IF MedTechBuild with us

Build to Operate

We stay in after launch and keep running the technical side, the quality system, manufacturing and engineering changes, while you run the market.

When Build to Operate is the right model

For a complex product, or a founder without a technical background. We build the product and stay on as operating partner after launch.

  • Run operations after launch

    Engineering, quality and manufacturing stay with an operating partner, so the company can supply and support its device.

  • Back a non-technical founder

    The founder leads the market and the customers. The operating partner carries the technical side.

  • Handle a complex product

    A product with many disciplines and suppliers keeps one team that knows how it was built.

What you bring, and what you get back

You bring

  • The clinical need and the device
  • Your market plan and first customers
  • The founding team and the role you want to play
  • The company, or the plan to form it
  • What you want to own, and what you want run for you

You get back

  • The device, designed, developed and approved for its first market
  • A company built around it, with governance from the start
  • An operating partner after launch
  • A written split of who runs what
  • A quality system that runs from the first build

Who runs what, after launch

Services onlyYou own the companyWe deliver the workBuild to OperateWe build itWe stay as operatorBuild to TransferWe build itThen hand it all overThis serviceFull handover at maturity

The three models differ in what happens after launch. With services only, you buy the work and run everything yourself. In Build to Operate, we stay on and run the operational side while you focus on the market. In Build to Transfer, the whole company passes to you at maturity.

How Build to Operate works

  1. Step 1

    Assess the opportunity

    The clinical need, the market, the route to approval and the team.

  2. Step 2

    Agree the split

    What the founder leads, what the operating partner runs, set out in writing.

  3. Step 3

    Build the product

    Design, development, testing and approvals, with the design history file built as the work goes.

  4. Step 4

    Build the company

    Governance, the quality system and the supply chain, set up alongside the product.

  5. Step 5

    Operate after launch

    The operating partner runs the agreed functions while the founder grows the market.

Questions founders ask

What does the operating partner do after launch?

The scope is agreed for each programme. It can cover engineering, the quality system, manufacturing and regulatory upkeep, while the founder leads sales and customers.

Who holds the manufacturing licence?

In India, a manufacturing licence under the Medical Devices Rules, 2017 is granted to a named manufacturer for a named site. Agree at the start who that is.

Who owns the company?

Ownership, including any stake IF MedTech holds, is agreed in writing at the start. Seed funding explains how equity can be part of it.

An assembly bench with tools and parts trays

An operating partner with its own sites

IF MedTech runs 2 ISO 13485 certified sites, with a design office, labs and assembly in Navi Mumbai, and nine disciplines in one team.

Our quality system · About us

Not quite you?

Where this sits

  1. 01Co-Innovate
  2. 02Co-Design & Develop
  3. 03Co-Manufacturing
  4. 04Co-Commercialize
  5. +Co-Invest

Also in Co-Invest

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