A global medical device manufacturer needed to scale production for a breakthrough implantable drug-delivery combination device used in the treatment of non-muscle-invasive bladder cancer. The program required a compliant, scalable manufacturing operation capable of supporting both medical device and pharmaceutical regulations while reducing production bottlenecks and accelerating output.
Ascential supported the program from early clinical manufacturing through commercial-scale production, helping establish reliable, repeatable processes. This breakthrough device has demonstrated an over 80% complete response rate in patients, offering a promising next-generation treatment path.
The client needed to scale production for a breakthrough-status combination device with a complex manufacturing process and strict compliance requirements.
The device combined implantable medical device components with drug-delivery functionality, requiring manufacturing controls aligned to both medical device and pharmaceutical standards. Early manufacturing instructions needed to be transitioned into reliable, repeatable production processes capable of supporting commercial-scale demand.
To reach production goals, the client needed to reduce bottlenecks in tablet inspection, handling, and insertion while scaling toward more than 1 million units in a short period of time. Their project goals were clear:
Build a manufacturing operation capable of producing more than 1 million units in a short period of time.
Support manufacturing requirements for a product involving both medical device and pharmaceutical compliance.
Transition early manufacturing processes into scalable, repeatable commercial manufacturing workflows.
Improve inspection, handling, and insertion steps for small, high-precision components.
Ascential developed scalable manufacturing processes to support the device from early clinical production through commercial batches.
The program required close coordination across manual assembly, semi-automated production, inspection, and quality documentation. Ascential designed, built, and integrated automation to improve inspection, handling, and production flow, including semi-automated tablet inspection, dispense, and placement capabilities.
To further improve the production model, Ascential advanced the line with cellular manufacturing and single-piece flow. This approach helped reduce bottlenecks, improve operator efficiency, and support continuous process improvement as the program moved from clinical production into commercial scale.
Ascential also supported compliant manufacturing through ISO 13485 certification, FDA registration, successful FDA inspection history, electronic batch records, and quality standards designed for a regulated combination-device environment.
The manufacturing operation integrated a combination of manual assembly expertise, automation, inspection, and quality controls to support commercial-scale production.
| Capability | What Ascential Built |
|---|---|
| Semi-Automated Tablet Handling | Mini-tablet inspection, dispense, and placement to reduce manual bottlenecks |
| Cellular Manufacturing | Single-piece flow production model to improve production flow and operator efficiency |
| Automation-Enabled Inspection | Inspection support for small, high-precision components |
| Combination Device Manufacturing Controls | Processes designed to support both medical device and pharmaceutical compliance requirements |
| Electronic Batch Records | Traceability and quality documentation for regulated manufacturing |
| Continuous Process Improvement | Ongoing optimization from clinical production through commercial scale |
Bringing an implantable combination device to commercial scale requires more than production capacity. It requires repeatable processes, precise handling of small components, compliant documentation, and the ability to continuously improve manufacturing as demand increases.
For the customer, Ascential provided a long-term manufacturing partner capable of supporting the program across the full path from early clinical production to commercial scale. For patients, the program supports access to a breakthrough therapy designed for sustained, local drug delivery in the treatment of non-muscle-invasive bladder cancer.
Ascential helps medical and life sciences companies transition from early production to reliable commercial manufacturing with the process discipline, automation expertise, and quality systems required.
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