DynaCellect
Magnetic Separation System
CLIENT
GIBCO
PROJECT TYPE
Industrial Design
LAUNCH
2022
MY DELIVERABLES
Design
Prototypes for testing
CAD in Solidworks
Artwork/CMF
CAR-T-cell Therapy is a revolutionary treatment that uses a patient’s own immune system to fight certain types of cancer.
PROBLEM
The existing manual-operated device suffers from limited throughput, difficulties in process control, and a lack of automated data tracking.
OPPORTUNITY
There is a need for an operator-independent system that can be used in a manufacturing setting, not only minimizes failures but also enhances robustness, precision, and traceability.
CHALLENGE & SOLUTION 1
Challenge: Filling, transporting & installing consumables at once is a significant challenge for a single user.
Solution: We designed two hangers: one for the bag kit and another for the cartridge.
CHALLENGE & SOLUTION 2
Challenge: User needs direct hands and visual access to all the major components, including bags, cartridge, rocker and touchscreen, meanwhile, the instrument's footprint needs to be as compact as possible.
Solution: We conducted multiple rounds of prototype testing and ultimately selected the current layout, which offers the best combination of these features.
OUTCOME
Despite the challenges posed by the COVID-19 pandemic and the complexity of the program, we successfully met the planned launch time with a user-centered, closed, and automated system (instrument plus consumable) for cell therapy development and manufacturing.
AFTER
Hight throughput
With process control
Fully trackable
Closed system
Automated operation
BEFORE
Low throughput
Without process control
Low traceability
Contamination risk
Manual operation
Process: Overview
It was a team effort. I led and executed most ID strategies, including a variety of deliverables and workshops with subject matter experts, business teams, tech engineers/developers and researchers. I encouraged engagement and requirement alignment from concept through completion.
KICK OFF & GOALS
Team Intros
Team member introduction, confirm the lead contact for each functions.
Kick Off & Goals
Review goals and initial product planning documents. Clarify business need and value.
Design Process Overview
Review proposed design process, timelines, deliverables and define support needed from broader team.
Initial Research & Review
Review any existing or new docs of VoC, customer want, product goals or priority order. Define tentative types of research ahead.
USER NEEDS
Workflow Observation
Observing and shadowing
the use of the product; Physically interact with the target products.
User Needs Prioritization
Review and get group consensus for the top user needs in priority order.
User Persona
Create and get group consensus for the top 2-5 user personas and %
Workflow Map Out
Map out current workflow and look for potential opportunities.
CONCEPT DEVELOPMENT
Brainstorming
Initial brainstorm with cross-functional team to get quick ideas, the sky is unlimited.
Concept Development & Refinement
Work closely with cross-functional partners, especially with system engineers and mechanic engineers to develop multiple rounds of the concept, and refine them according to the feedbacks collected after each of the round.
Prototype Testing
Create quick prototypes to collect additional feedback & narrow down selections after each concept development cycle. As well as supporting Alpha, Beta testing in much later stage.
ASSETS & DOCS CREATION
3-Dimensional CAD
Create high quality parametric 3D CAD models for mechanic engineers’ detail design. Break the parts, shell the parts and draft the external & internal surfaces.
CMF & Artwork
Create Color, Material and Finishing (CMF) and Artwork documents for production purpose.
Rendering
Create photo realistic renderings to visually communicate the design before it’s been built.
Appearance Model
Create aesthetic model that look and feel like the real product to support sales & marketing needs.
POST HANDOFF SUPPORT
DFM (Design for manufacturability)
Adjust the CAD model based on vendor tooling assessment, including but not limited to wall thickness, drafting angle, etc
Parts checking
Check and support the trial parts improvement until all the parts receive final approval.
TOOLS
Create Concept Sketches
Create 3-dimensional CAD
Create Rendering Assets
Process: Discover & Research
Before the project officially kick-off, we went to the lab to shadow scientists (the primary user) using existing product, as well as observed the upper stream and down stream workflows. Interviewed them for any of the pain points and wish lists.
Process: Project Kick-off Meeting
We sat down with product team and subject matter experts reviewed business goals and initial product planning documents, map out current workflow and brainstormed user needs.
Process: Sketching
After an initial brainstorming with the team, I converted all the ideas into sketches to visually communicate with the project team. The ideas presented has to address the top user needs and meet other product requirements.
Process: Layout Study
Various concept layouts were explored by arranging main components in different ways to facilitate the feasibility study further.
Process: Research Support
I supported the research team from project start through completion with strategy, test focus, prototypes and user feedback collection. Research included surveys, interviews, user testing and pre-launch alpha & beta testing
Process: More User Testing
More quick foam board models were made, and user testing was conducted as we quickly iterated the design as the project progressed.
Process: CAD and Engineering Build
High quality CAD were created in support of engineer’s detail design. CAD models were shelled, drafted externally and internally.
Process: Rendering
Photo realistic rendering were created in Keyshot to visually communicate the final design with stakeholders.
Process: Product Launch
Final product was launched on Oct, 2022 to help cell therapy developers easily move from process and clinical development to commercial manufacturing.
Award and Recognition
DynaCellect magnetic Separation System won the 2023 R&D 100 Winner Award, in the Process category for manufacturing process improvements.
Xin Mathers ⏤ 2024