Commercialization and Business Development of Diabetic Monitoring Devices - Essay Example

?Commercialization Plan of Diabetic Monitoring Devices Executive Summary Commercialization and business development plan of a medical device would require focus, integration of services and many other specialties. The co ordination of varied multi complex activities is pre requisite for the time and cost efficiency and the collaboration of specialist are required for the medical product development. Technological assessment of patent drafting and mapping follows only with the development of an advanced medical equipment device. The author of the study has not only focused on the manufacturing of a diabetic monitoring device which is not only a clinically advantage product abut also a prerequisite product for every household. The study will highlight the entire commercialization plan developed for the Health Kart Diabetic Monitoring device which includes the patenting, drafting and the quality control process. Table of Contents Technology 6 Product Description: HealthKart Diabetz 6 Key Success Factors 6 Patents 7 Process of Acquiring Patents for Diabetic Monitoring Device 9 The Firm: Health Kart Diabetes 10 The Business Opportunity 11 Value Proposition 11 External Players 12 Market 13 Market Dynamics 13 External Forces 13 Environmental Impact 13 Marketing Strategies 14 Strategic Positioning of HealthKare Diabetes 17 Quality Control Monitoring Process 21 Action Plan 23 Implementation of Milestones 24 Marketing Tasks 24 Timings 24 Mass Targeting Strategy for HealthKare Diabetes 24 Commercial Risk Assessment 25 Financials 26 Conclusion 27 References 28 Background: Commercialization of Diabetic Monitoring Devices The commercialization activity is regarded as an important business activity, which leads to the development of a new market plan for the introduction of a new product into the market (Ahmed & Rafiq, 2002). This activity involves the formulation of new marketing strategies and also the development of effective marketing devices, which would help in checking the feasibility of the marketing plan. Commercialization would also help in monitoring whether the marketing activities adhere with the executed plan (CIM, n.d.). However, commercialization would also include various marketing strategies required for the launch of new product and production process, which would also require financial and non-financial assistance from the management perspective. The study will deal with commercialization of diabetic monitoring devices, which forms an integral part among the medical equipment. Diabetic monitoring devices not only help in checking the glucose levels of an individual, but also prevent from increasing the glucose levels in medical patients. The main objective of the monitoring devices would be to check the glucose content and the concentration of glucose levels in an individual. The study will deal with the commercialization plan of diabetic monitoring device, which has been the aid for several medial patients. The author of the study has formulated a marketing plan, which consists of varied marketing strategies for introducing new product into the market and also for the development of a commercialization process for this particular product. Technology Product Description: HealthKart Diabetz The product would be named HealthKart Diabetz and will be initially marketed in the US and UK to cater to the needs of the mass population suffering from diabetes and other glucose content related diseases. The main objective of the marketer would be to develop a product whose functionality would be simple and would produce accurate results. The medical device would help in providing quantitative test and would reflect the glucose content in the blood levels of the individual. The product will help in monitoring the glucose level of an individual and the results can be shown to the doctor for daily adjustment in the treatment, checking high and low level sugar content, understand whether the patient requires change in the existing diet and exercise plan. The product will be environment friendly and will provide an opportunity to the individuals for obtaining accurate blood results (Environment.fi, 2012). The product will be covered with a thin film protection for the betterment of the patients, who are non oblivious to blood. Key Success Factors There are various critical success factors responsible for the profitability of the medical device. This would include the following the factors: Mature Market for Diabetic Monitoring Device: Diabetes affects almost 24 million patients in United States of America with an estimated of 24 million adults worldwide and is also the fifth death causing disease in the country (BioSpectrum, 2013). This disease has affected the common people of USA, monetary wise also because of its high price. Although, the government is trying its best to curb down the spiraling effect of diabetes, the diabetes management program developed by them has not proved to be effective (BioSpectrum, 2013). Advanced Technology: Technologically advanced equipment like glucose meter testing strips along with a thin strip would prevent people with phobia of blood to feel nauseous. The device would also include testing the glucose content in the blood levels of the patients within one second, which the competitor products do not offer. This would help in monitoring the health regime of the diabetes patients. Unique Commercialization Process: The commercialization process included for Health Kartz diabetes is quite an extensive process, which includes the usage of technology transfer and varied other