Case Studies

Mapping reimbursement to commercial results

Improved medical therapy and percutaneous stenting have caused a rapid decline in the total number of open chest Coronary Artery Bypass Graft (CABG) surgeries. Nevertheless, there are still well over 500.000 CABG surgeries performed annually throughout the world, according to statistics of international Cardiology Societies.

CABG is a surgery in which a vein is removed from a part of the body of the patient (usually the saphenous vein in the leg) and placed outside the heart to serve as a conduit and improve the blood flow of the coronary arteries... read more

Investigator-Initiated Study

Qmed Consulting was asked to help set up and manage an EU clinical study for eighty patients with an irreversible and life-threatening disease. The investigational product was originally approved for a different indication, but as this particular trial proposed a new indication, all regulatory approvals were required in order to start the study.

The principal investigator and Scandinavian-based sponsor of the study had no previous experience setting up European clinical trials and was also facing a heavy workload as director of department in the hospital where he worked... read more

Market Positioning

In response to neurosurgeon complaints surrounding traditional titanium cranial fixators, Company X developed a new non-metallic cranial fixator that eliminates the need for proprietary instrumentation as well as avoiding distortion in medical imaging systems due to the product’s unique material properties.

After a successful initial launch, this innovative product however was having a difficult time growing sales and saw new users steadily returning to titanium cranial fixators... read more

Market Potential Towers

Company Z is developing minimally invasive therapies for the treatment of mitral regurgitation, the second most frequent heart valve condition in Europe. Studies indicate that about half of the patients suffering from mitral regurgitation are not referred to surgery due to risk factors and the new valve replacement will represent a safe and effective treatment for them.

In planning their market entry into Europe, Company Z was unsure about which specific factors were keeping patients from having surgery and therefore could not assess whether its new valve would address these factors... read more

Value Apps

In the UK, patient monitoring is the standard care pathway for a certain gastric disease. About 12% of these patients develop serious complications, including cancer, thus leading to expensive treatments. The National Institute for Health and Care Excellence (NICE) had given positive appraisal for the new technology, however, local purchasers only focused on the upfront costs and did not understand the value of the innovation... read more