During these changing and somewhat confusing times, the selection of the right contract manufacturer is more critical now than it ever has been. It may be hard to find a team prepared to take on the challenge and complex molding applications to meet or exceed your expectations. In terms of medical device consumables, those expectations play a critical role in the health and wellness of people.
In the ultra-competitive world of contract manufacturing molding it is difficult to separate yourself. Most do it on price, others on capabilities, while some find ways to take a painful situation to make it, well, less painful. Every day, we live and breathe molding, while our customers do not. They have an endless list of actions they need to accomplish while working with countless other suppliers toward an end goal. In some cases that goal can be the launch of a new product or the transferring of a ten-year-old tool, so it is extremely important to select the right molder for your critical to function consumable.
Then how is it possible to select the right molder for your critical to function consumable?
Traditionally, companies would select based on a list of “qualified suppliers”, but as times change so do those relationships. It is critical to hit the refresh button on that approved qualified supplier list. The selection of a new molder should not be taken lightly, and care should be taken to find a molder who is aligned with your business model and that is prepared to help you get to market.
Where do you go from here?
During these times of uncertainty, it is imperative now more than ever to find the right contract manufacturer. Teams need to be flexible. Search for molders that meet the standard criteria you are looking for. The right ones will make it work via the “new normal” methods of meeting. Do not be scared or hesitate to schedule that engineering or quality audit via a virtual call. The same questions can be answered, and the expectations of the company can be showcased just as effectively.
A gap analysis of the current quality management system gives the customer an opportunity to not only understand the effectiveness but also give the molder an opportunity for continuous improvement. The fulfillment of those actions associated with the gap audit show the willingness and flexibility of the entire organization to “do what’s right”, especially with products that demand a consistent manufacturing process.
Customers outline their expectations from a timing perspective, qualification, and product validation. They establish the appropriate CPK values and approve the IQ/OQ/PQ layout. They often outline what the pain points were with an incumbent molder, so all potential pit falls are laid out in front of the team for the most efficient use of everyone’s time.
What if the Contract Manufacturer does not meet all the requirements based on your QMS Audit?
The right partner, over time, will be able to meet your requirements because they will adapt. Manufacturers that are invested in the medical device world will spend the time and resources needed to fulfill the requirements set forth by your Quality Management Team. Understanding that your product could aid in critical life or death decision making processes, they need to understand the product holistically and not just as a piece of plastic. Weekly meetings, whether virtual or onsite visits, shift in resource allocation, and facility upgrades are all part of creating that trusted quality partnership.
Communication is key. While this may seem straightforward incorporating not just the direct project team but the key members of the entire organization allow both the customer and contract manufacturer to voice concerns, hold each member of the team accountable and progress the project appropriately and to the committed timeline. Like any project, timing slips, items get pushed out, but it is the analysis conducted during the gap audit that gives you peace of mind that your partner will do what’s necessary to get the program back on track.
At Currier Plastics, we drive best practices for manufacturing your injection & blow molded consumables. We understand the complexity and regulations your teams face when dealing with products in the healthcare market. And we appreciate this is a data driven world, but it is the flexibility of our teams, the eye for details, and willingness to do what’s right that separates Currier Plastics from the competition. Currier’s approach is to remove the uncertainty of molding to bring your critical to function consumable to life.
We are in uncharted waters, an undiscovered planet, a changing world. We all need to stay focused on the ultimate goal!