As originally asked by Giovanni Lauricella.

The Medical Device Industry is certainly a global industry, but not equally successful around the world for numerous reasons.

• Japan has a challenging/difficult regulatory system
• Israel is known for heavy innovation but not marketing and sales
• Latin America is known for more use of distributors and experimental clinical trials as opposed to booming sales and innovation
• USA has increasing regulatory barriers and with the lack of available money for startups, it depends on the large company “acquisition system” for most commercialization
• Europe is where most commercialization begins for new innovation and is years ahead of most health systems
• Etc. Etc. Etc.

What are you thoughts of different parts of the world’s medical device system and what makes certain parts of the world challenging for commercialization?

Look forward to connecting www.LinkedIn.com/in/GiovanniLauricella

Gordon Millar
Owner
Was the question about pre-commercialisation ie regulatory hurdles or simply about entering a market? It differs from region to region.

Evert De Rijcker, BN, EMBA
International Business Unit Manager TFM at Deltrian International
I myself am responsible for medical device sales for a global filtration corporation in the Benelux, a small geographical area but even than regulatory and cultural differences in doing business can conflict or influence growth potential (KIWA and CEapproval in NL). Our corp. has offices all over the world (incl.for our medical division) in Islamic countries (where finance, regulation and culture is definitely different), emerging markets like India, Brazil…But even in settled markets like US, our home country, we’re facing struggling with legal. For Russia I know it’s important to have political contacts.
Some tip: I’m an EMBAstudent at Hult IBS. Our professor Global Management, Mrs.Ajah Bhalla, is a world autority on this. He’s a good advisor on how to deal with situations as mentioned by several of you.

John Strobel
Global Strategy Development and Execution (Medical Device and Industrial)
Patrice, Thanks for the comments. I agree China can be very challenging. We had many difficulties even working through Chinese regulatory consultants. Once we hired a direct employee(Chinese national in Beijing) to manage our regulatory the process went much faster(although still a year). Saudi Arabia has been on hold for us. There are regulatory requirements although not yet enforced(supposedly only 5-10% of companies are advanced in the process so it could be difficult to enforce in the short term). We have everything ready to finalize registration once things begin to move. How has your experience been in Brazil?

Patrice Napoda (Monroe)
Principal Consultant
This has been a great discussion to review and I agree with many of the points made above. The ability to commercialize is directly related in any regulated market to it regulatory processes and agency, therefore I am focusing my comments on the regulatory aspect. My experience is that the earlier in the learning curve a country’s regulatory agency is, the more difficult gaining approval may be. This is because the regulators are still defining what the requirements are and it is difficult to articulate to importers and manufacturers what documents and evidence are needed. An example of this phenomena is the experience many companies have had in the past year in some Middle Eastern countries, such as Saudi Arabia and UAE. While these may not be key markets alone, they are often the entry point to distribution to other countries in the region. However, another example of this learning curve in a more key market is the experience over the past few years in China. The regulatory processes and requirements here continue to develop, rapidly changing at times, with little advance notice and effective dates which are difficult to meet. The four year license approval time is also challenging with new requirements being applied at time of renewal as if the original approval had not been granted. Due to the importance of this market, I believe this may be the most challenging to commercialization.

Deepak Kuthyar
Applications and Product Development Manager at SriSai Multiskills
India is very challenging provided the price and quality we do have good manufacturing facilities to manufacture precision components for the devices and implants to commercialize economically any where in the world.

As pointed out by Mr David current market is very small but once the prices are competetive the market is very huge comparetively. Any manufacturers interested in collaborating with us for precision turned components we are open for discussions.

B.M Luklinski
Consultant Spine Specialist at SPINE BACK RACK LIMITED
Japan – crooks,stole my invention in Osaka ,made over 150 ml USD ! ,USA waste of time ,just talk ,no substance ….

John Strobel
Global Strategy Development and Execution (Medical Device and Industrial)
1) Regulations/paperwork
2) High Import duties
3) Corruption
4) Available focused/or trustworthy distribution channels
For difficulty, I would say:
Brazil (1&2)
Some African Countries(3&4)
Indonesia (4)
Iraq (1)
China has lengthy Regulatory approval but corruption seems to be decreasing, otherwise it is relatively open
Japan and Germany can be challenging due to local culture/needs, but are both very open and worth the time and effort.
Local teams really help cut through the regulatory barriers.

