We have reached an important milestone today! Our work has been featured on the Biodesign site —which is the companion to the 2nd edition of Biodesign: The Process of Innovating Medical Technologies—, the most important medical innovation book in the industry.
The "Update" section and the Strategy Development/Clinical Strategy chapter are profiling our work to make Colombia the top choice for early-stage clinical trials. This book was inspired by the world-renowned Stanford University's Biodesign program and was written by Paul Yock, MD, director of Biodesign, and one of the most respected authorities in the industry and other collaborators.
The mission of the Stanford global Biodesign program is to train the next generation of global medical technology innovators. Key components of the mission are:
- find and develop in-country innovators in select geographies
- train our partner institutions in the teaching of biodesign methodology
- promote exposure to our US-based fellows and students to foreign medical technology opportunities
- develop devices that are cost-effective and globally relevant
The inclusion of Colombia in the Biodesign book —as a top destination for medical technology clinical research destination— will increase global industry awareness of over 120 ICH/GCP-government-certified clinical research centers in the country that are pretty much unknown to the medtech and biotech industry.
Colombia, strategically located close to the US and on the same EST time zone, offers many strengths for medical device trials: It is the third-most populous country in Latin America, after Mexico and Brazil, and it's considered the most urbanized Latin American nation. Nearly 89% of its 50 million people live in big cities, it has good clinical practice guidance and over 120 hospitals licensed to run trials —trials in Colombia have been conducted for almost 30 years, and it receives about 120 annual trials, making it one of the leaders in the Latin America region. It has a centralized healthcare system that draws patients with particular needs to specialized or regional hospitals, which can help speed patient recruitment. A large number of experienced investigators working in certified sites means fewer concerns about generating high-quality data. Also, treatment-naive populations are plentiful. Strong doctor-patient relationships support high trial recruitment rates and low dropout rates. Furthermore, prices for hospital procedures in Colombia are considered to be about 30 lower than costs in the US and Europe.
We recognized that development stage medtech and biotech startups struggle to find highly talented medical staff that will give them the focus and energy to complete, on a timely manner, quality, ethical clinical research at a very competitive cost.
We recognized that clinical research sites in Colombia have had very little international exposure and have been unknown to the global medtech and biotech industry. These are highly qualified sites that receive a significant volume of trials sponsored mainly by the local Colombian subsidiaries of multinational pharmaceutical companies (e.g. Johnson & Johnson, Novartis, Roche, Pfizer, Sanofi, Merck, etc.). These sites are staffed by experienced and highly trained personnel and can be made available to the medtech and biotech industry.
Our founder —Dr. Pedro Martinez-Clark, a Harvard-trained interventional cardiologist— envisioned a clinical development and research organization that helped innovative medtech and biotech startups reach their clinical development and research goals by partnering them with cost-effective, quality and ethical clinical research sites in Colombia —a hidden gem unknown to the industry— and by operationalizing their trials at these sites. Our official Colombia presentation, along with our value proposition to medtech and biotech startups provide additional information about who we are, what we do and why we do it.