marketing technique, tools for the implementation of the marketing policies in a systematic process. This would help in the aggressive marketing of products, which would automatically lead to attraction of potential customers. Patents Acquiring patent for the Health Kartz diabetic monitoring device would include acquiring of patent and licensing approval from the health authorities. This process will include technology transfer and technology commercialization because it requires the transformation of research into various business practical applications (Taylor et al., 2008). It would also include research applications, commercial potential, seeking patents, value proposition development and other commercial considerations. After the process has been approved by medical officers, the main objective would be to identify the invention merit to determine the extent to which the invention merit would help in realizing the commercial potential and patentability. The process would also include assessing the marketing opportunities to understand the advantages of invention and technical merit of the medical device (Cleveland Clinic, n.d.). The purpose of patentability analysis would not only be done to understand the marketing potential but also the impact of the launch of product into the preliminary market (Consumer Affairs, 2013). In the second stage, technological testing would enable the initial evaluation of the product in the comprehensive market analysis. The potential licensing partners would be recognized and the confidential information related to the production process needs to be shared with the medical authorities. The phase would be divided into two parts: Market Analysis and Active Marketing (US Department of Health & Services, 2013). The market analysis would include identification of the products based upon the teachings of the invention process. Active marketing would include the promotional activities with respect to sales and marketing capabilities. It would also include technology transfer process (Medtronic, 2013). In the market analysis phase, the product should match its specific requirements with the disclosure forms. The relative authorities will record the details related to the product and will consider the market opportunities. This process will be completed within three to four weeks. The process will entail process and product approval and meetings with the marketing manager of the company at regular intervals. A patenting counsel would be required to draft a form, which will include a patent application (Life Science Intelligence, 2009). This is called the protection process because when the product would be yielding favorable results in the market, the protection of invention would begin. The non complexities of licensing transactions and various other facets of multi dimensional deals can help in solving the complexity of the legal transaction (Stanford Business, 2013). This process would require 3 to 4 months for finalizing the licensing, patenting agreement files. Obtainment of the licensing agreement and the intellectual rights would be a lengthy process, which would require filing of documents and also getting approval for the products in the regional USA (Edgell, Ruf & Agarwal, n.d.). Process of Acquiring Patents for Diabetic Monitoring Device Estimating the patent cost is difficult because it actually depends upon how much technology is used for manufacturing the product. In the US, acquiring patent would include Patent Attorney Fees and also the US Patent Office fees. The patent process actually means acquiring ownership for the medical device from the trademark office by filling in the patent application form. Since, Health Kart diabetic monitoring device would require obtaining intellectual property right, the biotechnology used would involve huge amount of expenditure and is a time consuming process (Ministry of Health, 2010). Before the patient application form is duly filled, the marketer needs to follow the below mentioned process: Creation of detailed discussion of the nature of diabetic monitoring device and its functionality process. Conducting patents search to identify whether the idea of the medical device is not already copied by some other manufacturer or not. Submission of a complete patent application form to the US Trademark and Patent Office (USPTO) and to another national body like World Intellectual Property Office (WIPO). Higher amount of fees will be paid for the application of patent and submission of patent of the device. The Firm: Health Kart Diabetes People: The Human Resource of the firm is the personnel who would look after the various activities involved right from manufacturing to marketing of the product. (Source: Authors Creation ) From the above hierarchy, it is observed that that each department would be administered by personnel. The finance department would be looking after the budget section and its accurate allocation to the respective departments. After the budget has been prepared, it would be allocated to the marketing department. The marketing department would ensure proper development of strategies and also its smooth execution. While the Human Resource (HR) department would ensure proper recruitment of personnel who would look after hiring candidate meant for effective marketing of products. The HR department would also ensure recruitment of personnel who would be responsible for management of employees working in the organization. Resources & Capabilities: It would require the utilization of resources through effective means and techniques for the successful marketing of activities (Hotel Alliance, 