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Molecular Diagnostics

SAMPLE MODELS AND BEST PRACTICES: APPLYING A RISK-BASED APPROACH TO QMS PROCESSES

November 30, 2020 | 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

Categories: Molecular Diagnostics, Engineering & Analysis, Product Development & Design, Medical

AMERICAN ASSOCIATION FOR CLINICAL CHEMISTRY ANNUAL MEETING

August 30, 2018 | 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

Categories: Events & Tradeshows, Molecular Diagnostics

TREATMENT, PREVENTION, AND MEDICAL ENGINEERING SOLUTIONS

October 4, 2017 | 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

Categories: Medical, Molecular Diagnostics

SAN DIEGO’S BIOTECH CONSORTIUM

June 9, 2017 | 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

Categories: Events & Tradeshows, Medical, Molecular Diagnostics

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Phase 3: Design Verification And Design Transfer

Design & Engineering

Software: Design Complete

Hardware: Pre-production units for design verification

Test: Design verification test

NPI

MFG. Readiness: CM schedule and budget, Unit build tracking

Quality: Quality metrics verification process, Process validation support

This phase occurs once the detailed design is complete, and prototypes are built with manufacturing-representative quality and detail. More extensive, formal testing is performed, such as life, reliability, safety, environmental, drop, and vibration.

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.

Typical deliverables:

Pre-production units
Formal verification test reports
Design transfer package, including Design History File (DHF) if needed for FDA submittal
Process validation support
Unit build tracking
Contract manufacturing schedule and budget
Quality metrics verification

Gate definition:

Design verification complete

Phase 2C: Detailed Design Prototype 2

Design & Engineering

Software: Full feature implementation

Hardware: Prototype 2 units with production-representative materials and processes

Test: Engineering confidence test, integration test

NPI

MFG. Readiness: CM onboarding Design transfer prep

Quality: Build Quality Plan

2C. Prototype 2 Design, Build And Test

Phase 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.

Typical deliverables:

Updated prototypes
Software and/or firmware binaries and source code
Updated schematics and layout
Updated 3D CAD files and 2D drawings
Verification/test plans and reports
Updated Bill of Materials (BOM) and Cost of Goods Sold (COGS)
Build Quality Plan development
Design transfer preparation
Contract Manufacturer onboarding

Gate definition:

Engineering confidence test reviews (integration tests)

Phase 2B: Detailed Design

Design & Engineering

Software: Core functionality implementation

Hardware: Prototype 1 units with rapid prototyped components

Test: Engineering confidence test, unit test

NPI

MFG: Readiness: Project build plan CM selection

Quality: Critical manufacturing process identification

2B. Prototype 1 Design, Build And Test

The 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.

Typical deliverables:

Prototypes (3D printed or other rapid prototypes, electrical PCAs, and/or preliminary code)
Software and hardware design documentation
Initial product firmware or software binaries and source code
Electrical schematics and layout
3D CAD files
Design failure mode and effect analysis
Test plans and reports
Project build plan – from prototype to pre-production
Initial Bill of Materials (BOM) and Cost of Goods Sold (COGS)
Manufacturing process identification
Contract Manufacturer (CM) selection

Gate definition:

Engineering confidence test reviews

Phase 1: Requirements & Planing

Design & Engineering

Project Plan Requirements

ID/UX Concepts

Risk Analysis

Manufacturing Strategy Identification

The business and user requirements are converted into engineering requirements for the product. The project planning activity is based on the schedule, budget, risk, and initial product requirements. This process is best done as a collaborative team effort with the client, who has the deepest understanding of the market needs and user requirements.

Typical deliverables:

Product requirements document
Project development plan (including plans for software/firmware electrical, quality, systems, and mechanical)
Risk analysis
Industrial Design (ID) and User Interface (UI) concepts

Gate definition:

Product requirements document complete
Client approval of project development plan

Production

Design & Engineering

Manufacturing design guidance and ongoing engineering support

Ongoing quality metrics monitoring & optimization

The Simplexity team can be as involved in the production phase as requested by our clients. For clients with internal manufacturing or established relationships with contract manufacturers, our engineers are available to ensure quality is maintained and provide ongoing engineering support as needed.

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.

Typical deliverables:

Manufacturing guidance and ongoing engineering support
Ongoing quality metrics monitoring and optimization

Phase 2: Detailed Design

Design & Engineering

Software: Architecture design: block, sequence and state diagrams

Hardware: Major Component definition & Proof of Concept subsystems build

Test: Characterization and qualification of high risk subsystems & components

NPI

Quality: Design for Manufacturing tradeoffs evaluation

2A. Architecture and Technology Feasability

The 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.

Typical deliverables:

System architecture design (including mechanical, electrical and software/firmware)
Initial product risk analysis
Breadboards or proof-of-concept prototypes of high-risk technologies or subsystems.
ID concept models

Gate definition:

Client approval following hardware and software architecture reviews

Phase 0: Exploration

Exploration

Research

Concept Work

Architecture explorations

Feasibility study

Phase 0 is an optional phase for projects where the technical feasibility of the idea has not yet been fully proven. It can consist of research, concept work, exploring initial architecture, performing feasibility studies, and basic prototyping and testing.

Typical deliverables:

Exploration report

Gate definition:

Client approval on feasibility of idea