Are there any topics in Project Management that one would find in a Medical Device company that are unique to the biomedical industry?
Conversely, are there any topics that appear frequently in Project Management for most industries but are rare in the biomedical industry?
In the field of medical devices, there is a new concept known as PM, which stands for Preventive Maintenance or Preserve Maintenance. Depending on a country's policies, one can choose to work on either of them. The Preventive Maintenance Policy for Medical Devices aims to prevent devices from becoming outdated and to keep them in a fresh state. On the other hand, the Preserve Maintenance Policy seeks to reduce the costs of medical devices and avoid rapid dismantling or repair. Most countries with strong economies tend to focus on Preventive Maintenance, as their medical devices undergo rapid and frequent changes. However, other countries with challenging economic conditions may opt for Preserve Maintenance, as they struggle to allocate budgets for purchasing new devices. This is due to the fact that, after one year, each new device depreciates by 10% to 15% of its original cost. Therefore, they may find it challenging to invest in new devices or may be reluctant to do so. Therefore, these countries or hospitals employ rapid calibration rotation services for medical devices provided by certain companies to obtain condition reports. These reports require dedicated time and effort, involving the completion of specific forms for each medical device on a daily, every 5 days, weekly, and monthly basis.
By the way, there are numerous institutes in the U.S. working in this field, with one of the most renowned being the ECRI Institute.
Based on my explanation, do you have any insights into why some countries with robust economies are not inclined to purchase new devices? Additionally, do you have any information about the specific forms used for reporting the conditions of medical devices?
In the context of the biomedical industry, the development and implementation of medical devices is a complex process that requires effective system management. This involves carefully considering regulatory requirements and the need for interdisciplinary collaboration. Effective system management should ensure that all process aspects are well-coordinated and that the final product meets regulatory standards.
My question is: What are the steps that a system manager needs to follow in order to navigate through different stages to develop implementations or medical devices?
@afshinsadri Your explanation of the differences between Preventive Maintenance and Preserve Maintenance in medical devices, based on economic conditions, is enlightening. To contribute to the discussion, I'd like to highlight that technical improvements influence the decision between different maintenance options.
In countries with robust economies, the rapid pace of technological innovation may drive a desire for Preventive Maintenance, ensuring that gadgets are up-to-date and in line with the most recent standards. This includes routinely updating and upgrading medical equipment to ensure it meets the most recent standards and regulatory requirements. Preventive Maintenance becomes a strategic investment, lowering the probability of device failure and increasing overall patient care.
On the other hand, in economically challenged times with tight budgets, Preserve Maintenance may be a strategic choice to extend the life of existing systems. This method seeks to extend the life of existing devices by carefully managing resources and avoiding unimportant replacements. Hospitals in such situations may prioritize cost-effectiveness and operational sustainability, choosing Preserve Maintenance to extend the life of their current medical devices.
Additionally, the role of international standards organizations in shaping maintenance practices could also be explored further.
As highlighted by @Zeinab Amoabediny development of medical devices is a complex process and also involves interdisciplinary collaborations such as engineering, design, regulatory affairs, and clinical experts. Interdisciplinary collaboration is a fundamental aspect of the medical device development process, and it brings together professionals with diverse skills and knowledge to ensure a comprehensive approach. There are various phases involved in the development and implementation of medical devices which can be classified as follows:
1. Device Discovery and Risk Analysis: - This includes Initial Design and Development Plan, Design inputs, Risk and Benefit Analysis and Risk Management Plan.
2. Formulation, Concept, and Feasibility: - In the second phase Customer Needs, Feasibility Study, Risk and Benefit Analysis and Refined Design Plan are illustrated.
3. Design and Development / Verification and Validation: - As the name suggest Design Outputs, Design and Prototyping Process, Verification of Design Outputs vs. Inputs, Initial Validation of Working Prototypes vs. User Needs and Traceability are taken into account.
4. Final Validation and Product Launch Preparation: - Before market release an update on Risk and Benefit analysis is conducted.
