Disposables: Four Tips for Selecting the Right Manufacturing Partner

With so many big-picture issues roiling the medical device industry, why bother with such a 'minor' issue as how to manufacture disposables? Simple: Unless they ask the right questions and choose the right partner, engineers, procurement managers, and anyone else involved in the development of single-use medical devices cannot make their projects run smoothly and efficiently. To help them achieve this end, Amber Sherrick, marketing manager at ASI (Millersburg, PA), offers four tips for manufacturers of disposable devices.

 TIP 1. Ensure
  your partner knows
  disposables.

The first thing to keep in mind is to select a contract manufacturer that has experience in the disposables market. This experience will help the OEM to satisfy regulatory standards, complete all required filings, and select the right materials for the project at hand. An experienced partner will also know how to grow the production process as the product volume grows.

Thus, the contractor should be FDA registered and ISO 13485:2003 certified. Similarly, it must be able to manage the supply chain from end to end while providing sufficient capacity, production capability, and engineering expertise. At the start of a project or as the project grows in volume, the contract partner should also be able to develop offshoring capability and automate its production processes.
 

 TIP 2. Be
  flexible about design
  modifications
.

OEM customers are the experts about their own products. However, while they know how their products are used, how they work, and much more, flexibility should be built into the initial design. A contract manufacturer should be able to modify a product design for a variety of reasons. First, the original design and the initial choice of materials may result in an inefficient production process. In such cases, the contracting partner may suggest a material or process to increase processing efficiency. Second, design modifications can sometimes lead to large savings. The contract manufacturer may be able to cut costs by optimizing the production line, selecting different materials, relying on different suppliers, or automating certain operations.

 

 TIP 3. Get it in
  writing
.

Start by defining the relationship, including by signing mutual nondisclosure agreements, noncompete agreements (depending on sales volumes), supplier agreements, and quality agreements. However, even when you have covered all of these bases, a site visit and audit of the supplier is crucial. While, these steps lengthen the process, they force you to ask questions and become comfortable with the group that will manufacture your product.

 

 TIP 4. Know
  your materials
.

The first question to consider is the contents of the bag or device. Will it contain leachables or extractables? If so, the film you select should offer the best profile for the application. In addition, you must consider how long the contents will remain inside the device and how long it will be stored. You should also ask, what are the biocompatibility requirements of the application in question, and what sterilization methods must it be able to withstand? For example, when a customer is concerned about permeability, a film should be employed that provides good barrier protection, such as a multilayered film over a single layer material. In addition, understanding medical plastics requires that a contract manufacturer have experience in the medical device or pharmaceutical field.

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