Question
Case Study - Development of Syringes (Class II Medical Device) The demands of designing safe and effective medical devices have significantly increased for the past
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, 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. 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?
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