A well written requirements document forms the cornerstone of a successful product development.   We can assist in the development of an effective product requirements specification that defines the product and it is used both to initiate and verify the design.

We can assist with the development of a risk management plan and hazard analysis document, in accordance with IEC 60601-1-4 General Requirements for Safety, and ISO 14971:2007 Application of Risk Management to Medical Devices.

The design of a product follows the design process and controls specified by our ISO 13485:2003 certified Quality System.   The CES MD team can engage and assist at any point during design and development cycle.   We can provide a balanced, appropriate design which meets the product and market requirements.

We work with our customers to set appropriate reliability targets consistent with the intended use of the device, and help our customer to achieve them.   It is particularly critical to define the reliability targets early in the process when it comes to active implantable Medical Devices.   We have both the resources and the equipment in house to set and help achieve your appropriate reliability targets.   We can review an existing design and make suggestions to improve reliability or lower cost.

Our build process is uniquely designed to utilize a sliding scale of control.   Manufacturing engineers begin creating build documentation as soon as a working prototype is developed.   A controlled prototype build allows the engineers the flexibility of changing a design parameter quickly without sacrificing the control necessary to begin documenting and performing engineer confidence test.   Once the engineers are confident that the design will meet the specifications, formal Verification can begin.

All of our controlled builds, whether pre-release or post release, are revision controlled and utilize workmanship standards derived from IPC.   Our work cells are ESD compliant and our tools and test equipment are under calibration control.

Our ISO 13485:2003 governed processes ensure that we produce medical devices of the highest quality. All incoming material is inspected, revision controlled and issued through our work order process.   All non-conforming material is dispositioned through the Material Review Board.   Our system is setup to allow our customer visibility and approval for disposition as well as notification, or customer approval, on ECNs requiring change to released drawings.

A detailed Design History File is kept for each product developed as well as Device History Records (for controlled builds).   Our Device History Records are uniquely tailored to each product and allow traceability for the build. With each assembly we produce a minimum of a build routing, an itemized pick list, and test conformance documentation along with all noted non-conformities and dispositions.

Component level traceability is derived from customer specific requirements, Risk Analysis and our Quality System requirements.

All Clinical builds are documented, traceable to the released specification, and auditable to ISO 13485:2003 as well as the 21CFR820 standards.

• ISO 13485, 21CFR820 and cGMP build process
• ESD-controlled work cells
• Traceability of components
• Documented training records
• IPC certified personnel
• Design History Files
• Device History Records

The key to a successful Medical Device launch is a well planned and well executed Verification and Validation process that results in no findings of non-conformities.

To achieve this feat, all product development activities must follow a regimented process that takes into account the discoveries, the challenges and the opportunities that exemplify a new product development process.

An effective V&V starts with the Hazard Analysis to define the risk mitigation strategies and the Class of the device and its software.   Once the device class is determined in accordance with FDA guidelines, then the appropriate development steps are followed.   Specifically, the hardware verification will be done in such a way to ensure that the mitigations are effective.   The class of the device (class II vs. class III) will determine the level of detail required at the Software Design Description level to support Black Box Testing and White Box Testing.

Engineering confidence testing will challenge all test cases prior to releasing the Verification Plan in order to ensure all hardware and software requirements are verifiable and that any mitigation is effective in its implementation.

A traceability matrix for each test and result is mapped to the initial product requirement and maintained to ensure product safety and conformance.

Cascade Engineering has extensive expertise in agency certification of Medical Devices. We leverage our on-going relationship with the safety agencies to ensure the product risks and mitigations are critically assessed and effectively implemented.

We use a consistent format for our reporting to the safety agency, and the quality of our work, the way we approach the safety agency involvement in a project and our timely response to their inquiries, ensures approval in the shortest time possible.

Our engineering teams are well versed in the IEC 60601 requirements, and we have in-depth experience with EN-45502 requirements for Active Implantable Medical Devices.

Early involvement, effective and quantifiable requirements, as well as a disciplined and thorough approach can go a long way toward a timely certification of your Medical Device.

