In today's dynamic business environment, suppliers play an important role in bringing biomedical products to market.
What are the steps to successfully bring a biomedical product to market? Here, KMC Systems shares the benefits of experience and knowledge in biomedical instrumentation development and contract manufacturing services.
It all starts with rigid standards. To become an aproved supplier and partner with KMC, the following is taken into consideration:
An evaluation is made based on a completed Supplier Survey. Ideally, a supplier holds an ISO certification, or, as a minimum, has a documented Quality Management System (QMS). Quality and Procurement are responsible for the evaluation and approval of the supplier placed on the Approved Supplier List (ASL). However, there are occasions when KMC is directed to a particular supplier who may or may not have a QMS. KMC evaluates the types of products/processes used in the material provided to KMC to determine potential risk to either the device or KMC business.
In order to mitigate risk to the product and/or KMC, the supplier is identified as a key/critical and placed on the key/critical supplier list. Examples of criteria can include:
- Tooling costs/Molded parts
- Sole source
- Critical device or component used in instrument
- Service that affects quality such as calibration/testing
Note: Quarterly supplier scorecards are provided to those identified as key/critical. Many use the scorecards as performance indicators in management reviews.
Providing off-the-shelf items, or products that can be moved and manufactured by another supplier without impacting the program, are not considered key/critical suppliers.
Another critical step is supplier performance monitoring. Data is gathered for each quarter that a supplier provides product to show quality rating for the quarter and the last 12 months. The data gathered is based on quantity of parts received and quantity of parts accepted, including in-process rejections.
KMC uses this data to examine the lowest-performing suppliers based on a quality rating of 85% or below. A review of all the defects determines whether a supplier will be presented at the quarterly executive management performance meeting, where additional actions may be required or recommended to improve the rating. Continued poor performance can reduce their opportunity for future or further business, and, eventually the supplier may be disqualified and removed from the ASL.
Key examples of this include:
- Supplier delivery: Late deliveries impact our ability to manufacture and deliver on time, causing cost overruns on the program and customer dissatisfaction.
- Supplier Corrective Action Requests (SCAR) are reviewed and reported on.
During an on site audit, we share the Supplier Material Review Request (SMRR) form and the KMC sampling inspection plan utilized (ANSI/ASQC Z1.4). We reinforce the importance of two-way communication and not deviating from specified requirements prior to having it approved in writing.
Being aligned with suppliers who have knowledge of biomedical device requirements and having been involved with KMC Engineering early on during the design process allows smoother transition for production and a greater benefit for all parties. Paramount is having clearly defined, documented requirements and open communication. Suppliers should always feel comfortable to ask questions, seek additional input or make recommendations.
For more information on becoming a KMC Systems supplier: