The biggest challenge faced by companies in the pharmaceutical industry is to develop, test, and manufacture drugs under the strict regulations laid out by the FDA. This presents companies with very low margin in causing any variance in the way they manufacture products. With the competition growing fierce, many companies will find the time to develop and market a patent drug extremely short. It takes years of extensive research, analysis, and testing to develop a drug that is then approved by the FDA. By the time the drug is launched in the market it is most likely that competitors have already taken a head start in manufacturing the same medicine. Attaining regulatory compliance within this environment in itself is a difficult task that only few pharmaceutical companies are able to achieve. There are very clear risks involved in manufacturing drugs when the pharmaceutical companies are constantly under observation by the stringent U.S. government mandates. Because of this reason, many companies are utilizing risk management software to excel their businesses.

The first priority of any pharmaceutical company is to spend less time researching a new drug. Many departments are working independently of each other in conducting groundwork for the research. This presents the problem of isolated work silos that consist of critical information trapped within the manufacturing process. Risk management systems help employees collaborate in an integrated environment where processes are linked together. Having a web-based repository allows companies to maintain consolidated data in a structural format. This eliminates data redundancy which hampers analysis and causes miscommunication between the employees. The risk management system provides companies with a common platform for collaboration, which offers centralized control for storing SOPs, research work, and all other kinds of related information.

Since pharmaceutical companies deal in life sensitive business, the FDA has adopted a risk-based paradigm to monitor the pharmaceutical industry as a whole. Compliance is something companies must achieve in order to sustain their business. FDA regulations and Pharmaceutical Current Good Manufacturing Practices demand companies adhere to certain rules. The FDA has devised a risk prevention methodology that companies must follow to avoid risks. The steps in this framework begin with the identification of a hazard, nonconformity, or source of variability. A risk management system can provide analytical capabilities and a reporting console that help identify the risks that are faced by companies. Once risks are identified, they can be prioritized using FDA and industry standards. This helps pharmaceutical companies comprehend which risks are prone to hit the business before others as well as the implications of each risk on an individual basis.

Several years ago I was asked by Tony Robbins to give a 2 hour talk to his 90 sales people during their annual sales rally. As they were highly trained people selling Tony’s products and seminars, I remember asking myself, “What can I share with them, that he hasn’t already taught them?” I decided to share with them the difference between playing to win vs. playing not to lose.

So many people are doing exactly that–playing not to lose vs. playing to win during these changing times. In fact, if you feel the recession has hit you in anyway, I would be so bold as to say you may be playing not to lose and missing out on the amazing opportunities that come when we play to win. The ride is much more fun when we are playing to win!

Here is how to Play To Win vs. Playing Not To Lose:

You must redefine your definition of winning and losing. Many experts are saying we are not going through a recession, but rather we are emerging into a new era of how we do business and how we live our lives. That in my humble opinion is very good news! However it requires us to redefine the rules of success and the rules of failure. Peter Drucker said, “The best way to predict the future is to create it.” As more and more Americans become entrepreneurs, the rules for running your own small business are rapidly evolving. If you find your business not growing as it did earlier in the game, or you find you are burning out much faster, or you are not earning more income each year, then continue reading. . .

Are you avoiding fear or avoiding risk? If you answered yes, then you are playing not to lose rather than playing to win. Henry David Thoreau wisely said, “Most people live lives of quiet desperation and go to the grave with the song still in them.” It is human nature to feel safe in a certain comfort zone. We value life being predictable to a large degree. We value sameness, structure, stability and security. Too much of these qualities, however, and our lives become stagnant. By attempting to maintain our comfort zone to feel safe, we actually begin shrinking it. The same applies in business. Unless we step out of our comfort zone by taking risks, learning new things, trying new adventures, we will stagnate. Avoiding fear in our lives and business begins to shrink our comfort zone. Until we decide to stretch ourselves, our comfort zone will continue to shrink with time, resulting in failure and unhappiness in our lives. It is healthy and natural to coast at times. It is important to remember, however, when we coast we are always going downhill! Here is a hint: If we are not playing full out, then we are not playing to win, but rather playing not to lose. This week, ask yourself, “What risks am I avoiding in my life or business?”

Is Your Business Thriving or Merely Surviving These Times? I hear so many entrepreneurs say, “I just want to get through this economic time.” Their thoughts are about surviving, their goal is not about thriving. Surviving is playing not to lose; setting the intention of thriving even now is playing to win. The difference between surviving this year or thriving is directly linked to whether we choose to play not to lose or play to win!

A good sales result, of course, is a key factor in your company being a good investment of your time, talent and money. However, to be a “Safe” investment, you also need to protect your enterprise from potential losses. Below you will find a list of some of these risks. Insurance is an important method of limiting your risk exposure and making your venture a safer investment.

