Case Study - Development of Syringes (Class II Medical Device)

The demands for designing safe and effective medical devices have significantly increased over the past decades. For example, medical experts expressed demand for improving current medical devices by illustrating and discussing the uses, general properties, and limitations of orthopedic biomaterials. The emergence of fraudulent devices drove the need for regulations. Countries all over the world have established laws and regulations to systematically manage medical devices in their respective markets. In the United States, for example, to assure the safety and effectiveness of medical devices in its market, the FDA (Food and Drug Administration) has established three regulatory classes based on the level of control: Class I General Controls (with or without exemptions), Class II General Controls and Special Controls (with or without exemptions), and Class III General Controls and Premarket Approval. For Class I and some Class II devices, simple controls will suffice for FDA clearance. Class III medical devices are subject to quality system requirements and stringent adverse event reporting and post-market surveillance. For companies that produce Class III medical devices, a premarket approval (PMA) will be required before the devices can be marketed. This is because the risk to the user or patient determines that a mass of trials must be done before approval. All device manufacturing facilities are expected to be inspected every two years.

Imagine you are asked to develop around 30,000 syringes (class II medical devices) that comply with industry and government standards. The basic components of a syringe would be a plunger, a barrel, and a needle hub. The budget associated with the project is 90M and the timeline is 3 years. These devices have medium to higher risks to patients or end users. The majority of medical devices (over 40%) fall into this device classification. These are the catheters that are surgically placed in patients who need to receive intravenous infusions of medication, blood products, or nutrition or who may require frequent blood sampling.

Medical device development should be set to meet the requirements of the area the device is to be used in, but there are some general steps in the medical device product development lifecycle that are followed across the board. The milestones include initial concept, product design, prototyping, device testing, device manufacturing, and product launch.

During the initial concept phase, the company needs to complete a basic market analysis, identifying the need for the product, competitive assessment, and plan for risk and regulatory assessment plans. During the design phase, the project core team is formed to define the project timelines, generation of customer requirements, connect generations, and subdivide the contractual tasks which may include the modeling, drafting, and documentation work to some contractual company. During the prototyping phase, the basic prototype is built to verify the customer requirements are met and that the concept is meeting the engineering requirements and plan for regulatory actions. During device testing, the engineering requirements are analyzed and then the change order is raised to order the components from vendors before device manufacturing. During the product launch phase, training is planned and all the risk management and regulatory plans are maintained. Standards are updated if necessary, and the lessons learned document is created for upcoming projects. Stakeholders are integrally involved in the healthcare system and would be substantially affected by reforms to the system. The major stakeholders involved in the development and usage of these devices include patients, physicians, employers, pharmaceutical firms (vendors and competitors), and the government. Apart from them, there would be an internal team working in a company indirectly responsible for the development and they are responsible for the product quality, product design, product manufacturing, process documentation, getting regulatory clearances, and supply chain for monitoring the required components and plan for change orders, marketing team to generate the sales in the market. All the stakeholders have duties and responsibilities. A Communication plan is established for the project communications and helps to identify how the information is shared with all the stakeholders and what is expected from each stakeholder as part of project execution. This plan consists of Milestones, Deliverables at each milestone, communication methodology, frequency of communication, priorities, and the participants. Typically for these projects, weekly meetings are preferred in all the phases of product development and a quality associate joins all the meetings along with the project manager. Regulatory associate joins during the initiation, verification, and review phases. All these are included in the project work breakdown structure. The WBS is a structure to see the milestones and the sub-tasks associated with the milestones and the executive responsible to task. Generally, in a WBS, Level 1 is the project, Level 2 is the milestones, Level 3 is the tasks, Level 4 is sub-tasks and Level 5 is activities.

Case Study Questions: 1. Identify the stakeholders required for the development of the medical device. (Classify the internal and external stakeholders using a context diagram). 2. Once the stakeholders are identified, classify the impact of each stakeholder throughout the product development process. (Make sure to justify your responses or ratings) 3. Develop a communication plan related to project stakeholders (Include all the essential elements required for a typical project communication plan) 4. Based on your understanding, Developing plan for the entire project that includes the budget for each phase, start and end date, responsible stakeholder(s), and milestones. (Make sure the durations are reasonable). 5. Develop a milestone plan for the project. 6. Design the network diagram and identify the critical path for the project. Based on your assumptions for most likely, pessimistic and optimistic times for each of the phases, what is the total project time? 7. What is the duration and probability of getting the project completed within 1, 2, and 3 of the total project time both from an optimistic and pessimistic point of view? 8. make project work breakdown structure to show the milestones and tasks. 9. Develop a detailed work package for two of the WBS items at two different levels. For the same WBS elements in the project at two different levels, identify the inputs and project success factors. 10. What are the project success factors according to your analysis? Do you see any perceived risks?

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Note: Project duration is 3 years and Budget is 90 Million (Provide report based on this information)