DPMInsight, LLC is dedicated to the practical application of engineering design methodologies to produce high-quality products that are manufacturable, marketable, and profitable.
Drawing on more than 25 years in industry, and 20 years in the medical device industry, our focus is on medical device and pharmaceutical companies operating under regulatory-monitored quality systems (FDA and ISO) (though these methodologies are portable to many other industries).
WHAT WE DO
- Systems Engineering
- Requirements Definition
- Design Controls
- Design for Six Sigma
- Lean Six Sigma
- Project Management
Medical device and related organizations operating under the oversight of the FDA and related international organizations must operate under the procedures of a Quality System. However, a Quality System can not be confused with, nor can it replace, the organization's practice of good and accepted engineering and project management practices. Failure to separate the two, or to place too high a focus on the Quality System alone, risks product quality and customer satisfaction.
The methodologies needed to consistently produce high-quality manufacturable products that meet customers' needs have long been known. Many of these approaches are shared by the best-practices taught by Systems Engineering, Design for Six Sigma, Lean Six Sigma, and Project Management.
We believe in the the use, teaching, and coaching of these methodologies used in a focused, but appropriate, way to yield high-quality designed products.
DMPInsight is a single member LLC owned by Cushing Hamlen, who holds degrees in Chemistry and Chemical Engineering, is a certified Project Management Professional, and a certified Master Black Belt (Lean Sigma)