1. Owner Safe? You, the owner needs to be safe for your firm to be safe.

a. Personal Liability

A venture owner is a particularly likely target for a lawsuit. A typical owner has both increased wealth and increased visibility. Your personal lawsuit risk is the back door to your company. Higher liability limits on your personal insurance policies including an Umbrella (Excess Liability) policy are important to lock and bolt this back door.

b. Owner Succession Plan (Life Insurance to fund?)

Proper estate planning and owner succession should be part of your business plan. Don’t work a lifetime to build wealth with company ownership and then pass it to Uncle Sam in taxes instead of your family. Also, the value of your venture depends on your leadership. If you are not available, a plan for a successor can be crucial to its value if you are no longer available to be that leader. Life insurance on you, the owner, can be a tool to help manage this risk.

c. Owner Health Insurance (personal bankruptcy risk)

If you are your own boss, you often will need to provide for your own health insurance. Approximately half of the bankruptcies in the United States are due to unpaid medical expenses. If you become overwhelmed with medical bills, it could impact your firm. Don’t expose yourself to the potential catastrophic financial risk of a major illness or injury by not protecting yourself with a major medical insurance plan.

I particularly like the High Deductible Health Insurance plans that are Health Savings Account compliant for business owners. Self-insure the everyday medical costs with your contributions to your H.S.A. funds but have the Major Medical Insurance backstop provided by the High Deductible Health Insurance to protect you (and your company) from the financial costs of a major illness or injury.

2. Asset Safe?

Your investment in the property assets of your firm can be critical to your operations and ability to continue to operate. Replacing business assets damaged or lost can also affect your profits. Protect your company assets from loss with commercial property insurance.

a. Buildings

If you own your firm’s facilities, loss due to fire, tornado or other perils can endanger this significant investment. If the buildings or other fixed assets are mortgaged, your bank loan normally will require insurance to protect the lien.

b. Building Improvements

Often overlooked, most commercial ventures with leased facilities have a considerable investment in fitting out the landlord’s space to suit their operations. This can include very expensive installed equipment. Think in terms of a fire that destroys the building. The landlord’s insurance normally will only rebuild your space to bare walls and concrete floor. Your insurance protection will need to be structured to fund the cost to rebuild this bare space back to the facility you need.

c. Contents / Equipment / Inventory

Business property includes all the loose items like tools, office equipment, computers and inventory that you have. Each specific item may not be significant in cost but they can add up to be a large investment. Visualize a total loss event like a tornado or building fire and think how much it would cost to replace all your contents.

3. Lawsuit Safe?

Liability = lawsuit. Most commercial operations have specific risks of lawsuits that can result in significant financial losses. The cost of a lawsuit includes the legal costs to defend the allegation and if found guilty, the cost to settle. The business environment in the United States is very litigious – check out any phonebook cover for opportunities to hire a lawyer and sue the company of your choice.

a. Premise Liability

Any enterprise that has a business location including jobsite locations has a premise liability risk. This is often also called the “Trip & Fall” risk — a person of the public getting hurt from walking on your location. A retail store is a clear illustration of the premise risk with an open door to the public to enter and browse.

Premise Liability protection is normally a key component of the Commercial General Liability insurance contract.

b. Products / Completed Operations Liability

Product Liability is the risk of offering to the public a product that may cause injury. An example would be a restaurant serving food that makes everyone sick or a manufacturer that creates a defective product which results in injury. Even if your business operations does not create products, your company still can have a significant lawsuit exposure to a defective product you resale or distribute that causes injury and results in a damaging lawsuit.

Completed Operations is the risk of work you have finished being defective and causing damage or injury. An example would be an auto garage installing brakes wrong causing a traffic accident. Another example would be an electrician installing wiring wrong resulting in a building fire.

Product & Completed Operations protection are normally components of the Commercial General Liability contract. Manufacturers typically have a separate Product Liability contract to provide the higher level of protection needed for that type of firm.

c. Worker Injury Liability

Any employer with hired help has the risk of a worker being injured while at work and suing the business. A frequent mistake is hiring “1099 Contract Labor” and not realizing that they are employees for purpose of work related injuries. A single lawsuit from a worker hurt on the job can result in a very large settlement and overwhelm your company finances.

Worker’s Compensation Insurance is a state mandated benefit package that shifts the worker injury risk from an employer. A Work Comp contract normally also includes Employer Liability to protect a company if a lawsuit attempts to skirt the Work Comp statute. The cost of Work Comp varies depending on the type of work being done.

d. Auto Liability for commercial vehicles (Work Truck Insurance)

Many enterprises provide delivery service or use vehicles for their operations. Auto accidents are the source of many lawsuits and a significant risk for any business with work trucks and other owned vehicles. Another less recognized risk is on “non-owned autos” (example: employee auto) that are on job errands and “hired autos” (example: rented truck for a special delivery) that are rented for company activities.

