Industries · 01
MedTech and medical devices.
Operations for regulated products, where the quality system is the product.
The PILTA lens
Two builds at once.
A medical device company runs two builds at once: the product, and the quality system that makes the product sellable. Most growth problems in MedTech are business problems wearing a regulatory costume. A supply chain that cannot pass an audit. A launch waiting on a channel strategy. A finance model that will not survive diligence.
PILTA operators have built device operations from the first SOP to national distribution. We work inside the constraint, not around it. Quality and speed as one build, not a tradeoff.
What we run into most.
ISO 13485 from a standing start
A quality management system built from scratch, shaped to the company you are, not a template.
FDA pathway readiness
Operations lined up with the submission: design controls, document discipline, audit-ready records.
Regulated 3PL and lot control
Medical inventory needs traceability most 3PLs do not offer out of the box. We set up the ones that do.
Commercial readiness
Channel strategy, distributor terms, and the sales operations that land the first big accounts.
Manufacturing transfer
From prototype builds to contract manufacturing with quality intact.
Executive bandwidth
Senior operating leadership while the founders carry the science and the capital story.
Engagement patterns
How engagements run here.
MedTech engagements usually start as a project: an operations assessment, a quality system build, a regulated 3PL setup. As launch approaches they grow into a fractional executive or an embedded team, because the workload stops being one seat’s worth.
A typical embedded team here pairs an operations lead with quality and supply chain expertise under one operating partner, at the hours the stage actually needs.
Straight answers
Questions device founders actually ask.
How do you set up operations for an FDA Class 2 device?
Start with the quality system, because every other operational choice hangs off it. Stand up ISO 13485-aligned processes early, choose suppliers and a 3PL that can hold lot-level traceability, and build the document discipline before volume arrives. Retrofitting quality onto a running operation costs multiples of building it in.
What does ISO 13485 implementation from scratch involve?
A scoped quality manual, the SOPs your actual processes need, training records, supplier controls, and a document system people will really use. The mistake is buying a template binder that describes a company you are not. The system has to match the work, then grow with it.
When does a device startup need senior experts?
When decisions start blocking the build: manufacturing partners to choose, a supply chain to stand up, a submission timeline to hold, a launch to plan, and no senior expert in the room. PILTA brings quality, regulatory, supply chain, commercial and finance experts into the company as a project, a fractional executive or an embedded team, and scales up as the company does.