Medical Device Design & Manufacturing
Minnesota | California. Partnering worldwide.
Call for an estimate:

+1 763.703.5000




The Medical Device Design Lifecycle



  • We can assist 510k, PMA device, timing and budgets
  • Develop tool designs, VnV protocols, and tool launch strategies
  • Design for manufacturability part review meetings
  • PFMEA control plans
  • Work Instructions, validation, verification, review baselines
  • Give you feedback, assessment, and corrective actions to tackle any problems

Medical Device Manufacturing Medical Device Manufacturing Medical Device Manufacturing

As you begin researching the product design needs for your medical device, this is the time to collaborate with our engineers at JunoPacific for support, guidance, and medical manufacturing expertise. Our product design engineers will provide careful attention to end-user experience needs, manufacturing pitfalls, and help quickly iterate your design while adhering FDA device design requirements. By taking manufacturing into account early in the design stage, we can help you save significant amounts of money during the tooling and production phase. Our engineers and product designers have a world class record for helping you meet your medical device product development milestones while continuing to drive your medical device production planning forward. Over JunoPacific's decades of experience bringing medical devices from design through approval, we have continually seen the value added by collaborating with our engineers early in your product design process.

From our manufacturing centers in California and Minnesota, connecting with you anywhere in the world, our engineers and product design team will help you navigate the three main phases of the medical device design life cycle, starting with:

The Early Product LifeCycle

How JunoPacific Gets Your Medical Device to Market Faster

Many of the decisions that you make in this early product design phase will have tremendous impact on the success of your medical device manufacturing outcomes and success. For a more sure-footed device development cycle, we can't say it often enough: reach out to our engineers while you are still researching and designing.


The Middle Product LifeCycle

How JunoPacific Gets Your Medical Device to Market Faster

As you complete your research and finish gathering user requirements to begin the design for manufacturability and developing a scalable approach to bring your product to market starting with prototype tools and pilot assembly lines. These will help validate and verify the production of the device for FDA approval. With this middle phase of the medical device design life cycle taking shape, the engineers at JunoPacific will have developed for you well-defined manufacturing specification documents that provide clear and measurable requirements, all adhering to FDA GMP guidelines for medical devices. This stage centers on not only having the right medical device product design, but putting in place the right manufacturing process, one that is scalable, repeatable, traceable, and well documented for your reviewers.

Over 25 years, our experience with startups and large design firms alike has revealed that how this middle phase is handled can forecast a medical device's successful outcome or failure. How thoroughly were the requirements researched? This will show in the manufacturing specification documents. Does the process produce high quality parts? Where are the components sourced from? Who is involved and what are their records? Is the process dependent on a particular operator? Are the manufacturing steps repeatable? Are the outcomes consistent? Is the stress testing rigorous and measurable? Is every step, decision, change, and outcome documented for the FDA?

At JunoPacific, we guide medical device product designers working at all levels in the industry to avoid the pitfalls of poor production planning. By utilizing our design team well before a device prototype is needed, our engineers will lead your team down paths that are less expensive, less complex, more robust, and easier to validate so that you can submit to the FDA (or registered body – depending on the device class) with a strong prospect for success. And this doesn't only benefit your chances for approval. A more robust process that produces a higher yield reduces your costs, minimizes the number of units that fail, and has a direct impact on your bottom line and your relationship with your investors -- now and in the future. The impact that a collaborative partnership with JunoPacific can have for your business is, simply put, fundamental to your bottom line.

The Late Product LifeCycle

How JunoPacific Gets Your Medical Device to Market Faster

Finally, after the research and inquiry of Phase One, and the rigor, testing, validation, and 510k approval process of Phase Two, Phase Three in the medical device development life cycle centers on bringing your product to the market. Utilizing your prototype tooling as bridge tooling while we create high volume production lines and molds to meet your demand, we can help you bridge that gap and reap the rewards of your hard work.

In all aspects of the medical device design life cycle, it is important to choose a partner who will map a pathway and process for success not only for the medical device you are currently designing, but for the development of an industry-wide reputation that establishes you as a product design firm competent in taking your devices from design through approval. Anywhere in the world, at any scale of production, a partnership with JunoPacific is critical for successful medical device product development, for defining your reputation throughout the industry, and for transforming your business from where you are, to everywhere your creativity, ingenuity, and innovation can take you



About JunoPacific

Midwest

1040 Lund Blvd. NW
Anoka, Minnesota 55303
Tel: 763.703.5000


Silicon Valley

2840 Research Park Drive
Soquel, California 95073
831.462.1141

740 Broadway Street
Redwood City, CA 94063
650.361.8421