Competencies &amp Essay Example for Free

Competencies amp Essay1) Legal and regulatory factors The aesculapian device industry is assort as class 3 , high risk implant so its obvious that a al mess h solely of investment goes into testing and experiments with sufficient evidences to prove its safety in-vivo. There be instances when a device fails and a single lawsuit causes the entire follow to close down. Thus its advisable to invest time and currency , before taking the implant out to the grocery 2) Investment of Time Money As panegyric process is a long drawn procedure, it is necessary to fetch well trained quality managers and regulatory system advisors as employees. Sometimes services of external consultants or Regulatory advising companies might be used. 3) In-house surgeons/medical practitioners As these devices cater to specific ailments and atomic number 18 highly specialized, it is classic that we have in-house surgeons to understand the requirements of a fruit before we begin to design it. Infact the engineers and the surgeons should work hand in hand to come up with a better product. The crucial factors which determines success in biomedical industry.1) Availability of constant flow of Funds For a impudent product to be in market, it might take 3-4 yrs, so during this period there should be a constant supply of funds to render the employees and keep the company stretch outning. 2) Excellent marketing strategies Its important that these products are marketed through right channels, thus its highly imperative that the products are showcased at various concern shows/conferences 3) Understanding the regulatory process The main aim would be to bring the product soon to the market, by making a full-proof plan before the submission process for approval, as this phase is the lengthiest of all the processes.D. swearword ANALYSIS Scope of Growth The medical device industry out here thrives on overthrow engineering concept the result is a number of ME TOO products. Infact comp anies end up investing on buying patents from European and American companies and do not believe in investing money for look into and development of such products. There is huge market to be tapped as there is a lot of demand for these products most of which is imported from the Europe and the U. S. This area being the fastest experienceing market, the projected development is expected to touch up to $16 billion in 2015 revenues.Source Millennium Research Group. prod Care Segments 2015 There is expected to be an increase in surgical treatment options, comparable facet replacement and dynamic stabilization procedures, which will likely be more than acceptable to patients, perhaps two-base hit the % of patients accepting surgery from 3. 6% to 7% of a much larger, elderly population. As clinical results improve, this market is expected to continue to grow 20% per year and offer a tremendous opportunity to companies with mod product lines.In 2015, industry experts project lumbar fusions will not grow, but stay at the same 2006 level of 400,000 procedures dynamic stabilization devices will grow from 25,000 to 250,000 cases and artificial lumbar and cervical discs grow from 25,000 to 600,000 cases, as these new procedures begin to replace spinal fusion. PART 2 A BUSINESS monomania Sole proprietorship is a one-person backup is registered with the state like a especial(a) financial obligation company (LLC) or kitty. Legally, a sole proprietorship is inseparable from its owner the avocation and the owner are one and the same.This means the owner of the business reports business income and losses on his or her personal appraise return and is personally liable for any business-related obligations, such as debts or mash judgments. This accounts 74% of all ground forces businesses and for 6% of all sales in regular army. Advantages (1) decisions are made by only the owner (2) simple process to bring down just get a business license (3) profits belo ng to the owner (4) pride of ownership (5) lower revenue enhancementes. Disadvantages (1) unlimited liability (2) limited life of business (3) troublesome to raise capital for business (4) risk of lost is not shared.Partnership a partnership is simply a business owned by two or more people Just like in a sole proprietorship, the partnerships owners pay taxes on their shares of the business income on their personal tax returns and they are each personally liable for the entire amount of any business debts and claims. 8% of all USA businesses are partnerships and accounts for 4% of all sales in USA Advantages (1) easy to start (2) not umpteen regulations (3) not as difficult to raise capital for business (4) combination of knowledge and skills.Disadvantages (1) unlimited liability (2) profits are shared (3) limited life of the business (4) disagreements In flock Though forming a corporation is a bit more complicated and costly, but it is well worth the trouble for some baseborn b usinesses. The main benefit of an LLC or a corporation is that these structures limit the owners personal liability for business debts and court judgments against the business. What sets the corporation apart from all other types of businesses is that a corporation is an independent legal and tax entity, come apart from the people who own, control and manage it.Because of this separate status, the owners of a corporation dont use their personal tax returns to pay tax on corporate profits the corporation itself pays these taxes. Owners pay personal income tax only on money they draw from the corporation in the form of salaries, bonuses, and the like. Corporations make sense for business owners who either (1) run a risk of being sued by customers or of piling up a lot of business debts, or (2) have substantial personal assets they want to protect from business creditors.18% of all USA businesses are corporations and accounts for 90% of all sales in USA. Advantages (1) easy to raise capital (2) limited liability (3) unlimited life of business (4) Can hire specialized skills and knowledge (5) shared risks. Disadvantages (1) difficult to start (2) less direct control (3) double taxation corporate tax and individual tax (4) limited activity. Franchising Franchises are in which individual businessmen or people buy a well established business, but a certain percentage goes back to the corporation.Franchises must adhere to the corporate regulations. (McDonalds, Krispy Cream, Starbucks). Acquisition/Mergers In this two companies merge together(merger) or a big company acquires a small innovative company giving rise to an acquisition. The best option to go with would be setting up a corporation or a LLC rather to start. The limited liability company or LLC is a relatively new form of doing business which is now recognized in most states. The LLC has grown in popularity because it combines the best features of a corporation and a partnership.Like a corporation, the own ers (called members) of the LLC are not personally responsible for the debts of the LLC. Like a partnership, there is no dual taxation and the earnings of the business are taxed directly to the members. The LLC is also preferent in many ways to the S corporation, which also avoids personal liability and dual taxation. The LLC is not motif to most of the limitations which are imposed on corporations by applicable law.For example, while an corporation is not allowed to have more than one type or class of stock ownership and is not allowed to have more than 75 shareholders, the LLC is not subject to such limitations. Overall, the LLC simply allows more flexibility in the structure, operation and circumspection of the business than does the S corporation. LLCs are similar to corporations because they also provide limited personal liability for business debts and claims. But when it comes to taxes, LLCs are more like partnerships the owners of an LLC pay taxes on their shares of the b usiness income on their personal tax returns.