With more than 20 years’ experience developing software and systems for medical devices, we are here to support your efforts to put your digital and scalable patient solutions ‘beyond the pill’ into practice.
PATIENT-CENTRIC.
DATA-BASED.
We develop data science & analytics solutions for you at the crossroads of medicine, pharmaceutics, and biochemistry to enable personalized treatment, optimized for each patient.
CONNECTED.
Tapping our technical expertise and industry knowledge, we connect smart drug delivery devices such as inhalers and injectors to maximize therapy adherence.
FROM APPS TO HOLISTIC PATIENT SOLUTIONS.
PATIENT-CENTRIC DESIGN.
Adherence apps and app-based clinical studies for smartphones, tablets, wearables, and the like help patients and treating physicians manage therapies.
PATIENT-CENTRIC DESIGN.
What we do at a glance:
- Design scalable patient solutions
- From adherence apps to app-based clinical trials
- Factor in the user experience
- Incorporate information security and data protection (GDPR)
BUILT FOR APPROVAL.
Medical apps, secure backends, smart devices – we develop in compliance with standards (IEC 62304, IEC 60601-1, GAMP5) to get your new business models off the ground.
BUILT FOR APPROVAL.
What we do at a glance:
- Develop mobile and web apps to relevant quality standards (ISO 13485, EU-GxP Annex 11, GAMP5) and optimize the user experience and usability
- Develop backend solutions for highly sensitive data
- Develop connected smart drug delivery devices with electronics and embedded software for the most demanding cyber security requirements
- Engage in data analytics
PRACTICAL ADVICE.
Step by step to scalable and reusable IT solutions for patients with sound advice on regulations, technology such as health apps, and much more.
PRACTICAL ADVICE.
What we do at a glance:
- Provide regulatory consulting (ISO 13485, MDR/IVDR for CE, FDA, EU-GxP Annex 11, GAMP5)
- Consult on technical matters (architecture reviews, cyber security, IEC 62304, IEC 60601-1-compliant applications)
- Guide you through development processes for MDR/IVDR and FDA-compliant products
- Advise on the use of agile methods, DevOps and continuous integration / continuous delivery in regulated areas
DATA-DRIVEN LEARNING.
Harness the power of data science and modern methods such as machine and deep learning, we gain new insights and develop innovative business models.
DATA-DRIVEN LEARNING.
What we do at a glance:
- Design and build machine learning applications with regulatory demands in mind
- Put image recognition and cognitive systems to use
- Employ smart data
- Protect and anonymize data
Digital
therapeutics.
How ITK developed a personalized, app-based assistance system.
ITK Engineering teamed up with research partners to develop a personalized, app-based assistance system to treat people with bipolar disorders. Made of standards-compliant building blocks; the system helps patients through the day and provides doctors with indications that support ongoing therapy.
Digital therapeutics.
Treatments tailored to the individual have the potential to mitigate suffering and enhance the patient’s quality of life. This app-based assistance system taps a treasure-trove of disease-related data collected in the course of the patient’s day-to-day life. Caregivers and relatives can also contribute their observations to this data pool. The valuable insights provided, assist the treating physicians or therapists in developing a more personalized treatment method. The app also benefits the patient by affording instant access to tips and first-aid measures.
Our solution:
- Work together with patients, therapists, and research and industry partners to develop user-centric applications, that factor in the need for personal privacy in a bid to boost transparency and acceptance
- Drive the cross-platform development of mobile and web medical apps for patients, caregivers, relatives and therapists
- Develop the backend with security and data privacy demands in mind
- Develop algorithms and cognitive models, to eventually help forecast relapses
- Connect medical devices and fitness wearables
We were able to fast-track development with standards-compliant digital health building blocks. A clinical trial is underway at Stuttgart Hospital to test this app-based assistance system.
A partner in the medical industry.
How ITK helps startups get ISO 13485-certified.
Standards, rules and regulations lay down the prerequisites in the digital health market; this poses a major challenge for startups. ITK Engineering provides advice and hands-on support to help newcomers gear up to certify their quality management systems to the ISO 13485:2016 standard.
A partner in the medical industry.
Drawing on many years’ experience with medical technology and regulatory issues, ITK Engineering helps startups set up quality management systems in accordance with ISO 13485. Concrete recommendations for action and references based on our practical experience allow these fledgling companies to quickly and cost-effectively create the templates and artifacts needed to obtain certification.
Our solution:
- Develop a suitable regulatory framework
- Jointly analyze quality management structures, review the product portfolio and the company’s set-up
- Create a description of processes based on the company’s approach and procedures
- Perform internal audits and conduct a gap analysis for ISO 13485 certification
- Support efforts to adopt DIN EN 62366 usability and DIN EN ISO 14971 risk management standards
- Share practical tips and tricks to help align software development with IEC 62304 and IEC 60601-1
Startup benefits:
- Deep well of industry experience to draw on
- Less money and time spent on preparing for certification
Medicine paired with smartphones.
How ITK developed a smarter, connected concept to deliver medication.
Patients’ quick recovery hinges on their ability to take the right medication, in the right amount, at the right time. ITK Engineering developed a concept for an innovative drug delivery device that connects to the patient’s smartphone.
Medicine paired with smartphones.
But how can a smartphone actually help people stick to their regimen? Smartphones are constant companions – always at hand, they are perfect for controlling an individual’s medication intake. ITK Engineering developed an innovative drug delivery device for this purpose, for a customer in the pharmaceutical industry. The great challenge of this project was to come up with a design that pairs user-friendliness with low production costs.
Our solution:
- Analyze use cases and identify user requirements
- Draw up a system design concept for the software and electronics
- Team up with the manufacturer to devise a hardware/electronics concept to streamline the production process
Customer benefits:
- Speed and freedom of choice: We rapidly developed two electronics designs that simplify production and cut costs, yet deliver the required performance
- Informed decision: We prepared a cost/benefit analysis to support the decision-making process
EN ISO 13485
ISO 9001
ISO 27001