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New Product Concept with High Volumes Success Story

A US-based start-up company had developed a unique point-of-care process for the monitoring and treatment of individuals living with HIV.

desk top with a variety of papers and drawings including sample product parts 

Challenge

This company approached us for help with their manufacturing strategy. They specifically wanted to know:

  • what product design changes would be required to meet their low cost manufacturing plan
  • what was the minimum capital expenditure required to transition from the current state to field clinical trials with manufacturing equipment representative of the high-volume GMP line of the future

Approach

Beginning with supplier site visits and a clear understanding of the long-term business plan, we embarked on a two-phased collaboration. The first phase, “Pre-Automation Design and Process Development,” included the following activities:

  • process mapping and development
  • risk assessment and risk mitigation planning
  • automation development and optimization
  • concept evaluation and financial analysis

During our study of the existing process using Design for Manufacturability and Automation (DFMA) tools, we recommended numerous design changes. The Pre Automation Solutions team recommended process alternatives by leveraging ATS’ global engineering team and cross-industry experience.  We also recommended specific Proof of Principle (POP) studies for some of the proposed changes; these were completed on approval of our client. 

With confidence in all critical to quality processes, we were able to move into the second phase and generate multiple automation solutions. Each potential solution was reviewed with the company and evaluated on GMP, ability to scale-up, and cash-flow.

The most promising solution was better understood with simulation modeling of the equipment in operation. The simulation exercise predicted the line overall production effectiveness (OPE) and verified the number of line operators. Finally, a Total Cost of Ownership (TCO) financial analysis validated that several options would result in the business case targeted by the company.

Result

The company was able to demonstrate:

  • significant risk reduction to potential investors
  • the manufacturing process that was scalable
  • the calculated cost of goods fit their business plans
  • they had a global partner that would help them execute the next phase in the project