Challenge:

Connectivity of medical devices is the ability to connect multiple applications via the Internet of Medical Things (IoMT). It directly benefits patients and healthcare providers by contributing to personalized and data-based treatment. The interoperability of medical devices is also a prerequisite for the application of artificial intelligence and big data in digital medicine.

UNITY solution approach:

• Development of the product system MVP (Boostcamp)
• Development and validation of connectivity use cases
• Coaching on interface standards (SDC, HL7, FHIR, SDC)
• Interface specification and IoT architecture
• Development of an integrated governance structure
• Action plan for cyber security

Challenge

In order to successfully exploit the possibilities and opportunities of digital health and new technologies such as artificial intelligence, interoperability and big data, networked digital ecosystems must be established based on consolidated and accessible data. Realizing a foundation for data-driven decision-making requires optimal integration and connectivity of systems and devices, based on a robust IT strategy.

UNITY solution approach

• IT strategy & digital governance
• IT and data architecture design
• Data management strategy (e.g. integration layer)
• Product documentation (Enablement of digital twin)
• Analysis of structured and unstructured data
• Upstream and downstream data compliance (e.g. UDI)

Challenge

The digitalization of the healthcare sector offers new solutions for nursing staff and patients, while at the same time raising the standard and efficiency of care. Technological trends, such as the Internet of Medical Things (IoMT) and big data, are further strengthening prevention, patient empowerment and out-of-hospital care. The digital revolution will therefore change the entire healthcare industry and offers enormous business opportunities for digital, personalized medicine.

UNITY solution approach

• Market and product evaluation and pricing strategy
• Data Driven Services & Artificial Intelligence
• Definition of product design and digital business models incl. market approach
• Development process according to current regulations (IEC 82304-X, IEC 62304)
• Establishment of continuous development cycles & pipelines and enabling agile development

Challenge

The focus of a quality management system (QMS) is to prove that customer and regulatory requirements are met in equal measure. The QMS must be appropriate to the complexity of the product portfolio and be able to react quickly to changing regulatory conditions. Ideally, quality management should be integrated into the company's core processes without compromising their efficiency and effectiveness. This is becoming an increasing challenge, particularly in established, global structures.

UNITY solution approach 

• Development and implementation of a business-driven quality strategy
• Blueprint QMS for start-ups, SaMD and Class I medical device manufacturers
• Implementation of efficient ISO 13485, 21 CFR 820 and MDR-compliant QMS
• Global harmonization of different quality management systems, including efficient process governance
• Implementation of efficiency-enhancing business process management and eQMS tools