Digital Technology Platforms

DIGITAL TECHNOLOGY PLATFORMS

DIGITAL INNOVATION TRAINING OUR APPROACH, METHODS AND PLATFORMS

OUR APPROACH INNOVATE TO VALUE User-centric, value-based innovation to drive medical technology access.

Innovate to Value is a technology innovation approach that focuses on optimising the value delivered by a product or service to a user.

It aims to craft medical technology solutions that effectively meet the needs of all stakeholders, including healthcare providers and professionals, patients, and payers while managing costs and ensuring regulatory compliance.

An Innovate to Value approach is based on a comprehensive understanding of how user needs and requirements are linked to perceived value. Medical technology operates within a complex stakeholder ecosystem.

QUALITY-CENTRICITY Emphasising Quality as the core focus of our company using a compliance-driven strategy.

A user-centric approach ensures that products address real-world challenges and provide value to all stakeholders at an appropriate cost. Innovate to Value embraces human-centred design to promote equitable access to medical technologies.

SUSTAINABILITY Designing, using, and managing digital technologies and resources in an environmentally responsible and energy-efficient manner.

COLLABORATIVE ECOSYSTEMS Medical technology does not launch into a vacuum.

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OUR APPROACH INNOVATE TO VALUE User-centric, value-based innovation to drive medical technology access.

QUALITY-CENTRICITY Emphasising Quality as the core focus of our company using a compliance-driven strategy.

SUSTAINABILITY Designing, using, and managing digital technologies and resources in an environmentally responsible and energy-efficient manner.

COLLABORATIVE ECOSYSTEMS Medical technology does not launch into a vacuum.

Our compliance-driven culture prioritises adherence to regulations and standards to promote a quality-centric culture, prioritising excellence and user satisfaction through: •

Consistency and standardisation: A well-planned regulatory and quality strategy promotes product development, manufacturing, and post-market surveillance consistency. It ensures that products meet rigorous international standards and stakeholder expectations consistently. A strong risk management strategy helps to proactively identify and manage risks related to product safety, efficacy, and compliance.

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Continuous improvement: Our strategy incorporates processes for continuous improvement and adaptation to changing regulatory landscapes, industry trends, and stakeholder needs. This is particularly important in LMIC markets where rapid economic development and social change can lead to volatile conditions.

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Compliance with regulations: A well-defined regulatory strategy ensures that the company’s products and processes comply with the applicable laws and regulations. An effective regulatory and quality strategy minimises the likelihood of non-conformities, reducing the potential financial and reputational impacts on our company and its partners.

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Efficient market access: A clear regulatory strategy will help streamline the approval process for new products and reduce the risk of unexpected regulatory and reimbursement obstacles that could delay commercialisation.

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OUR APPROACH INNOVATE TO VALUE User-centric, value-based innovation to drive medical technology access.

QUALITY-CENTRICITY Emphasising Quality as the core focus of our company using a compliance-driven strategy.

SUSTAINABILITY Designing, using, and managing digital technologies and resources in an environmentally responsible and energy-efficient manner.

COLLABORATIVE ECOSYSTEMS Medical technology does not launch into a vacuum.

We embrace strategies and initiatives to reduce digital technology’s environmental impact throughout its lifecycle, from production and usage to disposal: •

Green Software Development: Sustainable software development practices involve creating applications that use fewer system resources, are optimised for energy efficiency, and have minimal impact on hardware.

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Energy Efficiency: Designing and operating hardware and software systems to minimise energy consumption. This includes optimising data centres, using energy-efficient components, and developing efficient software. Transitioning to renewable energy sources to reduce the carbon footprint of digital infrastructure.

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E-Waste Management: Proper disposal and recycling of electronic waste, including responsible procurement and recycling of old devices to reduce the environmental impact of electronic waste.

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OUR APPROACH INNOVATE TO VALUE User-centric, value-based innovation to drive medical technology access.

QUALITY-CENTRICITY Emphasising Quality as the core focus of our company using a compliance-driven strategy.

SUSTAINABILITY Designing, using, and managing digital technologies and resources in an environmentally responsible and energy-efficient manner.

COLLABORATIVE ECOSYSTEMS Medical technology does not launch into a vacuum.

We understand that the path to sustainable healthcare requires building ecosystems based on collaboration.We partner with research organisations, healthcare providers and like-minded businesses to amplify our impact and drive systemic change: •

We leverage local expertise through collaboration with healthcare providers, professionals and community leaders to co-create solutions that address specific healthcare challenges while respecting cultural norms.

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We don’t just provide technology; we build capacity. Through training, education, and knowledge transfer, we empower innovators, manufacturers and healthcare providers to effectively leverage our tools, ensuring sustainable impact beyond the initial implementation.

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We value diverse perspectives and experiences. By embracing 5 the rich tapestry of cultures and ideas, we create solutions that truly resonate with and serve the communities we work in.

