An Early Regulatory Roadmap for Medical Imaging Startups

If you are an early-stage founder, CTO, or clinical lead, this guide will help you:

• Avoid costly regulatory rework

• Align technical development with future approvals

• Build investor confidence through regulatory clarity

The “Medical Imaging Is Not SaaS” Reality Check

Software as a Service (SaaS) companies like Slack, Zoom or Netflix are known to “launch and iterate.” However, in medical imaging, SaMD and system-level products alike carry early decisions that are costly or impossible to reverse. Establishing a strong regulatory foundation can produce a well-considered development approach; avoiding the devastating “rework loop”. So, in an attempt to prevent these errors from occurring in the first place, here we provide a conceptual sequencing roadmap for early-stage medical imaging technologies looking to come to market.

MedTech speed comes from strong regulatory foundations that prevent rework 

Defining the “What” and “Who”

First, define the general Indication for Use (IFU) which describes exactly who the device is to be used on and who is using it. For medical imaging, one would need to also specify:

• Imaging modality (ultrasound/X-ray etc)

• Anatomical region

• Clinical task (e.g. visualization, measurement, detection, triage, workflow support)

• Whether the output is diagnostic, adjunctive, or informational

From here, select your market, the US generally offers easier commercial access so we will be providing guidelines for this but also consider other country regulations and ISO 13485 to avoid re-working. Following this, form a defensible initial classification hypothesis (Class I, II, III or De Novo.) Classifications can change but having a rationale and idea is a great start. Medical Imaging classification is primarily driven by intended use, claims and risks to patients rather than the underlying technology and this is where the IFU comes in handy. 

Define intended use, market selection and classification hypothesis

Clinical & IP Validation

Your technology must be filling a legitimate need and it should be viewed as a method to revolutionise clinical methodology. A clinical advisory board allows your team to stress-test clinical relevance and workflow assumptions. Radiologists, imaging specialists or modality experts are the typical suspects and assigning a Key Opinion Leader (KOL) is important. Next, to further provide clinical relevance, establish an imaging workflow mapping: 

• Order -> Acquisition -> Interpretation -> Report -> Downstream Action

With respect to Intellectual Property(IP), make sure your imaging technology has Freedom to Operate (FTO); conduct a patent search, ensuring you aren’t building something that already has IP claims attached to it. 

Ensure the clinical problem you are addressing is real and that the space is “ownable”.

Technical De-risking & the “Proof of Concept”

Risk management is critical in medical imaging technology. First, we will tackle reimbursement risks of which there are three main types:

• Coding: can we bill it?

• Coverage: will payers pay for it?

• Payment: how much and to whom?

Medical imaging is typically more nuanced in this respect; value provided is usually indirect: downstream cost reduction, diagnostic confidence and efficiency, are typical “Payer” aspects. Next, technical derisking, identify the “killer risk”, this could be image quality consistency, false positives/negatives, clinical interpretability, etc… Once identified, building a prototype to tackle the killer risk will be an important step in the right direction. This would be considered exploratory bench testing for supporting IFU claims, and doesn’t require verification grade. Here it is also important to consider patient harm, like image misinterpretation or inherent technology hazards. In this context, an FDA Q-Submission (Pre-Sub) provides early FDA feedback for novel intended uses and software-driven imaging, supporting de-risked testing and ISO 14971 initiation.

Manage risk through a reimbursement strategy, identifying and quenching a killer technical risk and laying out potential patient harm

Design Controls & QMS Readiness

At this stage, it is now time to formalise design controls. Start building a Design History File (DHF) by documenting design inputs, especially those tied to imaging performance and clinical claims. Next, any medical imaging system that is connected would need to consider cybersecurity risk (ISO 27001 / 27799) and electrical safety (IEC 60601) if plugged in. Regarding traceability, begin to link user needs and imaging claims to technical requirements, performance metrics and validation plans. Lastly, consider usability: display, annotations and outputs can influence clinical onboarding. A full fledged QMS isn’t necessary just yet but getting things in order is critical. 

Build up a Design History File and consider cybersecurity, electrical safety, traceability and usability.

The Sanity Check 

By now, you should have a clean package of IFU, classification hypothesis, IP status, a reimbursement strategy and an early clinical validation hypothesis. This is now the stage when you should self-audit; begin with a “Red Team” review, an external imaging expert tasked with finding issues with your current progress. In addition, it is a good idea to broadly detail the next 12 months; what will you need to accomplish? Design verification, validation, etc… 

Conduct a Red Team review and plan out the next 12 months

Direction Over Velocity

Investors don’t fund approvals, they fund teams that understand what it takes to achieve them, and having the above in place helps demonstrate that capability. In addition, a disciplined start leads to faster and more streamlined progress. Now it is important to understand that reality is messy and every project is unique with its own unknowns and unknown unknowns.

If you’re facing the uncertainty that comes with building a medical imaging product, an experienced external perspective can help. We work with early-stage teams to bring clarity and avoid costly rework.