Qmc - Quirk Management Consulting

Our goal is to help companies deliver products that improve the quality of life of patients quicker and more effectively. Developing a medical device from inception to market is a huge undertaking. From design and development, regulatory approval, commercialization, and post-market activities, it can get tricky and messy fast! A lot of times, medical device companies fail before they even make it to market. They fail because of poor planning. This encompasses plans for resources of time, money, and scope. If one fails, they all fail. We help medical device companies manage their business of developing products from device conception through to end users and patient use. We optimize product-level governance so business decision makers can make effective decisions quickly. We optimize program-level management to consistently complete the projects under the program portfolio. We optimize project-level management to consistently produce quality project deliverables to inform program direction. We offer 3 services that we believe are of value to potential clients:(1) full product-level governance and product and project management implementation service,(2) audits to understand gap analysis and areas of improvement of current systems and provide feedback and direction, and (3) straight-up management of company programs/projects. Our unfair advantage in the market is that we have the experience of doing it among all size scales of types of devices and businesses. From Band-Aids and respirators, to catheters, stents, orthopedic robots and combination implantable devices, we have done it all. From start-up companies and industry leading fortune 500 companies, to the FDA and international regulators, we have experience working either for them and with them all. Our experience and know-how will help businesses develop any product from start to finish to successfully deliver important and crucial devices to patients to improve their quality of life quicker!