Global Medical Device Market Outlook

As with most industries, the medical device sector was not untouched by the economic crisis, though it has not deterred the industry’s overall growth. Smaller firms, unable to pick up the slack of product development costs previously covered by venture capital investors – now made more cautious by the economic slump – were obliged to curb their activity. Some other small firms, however, chose to merge with larger firms, thereby continuing technological advances without bearing the full burden of the cost. Domestic and international acquisitions and mergers allow a cross-border sharing of resources and knowledge, facilitating continued medical technology innovation despite the tough economic climate.

More evident challenges to the medical device sector include taxes on products in overseas markets as well as incongruous foreign regulatory controls and varying implementation of standards.

Key Players & Regional Markets

The medical device industry covers a wide spectrum of products used in the treatment of patients, including cardiovascular devices, dental equipment, diagnostic devices, medical equipment and supplies, ophthalmic devices, orthopedic devices, respiratory devices and surgical equipment. In the US, medical devices are recognized as such in a book of public pharmacopeial standards, called the United States Pharmacopeia-National Formulary (USP- NF), and its supplements.

Top names in the industry include such medical technology leaders as: Johnson & Johnson, who ranked 40th in the Fortune 500 list for 2011, Abbott Labs (ranked 69), Medtronic (ranked 158), Baxter (ranked 192), Boston Scientific, GE Healthcare Technologies, Becton Dickinson, St. Jude, Stryker Corporation and Beckman Coulter.

Regionally speaking, the US is the leading competitor, holding in excess of 40% of the world medical device market, reports Exvere private investment bank. The US is not only an important player in manufacturing and exporting medical device products but also creates about half of global market demand. It imports lower-technology medical device products, with a notable share coming from China, and tends to export higher-technology device products. While the US may see its stakes in the global market rise in the event of taxes being lowered, practices standardized and standards harmonized, it would also see more staunch foreign competition from countries that, even if they lag behind in innovation or expertise, could compete through the cheaper production of lower-technology medical devices.

Growing domestic production of lower-technology devices not just in China but also in India, Korea, Taiwan and Brazil will help those nations become relative competitors to the US in the future; though the US is set to remain at the top of the higher-technology device market for some time. In fact, the US market is forecast to climb to $ 140 billion in 2013, over double its worth of $ 60 billion just a decade earlier, as indicated by the preliminary results of a Washington State biomedical device study.

While demand for medical devices in developed regions such as Japan, Canada, the EU and the US remains steady with annual growth rates of between 3% and 5%, developing regions are to prove lucrative for US exports, with demand in countries such as India and China showing more than twice the rate of developed countries. China’s sizeable population and healthy economic growth make it an increasingly promising target market. India equally shows potential as an export market for the US medical device sector due to its ever-more affluent population and strong accompanying private healthcare system.

At the moment Germany and the Netherlands are key competitors to the US for market share in higher-technology medical devices. However, some companies, such as Dutch firm Philips Electronics, are not completely independent players in so far as a good deal of their production is carried out in the US.

Medical Device Product Life Cycle

To enter the marketplace, medical devices must comply with pre-defined product life cycle parameters intended to maximize patient safety and ensure the highest quality standards. The product life cycle can be divided into three main phases. The first phase, or early product life cycle, consists of a product concept with its relevant market strategy and financing. The second phase, or the middle product life cycle, involves manufacturing and validation through clinical trials along with packaging and labeling. Lastly, the late product life cycle phase consists of not only the market launch of the medical device but also market analysis that subsequently impacts on successive generations of the product.

Professional Certification

The Medical Device Body of Knowledge, created by the World Medical Device Organization, is an accrediting body that provides online multimedia medical device training. It offers three levels of qualification:

Certified Medical Device Associate (CMDA) – A basic level of knowledge that covers legislation, medical directives, assessment, classification, standards and the role of notified bodies.
Certified Medical Device Professional (CMDP) – This intermediate accreditation teaches the latest standards as applicable in the product life cycle. This course offers training in diverse aspects of medical device knowledge, including project management, worldwide device regulatory systems, clinical investigation submission, and clinical project financing and reporting.
Master Medical Device Professional (MMDP) – This qualification facilitates a more in-depth understanding of regulatory systems and strategies, and also involves training in ethics, reviewing clinical research, post-market assessment, traceability and product recall.

Regulatory Bodies

Australia, Japan, the US, Canada and the EU are the five founding members of the Global Harmonization Task Force (GHTF), a body that seeks to maintain regulatory control over medical devices in a cohesive manner across global markets. The organization has three broad phases of regulatory control for medical devices, which are divided into premarket, placing-on market and post-market frames. Though different regions differ in the specifics of regulatory control, the first two phases involve risk management, licensing and registration while the post-market surveillance phase includes recording distribution, recall procedures and processing complaints.

