EXCEL INNOVATION CONSULTING LLC
Our GOAL is accelerating our client’s product development process while keeping costs under control and developing a quality product. Our performance is measured on three elements:
Quality System
EIC can work within the clients Quality System to assure Design Control processes are effectively carried out. If a client doesn’t have a fully developed Quality System, the EIC Quality System may sub-lament where needed.
At EIC we don’t leave the quality of our service to chance, we plan for quality at the start of a project by:
- Clearly defining the project goal statement
- Establishing a communication plan with the client and project team
- Defined roles and responsibilities for the project team including the customer
- Assuring team agreement on milestones
Speed
EIC is able to accelerate projects through a number of tenants:
- TEAM WORK
EIC’s team approach, clients aren’t relying on one person knowing the best approach at each stage in the PD process. They get a team, where drawing on experience of the team can save time and money. EIC Project Engineers know that help is only a phone call away. Each team member brings a slightly different set of tools to the project.
- Knowledge and Experience
The EIC team industry tenure is over 15 years.
- Strategic Collaboration with Vendors
Our relationship with strategic vendors goes back 20 years.
Bringing years of collaboration and trust to a project saves time.
- Rapid Prototyping Technologies
3-D printing is a valuable tool, but is not always the best tool. There are many other rapid prototyping methods that we employee to screen product designs early. We believe in early and frequent testing to find the weaknesses of a design long before verification testing.
Cost
EIC’s primary driver in keeping costs down is not paying for the overhead of bricks and mortar office. Unlike Industrial design or engineering firms that have “studios,” EIC team members work at the clients facility or their home offices.
EIC Executive Summary:
We believe that meeting our clients needs is the key for EIC success and revenue generation. Our services fit well with medical device, regulated industries and precision OEM products that require detailed design, verification, validation and controlled documentation.
EIC can drive a project from start to finish or augment a clients team at any point along the product life cycle. When unanticipated challenges stand in the way of progress, EIC’s experienced team can assist, to keep the project on track. At the start of the product life cycle EIC can research and define unmet or under served customer needs. Having developed FDA Class I, II and III products our experience can accelerate the project planning and assessment process.
One key to a smooth development process, is well defined product specifications that feed the design and CAD modeling processes. Through the use of solid modeling we can apply Finite Element Analysis (FEA) early in the process to reduce the risk of unforeseen product performance issues. While computational analysis is an excellent tool for early evaluation of product designs; we believe there is no substitution for building engineering prototypes as soon as possible. Finding performance short comings and even possible product failures early allows for better solutions that don’t compromise the clients program.
EIC believes in and practices fast iterations in the early development stages to identify the strengths and weaknesses of a given design concept. We utilize the latest CAD and Rapid Prototyping technology to produce visual and functional prototypes for early customer reviews and screening tests.
In the design verification, process validation and design validation stages we have the technical know-how and experience to write easily understood and followed protocols and reports. Having worked with clinician around the world we have the experience to execute well thought out design validation studies. Examining not only the product performance and human factors but testing the effectiveness of Instructions for Use (IFU), aseptic handling of sterile products and integrity of packaging and labeling elements.
Regulatory bodies expect defined design transfers that provide the linkage between design specification and process validations. Whether your manufacturing in house or using outside contract manufactures the key is planning and early communication.
International Assistance:
While large multinational companies usually don’t need assistance with preparations for launching a product, our small and mid-sized clients may need a hand with establishing multinational marketing, sales, and distribution strategies. EIC is fortunate to have an association with several veterans of international marketing, operations and sales. These associates have have a strong net work of in country distributor and sales representatives in all the major international markets.