Phases of Life Science Development
This phase is crucial for projects where requirements are not fully defined, feasibility is not known, or research is required. It is important to use this time to fully understand the client's product goals, vision, target users, and key risks. Depending on the project/client needs we offer the following de-risking options that lay a solid foundation for the rest of the project.
Research report
Preliminary risk analysis
Early feasibility or risk reduction prototyping/testing
User needs identification/analysis
Workflow analysis
High-level architecture concepts
Consumable concepts
Requirements development assistance
Once requirements are clearly defined, we can then create a project-specific plan with key phases focused on achieving major goals.
Phase 1 is typically where requirements are finalized, risks are documented, concepts are developed, and feasibility is proven. During this critical phase, we work closely with the client to give them the confidence to explore and down-select concepts, ultimately leading to the ideal project path. Early engineering prototypes are used to develop and prove technical feasibility, often going through multiple iterations to achieve mechanical, electrical, and systems engineering solutions.
As system architecture is defined, user interface and industrial design concepts are developed that explore human factors, ergonomics, and usability. We engage with suppliers and potential CM’s early to have critical DFM and Cost trade off discussions.
This is where the details are worked out and the design is brought to life. Requirements established in Phase 1 are now released under design control. Contract manufacturers are also contacted to provide specific design input to ensure a seamless transition later during the production stage. Throughout this phase, risk management activities continue, and design activities from all disciplines are completed and documented.
As components begin to take shape, the listed activities are performed to reveal any changes needed before moving to the next stage.
Industrial design and human factors review
Fully functional devices are built and tested
Engineering verification testing and iterations to meet specs and requirements
Consumable development completed and includes system-level testing and iterations
A design review closes out the phase to ensure the design satisfies all the specified requirements. This reduces the risks/issues found in design verification so the device is ready to progress to Phase 3.
Phase 3 is where the design is put to the test, and outputs are compared to inputs. At Acorn we have facilities to perform verification testing and build Research Use Only (RUO) devices (A regulated device must be built by a licensed CM). Detailed records are kept as formal testing to all requirements and specs are documented and completed.
Protocols are written, tests are executed, and reports are issued. The design review at the end of this phase confirms design verification requirements have been met and documented to ISO 13485 standards.
Phase 4 is dedicated to Regulated Devices only. This is where the system's safety and efficacy are validated in clinical trials. A licensed CM is required for the build of the device. Acorn provides support as needed to ensure progress is maintained.
In the final phase, all relevant documentation is transferred from Acorn to the CM. This handoff allows the first commercial devices to be built. As the CM performs production validation, Acorn can support initial builds as well as provide manufacturing process optimization.
Whether you need a full turnkey project plan or just help to get to the next phase, the Acorn team can help.
Acorn can take on development projects at any stage from Phase 0 to after production is underway with DFM or design improvements. We have a proven Phase based ISO 13485-compliant development process that encompasses a complete list of offerings for your Life Science development project.