Project Portfolio: Business and Strategy Consulting

BUSINESS AND STRATEGY CONSULTING Strategy, transformation and innovation consulting and research services through the medical device lifecycle.

Our business and strategy consulting services span the complete medical device value chain, from ideation to commercialisation and post-market activities. Our approach and methods are underpinned by almost 20 years of professional experience. Business consulting services include: •

Innovation and R&D Consulting

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Contract Research •

Technology and IP Landscaping and Scouting

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Market Research

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Competitive Intelligence

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Due Diligence (technical) and Investment Analysis

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Regulatory and Market Access Strategy

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Strategy Consulting (multinationals, SMEs, and start-ups)

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Transformation and Change Management

We have in-house consulting toolkits and access to platforms supporting our business consulting activities. In addition, we can draw on external expertise from an established network of business partners and freelance professionals to support our clients when required.

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CASE STUDIES

This portfolio of case studies outlines a selection of the bespoke projects conducted for clients including multinational medical device manufacturers, not-forprofit organisations and private equity firms.

Market research, technology landscaping, competitive analysis and due diligence support

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Regulatory Software Market Research

Competitive Intelligence Company Profiling - IVD

Diabetes Care Advanced Services Analysis

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PoC COVID-19 Test Development

HbA1c PoC Market Landscape

Competitive Technical Due Diligence

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MEDICAL DEVICE REGULATORY SOFTWARE MARKET RESEARCH CLIENT: DIGITAL CONSULTING COMPANY LOCATION: INDIA DATE: 3 MONTHS PART-TIME (2022)

Market research project to investigate the potential for digitalising medical device regulatory processes in Europe.

Aim: To conduct market research into the potential for a suite of software products and services to digitalise regulatory processes for medical device manufacturers in Europe.

Background: The recent introduction of the Medical Device Regulations (EU MDR 2017/745) has increased the burden on medical device manufacturers to meet stringent regulatory and quality requirements.

Software that can assist in aiding the assembly and maintenance of medical device technical documentation through the lifecycle is potentially of interest to manufacturers and service providers.

Methods: This project involved conducting semi-structured interviews and demonstrations with software vendors, systematic literature review (SLR) specialists, regulatory and quality experts and medical device manufacturers.

Deliverables: •

A market research summary report on the competitive landscape of digital SLR and clinical evaluation tools and vendors.

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Interview transcripts and meeting notes documenting primary research findings.

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Recommendations for market potential and early user requirements.

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COMPETITIVE INTELLIGENCE - IVD COMPANY PROFILES CLIENT: GLOBAL IVD COMPANY LOCATION: U.S.A. (REMOTE) DATE: 14 MONTHS PART-TIME (2020-1)

Strategic profiling of leading in vitro diagnostics (IVD) companies to inform corporate strategy.

Part 1: This competitive intelligence project involved constructing company profiles on 17 top-tier and second-tier IVD manufacturers through primary and secondary research. The scope included collating information on organisation structure and strategy, financial data, product/service portfolio and pipeline, manufacturing, commercial, and R&D activities. The deliverables were PowerPoint slide decks that were subsequently presented to the client’s executive management and used to guide the company strategy.

Part 2: A second competitive intelligence project profiled the near-term strategy of a leading molecular diagnostics company following their rapid expansion to meet COVID-19 testing demand. The client requested insight into the global installation base for PCR and genomics instruments, test pipeline, market share, geographic expansion plans and strategy for converting life science installations to clinical diagnostics applications.

Methods: Both projects involved gathering primary intelligence (interviews) and secondary research using company data sources, patent and funding databases and press releases.

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DIABETES DIGITAL SERVICES CLIENT: GLOBAL DIABETES CARE COMPANY LOCATION: GERMANY (RMEOTE) DATE: 6 MONTHS PART-TIME (2020)

Advanced diabetes care services for insulin pumps and continuous glucose monitoring (CGM) devices.

Aim: This competitive intelligence project analysed the advanced services for patients and healthcare professionals provided by eight global diabetes care companies.

Background: Diabetes care companies offer advanced services to enhance patient outcomes, improve treatment efficacy, and differentiate themselves in a competitive market. These services include advanced data analytics, personalised treatment management, remote monitoring, and patient and healthcare professional training and education.

