5 Factors Startups Overlook in Early Medical Device Product Development
For many medical device startups, the first major technical milestone is proving that the concept works. While a functional prototype proves an idea is possible, it reveals little about whether the device can be built the same way, at volume, under a compliant quality system, by people who aren’t the engineers who built the first […]
Scaling a cGMP Cell Therapy Manufacturing Platform from Prototype to Clinical Production
From Design Transfer to First Shipment in 5 Months, Earning FDA Advanced Manufacturing Technology Designation A fast-growing cell therapy company needed to transition a fully integrated, cGMP-compliant CAR-T manufacturing platform from laboratory prototype to low-volume production in preparation for clinical trial deployment. Ascential assumed turn-key manufacturing responsibility and delivered the first completed instrument within 5 […]
Scaling Complex Medical Device Production with Integrated Automation
From Manual Production to High-Level Automation A Fortune 100 medical device manufacturer needed to transition complex, custom-built clinical products from manual production to commercial-scale manufacturing. Facing long development cycles, intensifying pressure to accelerate time to market, and the need to maintain strict GMP compliance throughout, the company required a partner capable of owning both automation […]
Delivering a First-to-Market Thermocycler with Real-Time DNA Amplification and Sequencing for Genetic Analysis
A genomics technology company had a concept for a novel real-time thermocycler that they wanted to bring to market. This special thermocycler would offer 96 individually controlled wells for greater flexibility and precision in DNA amplification and sequencing. Ascential provided full-scale development and contract manufacturing support, helping reduce development time while enabling a first-to-market platform […]
Developing a Scalable Next-Generation Sequencer with Proprietary Chemistry
Integrating Complex Subsystems for Class II IVD Compliance A leading life sciences company needed a fully automated, high-precision sequencing system capable of handling sensitive reagents, managing complex multi-channel fluidics, and integrating third-party components for efficient sequencing based on proprietary chemistry. The system had to support strict regulatory compliance for Class II IVD and IEC 61010 […]
Scaling Manufacturing for an Implantable Combination Device
From Early Clinical Production to Commercial Scale 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. […]
Sustaining a High-Throughput Genomic Analysis Platform for Long-Term Market Success
From Concept to FDA Breakthrough A precision diagnostics client sought to dramatically reduce the time required to identify effective antibiotics for critically ill patients — without sacrificing accuracy or throughput. Ascential delivered a three-instrument automated system that achieved FDA Breakthrough Device Designation. Faster reagent dispensing across the full testing workflow 0 x Increase in throughput, […]
Transforming a Proof-of-Concept Optofluidic Platform into a Commercial-Grade Instrument
From Concept to FDA Breakthrough A precision diagnostics client sought to dramatically reduce the time required to identify effective antibiotics for critically ill patients — without sacrificing accuracy or throughput. Ascential delivered a three-instrument automated system that achieved FDA Breakthrough Device Designation. Faster reagent dispensing across the full testing workflow 0 x Increase in throughput, […]
Scaling a Prototype Research Platform into a Manufacturable, Automated System
From Concept to FDA Breakthrough A precision diagnostics client sought to dramatically reduce the time required to identify effective antibiotics for critically ill patients — without sacrificing accuracy or throughput. Ascential delivered a three-instrument automated system that achieved FDA Breakthrough Device Designation. Faster reagent dispensing across the full testing workflow 0 x Increase in throughput, […]
Automating Pre-Analytical Sample Preparation to Clinical Scale
From Concept to FDA Breakthrough A precision diagnostics client sought to dramatically reduce the time required to identify effective antibiotics for critically ill patients — without sacrificing accuracy or throughput. Ascential delivered a three-instrument automated system that achieved FDA Breakthrough Device Designation. Faster reagent dispensing across the full testing workflow 0 x Increase in throughput, […]