Thursday, July 18, 2019
Competencies & Essay
1) Legal and regulatory factors: The medical device industry is classified as class 3 , high risk implant so its obvious that a lot of investment goes into testing and experiments with sufficient evidences to prove its safety in-vivo. There are instances when a device fails and a single lawsuit causes the entire company to close down. Thus its advisable to invest time and money , before taking the implant out to the market 2) Investment of Time & Money: As approval process is a long drawn procedure, it is necessary to have 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 are highly specialized, it is important that we have in-house surgeons to understand the requirements of a product 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 new product to be in market, it might take 3-4 yrs, so during this period there should be a constant supply of funds to pay the employees and keep the company running. 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 trade 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. PEST ANALYSIS: Scope of Growth: The medical device industry out here thrives on reverse engineering concept the result is a number of ME TOO products. Infact companies end up investing on buying patents from European and American companies and do not believe in investing money for research 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 growing market, the projected growth is expected to touch up to $16 billion in 2015 revenues. Source: Millennium Research Group. Spine Care Segments 2015 There is expected to be an increase in surgical treatment options, like facet replacement and dynamic stabilization procedures, which will likely be more acceptable to patients, perhaps doubling 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 innovative 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 OWNERSHIP: Sole proprietorship is a one-person business is registered with the state like a limited liability company (LLC) or corporation. Legally, a sole proprietorship is inseparable from its owner Ã¢â¬â the business 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 tax return and is personally liable for any business-related obligations, such as debts or court judgments. This accounts 74% of all USA businesses and for 6% of all sales in USA. Advantages: (1) decisions are made by only the owner; (2) simple process to start Ã¢â¬â just get a business license (3) profits belong to the owner; (4) pride of ownership; (5) lower taxes. Disadvantages: (1) unlimited liability (2) limited life of business (3) difficult 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 partnershipÃ¢â¬â¢s 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 many 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 Incorporation: Though forming a corporation is a bit more complicated and costly, but it is well worth the trouble for some small businesses. The main benefit of an LLC or a corporation is that these structures limit the ownersÃ¢â¬â¢ 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, separate from the people who own, control and manage it. Because of this separate status, the owners of a corporation donÃ¢â¬â¢t use their personal tax returns to pay tax on corporate profits Ã¢â¬â 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 Ã¢â¬Å"LLCÃ¢â¬ 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 owners (called Ã¢â¬Å"membersÃ¢â¬ ) 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 preferable in many ways to the Ã¢â¬Å"S corporation,Ã¢â¬ which also avoids personal liability and dual taxation. The LLC is not subject 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 management 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 business income on their personal tax returns.