...M U M B AI SILICON VALLEY BANGA LORE SINGA P ORE MUMBA I BK C NE W DE L HI MUNICH The Indian Medical Device Industry Regulatory, Legal and Tax Overview March 2015 © Copyright 2015 Nishith Desai Associates www.nishithdesai.com The Indian Medical Device Industry Regulatory, Legal and Tax Overview About NDA Nishith Desai Associates (NDA) is a research based international law firm with offices in Mumbai, Bangalore, Silicon Valley, Singapore, New Delhi, Munich. We specialize in strategic legal, regulatory and tax advice coupled with industry expertise in an integrated manner. We focus on niche areas in which we provide significant value and are invariably involved in select highly complex, innovative transactions. Our key clients include marquee repeat Fortune 500 clientele. Core practice areas include International Tax, International Tax Litigation, Litigation & Dispute Resolution, Fund Formation, Fund Investments, Capital Markets, Employment and HR, Intellectual Property, Corporate & Securities Law, Competition Law, Mergers & Acquisitions, JVs & Restructuring, General Commercial Law and Succession and Estate Planning. Our specialized industry niches include financial services, IT and telecom, education, pharma and life sciences, media and entertainment, real estate and infrastructure. Nishith Desai Associates has been ranked as the Most Innovative Indian Law Firm (2014) and the Second Most Innovative Asia - Pacific Law Firm (2014)...
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...NAICS: 325412: Pharmaceutical Preparation Manufacturing Primary SIC: 3845- Electromedical and Electrotherapeutic Apparatus Manufacturing Secondary SIC: 339112- Surgical and Medical Instrument Manufacturing. Auditor: PricewaterhouseCoopers LLP, New York, NY Primary Bank: Wells Fargo Bank, N.A., Minneapolis, MN Company started: 1949 Number of Employees: 45,499 Table of Contents: Sl. | Topics | Page | 1 | General Description of Medtronic Inc. | 1 | 2 | Challenges 2.a. Medical Device Industry2.b. Medtronic Inc. | 3 | 3 | Ethical issues | 5 | 4 | Financial Analysis4.a. Financial Analysis of 10K 4.b.Cost and expenses analysis 4.c. Financial Ratios | 689 | 5 | Industry/Competitor Analysis | 11 | 6 | Conclusion | 13 | 7 | Bibliography | 14 | By Geethapriya Setty (100918266) Address: 1300 Hennepin Ave, Apt M101, Minneapolis, Minnesota-55403 Section 1: General Description of Medtronic Inc. Medtronic Inc., a medical technology company, was founded in 1949 by Earl Bakken and Palmer Hermundslie. It was incorporated in 1957 in Minneapolis, Minnesota. They were the first to create a wearable cardiac pacemaker in 1957. They have been able to expand their business from a small repair company, which serviced medical equipment in hospitals, to being able to serve physicians and patients in more than 120 countries worldwide. From then on they focused on cardiac rhythm technology that makes...
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...Stryker BUAD 341-0, MWF 1:00PM Isral Hadero 04/28/2014 Table of Contents Introduction 1 Theme 1 History of the Firm 1 Product Line of the Company 3 Industry History and Analysis 4 Major Competitors 4 NAICS Numbers 5 Relative Industry Sales, Returns and Maturity 5 Stock Performance 6 Financial Analysis 7 Ratio Analysis 9 Pro forma 11 Assumption 12 Growth Rate of Sales 12 Asset Acquisition 13 Financing Needs 13 Conclusion 14 Appendices 15 Income Statement 15 Balance Sheet 16 Sources and uses 17 Percentage of Sources and Uses 19 Firm Ratios 21 Industry Ratios 22 Graphs of Ratios 23 Bibliography 26 Introduction This paper contains the financial analysis of Stryker corporation and its major competitors during the past 5 years. Also a 3 year forecast is created to show were the company is heading and changes needed to be made to be more efficient. Theme Time are hard for the medical industry with the global economic crisis and with the announcement of the Affordable Care Act’s medical device excise tax. Stryker corporation has done better than the industry on average sustaining a strong financial while presenting new products in the market. Growth is becoming slow for mature firms but Stryker is making all the right moves to dominate the market. To increase growth the company has shifted its focus on acquisitions. With the acquisition of Trauson, a Chinese leading manufacturer of surgical products...
