Medical Device Courses | Torikul | Activity

Torikul replied to the topic "Factors to consider when executing the NDA" -

Mon, 02 Dec 2024 03:02:22 -0500

i agree with others and i think that company decides how much information to disclose in an NDA by assessing the nature of the collaboration, tthe sensitivity of the information, and the level of access required for the other party… Read more»

Torikul replied to the topic "Legal Agreements in Effective Collaboration" -

Mon, 02 Dec 2024 02:56:22 -0500

I think that when drafting agreements in the medical device sector, clarity and mutual understanding are crucial to balance cooperation and protection. I’ve observed that incorporating well-defined deliverables, timelines, and measurable outcomes ensures both parties have clear expectations while leaving… Read more»

Torikul replied to the topic "Confidentiality and Transparency in Consulting Agreements" -

Mon, 02 Dec 2024 02:54:46 -0500

I think that to effectively balance confidentiality and transparency when hiring consultants, companies should establish robust Non-Disclosure Agreements (NDAs) that clearly define what constitutes proprietary information while allowing consultants access to the data necessary for project success. Transparency can be… Read more»

Torikul replied to the topic "Group Projects: Organizational Types" -

Mon, 25 Nov 2024 04:17:37 -0500

I agree with others. People may have different option’s. however i believe that a matrix organization structure would benefit our group and device development by combining the strengths of both functional and project-based approaches. It allows us to leverage specialized… Read more»

Torikul replied to the topic "AI & IoT in medical device industries." -

Mon, 25 Nov 2024 04:15:27 -0500

I think organizational development plays a pivotal role in helping medical device companies integrate advanced technologies like AI and IoT. It fosters a culture of innovation and continuous learning, ensuring that employees are equipped with the necessary skills and knowledge… Read more»

Torikul replied to the topic "Value-based healthcare: "Dos and Don'ts"" -

Mon, 25 Nov 2024 04:14:36 -0500

I agree with others. I believe that medical device companies can adopt several organizational development strategies to align with value-based healthcare. Firstly, they should focus on developing products that demonstrate clear clinical efficacy, cost-effectiveness, and improved patient outcomes, supported by… Read more»

Torikul replied to the topic "Risk Management: Risk v.s. Reward" -

Mon, 18 Nov 2024 04:15:16 -0500

I think many biotechnology companies prioritize rewards, especially when potential breakthroughs promise significant financial and clinical impact, but they cannot ignore risks due to regulatory scrutiny. Companies often balance risks and rewards by conducting formal risk-benefit analyses, which are required… Read more»

Torikul replied to the topic "Risk Management Tools" -

Mon, 18 Nov 2024 04:10:25 -0500

I have used FMEA and Fish Bone Diagrams in past projects to identify and analyze potential risks systematically. FMEA is my preferred tool because it provides a structured approach to prioritize risks based on severity, occurrence, and detectability, making it… Read more»

Torikul replied to the topic "Residual risk during device development" -

Mon, 18 Nov 2024 04:09:04 -0500

i believe that determining the acceptable level of residual risk requires clear criteria aligned with ISO 14971 and patient safety expectations. A risk-benefit analysis is crucial to justify that the device’s benefits outweigh residual risks. Risk assessments should use tools… Read more»

Torikul replied to the topic "Validation Study Success Defined" -

Mon, 11 Nov 2024 04:43:56 -0500

I agree with others. I believe that to define success criteria, a team first engages stakeholders to understand their needs and expectations. They set clear, measurable objectives that align with the project’s overall goals. The team gathers detailed requirements, including… Read more»

Torikul replied to the topic "The Relationship Between Verification and Validation" -

Mon, 11 Nov 2024 04:42:04 -0500

Verification ensures a product meets its design specifications, while validation ensures it meets user needs. These processes can be conducted simultaneously, especially in iterative and agile development methodologies. Integrating both allows for early detection of issues, improving product quality by… Read more»

Torikul replied to the topic "Impact of customer feedback on design inputs" -

Mon, 11 Nov 2024 04:40:07 -0500

I think design teams prioritize customer feedback by identifying common themes across various sources. They segment customers into distinct user personas to tailor solutions to specific needs. Prioritization frameworks like MoSCoW or the Kano Model help assess which features to… Read more»

