Medical devicesResilience & continuity

Business continuity planning for neurovascular devices

Opyflow built a business continuity plan for a neurovascular-device manufacturer that ties the order in which products recover to how their supply is protected, including a second way to manufacture them.

Situation

About 20,000 devices a year come from one concentrated footprint, and each of the risks to it was already known.

Opyflow's role

Opyflow worked out which products and processes had to recover first, then gave every critical exposure a treatment and a named owner.

Documented outcomePlan or design

Signed continuity plan · Alternative manufacturing routes defined · Recovery actions and owners assigned

The challenge

Supply could be stopped by geopolitical events, regulatory constraints, a logistics interruption or a site outage. The company had no single answer that tied product priorities, inventory and suppliers to manufacturing recovery and said who decides.

Opyflow's work

Opyflow started with the business-impact analysis. It set the order in which products and processes must recover and identified the time-critical decisions along the way. Each critical exposure got its own treatment. Where the exposure justified it, that meant external inventory of critical raw materials and finished goods; for critical materials it also meant dual sourcing and contingency actions. The second way to manufacture combines an alternative company site with an external contract manufacturer. Opyflow sequenced the transfer activities, their owners and the crisis-governance actions into one plan, which leadership reviewed and signed.

Recovery prioritiesInventory and suppliercontingenciesAlternativemanufacturing routesOne signed continuityplan
Illustrative explanation of the plan structure; not a client deliverable.

What changed

Leadership has signed the plan, so the recovery sequence is agreed in advance and ready to activate. The alternative site and the contract manufacturer each have a defined role in it.

What separates a credible continuity plan from a risk register?

A credible plan connects four things: the business impact of an interruption, product by product; the order in which products and processes must recover; a specific treatment and a named owner for each critical exposure; and a feasible second way to supply, through a second site, a contract manufacturer or both, chosen and sequenced before the day it is needed. If the fourth is missing, the plan only documents the risks. The value is created before any crisis, because decisions and negotiations are settled early and ambiguity is removed from the moment when time is shortest.

See the capability: Supply risk and dual-sourcing strategy →

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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 concentrated footprint with no agreed recovery order is worth talking through before anything goes wrong. We can start from the products you would need back first.