by Kathryn Cullen, Head of Client Delivery & Operations
Many MedTech change programmes don’t fail in the conventional sense. They deliver on time, on budget and to scope. Then too little changes.
Over years of overseeing large regulatory, digital and process programmes, I’ve seen the same pattern. The system goes live, the procedure is approved, the submission goes in, and the organisation gradually drifts back to how it worked before. The programme closes as a success, but the value it promised never fully arrives.
That gap matters more than ever. Regulation, AI, changing patient pathways and market expectations are all shifting at once.
A common regulatory or technology change does not create the same starting point for every manufacturer. The difference is often how well an organisation can absorb change, not just deliver a project.
In MedTech, change readiness is the ability to introduce new ways of working while maintaining control of quality, compliance and patient safety. It requires people with the capacity to participate, clear decision-making responsibilities and accountability that continues after implementation. Readiness starts before a programme is approved and is tested in what happens after it closes.
Here are three questions I’d put to a leadership team.
1. What business value was each programme expected to deliver, and has it been realised?
Many programmes are approved on a business case and closed on a milestone plan. Somewhere between the two, the expected business value can get lost. Launch dates and completed deliverables are visible and easy to report. Outcomes such as less rework or faster decisions may take longer to establish and require someone to keep measuring them.
Start with a baseline. Then track the value created: faster market access, shorter time to market, increased capacity, improved margin, lower cost of poor quality or reduced risk. Some benefits may be difficult to express as immediate revenue, but they should still have a clear rationale and measures.
For each intended benefit, agree the starting position, how progress will be measured, who owns the result and when it is reasonable to expect it. Review efficiency measures alongside quality measures. Shorter turnaround times are useful only if they are achieved without weakening the decisions or controls the process exists to support.
Regulatory and quality change is no exception. A QMSR transition or MDR remediation should not be judged only by whether the organisation is prepared for an inspection or review. The broader opportunity may be to improve evidence access, process consistency and decision-making, or reduce rework. Such additional benefits should be defined separately and resourced within the programme, where the programme’s scope and business case support it.
My colleague Amie Smirthwaite makes a related point about clinical evidence: an evidence strategy should consider not only what is needed to support approval, but also what may be needed for market access and adoption. The same discipline applies to organisational change: define the intended outcome early enough for it to influence the work, then monitor and assess its results. If no one is tracking the expected return, it is difficult to know whether the programme delivered it.
Consider this example: a manufacturer introduces an electronic quality system to reduce time spent finding records and coordinating approvals. The system goes live and training is completed, but teams continue using parallel document systems to store updated records because responsibilities and exception handling remain unclear. The implementation milestone has been met; the intended operating benefit has not.
In that situation, additional training alone may not resolve the problem. The team needs to understand what the intended change provides, address the workflow gaps and agree how duplicate working can be retired without compromising required records or controls. Progress can then be assessed through retrieval time, approval turnaround, rework and discontinued use of parallel processes.
2. Can you name the five people every one of your change programmes depends on, and what you’ve taken off their plate?
Most leaders can name the people. Very few have taken anything away from them.
In many MedTech programmes, a relatively small group of experienced Quality, Regulatory, Clinical and technical specialists is asked to lead change while keeping day-to-day responsibilities on track. When those people are overloaded, decisions can slow, workarounds can emerge and important work can compete for the same attention.
You have to create capacity to make capacity. Change may be intended to free up time, but building and embedding it takes time too. Leaders need to decide what can be stopped, simplified, delegated or resourced differently while the change is under way.
This is also why training completion is a weak proxy for readiness. Someone may understand the new procedure but lack the time to apply it, the authority to resolve an exception or clarity about which previous activity should stop. What appears to be resistance may be a practical problem that the delivery plan has not addressed.
Capacity needs to be considered across the whole change portfolio. If several programmes depend on the same specialists, each project plan can look achievable while the combined workload is not. Leaders need to sequence competing demands and protect time for testing, decisions and the early period of adoption.
AI is one area where organisations hope to release capacity. But introducing a tool does not automatically reduce workload. It needs to fit a real workflow, use appropriate data, have clear governance and retain human accountability. Otherwise, it can create parallel work and new review burdens.
Before introducing AI, ask what work it will remove, what review work it will introduce and who will own the resulting workflow. Will it be trusted and governed? A faster first draft is not necessarily a faster end-to-end process if checking and correcting it consumes the time saved and if the outputs can’t be validated. The relevant measure is the net effect on capacity and quality.
The challenge is not only how to adopt AI, but how to make its use trusted, governed and useful in practice.
3. Look at the last three programmes you closed. Who owns the outcome today, and would they agree?
Programmes are temporary. The benefits they promise are not.
When a programme closes, the forum that brought Quality, Regulatory, Clinical, Engineering, Digital and Operations together often closes with it. Teams return to their day-to-day priorities, and accountability for sustaining the new way of working can become unclear.
Name the business owner when the intended outcomes are agreed, rather than waiting until go-live. Give them the authority and support to sustain the change, and keep an appropriate cross-functional forum in place to review whether the intended outcomes are being achieved.
Ownership needs to be operational. The owner should know which measures they will review, which decisions they can make and how to escalate issues that cross functional boundaries. Otherwise, accountability can remain nominal while the same unresolved dependencies continue.
Agree a review rhythm that fits the risk and pace of the change. Review whether people are using the new process, where workarounds persist and whether the intended benefits are emerging. Bring user feedback and quality signals into the same conversation so that adjustments strengthen performance without weakening control.
Closure should include an explicit agreement about what continues: monitoring, support, outstanding decisions and responsibility for further changes. Where benefits will take time to appear, make the remaining assumptions and review dates visible to the receiving business owner.
Change Readiness is a Competitive Capability
A programme can be on time, on budget and to scope, yet still fall short if it does not create lasting change or deliver the value the business expected.
Change readiness is more than a plan or a technology investment. It is the organisation’s ability to learn, decide and adapt in ways that strengthen performance while protecting quality and patients. That capability is becoming a real competitive advantage. The value lies in making each new requirement or opportunity less disruptive: teams can respond with clearer decisions, usable evidence and the capacity to act.
Before approving the next programme, ask for three things alongside the delivery plan: a measurable outcome, a realistic allocation of people’s time and an owner with the authority and capacity to sustain the change, during implementation and after the handover. The creates a practical connection between investment approval and the value the organisation ultimately receives.
The test is what the organisation can do consistently after the project team has moved on.
Which of these questions would make your leadership team pause?