Torikul replied to the topic "Benefits of Software Validation" -

Mon, 04 Nov 2024 03:05:41 -0500

I agree with others comments. I believe that two additional long-term benefits of software validation that positively impact a device with software over its life cycle are:Improved Regulatory Compliance: Validated software ensures that the device meets regulatory standards from the… Read more»

Torikul replied to the topic "The Defines of Design Controls" -

Mon, 04 Nov 2024 03:04:06 -0500

I agree with you. I believe that design controls are essential quality practices applied in the medical device design and development process to ensure that devices are safe and effective for their intended use. This structured approach covers planning, design… Read more»

Torikul replied to the topic "Details needed in a DHF for complex devices" -

Mon, 04 Nov 2024 03:01:10 -0500

To manage a large DHF effectively, break it down into modular sections aligned with design phases and use a detailed, hyperlinked table of contents. Maintain document control through a versioned management system, keeping only current documents in the DHF and… Read more»

Torikul replied to the topic "Double Blind Vs Single blind Study" -

Mon, 28 Oct 2024 05:00:07 -0400

I agree with others comment. I believe that Double-blind studies are preferred because they reduce bias from both patients and investigators. In single-blind studies, if investigators know who receives the treatment, it can influence their assessments, expectations, or behavior toward… Read more»

Torikul replied to the topic "Benefits for Patients in Clinical Research" -

Mon, 28 Oct 2024 04:56:53 -0400

I think that Paying patients in clinical trials is ethical if it fairly compensates them for their time and risk. However, it can be problematic if high payments coerce vulnerable individuals to participate despite risks. The key is to balance… Read more»

Torikul replied to the topic "Ethical Challenges of AI in Clinical Trials" -

Mon, 28 Oct 2024 04:55:39 -0400

Thats a good question. AI in clinical trials raises ethical concerns like bias in participant selection, opaque data analysis, and privacy risks. Bias can lead to unrepresentative trial groups, reducing the reliability of results, while opaque AI systems make findings… Read more»

Torikul replied to the topic "Long-term customer relationships in the face of increasing competition" -

Mon, 21 Oct 2024 04:21:20 -0400

I agree with others’ plan . Here is my opinion. How Businesses Can Apply Customer Retention Plans: Personalized Customer Experience, Loyalty Programs, Proactive Customer Support, Regular Engagement and Follow-ups, Customer Feedback and Continuous Improvement, Exclusive Content or Offers2. Role of… Read more»

Torikul replied to the topic "Importance of brand storytelling in sales and marketing strategies" -

Mon, 21 Oct 2024 04:16:07 -0400

Storytelling has become a powerful tool for brands to create strong emotional connections, foster loyalty, and differentiate themselves from competitors. Here’s how brands can effectively use narratives to build loyalty, along with examples of successful storytelling, and the challenges companies… Read more»

Torikul replied to the topic "Building marketing trust in medical devices: healthcare providers vs patients" -

Mon, 21 Oct 2024 04:12:29 -0400

Medical device companies can use marketing strategies to build trust with both doctors and patients by focusing on transparency, clear communication, and evidence-based messaging. Here are a few key ways they can achieve this:1. Evidence-Based Marketing for DoctorsDoctors, as experts,… Read more»

Torikul replied to the topic "Difference between type of company to work for and to start" -

Mon, 14 Oct 2024 02:13:29 -0400

It is a good question. I also agree with you. If I want to work then I will definitely work for a large company. There are lessen risks. I can gather more skills quickly. Most importantly it is more secure…. Read more»

Torikul replied to the topic "First Job: What type of company to choose?" -

Sun, 13 Oct 2024 18:38:15 -0400

The answer of this question may vary people to people. I believe that start-up and established compnay both have pros and cons. As pros of start-ups are: Exposure to Many Areas and Rapid Learning. Cons of start-ups are: Uncertainty, Heavy Workload…. Read more»

Torikul replied to the topic "First Job: What type of company to choose?" -

Sun, 13 Oct 2024 18:36:37 -0400

Torikul replied to the topic "Business Courses for Engineering Students?" -

Sun, 13 Oct 2024 18:27:59 -0400

It is a very important question. I believe that the choice of additional courses and workshops depends on student career goals. It is true that additional business course for engineering students can be highly beneficial for preparing them for industry…. Read more»