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... Introduction MDCM, Inc., one of the world’s largest contract manufacturers for medical devices, had just announced its fifth consecutive quarterly loss. The firm posted revenues of $1.12 billion with net losses of $33 million for the second quarter of 2002. For Max McMullen, this was yet another agonizing episode since he took over as CEO two years earlier. Despite major company reorganizations, his promises to the shareholders for operational and cost improvements had not been realized. Given the company’s lackluster record, the next twelve months were critical in proving that these promises could indeed be kept. Concerned, McMullen called a meeting of MDCM’s senior executives to discuss the situation. “Our jobs depend on what happens the next few quarters. I know we have a good strategy, but we need to get our implementation right,” he explained. CFO Sharon Leis responded, “Well, our margins have been shrinking for eight consecutive quarters. We’ve got too much in working capital, not to mention one of the least efficient cost structures in the industry. I can’t fix any of these things, though, because by the time I get any information, it’s often more than forty-five days old! In my mind, we need to continue to cut costs.” Pat Perry, the vice president of marketing and sales, argued, “Our marketing and sales staff is actually really productive, maybe the best in the industry. But we spend a lot of time on tasks that could be done by customers using some type...
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...CONTENTS I EXECUTIVE SUMMARY……………………………………………………………………………………….3 II ABSTRACT………………………………………………………………………………………………………….3 III OVERVIEW AND COMPETENCIES…………………………….………………………………………….4 IV DISCUSSION OF CURRENT INDUSTRY DYNAMICS………………………………………………..5 V POTENTIAL SOLUTIONS AND SOURCING…………………………………………………………….8 VI RECOMMENDATIONS FOR EXECUTIVE COMMITTEE……………………………………………9 VII ATTATCHMENT………………………………………………………………………………………….………12 VIII REFERENCES………………………………………………………………………………………………………13 I EXECUTIVE SUMMARY This research paper examines the capabilities of remote diagnostic access (RDA), and a proactive monitoring system as a foundation of medical equipment telemaintenance framework. In addition, this research will show how the cost effectiveness of such a system, can provide consistent monitoring of elaborate time sensitive data and systems without constraints. Due to recent growth and expansion into the medical equipment industry, the centralization of resources can expedite repair services, and this paper will give solutions to many reoccurring problems of the past. Lastly, this paper will propose the best solution for the best outcome to address the current problems as a whole. II ABSTRACT As it stands today, the current medical equipment maintenance model is on site and hands on, versus remote and virtual. There is no standardized remote diagnostic access capability for biomedical...
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...and if the company is mechanistic or more organic. As the medical industry is one of the leading industries in the Danish business world Almeco CM Lab is very provocative and interesting subject for analysing. The company has the ability to differentiate in such a big environment, because of that fact, the main aim of their organisation is to keep innovation. 2. External environmental analysis Each organisation’s activies, structure and choices are influenced by different factors, conditions, entitles and events. The main stakeholders of an organisations can be the surrounding industry, raw materials, Human Resource Management, financial resources, market, technology, economy, government and the internationalisation. The medical industry, being one of the leading industries in Denmark, has the biggest influence of Almeco CM Lab. The industry has expirienced global growth rates of approximately 7 % over a period of 4-5 years , owning to this fact, the ability to be more innovative is being given to the organistion, which means that the company should provide higher level of professionalism and specialisation. Almeco set up 1 000 m2 of production facilities and their plan is to grow and create more jobs, so the formalisation of the organisaion will be influenced. As long as the medical industry is young and diverse , it can easily satisfied the need of raw materials for production of medical treatments. So the competion in this area is mostly dependant...
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...The Future of Cardiovascular Diagnostics THE MARKET, TRENDS & FUTURE DIRECTIONS Extracted on: 20 Apr 2011 Reference Code: BI00021-008 Publication Date: 02 Mar 2010 Publisher: Datamonitor © Datamonitor This content is a licensed product, no part of this publication shall be reproduced, sold, modified or stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise, without the prior permission of Datamonitor. The information in this document has been extracted from published research by a registered user of the Datamonitor360 platform. Datamonitor shall not be responsible for any loss of original context and for any changes made to information following its extraction. All information was current at the time of extraction although the original content may have been subsequently updated. Please refer back to the website http://360.datamonitor.com/ to view the most recent content and the original source of the information. To the maximum extent permitted by applicable law we exclude all representations, warranties and conditions relating to the facts of all publications. At time of publication no guarantee of accuracy or suitability, whether express or implied, shall attach to this publication (including, without limitation, any warranties implied by law of satisfactory quality, fitness for purpose and/or the use of reasonable care and skill). Please note that the findings, conclusions and recommendations...
