The most successful Medical Devices Startups outsource development and manufacturing activities. Why? It allows them the most important thing to achieve success: to focus on their funding, traction and commercial activities.
In the medical device industry, contract development and manufacturing has become a fundamental pillar for speed to market. By outsourcing with experienced partners, startups are able to mitigate risks, reduce costs and investment, and reduce lead times.
A development partner is responsible for creating the design outputs / specifications that will become the inputs for the contract manufacturer to translate into production specifications in order to manufacture the device. We call this transition a Design Transfer and is accompanied with months of collaboration and back and forth between the parties.
It serves as a great advantage if your Development Partner could also become your Contract Manufacturer and here is why:
Seamless transition: Working with a single partner for both development and manufacturing can lead to a smoother transition from the design phase to production. The manufacturer is intimately familiar with the product, which can reduce errors and streamline the process.
Efficiency: A partner that handles both development and manufacturing can optimize the design for manufacturability. This can lead to more efficient production processes, shorter lead times, and ultimately faster time-to-market.
Quality Assurance: With a single partner responsible for both development and manufacturing, there is greater accountability for the quality of the final product. The partner is motivated to deliver a high-quality product that meets both design and manufacturing requirements.
Collaboration: Close collaboration between the development and manufacturing teams leads to better communication, problem-solving, and innovation throughout the product life cycle.
Regulatory Compliance: A partner with experience in both development and manufacturing can help ensure regulatory compliance at every stage of the process. This is especially valuable in the highly regulated medical device industry.
Rapid change implementation: When encountering problems during manufacturing, the design team can easily jump in to solve the issues through design.
Now, you still want to choose different parties for your Development and your Manufacturing? No problem! Just a quick tip: make sure your Development partner has Design Controls implemented and that your Contract Manufacturer has a Design Transfer phase that will be triggered.
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“Bioana team, you guys are simply amazing. Thanks so much for all your team’s hard work on this. We remain impressed beyond measure.”
Mark Lee
CEO, Ocumetics
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CRO , Bolb Inc.