For medical device startups, entering the manufacturing stage can be a daunting, frustrating and time-consuming process. Often, medical device startups will meet no-quotes or show stopping quotes from contract manufacturing organizations (CMOs) for their pilot builds. This is often due to the economic realities facing CMOs. It takes a significant amount of up-front time to identify the right suppliers, procure quotations and build manufacturing processes that result in high quality medical devices. This up-front time investment incurred by CMOs simply may not be justified by the downstream manufacturing revenues for a low-volume pilot build.
For medical device startups, a “divide and conquer” strategy may be the most logical one for pilot builds. Although this puts more of the supply chain and manufacturing responsibilities on the product engineering team, it also presents a number of advantages that should be considered.
Gaining component supplier insights
Medical devices are typically comprised of various plastics, electronics, metals and fasteners received from numerous suppliers. Component suppliers, such as injection molders and machine shops, are often willing to engage in low-volume production orders. In addition to their production collaborations, component suppliers are often willing to provide material samples and feedback on designs in order to optimize manufacturing processes. Implementing this supplier feedback can often drive down costs and improve quality of a new medical device.
Reducing supplier risks
Many times there are one or several components within a new medical device that require specific expertise of a particular supplier. These may be optical components, precision sensors, reinforced catheters or other specialty components. When the success of a new medical device heavily relies on one specific supplier, it is typically known as “supplier risk” and can present a challenging scenario for a medical device company. These suppliers may drive pricing, bottleneck timing and cause other issues during production. In these cases, it’s valuable for a medical device company to have direct communications with the specialty component supplier to address issues real-time. Additionally, knowledge of this “supplier risk” may lead a medical device company to seek alternative suppliers as back-ups for the critical components that may exist.
Lean assembly methods
After components and suppliers have been identified, the pilot products still need to be assembled and packaged. Having developed the supply chain fully, vetted component suppliers through sample rush and constructed a comprehensive Bill of Materials, a medical device company may be well-positioned to collaborate with a small manufacturing facility that focuses primarily on assembly to get through the pilot build. Alternatively, the medical device startup may opt for more of a DIY manufacturing strategy for the pilot build.
Not only can a “divide-and-conquer” strategy accelerate transfer into manufacturing for a pilot build, it can provide the product engineering team valuable insight that improves quality, lowers costs, and reduces supplier risk. After successfully navigating the pilot build process, the team will be well positioned to engage in conversations with CMOs to scale-up.