Once the test requirements are defined and solidified the test specification document can take shape.  The test specification is developed with an eye toward verification.   A clearly defined test specification ensures that the testability requirements are considered during the design and development processes.

Product Specific Test Strategy

Test Implementation

The test implementation takes into account system, sub-system and board level limits and ensures tests are created to confirm that the target system meets the specifications.   Tests are then validated to complete this phase.  Test equipment resolution is chosen based on functionality and accuracy requirments.

Once the system level tests are refined they form the basis for automated testing within ATE test fixtures.We have experience developing both rack-n-stack based and VXI/PXI instrumentation tailored to the particular needs of the product and support environment.   Particular attention is given to the connectivity, wiring, and switching arrangements to maximize signal integrity and minimize down time.   ATE tests are typically implemented using tools such as LabView or LabWindows™/CVI.   Legacy test scripts can be retained and used within a test executive such as NIs TestStand.

The majority of a product cost is a function of design and development.  Since cost is hard to remove later, a great deal of effort is placed on initial cost objective by reducing parts count, and reducing the labor required to build and test it during the design process.

Opportunities for cost reduction often present themselves as technology evolves and new parts and processes become available.  We can help evaluate these opportunities and make recommendations.

High failure rates in production and in the field add to the cost of the product over time.   To reduce the exposure in the current product, and possibly future generations, it may be necessary to investigate failure trends and identify product weak points.   CES MD has the experience and tools to assist in these investigations.   We perform an analysis based on a Physics of Failure reliability methodology.

The key objectives of this analysis include:

• Review of the Manufacturing and Field Service Data to determine areas for improvement
• Review of Construction and Operating Limits to determine operating margins
• Design Suite of Tests to be performed based on the Reviews outcome
• Execution of the Test Suite
• Troubleshoot, analyze, and document failures for failure mechanism determination
• Collate Test Data with Review Data to determine areas for improvement

The root-cause failure investigation has the added benefit of providing an independent opinion as to whether the design, process, supplier or other cause contributed to a particular failure and what action may be required to address the problems. Based on the results of our investigation our customers can work with the appropriate suppliers and processes to implement corrective actions.

Obsolescence of parts can occur for a number of reasons, generally lower cost or newer technology superseding earlier ones.   It is beneficial to have a plan in place to proactively mitigate the ramifications of obsolescence before there is a detrimental impact to Production or Service of your product.

The CES MD philosophy is to actively manage obsolescence though periodic reviews and monitoring of End-of-Life (EOL) and Product Change Notices (PCNs), to ensure Last-Time-Buy (LTB) dates are not missed.   Our qualified suppliers are in a key position to assist in this process and notify us early of any potential upsets in the supply chain enabling us to act and help our customers in a meaningful, systematic manner.

CES MD is equipped to review BOMs to flag at-risk parts, identify alternate parts that are Form-Fit-Function (FFF) compatible, or evaluate and plan LTBs that are consistent with your business goals.   We can help with component qualification and testing or, if necessary, printed circuit board re-layouts in the event component packages change.

Capabilities

• Material Planning and Engineering Analysis to mitigate:
  • Risk to Production
  • Cost of Corrective Action
• Corrective Action Based on Analysis
  • Qualification of FFF replacement parts
  • Last Time Buy
  • Redesign

The CES MD Philosophy with our suppliers is to create a partnership and grow the relationship.   We actively communicate and encourage two-way feedback to ensure we both understand each others capabilities and requirements in order to maintain and improve quality and timeliness and to minimize turnover.

When selecting suppliers for a project we start with our current supplier base and qualify new suppliers as necessary.   Using our supplier qualification process, which includes surveys, audits, and NDAs for custom material suppliers, we ensure that our approved supplier list is populated with quality minded organizations.

We monitor supplier performance and provide feedback on material quality and on-time delivery.   We expect our suppliers to participate in the design process by providing technical feedback for Design For Manufacturability (DFM), documentation, and other improvements.

To ensure a smooth transition to production, we can work with suppliers from the start of a project through product introduction and into product support phase.   We will work closely with the Tier 1 or 2 suppliers to ensure that product requirements are maintained.