"Sales practices in certain international markets may be inconsistent with our desired business practices and U.S. legal requirements, which may impact our ability to expand as planned [in India and China]. ... Further, international markets are increasingly being affected by economic pressure to contain reimbursement levels and healthcare costs; and certain international markets may also be impacted by foreign government efforts to understand healthcare practices and pricing in other countries, which could result in increased pricing transparency across geographies and pressure to harmonize reimbursement and ultimately reduce the selling prices of our products. Further, certain foreign governments allow favorable reimbursements for locally-manufactured products, which may put us at a competitive disadvantage and negatively affect our market share, including in China if we are unable to executive our business strategy in that market or do so in a timely manner."
It's time for everyone to unite and direct our own personal 'reimbursement rates' (spending) to countries and companies that don't engage in this kind of market distortion shenanigans and unethical behavior. Can you imagine if the FDA tied approval to where the device was manufactured or if reimbursement rates in the US were tied to country of origin?