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...Compensation and benefit packages can be strategic tools that reflect an organization’s commitment to the employee. They should be designed to meet the candidate’s needs and expectations to ensure acceptance. This paper represents a job proposal created by our team for the position of Senior Reliability Engineer at Medtronic, Inc. Various resources and websites were utilized to create a competitive package consistent with Medtronic’s high standards and company policies. Our team included justification of the chosen strategy and also identified potential obstacles and forms of resistance that could impede implementation of the package being offered. Background and Mission of Medtronic, Inc. Medtronic, Inc. was founded in 1949 as a medical equipment repair shop and has grown into a multinational company that has transformed the way debilitating, chronic diseases are treated (Medtronic, 2012). Its mission is to contribute to the human welfare through application of biomedical engineering in the research, design, manufacture, and sale of instruments or appliances that alleviate pain, restore health, and extend life. Every employee worldwide receives a Medtronic medallion from senior executives as a reminder of the honor and responsibility they have in fulfilling the company’s mission (Medtronic, 2012). Job Description for Senior Reliability Engineer A Senior Reliability Engineer is a valued position at Medtronic, Inc. requiring a high level of education. He or she has...
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...New Medical Devices in the US August 13 2010 Table of Contents 1. Introduction……………………………………………………………………………………………………………………………………2 2. Background and Framework……………………………………………………………………………………………………………4 2.1 Priority Medical Devices for the Netherlands…..……………………………………………………………………4 2.2 The US Vision: From see and treat to predict and prevent……………………………………………………6 2.3 Conclusions…………………………………………………………………………………………………………………………..7 3. Medical device sector in the US………………………………………………………………………………………………………8 3.1 Economic Impact…..………………………………………………………………………………………………………………8 3.2 The Sector by State…..…………………………………………………………………………………………………………10 3.3 Key Institutes: Patent Applications in the Cluster Areas…..………………………………………………….13 3.4 Conclusions…..…………………………………………………………………………………………………………………….20 4. Turning research into novel medical devices………………………………………………………………………………….22 4.1 The Medical Device Development Process…..……………………………………………………………………..22 4.2 CIMIT: A Structure for Medical Device Innovation…..………………………………………………………….23 4.3 Stanford Biodesign: Innovation as a Discipline…..………………………………………………………………..26 4.4 Conclusions and Recommendations…..……………………………………………………………………………….28 5. Summary and Conclusions…………………………………………………………………………………………………………….30 6. Acknowledgements……………………………………………………………………………………………………………………….32 7. References…………………………………………………………………………………………………………………………………….33 Appendices A1 Selection of Key Institutes A2 Results Patent Analysis A3 Research...
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...Sterile Barrier Systems: Five Pitfalls for Medical Device Manufacturers It is crucial that medical devices maintain sterility until they arrive at the end user location. If sterility is lost, there may be serious consequences for the manufacturer: the return of the non-sterile product or, in the worst case, the negative impact on a patient's health leading to the device's approval being withdrawn. Therefore, medical technology companies make great efforts to ensure the correct packaging, testing and validation so the sterile barrier system remains intact. The burden on the packaging during its transition from the MDM to the patient is enormous and the risks to the integrity of the sterile barrier are numerous: The production method in the factory, the packing process, vibration during transport in trucks or aircraft, and careless packing workers are all potential sources of danger because hairline cracks or damage may be sufficient to affect the integrity of the medical product packaging, which may in turn effect the package's sterility. We spoke with industry experts and asked them to list from their perspective in the development and validation of medical packaging what are the most common errors. Transport Probably the biggest threat to the sterile barrier is during transport. The manufacturer has the responsibility to ensure the product arrives without damage to the customer. MDMs must be able to validate their packaging is capable of providing reasonable protection against...
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...Morgan STATE UNIVERSITY | Newland Medical Technologies | ENTR 664 Case 2 | | Olushola Ogundele I.D: 00147829 | 1/15/2016 | This assignment is being submitted January 15, 2016 for Dr. Leyland Lucas’s ENTR.664 Entrepreneurship course being offered in Winter 2016 | 1. Discuss the process that Sarah Foster and her partners have gone through to bring to market their medical device. How might they have avoided some of the pitfalls they have encountered? Even though Sarah Foster and her partner have done an awesome job in coming up with a great product it is however important to get advice and guidance from a professionals in that field in the case we find Sarah and her partner virtually stumbled upon the idea from testing and when they found out that the product could do more in the sense that the baskets could hold the kidney stones rather than just ease urine passage. The importance of involving experts in the project will give them a specialized point of view; provide wealth of experience from past tests and in a sense cut out errors that can cause broader complications in humans testing and ensure that it’s fit for use in the market. Another benefit proper endorsement which will enable Sarah foster can have a product that is endorsed by the national association of urologists or general doctors thereby enabling the product gets greater publicity or increased acceptance. In products testing and problem resolution Sarah and her partner only conducted tests on...