5. Production, Market Introduction, and Post-Market Follow-Up: - Lastly a validated and verified production plan to deliver products on time, within budget, and, most importantly, with safe and high-quality medical devices.
Therefore, to answer the question on the steps that a system manager needs to follow, is that throughout these stages, the system manager plays a crucial role in coordinating interdisciplinary teams, ensuring compliance with regulatory standards, and maintaining effective communication. Continuous improvement and adherence to quality management systems are integral aspects of successful medical device development and implementation. Additionally, the system manager should be proactive in addressing emerging challenges and adapting the development process as needed.
Some topics that are unique to the biomedical industry are risk management in clinical trials and regulatory compliance. Biomedical industries often involve clinical trials that require managing the risks associated with it. Such as integrity issues and handling experiment subjects as well as maintaining data integrity. This goes hand in hand with regulatory compliance where the biomedical industry must maintain FDA regulation guidelines.
A topic that is rarely seen in the biomedical industry is supply chain management since research and regulatory compliance are the main focus of the industry.
@afshinsadri Thank you for your explanation of both preventative maintenance and preserve maintenance, as I had never heard of these terms before. This aspect of project management seems especially important in biomedical engineering, where consumers have to balance cost with effectiveness. In terms of your question, I believe that consumers are often not inclined to purchase new products unless there is significant evidence that this product adds a new benefit that is worth the significant cost. For instance, if a radiology department has had an X-Ray for 15 years and continues to maintain it, they would not have any incentive to buy a new X-Ray machine unless a new technology comes out that is massively improved from the prior X-Ray technology. From my research, the only form I could find regarding reporting the quality of medical devices is the FDA 3500 form. This form is used to voluntarily report any product failures or adverse events that occur with a given medical device. However, I'm sure there are testing protocols for a given device that can be continually performed and documented on a case-by-case basis.
Another topic that is unique to medical devices include a robust quality management system or ISO 13485:2016 standards. This standard requires that a quality management system is implemented to meet the standards for safety and effectiveness of medical devices. Every company that manufactures or distributes medical devices needs to be compliant with this standard. The major difference is the highly robust risk management system that is implemented which includes identifying, assessing, and mitigating risks associated with the development, manufacturing, and use of medical devices. Every standards need to be documented and monitored to ensure that everything meets standard and these are checked during audits. Medical devices require a robust standard because at the end of the day, these are devices that are going into people's bodies.
@zeinab-amoabediny:
In my opinion, the best and most important management for medical equipment is developmental management, as without understanding the defects and strengths of a medical device, we cannot optimize it. However, the role of effective members in the development process is crucial.
For instance, hospital management should play a role in updating medical equipment in terms of safety and reporting it directly to the Food and Drug Administration and the manufacturing company to optimize the medical equipment in the relevant department, as most medical equipment performs similarly across departments. There is no difference from one hospital to another. By the way, my answer is related to Interdisciplinary Collaboration and Design and Development. However, there are other factors to consider, including Risk Management, Quality Management, Calibration, etc.
@noahyoussef
Thank you for your comments.
I have decided to discuss this topic further on my page at this link.
However, for more clarification, after the H1N1 virus outbreak in the U.S. in 2017, which unfortunately resulted in many casualties, the modus operandi and doctrine of medical management in the U.S. underwent significant changes. During President Obama's administration, the Health Ministry introduced a strategic plan for medical management known as BARDA (Biomedical Advanced Research and Development Authority) to address critical situations. This strategy evolved over time and proved to be invaluable during the COVID-19 pandemic.
In essence, the strategic plan aims to compel hospital management to prioritize the preservation of medical devices, emphasizing preventive maintenance over rapid repairs and working erosion. It also encourages hospitals to allocate funds for maintaining medical devices. This approach ensures readiness for unforeseen shifts in medical technology. The core doctrine of this strategy prompts us to consider that just as our cars have transitioned from fossil fuel to electric motors, a similar transformation in medical devices is inevitable.