The GHTF aims to coordinate regulatory efforts, aid technological growth and encourage trade by producing documentation that provides coherent guidelines for its members. The documents are made by GHTF study groups and are split into four areas of expertise: comparison of worldwide medical device regulatory systems, post-market analysis, study of already operational quality system stipulations, and lastly a study group that puts forth principles by which to review medical devices.

The Medical Device Manufacturers Association, a Washington DC-based national trade association, seeks to streamline policy decisions related to the medical device sector through cooperation with the US Congress, the Food and Drug Administration (FDA) and US healthcare payer the Centers for Medicare and Medicaid (CMS).

The FDA Center for Devices and Radiological Health (US FDA/CDRH) is also involved in the regulatory control of medical device products. This body aims to record adverse events of medical devices on the market. One of its initiatives proposes the establishment of a database that would allow easy access to information on US FDA-approved medical devices.

Moving forward, one of the most important tasks for bodies of regulatory control is to set medical device standards applicable in all countries to harmonize and facilitate global trade and promote patient safety.

Market Outlook

Medical device market research shows that the industry is likely to continue going from strength to strength, with the US keeping its top spot for the foreseeable future. The US remains a leader thanks to cutting edge technological innovation and demand from growing markets such as India and China. The industry as a whole is growing largely because of an ageing global population and climbing societal risk factors. In particular, diet-related chronic diseases, such as cardiovascular disease and diabetes, continue to create demand for medical healthcare services.

Equally, the need for medical devices continues to climb, with life expectancy jumping nearly 20 years over the past 50 years. In fact, worldwide demographics are increasingly shifting towards older populations: between 2000 and 2050, populations in developed regions will see those aged over 60 grow from less than 20% to 34%, while the proportion of children aged under 15 is set to decline by 2% from 18%. According to a United Nations report on ageing, by the 2050s, life expectancy at birth will reach 80 years for almost 60% of the global female population. This ageing population, combined with lifestyle-related disease, is the medical device industry’s assurance of increasing market demand.

Source: www.reportlinker.com

David Winer …..

Agricultural Machinery Manufacturing Market Segment Forecasts up to 2020, Research Reports

The demand for food supply is continuously increasing due to growing world population. Hence, various economies are focusing on increasing their capability to produce more food through using modern agricultural machinery. Farmers are trying to yield maximum amount of crops through using advanced farming techniques such as precession and integrated farming. Use of advanced agricultural machinery is an important factor for these types of farming techniques. Hence, farmers are focusing on using agricultural machinery to increase farm yield from limited land resource. Agriculture machinery helps in effective utilization of resources such as land and labor. Moreover, use of agricultural machinery helps in reducing manual labor for farming activities. Farmers use agriculture equipment for tillage, sowing, plant protection and threshing. The demand for dairy products in recent years has also increased demand for dairy farming. Dairy farmers are preferring automated feeding and milking equipment to fulfill demand and save time in dairy farming sector.

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The market for agricultural machinery can be segmented based on farm size. Farmers having large-size holding prefer using agricultural equipment which has more horsepower and can be used in large scale farm operation. On the other hand, farmers having small-size holding prefer using agricultural equipment having less horsepower. Thus, the cost of agricultural equipment mostly depends upon the power of the equipment. Currently, farmers with small holding have started using modern agricultural equipment to optimize their resources and save considerable cost and time.

Agricultural machinery market can be segmented depending upon farming operations such as farm tractors, harvesting machinery, fertilizing and planting machinery, cultivating and plowing machinery, threshing machinery and dairy equipment. Among these segments, the demand for farm tractors is going to increase in coming years. Farm tractors are largely used by small and large farmers for performing different type of agriculture operations. Through joining different attachments, a farm tractor can be used for tillage, seeding and transportation purpose. Thus, the market demand for tractor parts and attachments is also going to grow in coming years.

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The demand for agricultural equipment is mainly driven by the projection of crop production in next season or year. Thus, the demand for agricultural machinery can vary from year to year. Hence, most of the governments provide subsidy to farmers for buying agricultural machinery or equipment. This factor will help agricultural machinery market to grow in coming years.

Agriculture machinery manufacturers mostly prefer selling low power farm equipment such as tractors, harvesters to developing economies which have lower purchasing power. Farmers in these economies often rent large agricultural equipment for their farming operations. Hence, the demand for large agricultural equipment in developing economies is going to increase at a slow rate in coming years. In developed countries, agricultural machinery manufacturers mostly sell high power farming equipment as most of farmers own large farm land.

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Most of the agricultural machinery market in developing economies is dominated by regional players who focus on providing small and low power agriculture equipment to farmers. This can be a major challenge for large agricultural machinery manufacturers for expanding their market in developing economies in coming years. The market for agriculture machinery will continue to increase in developed economies such as North America and Europe due to large farm land and limited availability of labor. The growing demand of food supplies in countries such as China and India will increase the demand for low power agriculture machinery in coming years.