OUR METHODS •

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RESEARCH AND DEVELOPMENT

IEC 62366 compatible usability engineering systems incorporating design thinking and deep user research State-of-the-art assessments through the product lifecycle including: • Systematic literature reviews • Clinical guideline mapping • Stakeholder and competitive landscaping

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ASSESSMENT

Developing integrated evidence strategies supporting the value, safety, and effectiveness of digital health: • Economic evaluations to establish evidence of cost-effectiveness and economic impact through the product lifecycle • Organisational and Workflow Impact studies evaluate the technology’s usability, training requirements, and changes to existing practices.

• Stakeholder research and evidencerequirements synthesis

MANAGEMENT

REGULATORY AND QUALITY •

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Implementation of an ISO 13485-compliant Quality Management System (QMS) Processes for digital development aligned with International Standard requirements, including: • IEC 62304 • IEC 62366 • ISO 14971

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Designing and implementing user training and user support programmes across cultures Software maintenance through the lifecycle Post-market surveillance (PMS) through vigilance and postmarket clinical follow up studies Helping customers to maintain compliance

SPECTIO: LOW-RESOURCE COMPUTING ARCHITECTURE FOR DIGITAL HEALTH INTERVENTIONS

AIM To develop a modular, user-centric suite a digital health tools to improve the delivery of acute and non-communicable disease health services in lowresource settings.

SYSTEM MODULES • Patient Monitoring System based on an Internet-of-Things (IoT) infrastructure connecting smart medical devices. This system has been developed to minimise power consumption and data transmission. Mission-critical functions continue to function offline, enabling continuity of service provision when internet connectivity is disrupted and providing additional cybersecurity protection.

SYSTEM FEATURES Lightweight code supporting reduced computational and data storage requirements and lower power consumption.

Edge computing and Artificial Intelligence at the Edge for low latency and high availability. Cloud-native applications for flexible deployment on-premises or in the cloud.

Flexible and secure data transfer protocols to enable scheduled data transfers according to time and data transfer mechanisms.

• Clinical Decision Support Systems (CDSS) for acute and non-communicable diseases using established protocols and guidelines: • Integrated Management of Childhood Illness (IMCI) • Integrated Management of Adult Illness (IMAI) • Package of Essential Non-Communicable Disease Intervention (PEN) for the diagnosis and treatment of leading cardiovascular and respiratory diseases, cancer and diabetes. PEN-Plus extended protocols.

• Non-Communicable Disease and Injury Poverty (NCDI-Poverty) Commission recommendations • WHO Independent High-level Commission on NCDs guidelines

Integration with SMS technology for monitoring and communicating between healthcare providers and patients.

Rapid development cycle to tailor apps for local settings, enabling compliance with national clinical guidelines and adaptation to local user needs.

• Patient, health facility and medical device management Android applications capturing data integrated with Clinical Decision Support (CDS) Tools for managing cohesive primary, secondary and tertiary care.

• Patient communication and outreach platform based on SMS technology 7

MEDDEV CENTRAL KNOWLEDGE: IMPROVING ACCESS TO MEDICAL DEVICES IN LOW AND MIDDLE-INCOME COUNTRIES (LMICS)

AIM To develop and deploy a lightweight mobile-first digital platform designed for low-resource settings to promote knowledge resources for addressing barriers to medical devices and equipment (MDE) access.

SYSTEM MODULES • Resources for medical device innovation: • Country-level data on medical device policy, regulatory authorities and BMET organisations globally: • Medical device regulations and regulatory authorities

SYSTEM FEATURES A lightweight, responsive design enabling access for users with limited computing resources, fragmented internet access, low bandwidth or expensive data services.

Device, operating systems and browser agnostic.

• Health Technology Assessment processes and authorities • Digital health strategies, regulations and assessment frameworks • Training on conception to commercialisation through MEDDEV Central Academy • Medical device innovation training • Digital health and innovation training

Integration through APIs and Plug-ins to extend the platform capabilities through a microservices architecture.

Supports multiple languages to promote access in new geographies Search engine optimised (SEO) through on-page, off-page and technical approaches.

User support is provided through automated email and text messaging platforms, a help desk and FAQs. Web-based analytics platform to continuously improve user experience through performance data and user feedback REFERENCES Laurenson, S., 2022, Improving access to medical devices and equipment in Africa, Africa Health Laurenson, S., 2023, MEDDEV Central, Innov8 competition shortlist – SDG-track, Arab Health

• in vitro diagnostics training

• Resources supporting medical device assessment and procurement: • Buyer guides for priority medical devices in LMIC settings • Infrastructure and resource requirements • Medical device preventative and corrective maintenance • User training and support requirements • Tools for procuring and managing MDEs in resource-limited settings

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BASEL, SWITZERLAND

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KAMPALA, UGANDA

www.limeburnersbay.com info@limeburnersbay.com

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Title: Digital Innovation Edition: 3 Date: 2023 Direction: Dr. Sophie Laurenson 9