2013 a). The financial resources would enable the management to utilize the resources and capabilities of the organization like machinery, human resource effectively for the accomplishment of objectives of the organization (Hotel Alliance, 2013b). The Business Opportunity Value Proposition The value position of glucose testing device would be prepared with easy functionality process, so that the customers would be able to handle it effectively (Queensland Government, 2013). Apart from the product design, other related factors would also be considered for the development of a product for enhancement of the customer satisfaction Marketing Techniques: Several marketing modeling techniques for accurate analysis and performance would be used. Some of the important methods of market segmentation techniques are Automatic Interaction Detector (AID) and Multidimensional Scaling Techniques (MSD) and conjoint analysis (SmallBiz Connect, 2013). Price of the Product: The manufacturing of these testing devices would involve huge cost of production and involve various processes like clinical trials, approach from government. These processes would lead to huge expenditure apart from manufacturing cost, hence the marketer would have to mark high price of the product (Pittsburg University, n.d.). The target population for the device would mainly include customers in the higher income level (Jakobsen, 2002). However, the disease may compel the patients in the medium and lower income group to purchase the product hence, the target population for this product would be patients suffering from the disease. External Players Competitors Government Health Associations: In this case, the local government hospitals in the US provide glucose monitoring test facilities without any charge from the patients (McDonald, 2012). The glucose monitoring test and the results occur on the same day, which is one of the major advantages of the government hospitals. Companies: Apart from the government hospitals and local dispensaries companies manufacture glucose monitor devices at affordable prices are also regarded as threats (Morrello, 2013). Some of the major companies sell these products in major websites which makes the product availability easy. Market Market Dynamics In this context, it would be observed that the global market for healthcare devices and the glucose monitoring devices would be reaching $US 25 billion by the end of 2018 (SmallBiz Connect, 2013) and would require certain analysis from the marketing department (SmallBiz Connect, 2013). The US diabetic monitoring market is expected to reach more than $5 US billion mark, which can prove to be beneficial for our company. This is because the short term financial goals and objectives can be achieved easily. In this context, keeping the estimated forecast in mind, the company plans to sell almost 2 billion insulin and diabetic monitoring devices within the East and West American regions. The developed markets for these diabetic monitoring devices include big cities like Los Angeles, California etc hence; the initial marketing plan would include marketing the products in the rural areas. Testing would be first done in areas where the customers have thorough knowledge regarding the monitoring devices. External Forces Environmental Impact PEST Analysis would be done to understand the impact of external factors on the functioning of HealthKart Diabetes. Political: Presently, the corporate tax rate in US is 40 percent, which is quite high compared to the other countries. This has made the medical devices manufacturing companies difficult to penetrate into the US markets further. Economic: The current economic situation is quite weak in the US and due to the rise in the medical devices; the customers have increased their frequency of visit to the local hospital and dispensaries. This had lowered the chances of diabetic monitoring devices to penetrate further into the markets. Social: The fast paced lifestyle of the American common people and unhealthy eating habits have led to the increase in the number of diabetic patients in the US. This has led to the emergence of several diabetic monitoring devices, which have been able to yield profitability in the markets. Technological: It is prerequisite for the use of advance machinery, equipments and varied other advanced technological process for the manufacturing of diabetic monitoring devices. Marketing Strategies Process of Deciding Upon the Name of the Product Domain names for the product and its subsidiaries are kept after considering varied factor like the nature of the product, impact on the economy and customers. The name of the products signifies the identity of the organization. (Possey, 2013) The decision of the product naming takes into consideration factors like length of the name, reason kept for the name and the expectations of the customers. The varied factors taken while naming the diabetic monitoring devices would include the following: Health related product: The product has been named Health Kart Diabetes because it is regarded as a product, which offers a bundle of health benefits to the customers and patients. The product has been named keeping the nature of the product and its benefits in mind (Waters, 2013). Complexity of the product: The diabetic monitoring device will have easy functionality; therefore the name of the product would be also simple. The name of the product would be simple keeping the non complexity of the product in mind. Customer Satisfaction: The name of the product is also associated with customer satisfaction. This is because customer expects that the naming of the product