20 years of patient care and clinical research at a large, prestigious academic US medical institution; caring for patients with complex medical conditions
10+ years applying medical knowledge to develop medical devices at Fortune 500 manufacturers creating products used by patients and healthcare professionals makes NMDC your go-to expert for every stage of your product's lifecycle
Having developed products for North American, European, and Asian markets, NMDC has the regulatory knowledge for developing global products that comply with country specific standards
Northstar Medical Device Consulting, LLC was founded by Dr. Ira Davis, a physician with over 30 years of experience as an academic pediatrician, kidney specialist, educator, and physician executive at Case Western Reserve University School of Medicine and several Fortune 500 medical device and pharmaceutical companies. Dr. Davis is passionate about new product development and innovation to help improve the lives of patients with complex medical conditions and assist clinicians in their care of these individuals.
During the past 10 years, Dr. Davis functioned as a medical director at Baxter International and Hospira, A Pfizer Company, medical device and pharmaceutical companies providing medical and clinical expertise to a cross-functional team of colleagues from R&D, regulatory, quality, and commercial organizations regarding various issues dealing with new product development and support of on-market home dialysis and infusion therapy products.
Dr. Davis was instrumental in providing medical and clinical leadership for the successful launch of a next generation home dialysis device and remote patient management bi-directional software platform. He also has experience working at a clinical research organization where he provided medical expertise in the start-up and execution of several clinical trials in the areas of chronic kidney disease, hemodialysis vascular access, and orphan drug development in the domain of inherited metabolic diseases.
In-depth assessment of clinical product requirements, human factors study protocols, and risk assessments (including risk benefit analyses)
Assist with company-sponsored clinical study protocol development and final study report medical writing
Development of medical and nursing advisory boards-KOL identification; meeting objectives, agenda, and content
Development of training and education plan/materials for internal staff, healthcare providers, and patients
Publication plan development
Medical writing of product labeling materials, training materials, white papers, clinical study reports
Medical assessments of relevant product complaints
Investigator-initiated study programs
Medical writing to support clinical evidence generation