Strategic & Technical Expertise for the Medical Device Industry
Accelerate Your Medical Device Success: Full Lifecycle Consultancy
Accelerate Your Medical Device Success: Full Lifecycle Consultancy
HOF Consulting provides strategic and technical expertise to pharmaceutical and medical device companies, from innovative start-ups to established corporations. Led by Andy Walker, a seasoned executive with decades of senior leadership experience in the sector, we offer comprehensive support across the entire product lifecycle.
Leveraging deep industry knowledge and a network of trusted specialists, we help you overcome complex challenges, achieve regulatory compliance, optimise operations, and bring safe, effective products to market efficiently.
Strategic Product Development: Guiding your innovation from concept through to successful launch.
Regulatory & Quality Assurance: Navigating complex global standards (MHRA, FDA, EU MDR/IVDR, ISO 13485) with confidence.
Manufacturing & Supply Chain Optimisation: Streamlining processes from industrialisation to lifecycle management.
Technical & Operational Leadership: Providing expert guidance and building high-performing teams.
To be the trusted strategic and technical partner for medical device innovators, enabling the efficient development and commercialisation of safe and effective products that improve patient lives. We aim to provide unparalleled expertise and flexible support, helping clients navigate the complexities of the industry from concept to market success.
Led by Andy Walker, a seasoned executive with extensive senior leadership experience across the pharma and medical device sectors. Andrew brings deep expertise in full product lifecycle management, strategic planning, technical operations, regulatory compliance (MHRA, FDA, BSI), and supply chain optimisation.
HOF Consulting complements thi
Led by Andy Walker, a seasoned executive with extensive senior leadership experience across the pharma and medical device sectors. Andrew brings deep expertise in full product lifecycle management, strategic planning, technical operations, regulatory compliance (MHRA, FDA, BSI), and supply chain optimisation.
HOF Consulting complements this core leadership with a flexible network of trusted specialists, enabling us to provide bespoke, expert teams tailored precisely to your project's needs in development, quality, regulatory affairs, and manufacturing.
Results-Oriented: Focused on delivering tangible outcomes and achieving your strategic objectives.
Expert-Led: Leveraging deep industry knowledge and technical proficiency gained through decades of experience.
Flexible & Scalable: Adapting our support model, utilising our core leadership and trusted network to provide the right expertise ex
Results-Oriented: Focused on delivering tangible outcomes and achieving your strategic objectives.
Expert-Led: Leveraging deep industry knowledge and technical proficiency gained through decades of experience.
Flexible & Scalable: Adapting our support model, utilising our core leadership and trusted network to provide the right expertise exactly when needed.
Pragmatic: Providing practical, actionable advice and hands-on support.
Client-Centric: Understanding your unique challenges and tailoring solutions to meet your specific requirements, from start-ups to large corporations.
Concept to Commercialisation: Comprehensive guidance through all development phases.
R&D Strategy & Execution: Aligning technical development with business objectives.
Technology Integration: Incorporating novel technologies and processes effectively.
Product & Process Development: Designing robust and manufacturable devices and efficient processes.
Technical Leadership: Providing expert oversight for development programs.
Benefit: Bring innovative, viable products to market faster with reduced technical risk.
Regulatory Strategy: Developing clear pathways for UK (MHRA/UKCA), EU (MDR/IVDR/CE), and US (FDA) markets.
Compliance Management: Ensuring adherence to relevant standards (ISO 13485, GxP).
Technical File Authoring & Remediation: Compiling and updating essential documentation for submissions.
Quality Management System (QMS) Support: Implementation, auditing, and improvement of QMS.
Risk Management (ISO 14971): Implementing robust risk management processes.
Post-Market Surveillance (PMS): Establishing compliant PMS systems.
Benefit: Navigate complex regulations confidently, achieve timely approvals, and maintain compliance throughout the product lifecycle.
Industrialisation & Scale-Up: Transitioning designs into efficient, high-volume manufacturing.
Supplier Sourcing & Management: Identifying and managing key suppliers and contract manufacturers (CDMOs).
Process Improvement & Optimisation: Enhancing manufacturing efficiency and reducing costs.
Lifecycle Management: Managing post-launch changes, updates, and obsolescence.
Supply Chain Strategy: Designing resilient and cost-effective supply chains.
Benefit: Ensure reliable, cost-effective manufacturing and supply of your medical devices.
Interim Technical Leadership: Filling critical gaps in your technical management team.
Team Capability Building: Developing skills and competencies within your organisation.
Stakeholder Engagement: Facilitating effective communication across functions and with external partners.
Process Governance: Establishing efficient governance for technical and operational processes.
Benefit: Strengthen your internal capabilities and ensure effective execution of technical programs.
Technology Assessment: Evaluating the feasibility, maturity, and scalability of device technologies.
IP Landscape Review: Assessing intellectual property status and potential risks.
Development Plan Analysis: Reviewing project plans for robustness and potential roadblocks.
Manufacturing Readiness: Evaluating the preparedness for scale-up and commercial production.
Benefit: Enable informed investment decisions, support M&A activities, and mitigate risks in partnerships or acquisitions.
Partner Selection & Qualification: Identifying and vetting critical third-party partners (e.g., design houses, CDMOs, testing labs).
Contract Review & Negotiation Support: Providing technical input for service agreements.
Ongoing Relationship Management: Facilitating effective collaboration and performance monitoring.
Benefit: Secure reliable performance, foster strong collaborations, and effectively manage your external resources.
HOF Consulting partners with a diverse range of organisations within the pharmaceutical and medical device sectors across the UK and internationally.
We understand the unique challenges faced by:
Whether you are developing your first product or managing a mature portfolio, HOF Consulting provides the tailored expertise you need to succeed.