decides the functionality of the product. Customers associate the name of the product with its easy usage. The name of the diabetic monitoring device “Health Kart Diabetes has been kept so that customers can relate to the product very easily (Graham, 2007). Identity of the Organization: The name of the product is associated with nature of the organization also. The company provides health benefits and that is why a name associated with health has been kept to attract potential customers. The process of deciding upon the name of the diabetic monitoring device was sought by the management and employees in unification. Phase 1 In this phase, the nature of the product has been analyzed and brain storming sessions has been conducted. Different employees came up with different names and the alternatives will be evaluated Phase 2 The marketing department would analyze the different names considered by the employees and they would be evaluated (FDA Medical Device Regulations, 2010). Phase 3 The selection of the best name will be presented in front of the department and a unanimous decision would be taken. Phase 4 Once, the name is selected the process of copyright, intellectual property would be done. This would require complying with the guidelines of obtaining the rights dutifully from the authorities (Medipurpose, 2013). Phase 5 Once the selected name has obtained his copyright, the marketers can use it to sell and market the product through the standard procedure. Technological Process used while Manufacturing Health Kart Diabetes The general products characteristic of the Health Kart diabetic monitoring device would constitute of the following general physical characteristics: Blood Glucose Monitors, Glucose Test Strips, Control Solutions, Insulin Pens, Lancets and also needles, syringes would be provided additionally for the benefit of the patients (Quinn, 2013). Laser technology would be used in the manufacturing of the device, which would be instead of the lancet and would perforate the skin for obtaining blood sample for the measurement for glucose, experimental and investigational (Parker, 2013). The laser technology would provide more clinically advantages than the standard lancet technology. The diabetic monitoring device would contain glycated serum proteins, which would be included in the testing strip for health benefits of the customer. The diabetic monitoring device would also contain jet injections, which would be provided with a monitor, that would reflect the rising and decreasing glucose levels. Disposable glucose sensor would be provided, which would be placed under the skin and would be worn initially by the patients, so that a link from the sensor would enable the monitoring device to naturally detect the high or low glucose content. Advanced technology would be used, which would include calibrated technology and also the CGS finger stick method to test the interstitial fluid in the blood system of an individual. Strategic Positioning of HealthKare Diabetes After market segmentation and targeting is done, market positioning would enable the management of HealthKare Diabetes to design an organizational offering, which is distinctive and etched in the mind of the targeted customers (Ardalan, 2009).The main objective of market positioning would be to create a niche market for the product and also maximize the potential benefits of the products and services (Barrett et al., 2009).The product positioning map could serve the purpose of a guide for HealthKare Diabetes in positioning the products and services offered by them (Vanasco, 2000). The marketing mix model would also enable the management to develop simple strategic plans and help in effective positioning of services and products. (Source: Author’s Creation) Process of Price Setting for HealthKart Diabetic Monitoring Device Management of a product would require addressing the fundamental issues like (1) what should the rightful price of the product be? (2) How much discounts should be granted (3) how the marketing dynamics and the competition help in setting the pricing decision of the medical device (Smith, 2011). In this context, the price of the diabetic monitoring device would require group decision making and assistance from the financial, marketing department. Firstly, managing price variance would be followed to understand the price discounting methods to be used. Secondly, a price structure would be set to keeping the present marketing dynamics and competitor pricing strategy in mind. Thirdly, the management of Health Kartz Diabetic monitoring device has sought after considering several pricing models for guidance. The pricing strategy was developed after following the below mentioned process: Developing Pricing Strategy It was decided by the management to use the cost plus based pricing method for Health Kart Diabetic Monitoring device. In this method the organization would calculate the cost of manufacturing products and adding a slight percentage of profit. This is done since the cost of production for medical device is too high. Conducting market Assessment The entire diabetic monitoring device market was analyzed and it was found that it is a mature market and there is an existence of established players. However, it was also observed that the customers wedlock innovation in medical devices is quite open in this market. Design of Sales Program The sales program would be decided keeping in mind the budget allocated by the marketing department (Ozer & Phillips, 2012). Communication of Prices, Sales Promotion and Programs After the setting of cost of production, market price, promotion techniques have been