Project Management for Medical Devices
Outer Reef Technologies
When it comes to new medical device development, quality project management is crucial for success. Without a well-devised and strategic project management plan, the development process can slow down—costing your business a considerable price because of delay in time-to-market.
Put simply, a project management plan allows your team to work in synergy and greater focus, ensuring new medical devices are developed as intended—superior in performance and functionality, and more importantly, compliant with regulatory requirements.
Therefore, it is imperative to understand the essential stages of project management and plan accordingly for the best results. And this is what we are known for. At Outer Reef Technologies, our seasoned and knowledgeable team can provide you with step-by-step guidance to developing quality project management for medical devices.
The top benefits of quality project management for medical devices:
As industry experts, we believe that the following are the most crucial stages of a successful project management program:
The project scope addresses the project's purpose and all the necessary resources needed to execute and complete the project. Thus, it should include the specific need to start the project, deliverables, and goals to measure success. Also, make sure to determine factors like time, regulatory requirements to follow, and cost.
Just like no business is without risk, there is no project that doesn't come with its sheer of risks. Therefore, when developing a new medical device, it is vital to determine the risks involved, especially in design or critical deadlines.
Now that you know the scope and risks, you can create a strategic and realistic product development plan with a realistic timeline. To schedule for success, you should:
This is much needed as it will help you allocate the right person for the right job and hold the assigned individual accountable for the task assigned to them. When people know what is expected from them and are clear about their roles, they are more focused, resulting in better performance and productivity.
How you communicate is pivotal to ensure your entire project management plan falls in its right place. The top-down management style never works in the medical device development process. That is because there is too much pressure to conform to the directives of the higher management rather than focus on the goals of the project and regulatory requirements. Moreover, such a management style sometimes alienates or breaks the smooth communication flow across departments needed for the new device product development process.
Therefore, the ideal style of management and communication is the matrix style. It provides efficient collaborative channels across departments and empowers people to make precise decisions as and when needed.
To know more about medical project management or engineering consulting and assistance, contact us today. At Outer Reef Technologies, we are experts in new medical device product development and project management.
Our engineering consulting team can provide you with quality advice can help you get the next-generation new medical devices to the market efficiently. From providing you with a complete, clear, and result-focused project management plan to quality assistance from start to finish, we work as a trusted partner in your journey to success. We ensure that everything is completed on schedule and is tailored as per your needs. Contact us today for a roadmap to success.
Product development services include but are not limited to; medical device development, robotics, electronics, firmware, software, mechanical design. Our team can help from initial concept through product launch and anywhere in-between.
Our team excels in understanding regulatory requirements for developing a thorough and cost effective plan, to meet your specific needs. We can assist in developing a quality management system for your company, guiding products through regulatory testing, and formal submissions such as FDA/EU/CE.
As we have many years of experience in new product development and prototypes we have transitioned over the years into also supporting our clients from production equivalent builds used for verification and validation to full production line support of complex electro-mechanical and optical assemblies.
After working decades with the top surgeons, we have brought many Class III medical devices and suites to the industry from concept through clinical trials and 510k submission.
Our team has extensive knowlege and experience developing and manufactiring optical devices ranging from LED fiber optics to rigid and flexible scopes.
As nearly all of our products require the highest level of accuracy and precision, in a small form factor, we typically design our own encoder solution to meet the clients requirements.
We have partnered with some of the top companies in the world to develop world class virtual and augmented reality devices. Our specialty is in sensor calibration, system integartion and verifcation.
Our design team utilizes SolidWorks to design and develop all of the products mechanical components. We utilize FEA and 3D printing to ensure our designs meet all requirements, prior to manufacturing.
It is a project management type that focuses on engineering projects. These project managers play a pivotal role in developing new products, processes, or designs.
A project manager's role and responsibilities include planning, organizing, and directing the project, ensuring that it is completed on time, in budget, and within scope.
Also known as budget variance, it is the difference between the actual and budgeted cost. In other words, it determines what is expected to spend on the project and what is actually spent.
This is more beneficial as it gets the job done faster and right the first time. Teams are empowered to make decisions. Plus the project managers oversee functional managers participating in the project such as engineering, finance, marketing and manufacturing. However, these functional managers delegate responsibilities to the assigned worker. All this makes managing smooth and well-synchronized.
Also, as collaborative channels are present, it allows everyone to be fully aware of the project progress and collaborate efficiently.
Periodic review is carried to ensure the effectiveness of the project progress according to the plan. This further ensures the project is moving on the right track and against the predefined timeline.
Thank you for you interest and we look forward to speaking with you! Call us directly to speak with one of our engineers or feel free to email us and we will contact you within 24 hrs to discuss your project needs.