Torikul replied to the topic "Regulations with quality" -

Sun, 06 Oct 2024 21:07:29 -0400

Government involvement in regulation is crucial for ensuring public safety, particularly in industries like medical devices, pharmaceuticals, and biotechnology. Regulatory frameworks set minimum standards for safety, efficacy, and manufacturing practices, ensuring that products entering the market do not pose significant… Read more»

Torikul replied to the topic "FDA Advisory Panel Members with QC/QA Background" -

Sun, 06 Oct 2024 20:37:22 -0400

Thank you for your question. It is a very interesting question. I believe that there should be different types of people on the panel. 1. Scientific Expertise: people with relevant scientific expertise in the particular field should be in the… Read more»

Torikul replied to the topic "QA/QC Audits" -

Sun, 06 Oct 2024 16:41:51 -0400

thank you for your question. When a company is audited, the QA/QC processes themselves are indeed being examined to ensure they are functioning properly and that they adhere to the required standards and protocol. Audits can be done internally and… Read more»

Torikul replied to the topic "Regulatory Department Functions" -

Sun, 29 Sep 2024 15:33:47 -0400

I agree with others comment. I think both of the steps are important. In the overall project, both two major functions has significant impacts. However, i think prodeuct development will be slightly more significant. SInce it determines whether the product… Read more»

Torikul replied to the topic "Switching to a Regulatory Career" -

Sun, 29 Sep 2024 15:26:59 -0400

It’s a good question. In my opinion, there are several reasons why engineers choose regulatory roles. first of all Broader Impact: Here Engineers have the opportunity to shape the entire lifecycle of a product, from design to market approval. This… Read more»

Torikul replied to the topic "FDA biased?" -

Sun, 29 Sep 2024 15:18:35 -0400

Sources of Bias I also think That FDA is biased due to several factors. These are :1. Dependence for financial support: Since a significant portion of the FDA’s budget comes from user fees, there is concern that the FDA might… Read more»

Torikul replied to the topic "Balancing Medical Advancements and Ethical Concerns" -

Sun, 22 Sep 2024 04:25:27 -0400

It is a very important question. I think several things can be done. First of all, Advances in Alternative Methods can be developed: Develop In Vitro Models such as 3D cell culture, Computer Simulations, and Human-on-a-Chip Technology can be very… Read more»

Torikul replied to the topic "Why Are Dental Implants So Expensive?" -

Sun, 22 Sep 2024 04:18:24 -0400

Initially, it may be confusing why the cost is so high. There are several reasons for this. These are described below: 1. High-Quality Materials: materials used for dental implants typically are high-grade titanium or zirconia. it has excellent biocompatibility, corrosion… Read more»

Torikul replied to the topic "Challenges in Applying ISO 10993 Standards" -

Sun, 22 Sep 2024 04:02:01 -0400

I agree with others comment. During this week, I learned about ISO 10993 standards for biocompatibility. From my point of view, there can be several hurdles. Firstly, Identifying materials that meet biocompatibility is the most common hurdle. To solve this… Read more»

Torikul replied to the topic "How to Avoid Scope Creep" -

Sun, 15 Sep 2024 01:59:36 -0400

I agree with others’ answers. I believe that managing scope creep while maintaining a positive and collaborative environment is challenging. Therefore, we can use some strategies. 1. Establish clear Project Objectives. 2. Implement a Rigorous Change Control Process 3. Encourage Innovation… Read more»

Torikul replied to the topic "Project Planning: How Much Detail is Enough?" -

Sun, 15 Sep 2024 01:49:56 -0400

Well very good answers from everyone. From my perspective, it is a very challenging task to balance between too many details and little details. To resolve this problem we can focus on some important details. Therefore, we will only have… Read more»

Torikul replied to the topic "When Does It Makes Sense To Give Up On A Project?" -

Sun, 15 Sep 2024 01:27:54 -0400

I agree with others comment. However, I want to give my own opinion. From my point of view, it depends on several factors. 1. Escalating budget: if the budget escalates significantly then it is not feasible to complete the project…. Read more»

