Meeting at Roche
Updated: Sep 3, 2019
On Tuesday morning, Manish and I traveled to San Isidro to meet with Ms. Silvana Lay, the access manager at at Roche Pharmaceuticals, whom we had been put into contact with through Dr. Ernesto. Roche Farma is a pharmaceutical company that is involved in the biomedical technology industry in Peru. The goal of our interview was to learn more about the regulatory challenges faced by Roche in introducing new biomedical technology into the market in Peru, and we composed a list of questions regarding the processes that Roche goes through to get medical device approval, the products they make available to people in Peru, the manufacturing industry, the growth of the biomedical industry in Peru, and mHealth biomedical devices. Silvana led us through a beautiful glass office looking over Lima to the office of the medical director, Dr. Raul Velarde Lopez. We introduced ourselves and the POCkeT colposcope, and began our questions.
Dr. Lopez explained that he worked with pharmaceuticals rather than biomedical devices, but expected that we would need our protocol approved by the National Institute of Health and an import license from DIGEMID to get our device approved. Next, he explained that Roche imports products from other countries, primarily the US, and then uses a local distributor to send products to clinics and hospitals in big cities like Lima, Cusco and Arequipa. He also illustrated the need for a demand based “pull” system, essentially that Roche only distributes enough supplies to treat the patients, and operates based on a demand from clinics and hospitals because the products are usually high-cost and they want to ensure that they are not stolen or misused. One of my main goals is learning about cervical cancer treatment and we segued our conversation to his knowledge about cervical cancer prevention and treatment. Roche has one cervical cancer related product, Bervacizumab, which is used to treat cervical cancer which has not gotten better with other treatment, has metastasized, or has recurred. Dr. Lopez explained that that biggest obstacle in dealing with cervical cancer is that most of the focus of the Peruvian government is on prevention and late state treatment rather than early diagnosis because the government has very little data on cervical cancer rates outside of the major cities. We began talking about the POCkeT colposcope and how it can be used for early detection of cervical cancer and he became very interested in our work. He said that he wants to see how it can be used to collect more data which can be used to encourage government involvement.
We transitioned to the marketing industry, and learned that Roche does all their manufacturing abroad to ensure quality control. Dr. Lopez stated that the biggest challenges Roche faces in getting biomedical products into the market are government approval and patient enrollment. It was very interesting to learn that getting products to hospitals is not an issue, and shipments running to the main cities in Peru run every single day. Finally, when asked about any biomedical devices that use mobile applications, Dr. Lopez told us about his friend who is a Medical Science Liason at Doktuz, a company which builds mobile applications to call for emergency services. Dr. Lopez concluded our meeting by stating that he was very interested in our medical device, and would like to be kept in touch regarding the state of the POCkeT colposcope in Peru. We graciously thanked Silvana and Dr. Lopez for all their help and left the office. Manish and I were very happy, we had learned so much!
Manish and Raina at Roche Farma, Peru.