British Balance Gain Against the Cost of the Latest Drugs

For a very informative article (NY Times - December 2, 2008 by Gardiner Harris)on how the National Institute for Health and Clinical Excellence (NICE) is tackling the price of healthcare in the UK, please click on the above title.

Great export opportunities

Although the world economies are slowing down significantly, the IMF(1) predicts in its latest outlook report, dated October 2008, that real GDP will grow strongly in many emerging countries including those of Emerging Europe, CIS, Turkey, the Middle East and Africa.

Annual percent change in GDP

Region /FY2008 /FY2009

USA /+1.6% /+0.1%
EU /+1.3% /+0.2%
Japan /+0.7% /+0.5%
CIS (2) /+7.2% /+5.7%
Emerging Europe (3) /+5.0% /+3.5%
Turkey /+3.5% /+3.0%
Middle East /+6.4% /+5.9%
Africa /+5.9% /+6.0%
(Source: IMF)

Most of the growth in these emerging countries is being attributed to robust domestic demand boosted by terms-of-trade gains in most countries in the region, expansionary macroeconomic policies and activity in non-oil sectors.

Therefore if your company is not making the most of the growth in these regions we strongly advise that you start revising your export strategy accordingly.

For more information and or assistance regarding growth opportunities in the above mentioned regions, please contact Christian B. Chahine – MDT International at cchahine@mdtinternational.eu or Ph: (949) 500-6298 in Laguna Beach, CA.

Notes:
(1) World Economic Outlook (WEO) – Financial Stress, Downturns, and Recoveries – October 2008
(2) CIS – Commonwealth of Independent States – (Former Soviet Union States)
(3) Emerging Europe: Baltics, Central Europe, Southern and South-Eastern Europe

Achieve more with less - The Interim Manager Solution

When looking to fill a need, many senior executives think instantly about either recruiting a full time employee or hiring a consultant.

However, what many fail to realize is that, hiring full time employees can be costly in terms of money, time and effort, and hiring a consultant may not be the best solution as someone still needs to do the actual work.

The solution is an Interim Manager. Interim Managers, like most qualified recruits and consultants, provide the latest thinking, strategic capability and the ability to fast-track critical projects.

However, contrary to consultants, Interim Managers are also implementers who have your actual success at heart since they are putting their efforts, expertise and reputation to the test.

Compared to full time employees, Interim Managers cost a fraction of the compensation since there are no recruitment costs, social security, health care insurance, holiday pay, bonuses nor pension benefits for you to worry about.

Interim Managers can be an excellent source for testing the waters, implementing projects and/or expanding into new territories for a fraction of the cost and with minimal hassle and risk. They have no need to settle in like full time employees would and can focus on your desired objectives from the onset.

Interim Managers are not interested in office politics. They are doers who will hit the ground running from the word go. They are task oriented and are able to produce fast / concrete results.

For more information about Interim Managers for your medical device expansion into Europe and the Middle East, please contact Christian B. Chahine - MDT International at cchahine@mdtinternational.eu

The Middle-East

Although I strongly believe that Europe will remain the major target for growth for US medical device companies for the foreseeable future (currently representing over 30% market share of total expenditures of medical devices), a tactical move on the part of senior executives is to look for markets that have low entry barriers, good sales potential and that can justify the effort, time and focus spent, concurrently.

While pursuing market research, regulatory approvals and/or clinical trials in Europe, US companies should have the flexibility to be able to focus on other promising international markets such as the Middle-East.

The Middle-East is comprised of 16 countries spanning from Egypt to oil-rich Saudi Arabia and the Gulf States (Bahrain, Qatar, Kuwait, the UAE, etc.) to the reviving economy of Iraq. Some key figures and points to be considered are as follows:

• Total Middle-East market estimated to be close to USD $100 billion
• No additional regulatory approvals needed as FDA is widely approved and highly recognized
• Population: 341 Million
• Per capita GDP: $662 (Palestine) up to $29,100 (UAE)
• Estimated growth (source: IMF)
• 2008: +6.1%
• 2009: +6.1%
• Arab Health
• The premier event for the Middle-East. Brings together healthcare manufacturers, wholesalers, dealers and distributors. Annual event – next trade show: 26 – 29 January 2009.

For more information about the Middle-East market and/or Arab Health, please contact Christian B. Chahine - MDT International at: cchahine@mdtinternational.eu

All UK doctors to face annual competence test

According to The Times all 150,000 doctors in the UK will have to face an annual competence test starting two years from now.

