MedSurgPI: Frequently Asked Questions
1. What does “MedSurgPI” stand for? “MedSurgPI” is an abbreviated form of “Medical and Surgical Product Innovation,” which we achieve for our clients by providing a comprehensive platform of Medical Affairs capabilities.
2. What is unique about MedSurgPI?
a. Our broad experience covers both medicine and surgery, private practice and academia, basic and clinical research, and the experience of being regional and national Key Opinion Leaders (KOLs). The Principals have consulted for the largest pharmaceutical and biotechnology companies as well as small and virtual start-ups. They combine extensive medical and commercial expertise.
3. Do MedSurgPI's Principals have academic experience?
a. Their experience includes roles as Professor of Surgery, Business, Medicine, Pediatrics, Medicinal Chemistry and Pharmaceutics. They have been on the boards and have led national medical organizations, as well as serving as editors of several journals and have written numerous peer reviewed scientific manuscripts.
4. What can MedSurgPI add to our market research?
a. Our physicians are able to candidly speak to health care providers (HCPs) and determine their well-considered positions. We speak their language, whether it is a leading KOL, head of a large clinic, or a community physician. MedSurgPI will ascertain the clinical reality and provide the expert advice needed to enhance your program.
5. How can MedSurgPI enhance our clinical trials?
a. We have led global trials leading to biologic, drug, device, and diagnostic approvals. Reviewing your developmental and clinical plans may provide the critical direction that can improve your program, save time, money, and prevent major problems and delays.
6. Does MedSurgPI's experience extend beyond the United States?
a. We have worked on projects throughout North and South America, Europe, Asia, and Africa. These include diverse projects resulting in regulatory changes, favorable client reimbursement, drug and device approvals, and increased market penetration.
7. What significant regulatory issues has MedSurgPI handled?
a. We have successfully managed data integrity issues. We have also contributed to the international approval of a therapeutic for a rare disease by successfully negotiating the need for only one trial, despite a request for an additional trial by the FDA. Our team members have successfully addressed the regulatory and liability concerns of a complicated package insert, resulting in regulatory, HCP, and patient acceptance. This all resulted in increased product utilization.
8. Can MedSurgPI help us enhance our Safety and Pharmacovigilance Program?
a. MedSurgPI’s Principals have dealt with major product safety issues and have established transparent programs that not only alleviated the concern of regulatory agencies but also assured physicians of products' virtues. They understand the proper investigation and significance of adverse events.
9. Social Media and patient advocacy are increasingly important to marketers, what can MedSurgPI provide?
a. Our team knows how to communicate with patients and their families. Having years of direct patient care, national organization leadership, and commercial development has enhanced our ability to provide this service.
10. Why should a global major biopharmaceutical use MedSurgPI's services?
a. MedSurgPI’s Principals have successfully consulted for many of the major companies in the health care industry. We provide an outside perspective steeped in unique experience that may be invaluable to your organization.
11. How can MedSurgPI help small pharmaceutical, medical device and biotechnology companies?
a. We have not only worked with numerous start-ups but have founded and led them. MedSurgPI’s Principals understand the significant challenges you face and will work with you to quickly and economically achieve your goals.