considered as well as sales program has been designed. The sales program would have been designed keeping in mind the promotional offers and timings of the product. Development of Customer Deals and Programs After the budget of the medical devices has been tallied with the marketing techniques that need to be adopted, it had been observed that the diabetic monitoring device would come with certain discount offers and vouchers during the festive occasion. Managing Price Setting and Expectations The price setting process was done keeping in mind the cost and the availability of glycated serum, jet injections and disposable glucose sensor. Moreover, the marketing department had conducted a survey which included the price expectation of the customers regarding the product. Measuring and Reporting Price Information The price reporting information would include the measurement of the price setting process of the diabetic monitoring device in terms of opinion from the internal and external customers. Distribution Process of Health Kartz Diabetes The distribution process of medical devices would include supply chain and include handling, storage and transportation facilities, distribution and tracking, which need to be appropriately managed to ensure safety, smooth performance of the medical devices. In this case the standard procedure of the distribution process of the medical devices would be followed. The distribution process of diabetic monitoring devices would involve the receipt of the devices in bulk, storage and stock handling, stock rotation, delivery to customers and then return of medical devices if they are found to be faulty. There was more than one distributor in the entire supply chain procedure, who looked after the storage and transportation facilities. A field safety corrective action process would be undertaken for the serious damage in the state of health associated with the medical device. This would include the storage of medical device and then receipt of handling the devices was performed in a systematic manner. The return of medical devices, modification would also include filling of application form and then submitting it for acquiring a patent ownership. Quality Control Monitoring Process The risk of producing the Health Kartz diabetic monitoring devices in bulk was only realized when the monitoring device had to understand the process of combating risks effectively and then understand the functionality of the medical device is risk effective or not. The glucose monitoring device was first tested whether it complied with the FDA Quality System Regulation Act . This allows the management of Health Kartz Diabetic monitoring device to use a quality management approach to ensure product safety and risk effectiveness. The diabetic monitoring device was harmonized and ensured that they adhere with the ISO 9001 and ISO 13485. Most of this manufacturing device needs to adhere with the quality assurance standards because they are recognized worldwide. The quality assurance programs include a series of steps like: The constant approach of reduction error method in improvement in the existing system for record purposes To comply with the quality assurance standard and then deciding whether to launch the product or not Achievement of compliance through the standard risk assessment procedure To manage the supplier relationships and then ensuring that the correct amount and the right quality of goods is distributed The management of Health Kartz Diabetic monitoring device had ensured that an integrated quality management system was used which was configurable, easy to use software solution and also requires the software system. The software system is automatic and updates itself naturally and also helps in managing the document control, training and audit perspective. It also helps in cutting the validating system based on risk assessment and the solution drags automatically and reduces the risk of implementation of project through effective software up gradation. Process of Acquiring Finance for Health Kartz Diabetes Although, the process of procuring finance would require adhering with the medical policies of the state or national government, Health Kart Diabetes did not have any problem in acquiring finance from the banks. This is because filling of patent and medical equipment form would not be a time consuming process but involve large amount of expenses. Revenue: The purchase of the medical equipment and its related finance would be given a thought after taking into consideration the span of the medical product. Capital: Since, the medical equipment would be considered as a tangible asset with a life span of minimum one and half, the loan facility would be given to the management of the Health Kartz Diabetes only after the finance department is able to produce the success rate of the monitoring devices in a particular market. Mortgage: The mortgage to be provided for this particular product would be the fixed assets like the plant and machinery of the organization. Thus, the owner of the Health Kartz Diabetes would be approaching certain amount of investors who have earlier invested in small and medium enterprises manufacturing medical devices. Apart from the local investors, the owners would also be approaching the local bank for acquiring loan for around $125000, which would be further invested in the plant, machinery and other forms of fixed assets. Action Plan Action plan would enable us to prepare a schedule, which would reflect the marketing activities to be executed systematically. The action plans would also signify the specific marketing activities of the organization