The world of manufacturing medical devices can be a challenging one. As such, medtech OEMs seek aid from trusted contract manufacturing partners. These experts can often lend support in a variety of areas such as design, component fabrication, assembly, testing and inspection, packaging, and more. Allowing a firm to alleviate themselves of these aspects of the product development lifecycle enables a medical device OEM to focus on what they do best.
The process of bringing aboard a contract manufacturing partner to take on certain tasks, however, can go even smoother if certain actions and considerations are addressed by the OEM. Bringing that firm into the equation early can help reduce costs and ensure a timely pathway to market.
As such, Mike Conrad, vice president of business development at Precision Medical Technologies, offers a number of tips for OEMs to keep in mind when beginning a new medical device project. With regular communication and clear instructions on truly necessary specifications for a project, collaboration between contract manufacturer and OEM can be as seamless as if the product was being made all in-house.
Sean Fenske: What’s the biggest and/or most common misstep you see OEMs making with regard to enlisting the help of a contract manufacturer?
Mike Conrad: First, we don’t want to see any OEMs making any missteps. Their success is reflected back upon us as our success, so it’s in our best interest for a prosperous arrangement. That said, we of course see some challenges arise more often than others. One common issue that occurs when enlisting a contract manufacturer is the desired timeline an OEM has for obtaining the parts. Often, we are working with very quick lead times on custom parts, that on occasion, we don’t even have finalized prints at the time the PO is placed. We are working on Design for Manufacturing (DFM) and modifying the parts at the beginning and it isn’t uncommon to have changes arise. This results in delays for prints to be signed off; unfortunately, we cannot start manufacturing until all of the prints and inspection methods are aligned and signed off. If the project moves too quickly and a mistake is made, then rework can come into play and the timeline can be delayed even further. One of the best methods to avoid this is to engage with your contract manufacturer as early as possible.
Fenske: That’s certainly one reason for an OEM to bring you into a project as early as possible, but what other potential benefits can be realized from getting you involved closer to the start?
Conrad: An earlier invitation to a project allows us more time to focus on tooling, fixturing, gauging, programming, and print review to ensure everything required to manufacture properly is in line. We can optimize our process and ensure there aren’t any unforeseen delays on custom tooling and gauges.
Fenske: What considerations should an OEM keep in mind to improve the Design for Manufacturing process?
Conrad: Knowing what kind of tolerance will be allowable helps us keep our cycle times accurate and our scrap low. If our DFM recommendations aren’t considered, it can make the manufacturing of the components more difficult. If there are non-critical features that are over constrained, it can increase costs and delay production. Being open-minded to the recommended adjustments and feedback from the manufacturing team will allow the project to proceed much quicker through production. A common challenge encountered is when an OEM assigns too restrictive of tolerances on a part aspect where it’s not really required. Loosening that restriction can go a long way to aiding in the success of the overall project.
Fenske: How do you ensure you are working on a project in parallel with an OEM customer? For example, how do you ensure things like testing and inspection are performed in sync across both organizations?
Conrad: Clear communication between both parties is essential. We ensure we have alignment with our inspection plans from the start of the project and go as far as to share CMM [coordinate measuring machine] programs to confirm there is correlation in all aspects of inspection. If we are checking a part one way and the customer is using a different manner of inspection, we typically end up with a different result. We have weekly conference calls with our customer on open projects to keep the lines of communication open, which helps guarantee we are identifying and solving any potential issues or problems along the way.
Fenske: What does it mean for a customer to buy optimal lot quantities? How can this impact the price for the OEM?
Conrad: We work with our customers at the time of quoting to ensure we guide them to efficient purchase quantities. Often times, the quantity they are looking to purchase could be increased or decreased slightly so they have the advantage of realizing the most efficient price. Taking set-up times as well as cycle times into consideration, we help our customers determine the best quantity to purchase so they gain the maximum value for their investment.
Fenske: What other suggestions do you make to your OEM customers to help ensure they are gaining the most benefit for their spend?
Conrad: During our quoting process, we will offer DFM suggestions that allow us to reduce cycle times and the volume of scrap. As mentioned, tight tolerances can result in manufacturing and repeatability issues that can incur high scrap rates. If there is flexibility to open non-critical features, we can improve upon pricing. It goes back to being given the opportunity to collaborate on a project early in the process and maintaining open communication. This can only serve to benefit the overall proposal.
We also need to ensure we have the most efficient and accurate methods of inspecting. Often times, there are parts that have extremely long cycle times for the CMM. This is taken into consideration when quoting as production has to stop for some of these lengthy quality checks. If we can move that product to a more efficient method of inspection and ensure quality isn’t affected, then we would recommend that early in the quoting process. With the added capabilities of vision systems and other new technologies, we have been able to reduce inspection times significantly over the years and maintain high quality.
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