I build the governance, architecture, and clinical AI strategy to make sure yours doesn't. Twenty-five years in clinical trials, telehealth, digital health, and medical device software.
The challenge AI faces in clinical trials, telehealth, and regulated healthcare is not technical. The technology works. The challenge is that every architectural decision, every model deployment, every data handling choice carries regulatory consequence. A governance failure is not a bad quarter. It is an audit finding, a contract loss, or in the worst case, a patient safety event.
Most technology advisors understand one side of this. They understand AI or they understand regulated environments. The combination — genuine technical depth alongside fluency in FDA 21 CFR Part 11, GCP, MHRA, ISO 42001, CQC, and HIPAA — is rare at senior level.
I have worked in this specific intersection for 25 years. Not adjacent to it. In it.
From a single due diligence engagement to a 12-month interim mandate. Each engagement is scoped and priced to fit the specific situation.
An independent technical assessment of a regulated technology business, delivered in a format that stands up to investor and board scrutiny. This is not a code review. It is a structured evaluation of technical risk, AI maturity, regulatory compliance posture, and team capability — the questions that determine whether an acquisition, investment, or fundraise carries hidden technical liability.
I work on both sides of the transaction. Buy-side for PE and VC firms evaluating a target. Sell-side for founders preparing for Series B, Series C, or exit — where a credible technical assessment ahead of the process removes friction and prevents late-stage surprises.
What the assessment covers
Who it is for
PE firms and operating partners evaluating regulated HealthTech or clinical trials technology. VC investors who need independent technical verification before a round closes. Founders preparing for a funding process who want to identify and address technical risk before investors do.
What you will have at the end
A document you can put in front of your investment committee, your board, or your acquirer. The kind of assessment that gives senior stakeholders confidence rather than questions.
Pricing: on request. Scoped per engagement.
Get in touch about due diligence →Senior technology leadership for regulated businesses that need an experienced CTO without the timeline, cost, or risk of a permanent hire. I work directly with the CEO and board, lead the engineering organisation, and carry accountability for technology strategy, AI delivery, and regulatory compliance — for as long as the mandate requires.
This is not fractional in the diluted sense. When I take an interim mandate, it is the primary engagement. The business gets a CTO with full accountability, not a consultant who dips in once a week.
What the mandate typically covers
Who it is for
PE-backed HealthTech and RegTech scale-ups navigating transformation or preparing for exit. Series B and C companies where the technology organisation needs to be materially stronger before the next raise. Boards that need senior technology leadership in place quickly, without sacrificing quality.
What you will have at 90 days
A technology organisation that operates with more clarity, an AI programme that is moving toward production rather than pilot, and a board pack that reflects a function under control.
Pricing: on request.
Get in touch about an interim engagement →A time-boxed engagement for regulated organisations that have AI in use or in development and need the governance framework to match. In six to eight weeks, we go from "we have AI running in parts of the business" to "we have a governance framework we can defend to a regulator, an auditor, or a board."
ISO 42001 was published in December 2023. Most implementation guidance in the market is theoretical. I have implemented it at two regulated healthcare organisations. The sprint is built around that direct experience, not around reading the standard.
What the sprint covers
Who it is for
HealthTech, clinical trials, and MedTech companies preparing for ISO 42001 certification. Boards and leadership teams facing regulatory scrutiny of AI systems. PE portfolio companies where an upcoming audit includes AI governance as a scope item.
What you will have at the end
A governance framework you can implement, a clear certification readiness position, and a regulator-ready evidence trail for the AI systems currently in production.
Pricing: fixed fee. On request.
Get in touch about an AI governance sprint →An independent senior technology voice for boards and founders who have engineering leadership in place but want external perspective at the level where technology decisions intersect with investment strategy, regulatory risk, and commercial outcomes.
I work with a small number of organisations at this level at any one time. The value is in genuine independence: no vendor relationships, no equity position, no incentive other than giving you an honest view.
What this looks like in practice
Who it is for
Series B and later founders who have a CTO or senior engineer but want an independent perspective at board level. PE operating partners who want ongoing technical oversight of portfolio companies. Boards where regulated technology and AI governance decisions need a credible non-executive voice.
Pricing: monthly retainer. On request. By referral or application.
Apply for board advisory →I have spent 25 years at the intersection of regulated healthcare, clinical AI, and the commercial pressures that determine whether technology organisations succeed or fail. That is not a general technology background that includes some healthcare. Healthcare, clinical trials, and regulated digital health is where I have done the work.
The specific experiences that matter most for what I do now: scaling the Q doctor telehealth platform 30 times during the pandemic without a platform failure, because the engineering foundations we had built two years earlier made it possible. Leading the AI decisions at TRI that connected machine learning directly to £4.5M in NHS contract wins — not as a background factor, but as the stated reason those contracts moved. Implementing ISO 42001 at two regulated organisations at a point when almost no one had done it yet, which meant building the framework from first principles rather than copying an existing playbook.
I currently hold a retained M&A technology advisory engagement, advising investment teams on technical due diligence in regulated health and life sciences transactions. I also work with a small advisory portfolio that includes a Johns Hopkins BioPharma spinout, a UK primary care platform, and two stealth-mode startups in biomarkers and digital health.
I am a registered expert with Third Bridge, covering eClinical technology, clinical trials software, and AI in regulated healthcare.
FDA 21 CFR Part 11 and Part 50/56 | GCP / ICH E6 | EMA CTR | MHRA | HIPAA | ISO 42001 | ISO 27001 | CQC | DTAC | DSP Toolkit | DCB0129 | GAMP 5 | CSV / CSA
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I am currently engaged with a small number of clients in regulated sectors. One new interim engagement is available from Q3 2026.
Permanent opportunities in regulated HealthTech and clinical trials are considered selectively. If the mandate is genuinely at the intersection of AI, clinical technology, and regulatory complexity — and if the organisation is at a stage where that combination of skills creates measurable commercial value — I am interested in the conversation.
Interim and fractional engagements, due diligence work, and governance sprints can move faster depending on current capacity.
The right way to start: Tell me what you are working on and what the specific challenge is. I respond personally. If there is a fit, we will take it from there quickly.
Based in Berkhamsted, Hertfordshire. London: 35 minutes.
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