The mistake is not hiring badly. It is hiring from the wrong playbook. A SaMD company that looks at its commercial hiring problem and reaches for the traditional medical device hiring framework will find candidates who know how to sell to surgeons, manage capital equipment procurement cycles, and build territory infrastructure in an established reimbursement environment. Those skills are real and valuable. They are also, in significant part, the wrong skills for the job.
The companies building SaMD products are making this mistake at scale.
What SaMD is, and why it matters for commercial hiring
SaMD is software intended to be used for one or more medical purposes that performs those purposes without being part of a hardware medical device. Under EU MDR and the FDA's own classification framework, software that diagnoses, monitors, treats, or manages a medical condition qualifies as a medical device and is regulated accordingly. In the UK, UKCA marking or CE mark status applies. In the US, the FDA pathway is typically a 510(k) or De Novo submission, depending on the risk classification and the availability of a suitable predicate device.
This regulatory framing matters commercially because it determines what the company can claim, who it can sell to, and what evidence base it needs to construct before any commercial conversation becomes credible. A SaMD company without regulatory clearance is not selling a product. It is selling a promise. The commercial leader who doesn't understand the distinction between those two positions, and how to manage the buyer relationships through the transition from one to the other, will struggle from the first month in post.
Three structural differences that change the commercial hiring brief
The buyer is different
In traditional medical device sales, the primary buyer is typically a clinical decision-maker: a surgeon, a cardiologist, an interventionalist, or a department head with influence over procurement. The commercial case is built on clinical outcomes and procedural efficiency. The relationship is clinical in character, even when the final decision involves a procurement committee.
SaMD procurement, particularly in the NHS, works differently. The decision-making unit typically includes NHS informatics leads, Integrated Care Board digital transformation teams, hospital Chief Information Officers, and procurement committees assessing digital health tools against the NHS Digital Technology Assessment Criteria, known as DTAC. A SaMD company selling an AI diagnostic tool to an NHS trust is not primarily selling to a clinician. It is selling to a system, through a committee, against an assessment framework that most traditional medical device commercial leaders have never encountered.
The commercial leader who has built their career selling implants or capital equipment to clinical champions doesn't have the buyer map for this environment. They have an adjacent buyer map, which isn't the same thing, and the difference surfaces quickly once the procurement conversation begins in earnest.
The sales cycle is different
Traditional medical device sales, particularly for capital equipment or implantable devices, can involve long procurement cycles. But the structure of those cycles is relatively familiar: clinical evaluation, value analysis committee review, procurement negotiation, contract. The clinical champion relationship is the primary engine. Move the clinical champion and the procurement follows, eventually.
SaMD procurement in the UK NHS adds layers that don't exist in traditional device sales. DTAC assessment requires the software to meet standards across clinical safety, data protection, technical security, interoperability, and usability before an NHS organisation will seriously consider deployment. A company that arrives at an NHS trust with a CE-marked SaMD product but without a DTAC submission in progress is typically told to come back when the assessment is complete. The commercial leader who doesn't know this, and doesn't build the DTAC timeline into the commercial plan, will mismanage the pipeline from the outset.
Beyond DTAC, SaMD procurement often involves a pilot phase, an evaluation period against agreed outcome metrics, a business case to a committee or board, and then a contract negotiation that may involve NHS legal, information governance, and digital teams simultaneously. The commercial leader needs to manage a multi-stakeholder, long-horizon process with uncertain timelines and distributed decision-making authority. This is a different skill set from managing a capital equipment sale, and it requires a different kind of commercial experience to do it well.
The regulatory pathway creates a different commercialisation context
A traditional medical device with 510(k) clearance or UKCA marking has a relatively established regulatory status. The commercial conversation begins from a known position. SaMD under MDR and IVDR has a more complex certification profile, particularly for AI and machine learning-enabled software where the FDA has issued specific guidance on predetermined change control plans. The commercial leader for a SaMD company needs enough regulatory literacy to represent the product accurately in commercial conversations with NHS procurement teams and ICB digital leads who are themselves increasingly sophisticated about what regulatory certification does and doesn't mean.
A commercial leader who overstates the regulatory status of a SaMD product in an NHS procurement conversation, or who misunderstands the difference between CE marking under MDR and a DTAC-compliant product, will damage the commercial relationship before the contract has been signed. This isn't a hypothetical risk. It is a pattern that appears in companies that hire commercial leaders from outside the SaMD space without assessing their regulatory literacy specifically.
The talent pool and where the right profiles come from
The number of commercial leaders with genuine SaMD experience is growing but remains small relative to the demand. The segment has expanded faster than the talent market has developed, which means most companies hiring for a SaMD commercial leadership role are competing for a limited pool of candidates who have operated in this specific environment before.
The temptation is to hire from one of two adjacent pools. The first is traditional medical device commercial leadership, where product knowledge and clinical environment experience is strong but the buyer map, sales cycle structure, and regulatory literacy for software may be absent. Health technology or enterprise software sales is the other adjacent pool, where procurement cycle familiarity and multi-stakeholder management experience may be strong but clinical credibility, regulatory understanding, and NHS commissioning knowledge may be limited.
The right profile for a SaMD commercial leadership role typically sits at the intersection of these two pools: someone who has operated in a clinically regulated environment, understands what regulatory clearance means commercially, has managed complex NHS or health system procurement cycles, and can build a commercial case that stands up to scrutiny from both clinical and digital health decision-makers. That candidate exists. Finding them requires knowing specifically what the intersection looks like for this product, this market, and this stage of commercial development.
The brief question that clarifies everything
Before opening a SaMD commercial leadership search, one question tends to cut through the noise faster than any other: who is actually buying this product, and what does that buyer need to see before they will commit?
If the answer involves NHS informatics teams, DTAC assessment, and ICB digital procurement committees, the brief needs someone who has operated in that specific environment. US payer decisions and CMS coverage for digital therapeutics require a different profile entirely, one with US health system experience and an understanding of evolving CMS reimbursement pathways for remote patient monitoring and digital health.
SaMD is not medical device hiring with a software angle. It is a distinct commercial discipline with its own buyer map, its own procurement structure, and its own candidate profile. The companies that recognise this before the search begins are the ones that make the right hire the first time.