach one" applies to lifelong learning in medicine. Applied to the development of medical products, this means „See many, analyze all, simulate some“.

Typically, there are four phases being run in the multi-modality simulation during pre-clinical testing:

1. 3. This sum of all questions to be examined sets the framework for the planning and implementation of pre-clinical application of the medical device in the best simulated application situation. All this without a real patient, with one or more models in the replacement.

2. 4. EOnly in the comprehensive review, both directly with all those involved, carried out directly in the test laboratory, and subsequently with all other stakeholders in the development process does a perception of the quality and completeness of the test result emerge.

With the methodology of multi-modal simulation, preclinical tests become comprehensive and effective events, the best foundations are created for a successful approval and the market introduction of new and further developments in medical technology..

Objective - the process documentation

SMART.avd – safe and objective process documentation During preclinical evaluation it happens that critical events are only noted in the eyes of a few, but not all observers, which results in gaps in the documentation. Then it is a matter of reviewing all sources, sometimes also deepening and repeating in the testing laboratory.

We have made this process more efficient for everyone involved - especially in terms of invested time and costs. Our service SMART.avd allows you to improve planning and documentation in preclinical testing & evaluation.

The service is adaptable to almost any of your needs, easy to use and reliable. State-of-the-art technology supports the preparation and post-processing of the collected data, both during debriefing on site and at any time later.

Competent - the parties involved

In dialogue with experienced doctors and engineers: Innovation processes at the beginning of the development of innovative medical devices contribute to a better understanding of the future needs of users in hospitals. Aligned to this, new ideas can be verified early on in a confidential dialogue with experienced users in our test environment.

The final step is to specify the application idea with concrete product properties and to verify the technical feasibility. Use our modern application laboratory to specify and further develop identified needs in the practical application  of medical technology.

Our investigators are experts in their medical field. They advise and accompany the development cycle in everyday clinical practice and here in the testing laboratory of the medical competence centre. We are in constant professional exchange with experienced experts in almost all medical fields.

You and your team are very welcome to join us. Visit us at an early stage, talk to everyone involved and familiarise yourself with the technical possibilities on site. For us, too, this time is ideal for getting to know each other. If we have a good understanding of you and your professional environment, then together we will have a solid foundation for future cooperation. Take a look, the virtual tour awaits you.