For full access to the article please go the following website: http://www.timesonline.co.uk/tol/life_and_style/health/article4381245.ece

Similarities and differences between what FDA and CE certification mean

Companies expanding into the European Economic Area (EEA) need to conform to the EU regulatory requirements (CE Mark) before they can start selling their products in the territory. However many people are mislead about what the CE mark truly represents and often assume that it is equivalent to FDA approval or clearance, which is not quite accurate.

Understanding the similarities and differences between what FDA and CE certification mean will allow you to develop a more efficient and effective overall company strategy. It will also help reduce unnecessary duplication of efforts, cost and time.

To learn more about what the CE Mark is all about please go to our website at: http://mdtinternational.eu/mdt/Downloads.html

Major changes MDD 93/42/EEC versus modified Medical Device Directive

Per March 2010, the new modified Medical Device Directive becomes mandatory and there are several changes that needs to be prepared before March 2010. The major changes are:

1. Records must be retained for >5 years
Records must now be maintained for inspection by the Competent Authorities for the useful life of the product or 5 years from date of manufacture, whichever is greater. For implantable devices, records need to be kept for 15 years from the time the last product was manufactured.

2. Outsourced design and manufacturing must be more closely monitored
If the design or manufacturing of a device is done by a third party, you must demonstrate that you have adequate controls in place to ensure the continued efficient operation of the supplier's quality system.

3. Closer inspection of design documentation
Notified Bodies will be required to perform an inspection of design documentation for a representative sample of devices using industry standard statistical techniques and commensurate with the risk of the device.

4. Appointment of an Authorized Representative (AR) explicitly noted
The AR gets a mandate to act, and be contacted, in lieu of the manufacturer in terms of meeting the obligations by the Directives for all classes of devices.

5. Clinical data now required for ALL devices, including Class I
The new Directive imposes more stringent requirements as to what constitutes "clinical evidence" and mandates stronger enforcement by authorities. The definition of "clinical data" is included and the Essential Requirements includes a requirement for Clinical Evaluation according to Annex X, which has been significantly amended. We highly recommend you review the changes to Annex X.

6. Class I (Sterile and Measuring) devices may now choose Annex II
Class I Sterile and Measuring devices will have more flexibility to select a route to compliance as they will be given the option to select a full quality assurance conformity assessment module.

7. Software is now clearly defined as an active medical device
It does not matter whether the software is integral with the device or is a standalone product. Software validation will also be an Essential Requirement.

8. Custom devices now subject to post market surveillance
Custom devices will now require a post-market surveillance system that is reportable to Competent Authorities.

9. Instructions for Use (IFU) must now be revision controlled
Where appropriate, the new Directive states that the date of issue or latest revision of the IFU must be clearly indicated.

10. Human tissue
Devices that incorporate human tissue, blood or plasma will fall within the scope of Directive 2001/83/EC and be considered Class III.

This information was provided by: MediTech Strategic Consultants B.V. - EN Vaals, The Netherlands

Export-Import Bank (Ex-Im Bank)

For those of you who are not familiar with the Ex-Im Bank, I strongly suggest that you speak with one of their representatives as they may able to help not just your company but your overseas customers as well.

The Ex-Im bank is the official export credit agency of the United States that assists in financing the export of U.S. goods and services.

The Ex-Im Bank offers three types of services:

1- Export Credit Insurance - that protects against buyer nonpayment and extended credit too

2- Term Financing - for international buyers of U.S. "capital" goods or services

3- Working Capital Guarantees - enabling small and medium-sized U.S. companies to obtain credit lines for the production of goods and services.

For more information, please check the Ex-Im Bank website at www.exim.gov

Good selling!!

European medical device market expected to grow by 9% in 2008

In a forecast dated October 2007, the International Trade Administration (US Department of Commerce), expects the European Medical Device Market to continue its expansion and grow by 9% in 2008.

This increase is due to aging populations and increased spending on healthcare technologies.

That means the EU market potential will be well above the $100 billion mark for this year alone.

Also, according to earlier information from the European Medical Technology Association (Eucomed), the leading European countries of France, Germany, Italy, Spain and the UK have been importing on an average over 60% of their medical devices.

Need I say more!!!

Economic slowdown...says who?

Some analysts predict a recession others do not, whatever it is called we are experiencing a slowdown and that is a fact.

One thing though is certain, recession or not, the healthcare sector remains one area that people will need to keep spending money on.