Methods: This project involved conducting primary research (interviews) and secondary research using company data sources. The scope included collecting information on services strategy and access implications, investigating the regulatory requirements for training, clinical guidelines for training, and supplying a catalogue of the offerings for each company. Access challenges due to COVID-19 restrictions were also investigated.

Deliverables: PowerPoint slide decks and written reports summarising the advanced service strategy, portfolio and challenges for eight companies.

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POINT-OF-CARE (POC) COVID-19 TEST DEVELOPMENT CLIENT: PRIVATE EQUITY FIRM LOCATION: U.K. (REMOTE) DATE: 6 MONTHS (2020 - 2021)

Developing a PoC whole virion detection platform to support COVID-19 testing.

Aim: A PE-funded consortium required assistance in developing a flow cytometry instrument for COVID-19 testing.

Background: Diagnostic testing for COVID-19 during the pandemic was crucial for identifying and isolating infected individuals, allowing for the prompt treatment of those who tested positive and facilitating contact tracing to identify and notify individuals who may have been exposed. New technologies for testing individuals in remote, nonclinical settings were urgently needed during the pandemic.

Scope and deliverables: Our roles and responsibilities in this project included: •

Developing technical specifications and target product profile (TPP)

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Managing product development and assisting in building a Quality Management System (QMS)

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Conducting a market landscape of COVID-19 testing products and competitive analysis

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Developing a business model for out-licensing the technology. The out-licensing strategy involved identifying IVD and life sciences companies to target business development activities.

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Two further market landscapes were performed to form a strategy for extending the instrument to other disease areas, including respiratory pathogens and sepsis.

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HBA1C TESTING MARKET RESEARCH CLIENT: INTERNATIONAL GLOBAL HEALTH NGO LOCATION: GENEVA, SWITZERLAND (REMOTE) DATE: 1 MONTH (2021)

Point-of-care HbA1c testing platform market research in low and middleincome countries.

Aim: To identify and analyse platforms for point-of-care HbA1c testing in low and middle-income countries.

Background: Point-of-care HbA1c testing in low and middle-income countries addresses logistical and infrastructure challenges, facilitates timely and effective diabetes management, and ultimately contributes to better health outcomes for individuals with diabetes.

Methods: A list of all available HbA1c testing platforms was compiled based on industry databases and web and scientific literature searches. This long list was further refined by prioritising devices with peer-reviewed literature supporting clinical performance and manufacturers with a presence in several low and middle-income countries.

Deliverables: •

A report summarising the key findings

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A mind map containing relevant information on each included platform

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A comparison chart documenting the short-listed device specifications and available performance evidence.

References

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MOLECULAR PLATFORM TECHNICAL DUE DILIGENCE CLIENT: GLOBAL PRIVATE EQUITY FIRM LOCATION: U.S.A. (REMOTE) DATE: 1 WEEK (2020)

Competitive due diligence analysing the technical performance capabilities of molecular genomic and nucleic acid sequencing platforms.

Aim: This short project (2 weeks) involved performing a deep-dive analysis of pipeline products developed by an investment target in the life sciences sector. The target technologies were sequencing platforms and PCR instruments for genomics research, forensics and clinical in vitro diagnostics applications.

Background: DNA sequencing products are compelling investments due to their pivotal role in advancing personalised medicine, drug development, forensics and genomics research. The growing demand for precision diagnostics, therapeutic advancements, and increasing genomic data applications positions companies in this sector for substantial growth, fostering investor interest in their innovative technologies and solutions.

Methods: Key performance parameters were evaluated using public domain data (web and social media content, patents and scientific literature supplemented with informal interviews) and compared to competitor products. A small market landscape covering 20 genomics products was compiled, focusing only on technical specifications.

Deliverables: The project was suspended due to the COVID-19 pandemic.

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BASEL, SWITZERLAND

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KAMPALA, UGANDA

consulting@limeburnersbay.com

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LimeburnersBay

Title: Business Consulting Projects Edition: 3 Date: December 2023 Direction: Dr. Sophie Laurenson

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