Product Development
It takes iterations to get something right.
Product development takes time and should always have a couple of anticipated iterations. When a technology is not fully characterized or the User needs and product requirements are not fully understood, design work occurs at risk. All too often, companies that embark on detailed design too soon end up requiring additional design cycles and have to throw away expensive work. Our proven development process ensures that we have a 360-degree understanding of the product before embarking on detailed design. This approach reduces iterations on the back-side of the project and increases the probability of a product being a commercial success.
Development in a Regulated Industry
We have developed disposable and reusable devices in the regulated medical industry. Our development process generates deliverables in a specific sequence that begins with defining and de-risking and ends with deep understanding and control over the finest details. Although this process is required by regulatory agencies, it makes logical sense and can result in capital-efficient product development when done right.
We've been around...
... the body, that is. We've worked on Class II and Class III devices for a plethora of applications. Whether it's drug delivery, a therapeutic device, or an implant, we are familiar with interfacing with anatomical structures and physiological processes. Our methods capture all of the relevant requirements for your product before detailed design work begins to minimize iterations and surprises.