For your company to ride the storm you will need to work smarter. Going international is one way of doing so. Please see below an extract from an article:"Recession-Proof Jobs in 2008" by Larry Buhl, for Yahoo! HotJobs. http://hotjobs.yahoo.com/career-articles-recession_proof_jobs_in_2008-296

"...The Bright Spots

John Challenger, CEO of outplacement firm Challenger, Gray and Christmas, told Yahoo! HotJobs that careers in the following fields may offer a good chance of weathering a storm this year.

* Health care. Almost half the 30 fastest growing occupations are concentrated in health services -- including medical assistants, physical therapists, physician assistants, home health aides, and medical records and health information technicians -- according to the U.S. Bureau of Labor Statistics.

* International business. "If you have a strong knowledge of other cultures, and an ability to work in another country, you'll find plenty of opportunities," according to John Challenger. "If you're first generation Chinese, with business skills and Chinese language skills, you're in good shape..."

So medical device companies have nothing to complain about. Just work smarter and keep looking at the great opportunities that still exist out there . Need a hint: This is the time to devise or review your Export strategy!!

Do your homework first...

In reference to: "Riding the Export Wave - How to find good distributors overseas" by Sara Goldstein, Inc., January 2008
www.inc.com/magazine/20080101/riding-the-export-wave

Reply to the above mentioned Inc. Magazine article:

Although I agree with the Ms. Goldstein that export is the way to go I would go even further and say that export is always good, not just when the dollar plunges in value.

Some of the advantages of always focusing on export are: 1) it provides a new lifeline for your existing products, 2) it helps spread your bets, especially during economic slowdown, 3) it helps spread your fixed costs, 4) you may learn some useful ideas from foreign markets that you could adapt to your domestic market, 5) it helps fend off domestic and foreign competition. (For more information, please check the following blog: http://www.mdtinternational.blogspot.com/)

However, the one point that I disagree with Ms. Goldstein on is that working with a distributor may not be your best bet.

First and foremost, you need to do your own homework and find out for yourself what each targeted market is all about.

Relying on others to get an idea of the potential, challenges and ways to market your product means that you are giving up control of your destiny in that particular market. After all, how are you going to judge whether your distributor is doing a good job, giving you the right advice and/or focusing on your product line?

What I suggest instead is that you perform first and foremost an independent market research to gauge the market potential, the competition, the regulatory approvals as well as the best ways to market - as it can be via an Agent, Licensing, OEM or a distributor. Not just via a distributor.

The value of Strategic Planning

How do you know whether your sales and profits are the best you can get in any particular market? Are you selling to the right customers, are you selling the right product mix, are you using the best distribution channels?

These are all questions that will be best answered if you have taken the time to plan your strategy, ahead of time, and have a solid road map to refer to.

Some of the major points that need to be addressed, in the medical device industry, are:

Market Survey
What do you know about the country/market that you are focusing on? Who is your competition? What is preventing you from selling more/better?

Market Intelligence
How is the market evolving? What are the new trends/requirements?

Objectives
What are you aiming for? What is it that you want to achieve?

Manpower
Do you have the right people in place? Are your partners/distributors on the same wavelength?

Regulatory
What are the regulatory requirements? How are you addressing them?

Going to market
Is it best to sell via agents, distributors, direct, licensing, OEM or any combination of these?

Clinical trials
Do you have credible data you can use, to prove the efficacy of your product/therapy?

Key Opinion Leaders
Who is backing you in each market and giving you their blessing and support?

Reimbursement
All the hard work would be futile if your product is not reimbursed in some countries, especially in socialized healthcare Europe. Do you have the right contacts and a solid file proving cost benefits for your product?

Remember that our environment is constantly changing and is different from market to market. In order to keep up with what our customers' needs are, we need to initially well define what it is we are in business for, how to please our customers and make sure that we keep monitoring our main target's and market's evolving needs, laws and requirements.

Why you should always think about Export

Export is beneficial:

• it helps spread your bets, especially during economic slowdown
• it provides a new lifeline for your existing products
• it could provide faster revenues - you could sell your new products internationally first, while waiting for FDA approvals
• it helps fend off the impact of both domestic and foreign competition
• it helps spread your fixed costs
  
• when the exchange rate ($) v/s foreign currencies is favorable - as in now! (2008)
• when you have identified a need in a certain foreign market - you actually need to be actively seeking for new horizons
• when you can create a need in a foreign market for your product - make sure to adapt your products to the local needs and requirements
• when your home market gets saturated - ideally, you would have thought about export way before then
  
• when you want to learn from outside the borders - you could adapt foreign ideas to your domestic market
• when it can be beneficial for your domestic launch - may very well support your FDA trials

What are you then waiting for? - Start working on your strategic export plan, today!!!