Some of the key agricultural machinery manufacturers operating at a global level are Deere & Company, CNH Global NV, AGCO Corporation, Kubota Corporation, CLAAS KGaA mbH, Yanmar Co. Ltd, Escorts Group, Mahindra & Mahindra Ltd, Tractors & Farm Equipment (TAFE) Ltd and Caterpillar Inc.

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Will State Farm Florida Bail Out on the Florida Home Insurance Market Too?

State Farm Florida has been one of the few Fortune 500 home insurance companies still operating in Florida for a long time. As the largest private insurance company in the state for both homes and autos, it covers 1 million and 2.5 million policyholders respectively.

They deserve credit for that.

After all, many big insurance companies simply left Florida for good after Hurricane Andrew – and never looked back. That left Florida to deal with the problem on its own and caused it to create its own state run insurance company of last resort to help those who simply could not find coverage.

State Farm Florida did not pursue this path.

It has taken a prudent approach to the market that has been present in Florida since Hurricane Andrew. These steps have included:

Strict underwriting criteria for homes selected for new business

Multiline discounts for policyholders with home, auto, and life coverage

Selectively cancelling higher risk older homes closer to the coastline

This approach might have been successful during normal, reasonable periods of history. However, reasonable is not the right word to use for what has happened in Florida in recent years:

From 1992 to 2004, no large insurance companies re-entered the Florida home insurance market – leaving State Farm on its own.

Florida hurricane claims in 2004 and 2005 caused billions of dollars in damage. State Farm Florida paid millions in claims and had to request an emergency cash infusion from its parent company to recapitalize it.

While the company was able to get significant rate increases after the 04/05 hurricanes, massive rate increases granted to most of the companies in Florida in 2005 and 2006 caused a major political uproar. Quite honestly, the public demanded rate relief because Florida home insurance was simply not affordable.

The pressure for lower rates was far worse due to outrageous property taxes and the collapse of the Florida real estate market.

The State of Florida reacted to voter pressure. However the final impact was not impressive.

Legislation passed in 2007 and 2008 had a limited effect in lowering home insurance rates while shifting billions of dollars in catastrophic hurricane risk to the Florida Hurricane Catastrophe Fund – a state entity that has publicly stated that it can’t meet its reinsurance obligation to insurance companies in part due to the frozen bond markets.

As a result, all companies including State Farm Florida are concerned that the Florida Cat Fund won’t be there to pay them back after a major hurricane and are looking for new sources of backup reinsurance.

That, combined with other factors led the company to request a 47% rate increase a few months ago. After state regulators rejected the rate increase, the company appealed that decision in court. Recently a judge agreed with state regulators that State Farm’s 47% rate increase was not justified and also rejected the rate increase.

This brings us to where we are today – a time when many Floridians have to be wondering if State Farm Florida is preparing to exit the state for good. This would not be good news and would be sure to cause chaos in the Florida home insurance marketplace as consumers scramble to find alternative coverage.

You have to be ready for the realities that come with today’s uncertain times. One of those might be that your State Farm home insurance policy in Florida will be cancelled or dropped. If that happens there are several things you need to do to respond to this:

Shop your policy. Most State Farm Florida agents can only offer you homeowners coverage with Citizens after your policy is cancelled. Find a large independent agent who represents multiple companies in order to give you the best options for replacing State Farm Florida.

There are new Florida base regional insurance companies that have been created over the past 15 years, with many only being recently approved since the start of 2006. Some of these companies might be a good option to replace State Farm but you have to research each and every one of them. Check their financial ratings and customer service history thoroughly.

Insurance agents for State Farm Florida will be hurt by large cancellations of homeowners insurance policies. They have spent years building a book of insurance business in Florida. When they lose your home insurance business, it usually means they lose your car and life insurance business as well. While you can’t help but be sympathetic, you need to know that it is in your agent’s self interest to keep your auto and life insurance business while putting your home insurance coverage into Citizens Property Insurance. Don’t accept being placed with Citizens without looking for other private home insurance companies through other agents that can also offer you auto and life insurance.

If you are considering Citizens Property Insurance, get all the facts. Citizens has said that it does not charge enough premium to cover the risk that it takes. It is also experiencing problems with borrowing to pay major hurricane claims in today’s shaky bond markets. Major recommendations being presently considered at Citizens include raising rates, limiting coverage, and mandating certain home hardening measures. Research Citizens just like you would any other company.

While it is impossible to know how this drama with State Farm will conclude, by following these steps you’ll be way ahead of thousands of other policyholders who will all be scrambling to replace their coverage at the same time.

Michael Letcher is a former Fortune 500 executive and a licensed CPA. His on-line buyers guide will give you option if State Farm Florida drops your home insurance coverage. Get his free newsletter at =>
http://www.homeinsurancebuyers.org