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... Introduction MDCM, Inc., one of the world’s largest contract manufacturers for medical devices, had just announced its fifth consecutive quarterly loss. The firm posted revenues of $1.12 billion with net losses of $33 million for the second quarter of 2002. For Max McMullen, this was yet another agonizing episode since he took over as CEO two years earlier. Despite major company reorganizations, his promises to the shareholders for operational and cost improvements had not been realized. Given the company’s lackluster record, the next twelve months were critical in proving that these promises could indeed be kept. Concerned, McMullen called a meeting of MDCM’s senior executives to discuss the situation. “Our jobs depend on what happens the next few quarters. I know we have a good strategy, but we need to get our implementation right,” he explained. CFO Sharon Leis responded, “Well, our margins have been shrinking for eight consecutive quarters. We’ve got too much in working capital, not to mention one of the least efficient cost structures in the industry. I can’t fix any of these things, though, because by the time I get any information, it’s often more than forty-five days old! In my mind, we need to continue to cut costs.” Pat Perry, the vice president of marketing and sales, argued, “Our marketing and sales staff is actually really productive, maybe the best in the industry. But we spend a lot of time on tasks that could be done by customers using some type...
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...Christian Harbinson is an associate at Scharfstein Weekes (SW), a venture capital firm based in Palo Alto and specialised in Medical instrument industry. Harbinson joined the company 6 months ago and is responsible for covering the $600,000 investment (out of a $100m fund) in Seven Peaks Technologies (SP), a company that has developed an innovative cauterizer used for electro surgery. Jack Brandon, the founder of SP, has developed a new cauterizer that is faster and more reliable than currently available technologies. Its main feature is that it does not stick to tissues during the cauterizing process, contrary to other similar products available in the market. Brandon has invested $65k of his own money in the development of the product before he approached SW to raise capital. The product received good feedback from surgeons and got the FDA (Food & Drug Administration) approval for launch in the market. Nevertheless, the product’s sales have been disappointing. The life duration of the product is too long; consequently there is no opportunity for reordering the product and distributors are not willing to market it as the sales are not recurring. As a result, Brandon wants to develop a new product. He thinks there is a demand for new electrosurgical forceps that would use the same technology used in the cauterizer. The advantage of the forceps market is that surgeons use between 6 and 8 of them in every surgery. Thus the addressable market is much bigger. The product...
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...chronic disease. By working closely with the physicians around the world, they create therapies to help patients do things they never thought possible. Their medical technologies help make it possible for millions of people to resume everyday activities, return to work, and live better, longer. They are able to do this with the help of some very special people around the world: 38,000 dedicated employees who share a passionate purpose to improve lives, thousands of medical professionals who share their insights and ideas, and hundreds of advocacy associations that help us share information so people with debilitating diseases know relief is possible. MEDTRONIC PURPOSE Medtronic is one of the largest medical technology companies that manufactures implantable biomedical devices, with sales in over 120 countries. The Company treats chronic diseases by offering products including bradycardia pacing, heart failure, atreal fibulation, coronary vascular disease, heart valve replacement, etc. They operate Cardiac Rhythm Disease Management, Spinal and Biologicals, CardioVascular, Neuromodulation, Diabetes, and Surgical Technologies. Medtronic, Inc. was founded in 1949 by Earl Bakken and his brother in law Palmer Hermundslie out of their garage in northeast Minneapolis, Minnesota. They turned their garage into a medical equipment repair shop. They originally wanted to sell basketball pumps since there was a shortage of them in the Midwest during this time. Bakken was a grad...
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...company that manufactures high-tech medical equipment and devices like CAT Scanners, MRls and pacemakers. Currently, MedDevice earns more than 80% of its annual revenue from U.S. sales. Strategic studies indicate that MedDevice's greatest growth potential in the next decade is in developing its Asian and Southeast Asian markets. MedDevice has investigated the possibility of opening a wholly-owned branch office in Southeast Asia. However, logistical problems, the complexity of local laws, and the diffrculty of breaking into a foreign market that relies heavily on relationships and connections suggests that forming a joint venture may be necessary to gain access to key distribution channels in the region. Lee Medical Supply Lee Medical Supply is a family-owned company employing about 30 people, located in Bangkok, Thailand. Lee Medical specializes in the distribution and sales of medical products including operating tables, hospital beds, X-ray machines, ultrasounds, and a variety of disposable medical supplies like bandages and syringes. Lee Medical Supply has been in operation since 1960 under the ownership and direction of An Lee, who is now 64 years old. To date, Lee Medical Supply has focused its business on distributing equipment and supplies for overseas (mostly American and European) companies. Under such distributorship arrangements, Lee Medical purchases supplies and equipment from manufacturers and then sells them in Thailand. Lee Medical profits from the difference between...
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