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MedTech

Akina: Transforming physiotherapy with AI and compliance excellence

Globally, an estimated 2.4 billion people are currently living with a health condition that may benefit from rehabilitation. The need for these services is expected to grow due to population ageing and increasing prevalence of chronic diseases and disabilities. Akina may offer a solution – an AI-empowered platform that increases the effectiveness and adherence of physiotherapy. Zühlke supported the Swiss start-up with medical compliance, UX, and cybersecurity.

The project at a glance

Revolutionised User Experience

The user interface enhancements have set a new benchmark in medical application design, significantly boosting satisfaction for both healthcare providers and patients.

Pioneering Regulatory Compliance

Attaining compliance with IEC 62366-1 and ISO 13485 has strategically positioned Akina for regulatory success and market expansion.

Fortified Cybersecurity

Advanced security measures ensure the robust protection of sensitive patient data, fostering greater trust and widespread adoption of the application.

The challenge

Akina is a Swiss start-up that wants to support patients in reducing pain and improving mobility with digital physiotherapy solutions. The company’s vision is to provide innovative, user-friendly solutions that enhance patient outcomes and streamline physiotherapy practices.

Akina faced significant challenges in integrating advanced machine learning (ML) algorithms with complex usability practices within the Cloud. Achieving compliance with stringent medical regulations and enhancing user experience simultaneously required a multifaceted approach. Recognising the need for expert guidance, Akina engaged our team to navigate these complexities and support the journey towards a seamless, compliant, and user-centric digital solution, thereby accelerating the start-up’s time-to-market.

The solution

Our team implemented a comprehensive strategy, addressing usability (human factors) engineering, machine learning documentation, quality management, and cybersecurity.

Usability engineering excellence
To ensure that Akina's application met high usability standards, we provided hands-on support in planning, executing, and documenting usability activities. Akina established a usability engineering file (UEF) with our guidance, ensuring all processes adhered to the IEC 62366-1 standard. This included writing formal user requirements, conducting user error analysis, and performing formative evaluations. We also oversaw the summative evaluation, ensuring it met regulatory standards and user needs.
Streamlined Quality Management System (QMS)
Recognising the importance of regulatory compliance and operational efficiency, we assisted Akina in establishing a pragmatic QMS. This system was designed to meet ISO 13485 and EU MDR (2017/745) requirements. Our contributions included developing standard operating procedures (SOPs) and templates to streamline documentation and processes. Conducting internal audits prepared Akina for notified body certifications and ongoing support helped refine processes and enhance regulatory compliance.
Cybersecurity and data protection
Given the sensitive nature of patient data, Zühlke's cybersecurity experts implemented a robust program to safeguard information. This involved identifying potential threats through STRIDE threat modelling and integrating modern security principles into the development process. Ensuring secure configurations of the cloud environment and conducting in-house penetration testing were also key steps. Plus, establishing DevSecOps best practices maintained high security standards through automated testing and continuous monitoring.

In addition, we provided Akina access to our medical machine learning development framework and templates to ensure that the client’s algorithms were in line with best practices, further enhancing regulatory compliance as well as user safety and system performance.

The results

Zühlke’s comprehensive support resulted in transformative outcomes for Akina and its customers:

Enhanced user experience: The application’s user interface was significantly improved, boosting satisfaction for healthcare providers and patients, and setting a new benchmark in medical application design.
Regulatory compliance: Akina achieved compliance with IEC 62366-1 and ISO 13485, positioning them favourably for future regulatory audits and market expansions.
Operational efficiency: Streamlined processes reduced time-to-market, enabling Akina to adapt swiftly to regulatory changes and market demands.
Cyber resilience: Implemented security measures ensured robust protection of patient data, meeting industry standards and regulatory requirements.

Impact and benefits for Akina and its customers

Our collaboration with Akina has yielded substantial benefits. By adhering to the highest standards of usability and compliance, Akina strengthened its position in the digital physiotherapy market. The lean QMS and robust cybersecurity framework facilitated ongoing improvement and readiness for new regulatory challenges. Additionally, our methodological coaching empowered Akina’s team to maintain and enhance their UX and compliance capabilities independently.

For Akina’s customers, a more intuitive, efficient, and compliant digital tool enhances the overall healthcare experience. Plus, rigorous data protection measures ensure that users can trust that their sensitive information is secure, fostering greater adoption and usage of the application.

Our partnership with Akina exemplifies how strategic expertise and collaboration can speed up innovation and compliance in the healthcare sector. Now, Akina can confidently pursue its vision of helping patients reduce pain and improve their mobility.