Commercial Auto Insurance is available and can be customized to meet the particular insurance protection needs for your work vehicles.

e. Employment Practices Liability

Most employers don’t think about the lawsuits that can result from unintended mistakes in their relationships with their employees. Using professional practices in hiring, terminating and promoting employees is the best defense to lawsuits resulting from an angry ex-employee but any employer needs to have insurance protection as a backup.

Employment Practices Liability is often a component available with a Commercial Insurance Package policy.

f. Professional Errors & Omissions Liability

If you are a licensed professional or provide important professional advice, you are at risk of a lawsuit resulting from giving the wrong advice. Consultants are particularly at risk for Professional Liability because your business activity is professionally grounded advice. Even if your advice was sound, defending a lawsuit can still overwhelm your company finances.

Professional Errors & Omissions Liability is normally available as a separate insurance contract.

g. Other Lawsuit risks?

No one can predict all the possible events that could result in a lawsuit. A prudent owner should discuss their business liability risk with their lawyer on a regular basis. You visit your doctor for an annual health check-up, why not an annual legal liability check-up with your lawyer? Your insurance agent can then discuss insurance plans to provide protection for lawsuit risks identified by your lawyer.

4. Business Continuation?

The secondary economic hardship of an insured loss can be more challenging than the actual damage.

a. Income & Continuation – Ongoing wages and expenses

Income and Continuation keeps your firm alive while the damage is being restored. Most enterprises cannot afford to cease operations and must find an alternative location and continue to serve their customers. Also important to any company is retaining its important talent.

b. Extra Expense to accelerate reopening or relocation

Being out-of-business due to an insured loss can damage your market share as clients seek service elsewhere. The sooner you can reopen the better. Extra Expense helps accelerate re-opening or relocation by minimizing the time your firm is closed.

You don’t want to be part of the small business failure statistics. Therefore, it would be wise for you to learn the main reasons for these failures, and avoid making the same mistakes. With the necessary knowledge, discipline and a sensible plan, your Internet home based business idea will be successful.

Business Failure Rate

Did you know that almost 8,000 start a home Internet business every day in the United States? Now, take a look at this other statistic: According to the U.S. Small Business Association, only 2/3 of all small business startups survive the first two years and less than half make it to four years. Are you going to be part of this last group?

Like all of us, you’re going to make mistakes with a home business start up. However, you can correct the minor ones, but the major ones could wipe out the idea of starting a small home business. Here you have some causes of these failures.

Reason for Business Failure

1. Choosing the wrong type of business – Nothing will cause you more frustration, waste of time and money than choosing a business you don’t like or one that requires skills you don’t have. Find a line of work you love and where you can excel using your own natural talents.

2. Lack of the necessary knowledge – You need to learn all you can about your product or service and what you need to set up your business. Do a research about your competition and things such as marketing, software, equipment, working capital needed and budgeting, health insurance etc.

3. Lack of Planning – You need at least a basic idea of the steps you need to follow to develop and succeed in your business. Good home business systems must be based on reliable and current information. If you have questions or need direction, read articles, books, or find a sponsor to help you with guidance.

4. Lack of Discipline – Discipline and consistency necessary are absolutely necessary to be successful in any business. This also includes being organized and willing to sacrifice. Organize your time and activities so you can perform them on a regular basis. Also be willing to sacrifice time, money, and effort, especially at the beginning. All of these will pay big dividends later on.

5. Lack of Patience – Provided you do your part, you need at least one year before your work from home business idea starts showing some decent signs of success. Read the success stories of highly successful people and see how many became successful in a few weeks or months.

6. Falling Prey to Home Based Business Scams – Most of these so called “opportunities” are either total scams, or you work hours upon hours with little or no results. You need to make an informed, not an emotional decision for your in home business idea. See our recommendations for truly Legitimate Home Based Businesses.

7. Lack of a Website – In today’s world, a web site is a must business tool, and a low-cost investment compared to its potential. It’s the best and easiest way to show your products and services and reach millions of customers worldwide 24/7 365 days a year. Most of your competition has a web site, and not having it is like trying to compete with a hot dog stand across from a McDonald’s.

How to Avoid Business Failure

Home businesses fail for all kinds of reasons, and there are always risks. However you can reduce them by continually seeking the necessary knowledge about your home business niche and putting the required effort to succeed. You must develop the discipline of continuous learning from someone more experienced than you. Also, the Internet has an infinite supply of FREE information available; use it to your advantage.