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Senior leadership, when it counts

HOF Consulting provides fractional and interim senior leadership for medical device and drug-delivery companies, from injectables and wearables to hospital devices, diagnostics and digital health. We step in at the moments that matter: raising, partnering, scaling and turning around.

Start a conversation See what we do

Why HOF Consulting

Most growing medtech and drug-delivery businesses do not need another full-time executive. They need someone senior at the table for the decisions that shape the business: which customer to serve first, which partner to sign with, how the organisation should run as it grows. We sit alongside founders, owners and boards for exactly those moments, part time and for as long as it is useful.

Where we come in

Choose the description closest to you.

Start-ups and scale-ups

You have promising science, a prototype or a platform, and a small team being asked to act like a large one. Investors want to see a clear commercial focus and a plan they can believe in.

  • A fractional COO, CTO or strategy lead, embedded in your leadership team
  • A strategy workshop that settles which customer comes first, and why
  • An integrated plan linking development, regulatory, commercial and funding
  • Pitch, investor readiness and a realistic funding route
  • Partnerships with university and NHS clinical research groups to build early clinical evidence
  • A regulatory roadmap for Class I to III devices, combination products or software as a medical device, delivered through our specialist network
Talk to us about your start-up

Established manufacturers

You have products, sites and a quality system, but growth has outpaced the way the business is organised. Projects slip, change control slows everything down and nobody has a clear view of capacity.

  • An independent operational and organisational review, commissioned by the owner or board
  • Clear responsibilities and authority, so decisions get made
  • Cross-site delivery and change control in proportion to the risk
  • A single view of workload and capacity, with leading KPIs
  • Interim operations or technical leadership while the changes bed in
Talk to us about your business

Pharma and partners

Your molecule needs a device partner, or your platform needs the right pharma or CRO partner. The hard part is finding the fit, framing the opportunity and agreeing terms both sides can live with.

  • Introductions between pharma, device developers and CROs
  • Framing the opportunity so both sides can see the value
  • Agreeing data, material transfer and option terms
  • Negotiating on your behalf, alongside your legal advisers
  • Development oversight for drug-delivery programmes, from injectables and wearables to inhaled and transdermal systems
Talk to us about a partnership

Investors and acquirers

You are weighing up a medtech or drug-delivery business and need an independent view of whether the technology, the plan and the manufacturing story hold together.

  • Technical due diligence on the technology and the development plan
  • A view of the IP landscape, alongside your legal advisers
  • An honest read on the regulatory pathway and its timeline
  • Manufacturing readiness and supply chain risk
  • Operating partner support after the investment, at board or executive level
Talk to us about a deal

What we do

Six ways we work with clients, led by senior leadership and strategy. Most clients use two or three at once.

Fractional and interim leadership

  • Fractional or interim COO, CTO, or operations and strategy director
  • Embedded part time in your leadership team, not advising from the outside
  • Governance and decision-making that keep pace with growth
  • Building the team that will take the work on
  • Clear reporting to the board and investors

Strategy, commercial and go-to-market

  • Which customer first, and why
  • Platform positioning for pharma, CRO and device partners
  • Integrated plans linking product, regulatory, commercial and funding
  • Pitch, investor readiness and the story behind the numbers
  • Clinical evidence strategy and routes into the clinic
  • Support in investor and board meetings

Partnering and deal-making

  • Brokering introductions between pharma, device developers and CROs
  • Framing the opportunity for both sides
  • Agreeing data, material transfer and option terms
  • Negotiating on your behalf, with your legal advisers
  • Building partnerships with university and NHS clinical research groups
  • Keeping the partnership moving once it is signed

Operational and organisational reviews

  • Commissioned by owners and boards
  • Organisation, responsibilities and authority
  • Cross-site delivery and proportionate change control
  • A single view of workload and capacity
  • Leading KPIs that prompt decisions, and a practical plan to act on them

Technical due diligence

  • Technology and development plan review
  • IP landscape, working with your legal advisers
  • Regulatory pathway and timeline realism
  • Manufacturing readiness and supply risk
  • Written findings with clear next steps

Development and industrialisation oversight

  • Oversight from concept through to scale-up
  • Choosing and managing CDMO partners, with experience from both sides of the table
  • Design for manufacture and technology transfer
  • Scale-up readiness, checked before surprises get expensive
  • Regulatory and quality work delivered through our specialist network

The technical depth behind the advice

Strategy in this sector only holds up if the technical and regulatory story does. Behind every engagement sit three decades of device and drug-delivery development across many product types, and specialists who know the regulatory pathways in detail.

