ACMIT offers R&D services along the complete chain of actions regarding:
- clinical workflow,
- medical/surgical procedure performed by the clinical team,
- the development process.
In all aspects, we apply an integrative view.
Our research activities address the complete course of actions in the operating room before, during, and after a minimally invasive intervention, such as:
- tools for (preoperative) image-guided planning of an intervention,
- multi-functional tools,
- robotic systems for accurate tool positioning,
- optimized tool-tissue interaction,
- sensor systems for intra- or post-operative monitoring,
- intuitive interfaces and usability concepts,
- work-flow optimization and training of staff.
Improvements in medical technology can only be successfully achieved, when a variety of technologies are mastered and integrated into novel solutions.
ACMIT has long time experience in applying different kinds of technologies to medical applications. We therefore perfectly fulfill the requirements to advance minimally invasive procedures to the next level and to enable their use in a broad range of medical applications. Our expertise includes the following technologies:
- automation technology,
- mechanical design,
- applied materials technology,
- polymer chemistry,
- fiber optics,
- diffractive optics (e.g. multifocal intraocular lenses),
- image processing.
Our broad range of competencies enables us to cover R&D services along the entire development process. Our interdisciplinary team of experts is ready to offer you their skills.
From Idea to Clinical Use
From the initial idea to the clinical application of a medical technology product, many development steps are to take and obstacles to overcome. ACMIT is your ISO-13485 certified partner during the complete innovation process and offers expertise, guidance and assistance in every single step.
- technology research,
- state of the art analysis,
- feasibility studies,
- system design,
- prototype development,
- industrial compatibility adaptation,
- system integration,
- usability engineering and testing (formative and summative),
- validation under clinical conditions, i.e. in clinical trials,
- low-volume production.
Services for Medical Technology Startups
- R&D services all along the process chain from idea to clinical use of a medical device
- Fundraising support: Connecting with European and Austrian funding bodies (e.g. AWS, FFG, accent, INiTS) and international investor network
- International partner network (scientific and industrial)
- Clinical trial management
- Application-oriented anatomical models to reduce the number of cadaver tests during the development of a medical device
- Usability engineering and testing
- Contract manufacturing (small series) of medical devices
- Development milestones according to potential investment rounds
- Support intellectual property (e.g. IP strategy, IP design, patents)
- Support business planning (e.g. business plan check, business model design)
- Support implementing a quality management system (EN ISO 13485)
- Support regulatory affairs (defintion of intended use, classification, required certifications)
Main tasks are outlined below:
- review of already existing technical documentation, e.g. intended use, risk management,
- User Research incl. analysis, e.g. contextual inquiry, observation or other techniques,
- Use Error Risk Analysis to determine hazard-related use scenarios,
- Conceptual User Interface Design regarding usability according to generally accepted standards and style guides,
- Formative Usability Tests, e.g. documented verification, expert reviews, cognitive walk-throughs,
- Summative Usability Tests, i.e. worldwide on-site (mobile usability lab) or in our fully equipped usability lab consisting of an experimental OR, a living space environment and a surveillance room with modern video and audio technology. We plan the test and perform it with recruited real users.
Small Series of Medical Devices
Our subsidiary ACMIT Manufacturing GmbH offers small-volume contract manufacturing of medical devices (optional under clean room conditions). This also includes supply chain management.
We offer application-oriented anatomical models to significantly reduce the number of cadaver tests needed in the development of medical devices as well as to provide an advanced solution for education of clinicians. In addition, based on patient-specific manufactured models complex surgeries can be trained and optimized in order to improve patient safety. The big benefit of our application-oriented anatomical models is, that they are optimized regarding parameters, which are crucial for the clinical outcome.
QM-System Starter Package
ACMIT Gmbh offers companies, in particular start-ups a quality management system (QMS) as a starter package.
The QMS starter package currently includes about 30 sample standard operating procedures (SOP) and about 100 sample templates in MS Word and MS Excel format. These samples will help you to create procedures and templates specific to your organization. The detailed procedures and templates can be found in the document "Scope Starter Package".
Our experienced quality management staff will be happy to assist you with establishing and maintaining your quality management system to meet all necessary regulatory requirements of EN ISO 13485:2016 and Medical Devices Regulation (EU) 2017/745.