Risk Assesment

Project Description

The quality gauges of therapeutic devices contain numerous viewpoints, for example, plan control, Risk management, vendor management etc. (Singh, 2017) In this paper we are going to discuss the importance of Risk management for medical devices and steps to perform during the product development stage. Risk management is a critical part of the medical device product development lifecycle. (Singh, 2017) It enables medical device engineers to guarantee that the item is dependable, functions obviously and will be no damage to the patients, administrators or the earth. In other words, the main purpose of the Risk management cycle is to lessen or curb the odds of disappointment in the item.

Medical Needs is a company that designs and manufactures medical devices and will be opening a new company and would like for us to do the risk management involved with the materials used for these devices and the design to ensure the devices are compliant to all regulations during production. There are many areas we will cover during this project to ensure that a quality product is available for the public consumer. We are looking at completing this project in less than six months before the manufacturing process commences. We will look at everything from vendor, mechanical and that everything planned before the company is open will be as risk free as possible.

. We will be using an Agile Method to conduct this risk assessment. The agile methodology with more checkpoints, gives you a chance to refine what you are working for the client, and what they are at last given. (Tan, 2016) Agile gives the chance to take what you made, offer it to a customer, and bring out criticism. Considering the input, you can decide if you are going the correct way. (Tan, 2016) If changes are required, you give yourself the chance to adjust and alter. When creating medicinal devices, numerous sources of info that must be contemplated. Distinguish the requirements of the end client however comprehend the potential dangers that the item may present to end clients and guarantee that your item is adequately protected and powerful by structuring risk adjustment into your medical device.

When using the agile process, you must understand how the Risk management process fits in, and then consolidate that approach into the project development plan. (Tan, 2016) By using the agile process, even trying to determine any risk that can take place in each phase of the project, if there is a risk discovered, it is possible to go back and eliminate such risk

The strategy being used for risk management will involve four different steps:

Risk Analysis: Systematic utilization of accessible data to acknowledge perils and gauge a risk. Risk Estimation: Process used to allot esteems to the likelihood of occurrence and seriousness of damage. Risk Assessment: In general process including a risk investigation and risk assessment. Risk Evaluation: Procedure of looking at the assessed risk against given risk criteria to decide the worthiness of the risk. These four methods will be combined to create a competent risk management strategy. During every step, the company representatives and myself will be weekly to discuss how to proceed with the specific areas to perform analysis and estimations in order to come up with the Risk Evaluation. The idea is to determine all risk throughout this project before the product is put into place.

. Type of benefit(s): (Fda.gov, 2016) What is the medical device`s foreseen effect on clinical administration and patient wellbeing? What benefits were at first foreseen? Was a clinical preliminary directed? What benefits were normal dependent on comparable devices?

Magnitude of benefit(s): (Fda.gov, 2016) For each benefit assessed: What was the medical devices’ initially foreseen effect on patient wellbeing and clinical administration? What was the initially foreseen impact of the device on patient administration and personal satisfaction, probability of survival, enhancing quiet capacity, averting loss of capacity, or giving alleviation from the manifestations of the illness or condition? What was the foreseen size of every treatment impact? What scale is utilized to straightforwardly quantify the foreseen advantage? How did the foreseen advantage rank on that scale? Is the device life supporting or life continuing?

Likelihood of patients experiencing one or more benefits: (Fda.gov, 2016) What extent of patients was relied upon to profit by the device? Did the first marking demonstrate which patients will encounter an advantage? How did the benefits assessed vary across subpopulations? Was there a variation in public health benefit for different populations?

Duration of effects: Does the device fix a malady or give a brief treatment? (Fda.gov, 2016) Could the term, if applicable, of every treatment impact, be resolved? Provided that this is true, what was it?

Project Risks

Cost risk: Cost risk can include material cost, production time, mechanical failure. At times and depending on the economy, cost could be a risk that is unforeseen.

Performance risk: The medical device might not perform as expected and might cause harm to patients, operators and the environmental strategic risks. The technology chosen for the medical device may not work resulting in production delay.

Training: If the employees are not properly trained this could result in faulty devices and delays in production. Not to mention harm to fellow employees or possibly a customer. This is another area which could be very costly to the company.

Schedule risk: The medical device development lifecycle may take longer than expected. It might increase the cost and delay the project benefits. Several of the risk factors above could play a big part in schedule delays.

Contractual: Even though a contract has been signed, the terms of the contract are ambiguous. If there is ambiguity in a series of contracts, the health plan can incur additional cost in situations in which it did not expect to have any costs.

Risk Register

List the risks in the Risk Register, provide detailed descriptions of the risks, and discuss the potential impacts on the project if the risk events occur.

Perform a qualitative risk analysis on the risks, and determine the priority of the risks using the probability and impact matrix.

Perform a quantitative risk analysis on the risks that have been prioritized, and complete the quantitative risk analysis results matrix.

Describe the risk response strategies for each of your risks.

Discuss your plan for reviewing the risk responses.

Discuss the plan for identifying new risks in your project.

Complete the communications matrix for discussing risk elements with your stakeholders.

Write a memo to the project sponsor describing the risk approach, the appropriateness of the risk identification process, an overview of the risk analyses activities, the responses strategies you did not use, and improvement ideas.

Fda.gov. (2016). Factors to Consider Regarding Benefit Risk in Medical Device Product Availability, Compliance, and Enforcement Decisions. [online] Available at: https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM506679.pdf

Project Management Institute. (2009). Practice standard for project risk management. [VitalSource version]. Retrieved from https://online.vitalsource.com/#/books/9781933890388/cfi/0!/4/[email protected]:0.00