Medical device manufacturing

Nisthora for medical device manufacturing.

Medical device lines mould, assemble, test and pack in batches, with tight process windows. Nisthora shows each line's OEE live and keeps the machine history behind every batch.

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The challenge

What gets in the way.

Tight process windows

A temperature or pressure outside its range can make a device unusable.

Traceability

Customers and regulators ask what happened during the run that made a device.

Clean assembly

Lines in cleanrooms have planned stops for cleaning and gowning that must be kept apart from losses.

On your shop floor

What Nisthora connects to and measures.

Machines

  • Injection moulding machines
  • Assembly and bonding stations
  • Leak and function testers
  • Sealing and pouching machines
  • Labelling and packing
  • Cleanroom monitoring

Readings

  • Units completed
  • Run / stop signal
  • Test pass and fail
  • Mould and seal temperature
  • Seal pressure and dwell time
  • Room particle, temperature and humidity readings

Typical stop reasons

  • Product changeover
  • Cleaning
  • Test failure
  • Seal fault
  • Waiting for QA release
  • Material shortage

These are common examples. Each plant names its own machines and lines, and sets up its own stop reasons, in the words its team uses.

Traceability

Batch history, backed by machine data

Nisthora links each batch to its machines, shift, stops and process readings. We work with your quality team on the validation needs of your site.

A day with Nisthora

A pouch-sealing machine has limits on seal temperature and dwell time. When a reading leaves its window, an alert reaches the line lead, and the batch history shows exactly which units were sealed at the time.

Example for illustration.

How Nisthora helps

Built for plants like yours.

Live OEE per machine

Availability, performance and quality for every machine, live.

Tap-only machine panel

Operators press Start and Stop, and tap a picture for the stop reason.

Downtime Pareto

The few stop reasons that cost the most, sorted for you.

Maintenance forecast

Which machine needs maintenance in the next 30 days, and why.

Anomaly detection

Flags readings that look unusual for that machine.

Alerts

Limits on any reading, sent in-app, by email, SMS, push or webhook.

Root cause and fishbone

Find why a problem keeps coming back, and prove the fix.

Works with your PLCs

OPC UA, Modbus, Siemens S7, EtherNet/IP, MQTT and HTTP.

Other industries

See how Nisthora fits elsewhere.

Pharmaceutical manufacturing

Tablet presses, capsule fillers and packing lines, with batch records tied to machine data.

See how

Cosmetics and personal care

Mixing, filling and packing lines, batch by batch.

See how

Automotive and auto components

Stamping, welding, machining, paint and assembly lines, with OEE per station.

See how

See Nisthora in a medical device manufacturing plant.

Book a demo. We will show you live data and talk through your machines, lines and shifts.

Book a demo