in a synchronization manner. S.no Task Name 1 Defining Specifications 1.1 Identification of the target market 1.2 Categorizing the customers into various sub categories 1.3 Benchmark the products and then match its requirements with the customer specifications 2 Generation of Marketing Concepts & Strategies 2.1 Generation of ideas through marketing concepts 2.2 Feasibility test of these marketing ideas 2.3 Testing the ideas into a test market on small proportion internal and external customers 3 Actual Market Plan 3.1 Designing the Test Stand 3.2 Building the Test Stand and Capacity Requirements Implementation of Milestones Marketing Tasks Timings Formulation of Plans 01/09/2013 Implementation of Marketing Strategy 2/09/2013 to 15/09/2013 Promotional Scheme Formulation Plan 25/09/2013 Execution of the Promotional Strategies 20/09/2013 to 25/09/ 2013 Mass Targeting Strategy for HealthKare Diabetes The main objective of this strategy would be garner attention from various potential customers through various promotional modes and promote mass consumerism (New York Times 2013). Firstly, the management of Healthkare Diabetes should utilize the marketing promotional modes like online, print advertising and radio television because these are exemplary examples of mass media advertising (NKU, 2013).Advertisement through television and social media would enable the company to directly target customers between the age 30 to 45 years old because customers within this age group usually have high visual retention power (Papantoniou, 2000) and would be able to etch the message of the benefits associated with the medical device in their minds perfectly (Soard, 2013). Advertisement through billboard and radio are also perfect promotional platforms, which help the company to easily communicate with the target customer base and also facilitate customer retention (Santamaria & Ni, 2008). Billboards are mass media promotional strategy, which is less expensive and reaches out to a wider customer base (Soard, 2013). This would be an excellent marketing strategy because it would help in garnering attention from the potential customers and also updating the product knowledge of the existing customers (Suttle, 2013a). Billboards are simple and effective mass media strategies, which can be situated in any locations (Suttle, 2013b). Radio advertising helps in communicating with the customers effectively without the problem of distortion and diffusion (Udayton, n.d.). This will require the management of HealthKare Orbitz to advertise about their products through a popular radio channel and also connect to a wider audience base. The advertisement should be provided during morning slots, which help in targeting customers who are office goers and they would instead disseminate the information related to the product to the elderly people residing with them (USGCAO, 2003). This would be one of the most simple and effective communication tools, which will help in attracting potential customers. The crux of the marketing strategy would be to attract customers suffering from diabetes and the customer who want to purchase the products for gifting purposes (Kotler, Shalowitz & Stevens, 2008). Commercial Risk Assessment The risk assessment strategies would include assessment of the varied marketing activities and its outcome. This would include assessment of the activities taking into consideration the positive and negative situation hypothetically. Positive Outcome Negative Outcome With the increase in the rise of the number of diabetic patients there is a possibility of the product generating higher amount of revenue. To curb down their personal expenditure, the customers can test their glucose content in the local hospital, dispensaries etc. This would be a major threat to Health Kart Diabetes and they might not be able to attract potential customers. The other hypothetical situation may include when the marketer fails to generate higher amount of revenue due to varied reasons like decline in the number of diabetic patients, failure of the marketing of product, etc (Lamb, Hair& McDaniel, 2011). Financials The financial would include a general revenue forecast taking into consideration the estimated profit that can be yielded. This would include a hypothetical situation. Figure 1: Revenue Forecast Thus, it is observed from the above estimated revenue forecast that the sales of the diabetic monitoring device depends upon the increase in the number of patient, current industry growth and varied other factors. It has been estimated that the number of devices produced increases with the cost of the production. It has also been observed that the revenue of the company is constantly increasing taking into consideration the fact that there has been an increase in the per capita income of the individual, growth in the economy and the industry itself. Conclusion Thus, it is observed that the commercialization plan of HealthKart Diabetes would include not only the formulation of strategies, but would also lead to their smooth execution. This would require assistance from the marketing department of the company, who would help in checking whether the palms are feasible or not. The continuous monitoring of operational and manufacturing process would require effective analysis and implementation of strategy with the help of varied marketing tools and techniques. References Ahmed, P.K,. & Rafiq, M. (2002). Using the 7Ps as a generic marketing mix: An exploratory survey of UK and European marketing academics. Marketing Intelligence & Planning, 13(9), 01-12. Ardalan, K. (2009). 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