Limeburners Bay International Medical Device and Digital Innovation Consulting Services

CONSULTING SERVICES

“You can’t solve a problem on the same level that it was created.

You have to rise above it to the next level.”

Albert Einstein

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ABOUT US Sustainable Medical Technology Innovation

Healthcare organisations globally face a common challenge: To provide equitable access to high quality healthcare at an affordable cost.

Limeburners Bay is a social enterprise founded in 2017 to promote sustainable medical technology innovation.

We have acquired deep expertise and developed advanced platforms in medical technology innovation, which we offer to clients and partners through the company’s consulting arm.

We have provided consulting services to nearly 30 clients in the last years, including multinational corporations, consulting firms, start-ups, private equity firms and not-for-profit organisations.

We aim to problem-solve for our clients, adapting our engagement model and services based on their needs.

This portfolio is a snapshot of our innovation approach and previous projects.

Dr. Sophie Laurenson BSc. (Hons), PhD (Cantab), EMBA, MRSNZ, CDMP CARAQA (Clinical Affairs, Regulatory Affairs and Quality Assurance)-Certified CEO & Founder, Limeburners Bay International AG

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DISEASE AREA EXPERIENCE ONCOLOGY INFECTIOUS DISEASES

CARDIOVASCULAR DISEASE

RESPIRATORY DISEASE

MATERNAL AND CHILD HEALTH

DIABETES

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EXPERIENCE Limeburners Bay has a global footprint, spanning across continents and regions. We have cultivated diverse partnerships and expansive networks, addressing unique healthcare challenges worldwide. Our geographic experience reflects a commitment to expanding access to advanced medical solutions and improving patient care globally.

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SERVICES Limeburners Bay engages with clients through a multifaceted approach, working as a strategic partner to deliver solutions and continuous support to drive client success and sustainable growth. We offer a range of services to suit any budget and organisation, from startups to multinational corporations.

TRAINING We offer training services as part of a comprehensive approach to client empowerment. Training serves several purposes, including knowledge transfer, skill development, and organisational capability enhancement. By providing training, we help empower clients to independently navigate challenges, implement recommended strategies, and sustain improvements, creating more self-reliant and resilient organisations. Our training services are delivered under the MEDDEV Central Academy and Knowledge Hub umbrella organisation, offering a mixture of free and paid training courses.

WORKSHOPS We conduct workshops with clients as an interactive and collaborative method to facilitate learning, problem-solving, and strategy development. Workshops bring together key stakeholders, fostering open communication and idea exchange. Workshops serve as a platform for aligning diverse perspectives within an organisation, fostering consensus, and building a shared vision, often acting as catalysts for innovation. We host remote and onsite workshops covering specific topics, including intended purpose statement development, risk management, integrated regulatory and market access strategies, evidence planning and internationalisation strategies.

CONSULTING PROJECTS In bespoke consulting projects, we tailor our services to the unique needs and challenges of individual clients to provide targeted solutions that align with the client’s specific goals and circumstances. This personalised approach ensures that our services are not one-size-fits-all but rather finely tuned to address the client’s distinct requirements. Common requests include: • Innovation and R&D consulting services • Contract research: Technology and IP landscaping and scouting, Market research, Competitive intelligence • Due Diligence (technical) and investment analysis • Regulatory and market access strategy • Business strategy consulting for multinationals, SMEs, and start-ups • Digital innovation and transformation consulting • Digital and content marketing and management services 6

DIGITAL INNOVATION & TRANSFORMATION

CYBERPHYSICAL SYSTEMS

BUSINESS & STRATEGY CONSULTING DIGITAL & CONTENT MARKETING

BIOENGINEERING

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FRAMEWORKS An innovation framework is a structured approach or set of principles and methodologies designed to guide and support the process of generating, developing, and implementing innovative ideas within an organisation, helping to foster and manage the innovation process systematically.

Limeburners Bay specialises in leveraging the power of several popular innovation frameworks while maintaining compliance with global medical device regulations and international standards.

INNOVATE TO VALUE LBI’s proprietary innovation framework is a toolkit integrating best practices from popular innovation frameworks whilst maintaining compliance. Ensuring that innovations maximise their value creation potential.

“Innovate to Value” is a full lifecycle product development approach that focuses on optimising the value delivered by a product or service. Innovate to Value aims to create 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. The key features of Innovate to Value include: • • • • • • • •

User-centricity and usability engineering Integrated value assessment and cost analysis Iterative Development, including verification and validation Regulatory compliance focus Risk management Value engineering Lifecycle management Business model innovation

By applying the Innovate to Design principles to medical device development, companies can create products that are not only innovative and effective but also cost-efficient and capable of delivering value to both healthcare providers and patients.

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AGILE METHODOLOGIES Agile methodologies are iterative and flexible approaches to project management and product development that prioritise collaboration, adaptability, and user feedback throughout the development process.

We practice agile methodologies compliant with international standards, such as IEC 62304:2006 - Medical device software.

JOBS TO BE DONE

DESIGN THINKING

Design thinking is a problem-solving approach that prioritises empathy, ideation, and prototyping to address complex challenges, placing the end user at the centre of the creative and iterative process. We have developed toolkits to leverage Design Thinking approaches while maintaining compliance with international standards such as IEC 62366 medical devices - Application of usability engineering to medical devices.

The Jobs-to-be-Done innovation framework centres around identifying and fulfilling the fundamental needs and goals customers are trying to accomplish, emphasising a focus on the “job” or task they require a product or service to accomplish. We specialise in helping clients understand the tasks required by healthcare professionals across clinical settings.

PORTER’S FIVE FORCES

Porter’s Five Forces is a framework for analysing the competitive forces within an industry, including the bargaining power of buyers and suppliers, the threat of new entrants, the threat of substitute products or services, and the intensity of competitive rivalry.

BLUE OCEAN STRATEGY Blue Ocean Strategy is a business strategy framework that advocates creating uncontested market space by innovating and offering unique value propositions, making competitors irrelevant. We help clients identify new markets and business models for disruptive healthcare innovations.

FRUGAL INNOVATION

Frugal innovation involves the creation of cost-effective and simplified solutions to meet the essential needs of a wide range of users, often emphasising resource efficiency and affordability without compromising quality. We help clients apply frugal innovation principles to address the unmet needs of marginalised or underserved populations, especially in low and middle-income markets.

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BASEL, SWITZERLAND

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KAMPALA, UGANDA

consulting@limeburnersbay.com

limeburners-bay-international-ag

LimeburnersBay

Title: Consulting Services Edition: 3 Date: 2023 Direction: Dr. Sophie Laurenson

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