Torikul replied to the topic "Academia or Industry Preference?" -

Sat, 07 Sep 2024 23:24:26 -0400

Thank you for your question. After grad school, everyone has the same question. In the first lecture. I read about the duties in academia and industry. Both jobs have some advantage and disadvantages. However. i think a person should think… Read more»

Torikul posted a new topic "How to get prepare for the industry job during Ph.D. ?" -

Sat, 07 Sep 2024 23:17:32 -0400

I saw different roles of industry jobs during first lecture. For academic job, publication and research expererience might be helpful. However, I want to know how can i prepare myself for the industry job? What should i learn that might… Read more»

Torikul posted a new topic "How to be a successful professor ?" -

Sat, 07 Sep 2024 23:13:53 -0400

In the first class lecture, I learned about academia. I am interested in being a professor after completing my Ph.D. Therefore, I want to know how to be a successful professor in academia.

Torikul posted a new topic "What factors should be considered during selection a vendor?" -

Sun, 28 Apr 2024 17:48:55 -0400

In this week’s simulation, the project team had to select a vendor. During selection, the cost and quality of the product play a significant role.
Are there any other factors that should be considered?

Torikul replied to the topic "What should the project team learn from the failure project" -

Sun, 28 Apr 2024 17:45:34 -0400

It is very important question. I have gone through others’ comments. I agree with their points. However, I want to focus on a few points which I think are most important. First of all, lesson learned. project team should learn… Read more»

Torikul replied to the topic "Clinical Trials" -

Sun, 28 Apr 2024 17:36:40 -0400

The number of clinical trials can not be fixed. It varies from one to another. The number of clinical trials depends on several factors such as the nature of the device, patient population, regulatory requirements etc. It might happen that… Read more»

Torikul replied to the topic "Job Satisfaction" -

Sun, 28 Apr 2024 17:29:36 -0400

In my opinion, Money is an important factor. However, Other nonmonetary also play a significant role. I can tell you this from my personal experience. A good working environment, appreciation of good work, and supportive mentor are very important for… Read more»

Torikul replied to the topic "Scope Management in Biomedical Devices" -

Sun, 14 Apr 2024 15:47:38 -0400

we can apply some strategy to ensure that the scope of a biomedical devices project remains manageable and focused, considering the constant influx of new requirements, changing stakeholder expectations, and evolving technological capabilities. 1. Clear Objectives: Clearly define the project… Read more»

Torikul posted a new topic "Which factors should be followed while deciding number of alternative vendors ?" -

Sun, 14 Apr 2024 15:39:58 -0400

In mini-sim, we had to choose number of alternative vendors. Although it decreases the risk, it also increases cost and time. So, choosing the number of alternative vendors is complicated. Therefore, how can we choose a number of alternative vendors?

Torikul replied to the topic "Time Management in Medical Devices" -

Sun, 14 Apr 2024 15:33:19 -0400

I think we can apply some strategies so that we can manage time in the best way. Here, are some strategies that I think should be followed. 1. Planning: There should be a proper plan that describes the time for… Read more»

Torikul replied to the topic "Collaborative Research in Academia and Industry" -

Mon, 08 Apr 2024 00:37:57 -0400

Thank you for the question. I agree with other opinion. However, I want to add some more points. Here are some strategies to foster successful collaborations between academia and industry while safeguarding proprietary information. 1. Data Access Controls: Implement access… Read more»

Torikul replied to the topic "Monitoring and Controlling in a Project" -

Mon, 08 Apr 2024 00:32:11 -0400

it’s a good question. I agree with others opinion. They mentioned very good points. However, I also want to explain it briefly and give some major points. 1. Quality Assurance: For medical devices, quality assurance is very challenging. This includes… Read more»

Torikul replied to the topic "Verification & Validation NDAs" -

Mon, 08 Apr 2024 00:23:42 -0400

In my opinion, it is complicated. I agree with others’ answers. Since there are both advantages and disadvantages, so certain answer is not feasible. Advantages: 1. Maintaining confidentiality: it can prevent the leaking of important information. 2. Avoiding circulation of… Read more»