Drug delivery
Inhaled and nasal, injectables and autoinjectors, wearable and on-body, transdermal, oral and other combination products
Hospital
Airway management, anaesthesia, respiratory therapy, critical care and continence care
Diagnostics
Diagnostics, connected devices and digital health
UK
MHRA, UKCA
EU
MDR, IVDR, CE marking
US
FDA
Frameworks
ISO 13485, ISO 14971, GxP, post-market surveillance

Both sides of the CDMO table

We have worked inside contract development and manufacturing, and as a customer of it. So we know how development teams think and how manufacturers think, and where they most often miss each other: the industrialisation bridge between a working prototype and a product made at volume.

Loose points on the left, for development, joined by lines across a bridge to an ordered grid on the right, for manufacturing
R&D and developmentIndustrialisationManufacturing at volume

Selected engagements

Our clients are confidential, so these are described by the type of work rather than by name.

Fractional operations and strategy lead

Diagnostics and biosensing

Fractional operations and strategy lead for an early-stage diagnostic and biosensing venture. Ran the strategy workshop that set pharma and CRO customers as the first commercial priority, then built the integrated plan, pitch and funding route around it and opened a clinical research partnership with a UK university.

Operational review

Medical device manufacturing

An owner-commissioned review of an established UK medical device manufacturer: organisation and planning, responsibilities and authority, cross-site delivery, proportionate change control, and a single workload and capacity view with leading KPIs.

Inhalation partnership

Partnering and deal-making

Brokering a partnership between a specialist inhalation formulation group and an inhaled drug-device platform developer: framing the opportunity and shaping the data, material and MTA terms.

Interim CTO

Consumer health

Interim CTO for a consumer health venture, leading the product through development with an external design partner.

How we work

Every engagement is led by a senior executive from start to finish, working inside your team rather than reporting from the sidelines. We bring in trusted specialists from our network as the work needs them, so you get the right expertise without carrying a large team.

Scattered points at the left, drawn into one tight stream in the middle and set out in ordered rows at the right Scattered points at the top, drawn into one tight stream and set out in ordered rows at the bottom

  1. Diagnose

    We listen, read everything and find out what is really in the way.

  2. Decide

    Agree the priorities, the owners and the few measures that matter.

  3. Lead

    A seat in your leadership team, driving the work, with specialists brought in as needed.

  4. Hand over

    Your people own the result, with the structure in place to keep it going.

Founder
Andy Walker
Experience
30+ years in pharma and medtech
Based in
Nottinghamshire, UK
Working
Across the UK and internationally

A seat at your table

HOF Consulting was founded by Andy Walker, a fractional executive and adviser who sits alongside founders, owners and boards. Andy has spent more than 30 years in pharma and medtech, leading the development, industrialisation and commercialisation of medical devices, drug-delivery systems and consumer health technologies, including deep experience in respiratory products.

His career spans GSK, Vectura, Smith & Nephew, Kind Consumer and BAT (Nicovations), and he has worked both inside contract development and manufacturing and as a CDMO customer. Today he works inside the leadership teams he supports, backed by a growing network of senior independent specialists brought together for each engagement. Meet the team we are building

Capabilities

  • Fractional leadershipCOO, CTO, director
  • Strategy and go-to-marketCustomer focus
  • Partnering and dealsPharma, devices, CROs
  • Organisational reviewsOwners, boards
  • Investor readinessPitch, funding
  • Diagnostics and digital healthConnected devices
  • Technical due diligenceInvestors, acquirers
  • Development oversightConcept to scale
  • Drug-delivery systemsInhaled, injectable, wearable, transdermal
  • Hospital and critical careAirway, anaesthesia, continence
  • IndustrialisationCDMOs, suppliers
  • Regulatory and qualityThrough our network

More good people, more good products

We are building a group of senior fractional specialists: operators, technical leaders and advisers in device development, drug delivery, regulatory, quality and manufacturing. We plan to add permanent roles as the work grows. If you would like to hear about engagements or future roles, introduce yourself.

Introduce yourself

Start a conversation

Tell us where things stand: the business, the product and the decision or moment you are facing. We will tell you plainly whether, and how, we can help.

Prefer to talk first?

info@hofconsulting.co.uk +44 (0)7748 322256

Based in Nottinghamshire, UK. Working across the UK and internationally.

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