Medical Device Courses | td256 | Activity

td256 replied to the topic "NDA vs Patents" -

Sun, 01 Dec 2019 23:35:56 -0500

Patents represent rock-solid proof of ownership of an idea. And this is important because an idea is intangible. There are only two ways a court of law recognizes ownership of an idea – NDA and Patent. Whereas a patent is a federal… Read more»

td256 replied to the topic "Written Agreement v/s Verbal Agreement" -

Sun, 01 Dec 2019 23:23:27 -0500

From a practical standpoint, having a written agreement is a way of “vetting” the opposing side. Writing a formal agreement involves the review and assistance of legal counsel during the contract formation process. The act of preparing and negotiating a… Read more»

td256 replied to the topic "Advice before signing an NDA" -

Sun, 01 Dec 2019 23:15:45 -0500

It is important that you understand the terms of the agreement of NDA before signing it. NDAs generally contain a few specific pieces:Definitions of confidential informationObligations from all involved people or partiesTime periodsBe cautious of an overbroad agreement that seems… Read more»

td256 replied to the topic "Upper vs Middle Management." -

Sun, 17 Nov 2019 23:54:25 -0500

Most organizations have three management levels: first-level, middle-level, and top-level managers. These managers are classified according to a hierarchy of authority and perform different tasks. Middle management is the intermediate leadership level of a hierarchical organization, being subordinate to the… Read more»

td256 posted a new topic "Malsow's law in organization" -

Sun, 17 Nov 2019 23:42:48 -0500

Abraham Maslow, a psychologist from the behavioral era of management history, proposed a theory of motivation based on universal human needs. Maslow believed that each individual has a hierarchy of needs, consisting of physiological, safety, social, esteem, and self-actualization needs.Physiological… Read more»

td256 replied to the topic "Medical Device Project" -

Sun, 17 Nov 2019 23:38:04 -0500

It is interesting that you pointed out how we’re working in martix type organization. Our team has the first meeting on last Friday and we have decided to keep Fridays fixed for our weekly meeting. As we all weren’t aware… Read more»

td256 posted a new topic "Benefits of post-market surveillance" -

Sun, 17 Nov 2019 22:50:04 -0500

To make sure medical devices remain safe and effective once it’s on the market – medical post-market surveillance (PMS) is done. It a system that provides continuous feedback about a device on the market in order to maintain a high… Read more»

td256 posted a new topic "SWOT analysis for risk management" -

Sun, 17 Nov 2019 22:39:47 -0500

SWOT analysis is one of the techniques organizations use for risk management of their products. SWOT stands for Strengths Weaknesses, Opportunities, and Threats. The organizations employ the SWOT analysis to forecast, identify, resolve and guard against pending seen and unforeseen… Read more»

td256 posted a new topic "ISO 14971 standard in risk management" -

Thu, 14 Nov 2019 01:10:37 -0500

As of now, governments do not have own guidelines for performing risk management. They refer to ISO 14971, the global standard for medical device risk management. The intent of the standard is to identify hazards associated with medical devices at… Read more»

td256 posted a new topic "Steps of Process Validation" -

Sun, 10 Nov 2019 16:16:57 -0500

Design validation focuses on the device itself and involves creating evidence that it meets user needs and intended uses. Process validation, as the name implies, focuses on the production of the device. Most companies follow FDA requirements for design control… Read more»

td256 replied to the topic "What are Design Controls?" -

Sun, 10 Nov 2019 16:08:41 -0500

Medical devices used in the United States must comply with federal regulations established to ensure that specified requirements have been met. A high-level overview of these design control requirements is provided to increase awareness of the device development process and… Read more»

td256 replied to the topic "Design Controls in the other countries" -

Sun, 10 Nov 2019 15:59:13 -0500

Investment in artificial intelligence (AI) and digital health technologies has increased exponentially over the last few years. In the United Kingdom, the excitement and interest in this space has been supported by NHS policies, including proposals in the NHS Long… Read more»

td256 posted a new topic "examples of controlled device changes" -

Sun, 03 Nov 2019 21:54:07 -0500

Product development is inherently an evolutionary process. While change is a healthy and necessary part of product development, quality can only be maintained if those changes are controlled and documented. Design control involves establishing procedures to identify, document, review, verify,… Read more»

td256 posted a new topic "Medical Device Clinical Trials vs Drug Trials" -

Sun, 03 Nov 2019 21:31:54 -0500

Clinical trials for medical devices have many similarities to drug trials, there are some necessarydifferences in the way the trials are designed and carried out. And in some cases, for medical devices, clinical trials may not even be required. Clinical… Read more»

