Case Study - Development of Syringes (Class II Medical Device) The demands of designing safe and effective medical devices have significantly increased for the past decades. For example, medical experts expressed a demand of 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 their laws and regulations to systematically manage the 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 device) that complies with the industry and government standards. The basic components of a syringe would be 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. 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 do basic market analysis, identifying the need for the product, competitive assessment and plan for risk and regulatory assessment plans. During design phase, project core team is formed to define the project timelines, generation of customer requirements, connect generations, subdividing the contractual tasks which may include the modelling, drafting and documentation works to some contractual company. During prototyping phase, the basic prototype is built to verify the customer requirements are met and 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, trainings are planned and all the risk management, regulatory plans are maintained. Standards are updated if necessary, and the lessons learnt document is created for the 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 development and usage of these devices include the patients, physicians, employers, pharmaceutical firms (vendors and competitors) and 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, 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 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 for completing the task. Generally, in a WBS, Level 1 is the project, Level 2 are the milestones, Level 3 are the tasks, Level 4 are sub-tasks and Level 5 are 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, create a 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. Prepare a project work breakdown structure to show the milestones and tasks. 7. 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. 8. What are the project success factors according to your analysis? 9. What are the risks?