The benefits of transferring production to an experienced Contract Manufacturer with a track record for performance is the plethora of ideas and innovation that adds more value to the design of the end product. Additionally, a CM has trustworthy sources in their established network that will be aligned to the regional protocols.
An experienced CM has the ability to add extensive field knowledge to the design of a medical device which may greatly increase efficiency and reduce costs. Redesign enhances quality and durability and can possibly lead to the discovery of additional uses for the product. Not long ago, the norm was that OEM’s instructed the Contract Manufacturers on what to produce and how. However, as Contract Manufacturers kept servicing more customers, their know-how increased, and they updated their value propositions. Having grown and evolved, they are nowadays able to provide comprehensive services from concept to development; specialized manufacturing; and even supply chain management. From the raw material vendors all the way to the final consumers. Such is especially true when the Contract Manufacturer is involved as early as the design stage where key decisions for best manufacturability are determined. The Contract Manufacturer can influence the design of the manufacturing process to be of the highest quality, efficiency, and adaptability to future product updates. Understanding the significance of the impact to the bottom line, the medical device OEMs strive to involve the Contract Manufacturer in even the more detailed decisions such as product material selection and production methods.
A CM is a partner through the entire life cycle of the product.
The manufacturer’s role continues after the product launches. Postmarketing surveillance and necessary upgrades of the device are relayed from medical providers, end-users, and regulators. As incremental changes are made, the device can be further tailored to fit its user base. That translates into more market share, increased production, and ultimately a closer tie between the OEM and the CM.
A cooperative and mutually beneficial working relationship is based on communication.
A clearly defined communication policy that fosters openness and accountability for every stage in manufacturing creates a harmonious partnership. A pleasant, knowledgeable management contact person available to address ideas, concerns, and updates in development through the length of the partnership enhances collaboration.
Experienced CMs confidently add innovation and improvements to medical device design. Their vast experience with different equipment and technologies will have new answers for your device in areas that were overlooked before. This is important in the context of the validation process. Less experienced manufacturers are reluctant to initiate design for manufacturability and reliability because of the time and cost involved in the validation process. A professional CM won’t hesitate to challenge the status quo just to avoid the paperwork involved in modifying a design when it will increase the quality of the product.
A CM must develop a permanent supply chain database network of multiple vendors in various locales for acquiring raw materials. Cooperation with the suppliers leads to transparency of inventory levels, delivery capacity, and flexibility which minimizes costs. Localization activities and understanding cultural norms, reduce the time lag on customs, exports, and logistics. Differences in costs between countries can be prohibitive. The trade-off between quality vs. costs is best determined by an experienced CM. OEMs that seek a manufacturing partner to take on sourcing of raw materials need to rely on the CM’s network and ability to find the highest quality vendors for the best price point.
Choosing the right partner to develop and produce your medical device products, plays a critical role in how you bring your products to market and can make or break a medical device product’s success. Contact us to discover how Quasar’s 30-year experience, infrastructure, and know-how, can help you bring the best version of your medical device to market.
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