TOPICS: Consulting & Special Projects

Global Product Launch Considerations: Lessons Learned

Back in the 1990’s I admit to making a medical cultural blunder that has remained indelibly etched in my mind. A patient of mine, a Chinese national was experiencing a high postoperative fever. Like any well-trained American clinician I followed protocol. I pulled off his blankets, made as many ice packs I could (OK, they were crushed ice in rubber gloves) and proceeded with my goal to make his bed equal to winter in Minneapolis. To my surprise, his response was not relief but horror and sat up and threw all my hard work to the floor. Speaking no Chinese I could not understand his concern and was further perplexed when he started reaching for the hot tea brought earlier by his family. It was only years later when I was researching cultural issues in medicine that I learned that hot blankets and hot tea are remedies for fever in traditional Chinese medicine (TCM).

While this experience lasted but a short time and at incurred little to no obvious monetary cost, there was a blow to the trust between myself and my patient. This could have been avoided by more knowledge on such cultural and geographical nuances.

Fast forward 20 years. Our entire industry is interacting globally. From selling and running trials to mobility of patients across borders, such understanding of local and cultural mores, practices and issues is critical for conducting business on multiple fronts. That said there are various matters that require careful consideration. Most often the focus is on reimbursement and overall health system issues. Akin to my own experience with the patient described above, many of these go much deeper to the institution and individual clinician level. For the past 10+ years, Snowfish has worked globally with multinational and local companies and have paid special attention to the micro-issues. When they are addressed most effectually, this is how companies can make a real difference. Our experience has identified a number of information tidbits which have proven to be crucial to the success of global healthcare business.

Learning: Don’t assume a product used in one country is equally compatible in another.
A major German company with a device used to deliver intraoperative radiation to treat breast cancer launched in the U.S. with surprisingly low penetration despite a very successful European launch. The company was clearly interested in understanding the root cause. With thorough analysis and comparison of the two markets, Snowfish found that this failure was related to differences in physician responsibilities, patient flow, as well as systems in place for intraoperative tumor biopsy and pathology services.

First off, in Germany radiation oncologists were found to get involved much earlier in the treatment planning process, i.e., before surgery. Therefore, the radiation oncologists were far more instrumental in the use of this technology and the adoption. Alternatively, patients managed for breast cancer in the U.S. are less likely to see a radiation oncologist until after surgery. Therefore most of the decisions about which treatment device falls upon the surgeon, who is not focused on the radiation component of treatment. Even if the surgeon is supportive of the particular type of radiation therapy, multiple logistical issues posed by many U.S. hospitals added additional changes that impeded adoption including the time to receive the initial pathology report and the overall patient flow. Clearly, three major components were different, physician targets, pathology process, and operating room flow. The cumulative impact slowed adoption of an innovative product. Had the company fully analyzed upfront the various country anomalies the U.S. adoption could have been smoother.

Learning: Medical specialties do not always translate across geographies.
For particular therapeutic area knowing the target specialties to focus upon is not always the same across countries. One example is the specialty of angiology. Referred to as “vascular medicine” in the U.S, angiologists play a critical role in the treatment of various vascular diseases in a number of countries including the UK and the Netherlands. Adding to the complexity is for conditions such as hypertension where in the U.S., clinical cardiology and nephrology take the lead, angiologists are integral in the diagnosis and management. Furthermore, unlike the other specialties mentioned, angiology will also perform catheter-based interventions. Even within the European Union (EU) the role of the angiologist will vary significantly, so much for the EU being one integrated market. If key specialties such as these are missed, serious gaps with respect to clinical trial evidence, product specifications, targeting and KOL engagements will occur.

Learning: Geographic clinician challenges are often unrelated to disease or reimbursement and need to be understood.
A recent project brought us full circle, back to China. Health care reform measures and entry of many into the middle class have resulted in an explosion of patients into China’s healthcare system. With this has come new-found stress for an already over-stretched clinician workforce. Couple that with growing violence against them by patients and you have a situation that is unsustainable for the long term. Recent reports have highlighted attacks against physicians and other health care workers by patients who claim wrongdoing. While it is not clear if these patients are just misinformed or have unrealistic expectations the results are ultimately devastating to China’s healthcare system and their patient’s well-being.

There is no simple solution to the situation given other related challenges such as variability in medical education, role of government, the disparity between urban and rural environments/services and prominent role of TCM. Nevertheless, such information regarding the state of the clinician can be very useful to better ensure more effective engagement and clinical value delivery.

Conclusion
Snowfish has worked on multiple products developed at the world-wide level. It is very important to take into consideration the various factors in the planning stages that could affect adoption. We have pointed out critical factors such as varying physician treatment responsibilities, product design, hospital processes, and cultural issues. A company cannot be complacent and simply focus upon regulatory, reimbursement and distribution and expect a successful product launch. A company needs to fully understanding and assess a country’s micro-environment. To borrow a phrase from a former Speaker of the U.S. House of Representatives, Tip O’Neill, “all politics is local” I might add so are successful world-wide product introductions.