| by Theresa Ramirez
The ISO 13485:2016 standard for medical devices requires that a“risk-based approach” be used in the control of appropriate process needed for the Quality Management System (QMS). This informative blog written… Read More
| by Gabriel Aldaz
The American Association for Clinical Chemistry (AACC) hosted its annual scientific meeting from July 29 to August 2, 2018. An estimated 20,000 attendees walked through the doors of the McCormick Place Convention… Read More
| by Scott Jarnagin
Human beings have been practicing medicine in one form or another since we first began using tools. Until very recently, however, all approaches to medicine had one thing in common… Read More
| by Raj Oswal
The San Diego Biotech Consortium is a regional partnership of service companies dedicated to promoting best practices in product development for the Biotech industry. The Consortium offers leaders of biotech… Read More
Software: Design Complete
Hardware: Pre-production units for design verification
MFG. Readiness: CM schedule and budget, Unit build tracking
The design team works closely with the manufacturing team to enable a smooth transfer, often with Simplexity engineers traveling to the contract manufacturer sites to ensure product quality. The design is transferred to the client based upon specific needs, most often after all tests are complete and the design is verified.
Software: Full feature implementationHardware: Prototype 2 units with production-representative materials and processes
Quality: Build Quality PlanPhase 2C iterates on the learnings of Phase 2B and involves a refined prototype build of a fully integrated system. Some projects also benefit from additional iterations of the product based on prior learnings through additional phases (2D, 2E, etc), which are not represented in this graphic. All requirements are intended to be tested, and at the end of Phase 2 there will be confidence that the units will pass verification in Phase 3. The Bill of Materials is further refined, and the team updates estimates for the per unit cost of the product by receiving pricing from vendors and suppliers.
Software: Core functionality implementationHardware: Prototype 1 units with rapid prototyped components
Quality: Critical manufacturing process identificationThe detailed design phase usually has multiple, iterative sub-phases as the design progresses and representative prototypes are built. Phases 2B and 2C are typically the largest efforts in the product development process, where the specific implementation for all disciplines occurs (mechanical, industrial design, electrical, firmware, systems, software, manufacturing, and quality).
Simplexity typically engages with production component suppliers and contract manufacturing groups early in this phase to provide additional manufacturing input on the design. If the product has stringent testing or certification requirements, pre-screens are performed in this phase prior to formal regulatory agency testing.
Simplexity has a dedicated New Product Introduction (NPI) team that can guide the transition from design into production. The NPI team presents multiple options for manufacturing to the client, allowing clients to choose the solution that best suits their needs. This can involve Simplexity performing initial builds in-house prior to full handoff to a contract manufacturer or building the product via established relationships with contract manufacturing partners either domestically or overseas early in the process.
Software: Architecture design: block, sequence and state diagramsHardware: Major Component definition & Proof of Concept subsystems build
Quality: Design for Manufacturing tradeoffs evaluationThe detailed design phase starts with defining options for the product architecture, with the goal of having the greatest chance of successfully meeting product requirements while best mitigating risk. Engineering activities in this phase include presenting options for hardware components, outlining the system block, sequence, and state diagrams, creating rough CAD, and breadboarding of high-risk subsystems. Results are presented with a description of the pros, cons, and key tradeoffs for each scenario.
