Design & Development
Accellent's idea centers are the birthplace of pioneering engineering that makes your vision a reality. Accellent offers a unique, comprehensive solution to design challenges by utilizing a phased approach, compressing the design process to achieve rapid, high-quality design solutions.
Prototyping
Your prototype is the key in the ignition of your innovation. Accellent believes producing the perfect prototype is the key to a seamless design process, and our Idea Center engineers have plenty of experience endeavoring toward perfection.
Ideation
Our Idea Centers are the birthplace of cutting edge, creative innovations. That's why we call them Idea Centers. At Accellent, we know that the cookie cutter approach doesn't result in an increase in ROI. Our engineers are passionate about finding out-of-the box ways to bring your project to life quickly and efficiently.
Refinement
When you partner with Accellent, you partner with a perfectionist. Our Idea Center engineers are extremely adept at examining potential devices and processes for flaws and inefficiencies. Once we find them, we eliminate them.
Realization
You've got an idea. Now what? When you partner with Accellent, we will take you through the steps of making your innovation a reality. Accellent's Idea Center engineers are experts at bringing ideas to the production phase with quick turnaround and few flaws.
Engineering Services
Our Idea Center engineers understand test requirements. As a result, we know how to test your device for potential flaws and weaknesses. Of course, this means that you don't have to, which means greater ROI. Our engineers are well versed in the following:
- Biocompatibility Testing
- Design for Manufacturing and Assembly (DFMA) Studies
- Failure Analysis
- Finite Element Analysis
- Materials Analysis
- Moldflow Analysis
- Packaging Testing
- Shelf Life/Aging Studies
- Sterility Testing
- Tolerance Studies
- Transit Testing
FAQs
At what stage of product design and development can Accellent get involved?
Accellent's product development team utilizes a three-phase product development process with clearly defined tasks and deliverables. This process allows the Accellent team to begin work at any point during your design and development plan from brainstorming concepts and feasibility studies to detailed design for manufacturability and assembly, validation and transfer.
Can Accellent manage my Device History File (DHF) and Device Master Record (DMR)?
Yes! Accellent has full document and release control capabilities. Accellent has the ability to track both paper and electronic Device History Files (DHF).
What is the advantage of using Accellent for contract design and development as opposed to a contract design firm?
Accellent engineering services group focuses solely on the development of medical devices. The team is multidisciplinary and includes experts in design, analysis, manufacturing, quality, and operations. Process experts from Accellent's facilities as well as other experts from Accellent's extensive supply chain provide critical design and manufacturing input throughout the development process. These individuals have extensive experience in transitioning their designs to the Accellent facilities, thus shortening development time and minimizing risks associated with manufacturing transfers.
What resources do I need to provide to work with Accellent during the development of my product?
Accellent will tailor a project team to meet your requirements and your available resources. However, based on the success of previous development projects, we recommend that you have a program or project manager, a quality engineering contact and in some cases, a marketing contact.
How can I be sure that my project is moving along on time and on budget?
Accellent engineering services uses a periodic reporting structure that tracks the following items:
- Scope
- Budget
- Schedule
- Cost of Goods (COG's)
- Critical Milestones
- Risk Management
- Materials
- Resources
By aggressively monitoring these activities and reporting progress both internally and externally with customers on a weekly basis, Accellent is able to design and manufacture products more efficiently.
We have completed the concept and feasibility phase of a new device and would like Accellent to complete the design for manufacturability and move the device into production. What do we need to do for Accellent to provide a proposal for these activities?
Accellent would prefer to begin this process with a product requirements document and any design engineering documentation generated to depict the device. In addition, Accellent's product development team would like to understand any schedule or budget constraints that may have been promised to the stakeholders. Prototypes and/or photos are also helpful. If the documentation, etc. is not available, Accellent can assist in creating this information as part of the project scope.
How will the Accellent team interface with our engineers and what will be their responsibility?
Each project has its own specific challenges and resource requirements; when partnering with Accellent, all projects begin with a kick-off meeting. During this meeting, the project team structure, roles and responsibilities are clearly defined and resources are assigned from Accellent, as well as your organization. Communication channels are clearly defined for routine activities, as well as regular updates of project scope, budget and timeline. Escalation plans are established so that issues can be resolved quickly and effectively. It is the responsibility of the Accellent Program Manager to set up the interface structure with the customer, and ensure that the team dynamics contribute to a successful project and a satisfied customer. Accellent utilizes "best practices" to provide complete program management, ensuring timely and successful project outcomes.
Will I have to provide quality engineering and design control functions for the Accellent team?
No. That is not necessary. Accellent has quality engineering expertise on staff. Quality engineering works collaboratively with Accellent engineering services. All Accellent quality engineers are trained, well versed, and follow ISO 13485 / FDA 21 CFR 820 requirements.
What technical skills does Accellent have?
Accellent employs a multidisciplinary team with experience in project management, mechanical design, design for manufacture and assembly, manufacturing, and quality engineering. In addition, Accellent has established a network of technical and product specialists to support the company's services. Accellent's process experts located across multiple manufacturing sites ensure that the resulting design can be produced using capable processes.
What is your project team structure?
Each engineering services project team consists of a Program Manager and the appropriate engineering disciplines specific to your project needs. Because Accellent's engineering services is a matrix organization, the company has the ability to adapt to various project scopes.
What are some of your success stories? Do you have any references that I can call?
Upon request, Accellent will be pleased to provide more detailed information in regards success stories without compromising the confidential nature of customer relationships. Our case studies also present a great deal of information on Accellent's past successes.
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