Create demand.
Networking, referrals, events, partnerships and targeted outbound across U.S. MedTech.
Build pipeline around real regulatory need.
Find medical-device companies at the moment software, quality, cybersecurity or regulatory work becomes commercially urgent. Win the first project, then expand into the rest of the product lifecycle.
THE ROLE
Own the commercial path from first signal to signed engagement.
This is a hands-on IC role: prospect, qualify, run discovery, build the solution with technical experts, negotiate, forecast and drive the contract through execution.
Find the real gap.
Software capability, V&V, QMS, cyber, regulatory timing, internal bandwidth and budget.
Shape the engagement.
Staff augmentation, fixed-scope projects, turnkey delivery or leveraged quality infrastructure.
Compress the path.
Champion alignment, technical review, proposal, legal/IP, economic buyer and PO.
WHAT MEDDEV SELLS
One partner across the regulated software lifecycle.
That breadth is the commercial advantage: an initial pain can open several future projects.
Medical software development
Full-stack applications, GUI, cloud, embedded software and algorithm integration under a compliant SDLC.
SQA + V&V
Testing, requirements traceability, DHF documentation, NPS validation and audit readiness.
Secure the device
Threat modeling, SBOM, vulnerability work, penetration testing and ISO 14971 risk management.
Get to market
FDA/MDR support, ISO 13485, ALM/QMS implementation and submission-ready documentation.
THE COMMERCIAL MODEL
Signal → problem → first project → expansion.
The work sample follows that sequence.
1Choose account
ICP + stage + software complexity
2Find urgency
regulatory, funding, hiring, product shift
3Find person
CTO · R&D · RA/QA · founder
4Land project
gap review, V&V, dev, cyber, QMS
5Expand
next lifecycle problem already mapped