 Our ProcessBelow are the phases of all the activities and details that a project with Ximedica requires and each client can expect.
Phase 1--Concept Exploration Ximedica’s first phase delves into what is possible and what is the right mix of design and engineering to hit target objectives. It is important to balance design with cost engineering, keeping in mind the implications of design on capital requirements, development risk, and the cost for production.
At the end of this effort, the client will know exactly what the project will entail and will have a very targeted estimate on cost of goods, cost of development, and time to market. The client will also have a sculpt of the device, various color renderings, construction configuration illustrations, PCB schematics, and other supporting information to review.
Phase 2--Development Engineering The goal of Phase 2 is to convert the proof-of-principle mechanics and/or electronics and the selected body form from Phase 1 into a stylized, functioning prototype. This phase concentrates on merging design form and human factors with engineering. At the conclusion of this phase, the overall product design will have been proven to meet requirements and shall be ready to be finalized. The primary result of this phase is a “looks like, works like” prototype.
Product development engineers move forward by taking design elements from the initial concept exploration phase and then convert the design into fully engineered specifications. These specs are then built into prototype parts in order to make sure that each works as intended (e.g., fit, function, quality, etc).
We then plan for multiple iterations of prototype building, testing and refining to insure that we are going to production with a robust and reliable design.
Our ideal is to prepare and maintain the design control plan for the client and keep the design history file up to date and in order.
Phase 3—Final Engineering The goal of this phase is to fully define and finalize the design generated during Phase 2. This phase will convert the prototype design into a production-ready specification package. At the conclusion of this phase, it will be possible to place orders for capital equipment (e.g., molds, fixtures, etc.) and initiate the production turnover process. In addition, a fully functioning and fully featured software solution will be completed and tested.
The ultimate output of this phase is a complete specification package including 2D and 3D files for all components and assemblies, key inspection criteria, material callouts, extensive test data showing proper performance, and various design review documents showing that proper design controls have been maintained.
The next step in this phase is regulatory filing. Ximedica is able to prepare and submit regulatory filings for our client companies; especially if we have been maintaining the Design History File.
Phase 4--Design Transfer Once a design is selected that satisfies all requirements and all the specifications are fully documented, orders for production materials are placed. Ximedica then creates manufacturing procedures, quality inspection procedures, formalizes BOMs and routers, executes required vendor audits, designs packaging, and works with the client on the operator’s manual. The initial build of devices is then subjected to extensive testing including ship testing, hot/cold exposure testing, durability testing, drop testing and any other applicable tests to ensure that the device will operate as intended over its anticipated life span. A common and costly problem is to underestimate the amount of time, effort and rigor required to guarantee that problems do not arise when a product gets to market. Refinement and tweaking are required and critical during this phase as often times issues will appear that did not during the one-unit prototype trial.
Phase 5--Production Startup Once the design is finalized and the product and manufacturing processes are proven reliable, Ximedica is ready and set up to take orders. This is very straightforward: you place orders with us and we ship your product.
Phase 6--Warranty and Repair Service Ximedica offers a level of warranty with all of its products that it produces including repair of products that are out of warranty. In the event that a product that we built is faulty or not performing properly within the warranty period, we will have it returned to our facility for repair or replacement. If a device fails and was outside of the warranty period, we will still repair it based on an agreed upon fee schedule. Ximedica has the ability to maintain a repair and configuration history on all capital devices that we produce; another important requirement of the QSR. |