Bruce Wang
Vice President at Microport Scientific Corp
Low reimbursement price becomes a huge hurdle for companies to commercialize new products in countries like South Korea and Taiwan due to low profitability. The Korea FDA has gone so far as to asking medical device companies to submit company’s P/L to determine reimbursement price. They also fluctuate the reimbursement price based on the currency exchange rate fluctuations. In addition to low reimbursement price, in Taiwan, on the other hand, it takes 15 months from the date of submission to actually selling the products to the hospitals…

Niharika Midha
Service Segment Leader, Clinical Care Solutions, ASEAN at GE Healthcare
US and Japan are challenging if you have to take the PMA route – so it would depend on how ‘novel’ is the device you are trying to commercialize. In addition, I think China is challenging as rigorous regulatory systems are in place.

Robert Trinka, MBA
Senior Management: Sales | Marketing | Business Development
Brazil is tough as others have mentioned. China also, SFDA requires rigorous testing and results.

Luis Nieto
Serial entrepreneur & developer of the new era
Every country poses a challenge and a liability when things are not done right. Interesting how people can and will cast an opinion with little or no serious experience. I saw intuitive answers like USA, Brazil and Mexico, where regulation is tough and market size is appealing; Russia and Mexico, where market size is considerable and corruption is a concern. I was surprised to see Chile or South Africa and other countries where business is rather easy. People have the right to talk nonsense and it is quite amusing. But they also have the right to see well defined surveys that produce something other than mumbo jumbo.

Anil Bhalani
Consultant – Regulatory Affairs/Quality Assurance
China. Four years after marketing the product there, there is no guarantee that your product is not duplicated. Also the regulatory requirements of providing design and process information is risky for new inventions.

Urs Mattes
Healthcare Executive in Life Science and experienced Board Member
I have just attended a meeting in Beijing which focussed on compliance risks in China. At that meeting it was mentioned that the BRIC countries pose serious compliance risks to large as well as SME companies because most companies need intermediaries (distributors, sales agents, etc.). There are serious legislation in place such as the FCPA (1977, USA) and the UK Bribery Act (2010) which make running businesses in BRIC countries very risky.

Tsutomu Miki Kurosawa
Visiting Professor at Kagoshima University
Huum, I am not involved in market of medical devices but I have heard similar impression of EU and US members of ISO/TC194. Japanese government may follow ISO framework for medical device importation. And recently our government changes the policy for the importation of medical devices.
I presume that language barrier may be one of the causes and the paucity of competent consultants to you within Japan may be other problem for you.
I am attending ISO/TC194 Biological evaluation of medical devices next week held in Pavia, Italy as a convenor of WG3. If any of you are attending this conference, please ask me whatever you would like to know.

Richard Jeffery
Managing Director
With Australia we have get everything approved by the TGA, a Euro marks helps but from the US no as the standards are different. We have spent 9 months to get a class 1 scale registered which is US made, the testing does not match to our standards and we are now looking at another 25k just to get it registered, not fun. That is just one instance as the list gets longer here with TGA it gets harder…

Mahmoud Elaskary
Sr. Director of Strategic Planning
The higher the regulatory requirements to approve a medical device product, the difficult the commercialization process. If the medical device requires clinical trials (PMA route), both the U.S. and Japan are difficult markets to commercialize at and cost intensive. CE mark in Europe and 510K processes in the U.S. are not very vigorous and most companies can complete that successfully.

The issues with other international markets like China and Korea, is the protection of intellectual properties. Latain Americas markets issues are mostly economic stability and heavy discounts due to use of distributors. In the Middle East, bureaucracy, because almost all of the hospitals are controlled by the local governments.

Shohreh Behrouzi, MBA
MBA Commercial Leadership Development Program at AstraZeneca
How about Central Asian countries like Tajikistan, Uzbekistan,…? Can anyone share an idea?

Thomas Z. Lauritzen
Head of Data Science at Proteus Digital Health, Inc
I’d say regulatory is the biggest hurdle. There’s a reason most companies apply for CE first and then FDA. The order is for regulatory hoops and if you have those two, it’s more a formality to get it approved other places.

But reimbursement plays a big role. With the economy as it is, it’s nearly impossible to get a new (expensive) device covered for something new as it would increase health care costs. A cost cutting device for something existing is much easier. If you can reduce a $20bn/year cost to 2bn/year for treating/diagnosing some disease (and then take that market) everybody is happy.

Assaf Sayada
VP Corporate Development, mPrest
Of course dealing with language is not as complex as getting a FDA approval…
But it definitely represents a real challenge when moving to the next step. And if it is done professionally with the right experts in the Medical Device industry, it can even become a success accelerator.

Inge Boonen
Head Of Business Development Southern Europe * Multilingual Language Services * Helping businesses to be local
Is language to be considered as a challenge for medical device commercialization, or do you feel that once all regulations etc. are met, it is not such a big deal?