One way to help reduce the time and cost of developing a new medical device is to start with established protocols and procedures. When starting from scratch, even the first step of documenting customer/user requirements for a product can seem daunting. Established medical device companies will have a quality system that includes procedures, protocols, and templates that help guide and simplify the product development process. Additionally, established companies have staff that understands these procedures and how all the pieces fit together to make for smooth and controlled development process. However, this is not the case for a medical device startup. So what can early stage device companies do to help navigate the development process without established processes and procedures?
In my view, this is where outsourcing product development to company that has established procedures and development teams can add significant value to a medical device startup. I’ve seen first-hand how startups can struggle through product development because they don’t have established procedures and prior success using them. I’ve also seen how we’ve been able to add significant value to early stage companies by leveraging our established procedures and know-how. For example, we have established procedures for design planning, requirements management, biocompatibility, sterilization, packaging, risk management, electromagnetic compliance, etc.
At PADT Medical, we specialize in working with early stage companies. We are currently working exclusively with investment backed startups. In addition to providing engineering services and human-use prototypes, we can seamlessly integrate your product development in our Quality System to ensure a smooth and controlled development process that satisfies FDA regulatory requirements. Please contact us to learn more about how we work with early stage medical device companies.
In my view, this is where outsourcing product development to company that has established procedures and development teams can add significant value to a medical device startup. I’ve seen first-hand how startups can struggle through product development because they don’t have established procedures and prior success using them. I’ve also seen how we’ve been able to add significant value to early stage companies by leveraging our established procedures and know-how. For example, we have established procedures for design planning, requirements management, biocompatibility, sterilization, packaging, risk management, electromagnetic compliance, etc.
At PADT Medical, we specialize in working with early stage companies. We are currently working exclusively with investment backed startups. In addition to providing engineering services and human-use prototypes, we can seamlessly integrate your product development in our Quality System to ensure a smooth and controlled development process that satisfies FDA regulatory requirements. Please contact us to learn more about how we work with early stage medical device companies.
