Looking Ahead to 2014


What should orthopaedic device manufacturers consider when doing business in 2014? Regional experts provide advice specific to multiple geographies.



“If you are trying to convince a hospital in Canada to buy your new technology, you need to have credible, peer-reviewed studies that prove that the technology is indeed better for the patient or saves money. It doesn’t do any good to go in with a case study, or two case studies or a good salesman. Manufacturers that want to do business in Canada have to be armed with credible, peer-reviewed proof that their technology is better.” —Alan D. Tanner, President and CEO, Joint Solutions Alliance

United States

“Look at the big picture in terms of disease management and explore opportunities in non-traditional areas. Stay innovative, but keep technology simple, easy to use, better and less expensive. Continue to demonstrate value through clinical and economic outcomes. Embrace healthcare changes—consider different business models and fostering relationships with non-traditional partners. Remember—orthopaedics has had its share of ups and downs, but will continue to be a resilient and rewarding business.” —Don Urbanowicz, Principal, Urbanowicz Consulting


“Mexico remains an appealing market to manufacturers from Brazil, Canada, China, France, Germany, Switzerland and the U.S.—a market with a high number of orthopaedic manufacturers. We see continued interest in the market, primarily because Mexico relies heavily on imports and because COFEPRIS (Mexican Ministry of Health) offers a streamlined approval process through the use of accredited third party reviewers.”—Chris Schorre, Vice President of Global Marketing, Emergo Group


“I believe the first question manufacturers should ask before starting the process of entry into the Brazilian market is: am I going to manufacture my products in Brazil or only have distributors? The answer will define the policy and costs required by ANVISA for the registration of products, along with fees charged by Federal, state and district governments. Brazil is a continental country, and a market of great potential that must be respected in its particularities. The device company must have policies focused on fast and efficient logistics.”—Danny Arendt, Manager, Import Department, DMC Group, Razek Equipamentos


“The Argentine OEM market has turned rather difficult during 2013, and there is no sight of change during 2014. The economy is deteriorating due to restrictions to imports: the Secretary of Commerce has become tougher with the authorization of imports (DJAI); political environment: the actual governing party (Frente para la Victoria) lost power during the last national election, despite there being two years left before the next presidential election; the political environment will turn more conflictive, as the actual government is losing power and the future reactions to this are not known. On the other side, the U.S. dollar official exchange that is subsidized is a lower value.” —Ing. Pablo R. Carbonell, Chief of Quality Engineering and Regulatory Affairs, IMPLANTES FICO SRL


“I believe a key new development for OEMs doing business in Europe in 2014 is the potential impact of unannounced visits. The relevant information is contained within Commission Recommendation of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices. Critical subcontractors and crucial suppliers are mentioned within this document as having an active role to play. For example, the Commission Recommendation states, ‘Notified bodies may, instead of or in addition to visiting the manufacturer, visit one of the premises of the manufacturer’s critical subcontractors or crucial suppliers if this is likely to ensure more efficient control.’” —Hamish Forster, Ph.D., Product Expert and Scheme Manager Medical Devices, Orthopaedics & Dental, BSI


“Russia remains a market in flux from a regulatory perspective. Reforms to regulations initiated in 2013 have yet to be fully implemented, and this has led to confusion among device companies trying to enter the market. We hope the situation will improve in 2014 as pressure mounts on Roszdravnadzor (the Ministry of Health) to make the process more efficient and transparent. On the plus side, the Russian government is dedicating $200 billion through 2020, focused on updating its healthcare system. One such area of focus will be on rehabilitation and physiotherapy, which may result in new opportunities for orthopaedic manufacturers in the coming years.”—Chris Schorre, Vice President of Global Marketing, Emergo Group


“Doing business in China is a difficult thing, extensive due diligence is required. Manufacturing has gotten better in China, and the local companies are producing more and more complex Class III medical devices to compete with the foreign products. Intellectual property protection is still very weak, so companies must be very careful in this area. For registration, camouflaging key information is recommended.”—Ames Gross, President, Pacific Bridge Medical


“India is way behind China with respect to medical device manufacturing. Most device manufacturing in India relates to small and commodity types of devices. Devices with strong IT components will do well in India since the country is so high-tech, especially with the local software business.”—Ames Gross, President, Pacific Bridge Medical