Better medical device design and manufacturing processes
produce better results.
- Process failure mode and effect analysis (PFMEA)
- Corrective and preventative actions (CAPA)
- Kaizen Events
Robust processes. Reliable parts. Consistent results. These are the outcomes and the payback our clients realize by working with our engineers and utilizing their thoughtful and accomplished commitment to each medical device project. By focusing on the manufacturing process design and validation protocol, implementation becomes streamlined and simplified. The best medical device design won't necessarily become the product your team envisions without solid manufacturing processes in place, validated to the highest confidence levels and standards expected by the FDA. Our engineers at JunoPacific are carefully chosen to create a product design team with unparalleled experience in all corners of the medical device manufacturing industry. Utilizing their expertise, JunoPacific can design a medical device production process for you that is everything you need it to be: less expensive; less complex; more robust. Every time.
But it's not as easy as simply designing and manufacturing a product. There are specific requirements your medical device development process must adhere to before it can be produced. This is where our clients often look to us for the most guidance. The FDA imposes lots of detailed specifications and requirements during this phase of the manufacturing development process. But there's no reason this stage can't go smoothly and be stress-free. With JunoPacific by your side, you will be supported through all the technical details as well as any potential setbacks or frustrations you may experience. Working together allows the development and validation process to be more cost-efficient, more time-efficient, less stressful, and creates an all-around better medical device.
What level of quality is do you want for your customers? What level is required by law? How well does the process achieve the risk / benefit balance you want to meet? What is the risk of process failure? How will failures be detected? How effective are the test methods at detecting failures? What tools are required to detect failures? Are test results reproducible and repeatable with the measurement device or gauge chosen? What manufacturing processes must be validated? What are the advantages and disadvantages to validating a process? What are the process capability requirements? Is the process stable? What is the distribution function of the output being measured? Is it normally distributed or does it follow a non-normal distribution (i.e. Lognormal, Weibull, Chi-Square, Poisson)? What are the optimal process settings to meet the design specification? What designed experiments (DOE) can determine the optimal results that are also robust?
These are just some of the questions you will face, questions JunoPacific navigates and resolves every day.