Medical devicesOperational excellence & turnaround

Operational readiness for fivefold growth at a medical-device manufacturer

A specialised medical-device manufacturer planned to grow production fivefold. Opyflow's assessment found that only 56.1% of paid time went to producing sellable units, and set out a prioritised roadmap for the scale-up.

Situation

Leadership needed to know whether production, the supply chain and systems could scale, and where they would break first.

Opyflow's role

Opyflow worked on the floor and in the data. The brief was to diagnose the operation and set out a roadmap; implementation was left as a later decision.

Documented outcomeAssessment

Readiness for fivefold growth assessed · 56.1% of paid time on sellable units (baseline) · Scale-up roadmap adopted by leadership

The challenge

Before committing money to the fivefold plan, leadership wanted to know whether production volume could rise faster than headcount and whether the supply chain could keep up. They also wanted to see which costs would grow with volume.

Each process change would need time to qualify, so it was cheaper to find the current operation's limits before the extra volume arrived.

Opyflow's work

On the floor, Opyflow mapped the production flow step by step and watched how operators and material moved, where work queued and which stations set the pace. Capacity and workforce utilisation were checked against what the growth plan would demand. A breakdown of the product cost structure showed where cost would rise with volume.

Beyond the floor, the assessment looked at supply chain, inventory and procurement practices, engineering activities, the KPI framework and readiness for ERP. Each area got a maturity rating, and each finding was written up as an improvement opportunity with a priority.

Map the flow and thefloorAssess capacity and costRate maturity acrossfunctionsPrioritised scale-uproadmap
Illustrative explanation of the assessment; not a client deliverable.

What did the assessment find?

The assessment showed where growth would strain the operation first. The floor relied heavily on manual processes and batch-oriented workstations, assembly was complex, and there was a lot of operator movement and material handling. A primary bottleneck in assembly limited throughput. At baseline only 56.1% of paid time went to producing sellable units, and scaling fivefold by adding people would have scaled that loss too. Supply-chain planning ran on spreadsheets, with no formal S&OP process, MRP process or safety-stock policy and no defined supply-chain KPIs. Data was managed by hand and reporting was limited. The organisation needed a clearer operations leadership structure and stronger continuous-improvement practice.

The report gave leadership a current-state assessment, a quantified bottleneck map and a capacity assessment against the fivefold plan. Its prioritised roadmap, for growing volume faster than headcount, covers a move from batch production to one-piece flow in U-shaped cells, semi-automation at selected manual steps, formal S&OP, KPIs, inventory and planning, preparation for ERP, and a path to a lower target cost.

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About Opyflow

Opyflow is an operations and supply chain consultancy, founded in 2019, working with manufacturers in regulated and high-complexity industries. Offices in Kiryat Ono, Israel and Melbourne, Australia; projects across Israel, Europe, the US and India. The senior person you talk to is the one who does the work.

We are done when it's in the P&L.

A growth plan of this size raises questions about headcount and supply at whatever stage it has reached, and they are easier to answer early.