The importance of truly breakthrough medical innovation to individuals and to our society is over-shadowed by just two things - the costs and complexities in moving an idea or concept to an FDA-approved and fully adopted product. Product planning and execution is more critical than ever before as just the little missteps, even early-on in the process, can be crippling.
Having a product that works, and designing and executing large clinical trials that prove it, no longer guarantee approval, successful commercial launch, reimbursement, or adoption. The uncertainties of the healthcare delivery paradigm have introduced additional complications and have caused significant politicization of the process.
Breakthrough Medical Innovations, LLC is dedicated to ensuring that products and services that can save lives and make a real difference reach patients and have a meaningful impact, as fast as possible. It is a consulting, advisement, advocacy, and policy partner to the biopharma and medtech industries and their stakeholders.