Competencies &amp Essay

1) Legal and regulatory factors The medical device attention is companyified 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. in that respect be instances when a device fails and a single lawsuit causes the entire company to close down. Thus its better(predicate) to invest time and money , before taking the implant step up to the securities industry 2) Investment of Time & Money As approval help is a long drawn procedure, it is necessary to have well instruct quality managers and regulatory system advisors as employees.Sometimes services of out-of-door consultants or Regulatory advising companies might be used. 3) In-house surgeons/medical practitioners As these devices leave to specific ailments and ar highly vary, 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 mastery in biomedical perseverance.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 finances to deliver 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 puzzle 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(a) the processes.D. PEST ANALYSIS Scope of Growth The medical device industry out here thrives on reverse engineering concept the go away is a number of ME TOO products. Infact companies end up investing on sullying patents from European and American companies and do non believe in investing money for research and development of such products. There is considerable market to be tapped as there is a lot of have for these products virtually of which is imported from the Europe and the U. S. This area being the fastest growing market, the undertakinged growth is expected to touch up to $16 million in 2015 revenues.Source Millennium Research Group. Spine Care Segments 2015 There is expected to be an increase in surgical treatment options, wish facet replacement and dynamic stabilization procedures, which will likely be more(prenominal) 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 n ot grow, but stay at the resembling 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 work is registered with the state like a circumscribed liability company (LLC) or potentiometer. Legally, a touch on proprietorship is innate from its possessor 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 own(prenominal) measure return and is own(prenominal)ly liable for any business-related obligations, such as debts or court judgments. This accounts 74% of all USA businesses and for 6% of all gross revenue in USA. Advantages (1) decisions are made by only the owner (2) mere(a) process to start just get a business manifest (3) profits belong to the o wner (4) pride of ownership (5) lower appraisees. Disadvantages (1) un circumscribed liability (2) express life of business (3) difficult to raise capital for business (4) risk of lost is not dual-lane.Partnership a compact is simply a business owned by deuce 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 step 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 In locoweed Though forming a community is a bit more complicated and costly, but it is well value the trouble for some keen businesses. 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 effectual and tax entity, separate from the people who own, control condition 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 fatality 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 c apital (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 about states. The LLC has grown in popularity because it combines the best features of a corporation and a partnership. equivalent a corporation , the owners (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 preferable in many ways to the S corporation, 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, act and management of the business than does the S corporation. LLCs are similar to corporations because they also offer 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 bu siness income on their personal tax returns.