td256 replied to the topic "Combination Product Phase I clinical Studies" -

Sun, 03 Nov 2019 21:25:06 -0500

The design control requirements are basic controls needed to ensure that the device being designed will perform as intended when produced for commercial distribution. The elements of design controls are – planning, input, output, review, verification, validation, transfer, design changes… Read more»

td256 replied to the topic "Double Blind Vs Single blind Study" -

Fri, 25 Oct 2019 02:45:11 -0400

In a clinical trial, the two major models are single blind and double blind trials. Human behavior is influenced by what we know or believe. In research there is a particular risk of expectation influencing findings leading to biased results…. Read more»

td256 replied to the topic "Clinical Studies" -

Fri, 25 Oct 2019 02:25:51 -0400

Before clinical trial a drug or medical device cannot go into the market. Clinical trial has unavoidable moral conflict which cannot be solved permanently. Without clinical trial we won’t know the good or bad effects of the drug or device…. Read more»

td256 replied to the topic "Clinical Trial Roles" -

Fri, 25 Oct 2019 02:17:52 -0400

I want to be an investigator in clinical research trial. By being n investigator I will be directly in touch with the subjects and involved in the research methods. Being in a lab/research environment excites me. Seeing the results and… Read more»

td256 posted a new topic "Sales vs project management" -

Mon, 21 Oct 2019 00:44:06 -0400

The missions of sales and product management are very different. Sales is associated with quarterly and annual targets and incentives. Whereas product management is related to the product lifecycle, market share, and competitive positioning. In reality, product management and sales… Read more»

td256 replied to the topic "Medical Device SWOT Analysis" -

Mon, 21 Oct 2019 00:34:17 -0400

I am choosing Edwards Lifesciences for SWOT analysis :STRENGTH1. largest maker of heart valves2. strong free cash flow to expand into new peoducts3. increases R&D gives competitive aadvantage4. high level of customer satisfaction5. strong brand portfolio WEAKNESS1. need more invest in… Read more»

td256 replied to the topic "Discussion Topic: The Fifth "P" of Marketing" -

Mon, 21 Oct 2019 00:08:54 -0400

A very popular marketing technique is free trial. By free trial people can get an overview of the product and to access multiple features they need to buy the premium. This is a genius trick for marketing.

td256 posted a new topic "LLC vs LLP" -

Fri, 11 Oct 2019 21:48:33 -0400

An important aspect of starting a business is choosing which type of business entity to create. Two popular entities are Limited Liability Companies (LLC) and Limited Liability Partnerships (LLP). Both are very similar yet they have their unique characteristics including… Read more»

td256 posted a new topic "DBA Filing" -

Fri, 11 Oct 2019 21:40:40 -0400

A DBA( doing business as) allows a company to transact business using a different name. It generally takes place at the county level, but some states have state-level DBA filings. For sole partnership or partnership, unless a DBA is filed,… Read more»

td256 replied to the topic "Partnership characteristics" -

Fri, 11 Oct 2019 21:12:47 -0400

I agree with the fact that sole partnership and partnership are very similar. Depending on the business structure I will choose the partner. Choosing a partner depends on various factors. First thing do not mix personal and professional relations. It… Read more»

td256 posted a new topic "Emerging technologies and QA" -

Fri, 04 Oct 2019 20:52:44 -0400

In this age, different emerging technologies are beginning to rapidly change the nature of work. Internet of things(IoT), Artificial intelligence (AI), Machine learning are just a few examples of the new, disruptive technologies that are impacting the jobs in one… Read more»

td256 posted a new topic "organizational skills for QC" -

Fri, 04 Oct 2019 20:45:02 -0400

In this week’s lecture we came to know about the difference between QA and QC, what are their responsibility, goal etc. As a QC person, they have to run a specific team to identify the defects in the finished product…. Read more»

td256 replied to the topic "Discussion Topic: Quality Assurance vs. Quality Control" -

Fri, 04 Oct 2019 20:32:54 -0400

While QA ensure the quality in the process by which products are developed, QC focus on identifying defects in the finished products. By preventing defects during the process of making the product, it focuses on improving development and testing process… Read more»

td256 replied to the topic "Precision and Accuracy" -

Mon, 30 Sep 2019 01:08:12 -0400

With repeated use and over a period of time, all equipment tends to degrade which affects its accuracy and precision. In the medical device industry, a drift in the measurement is unacceptable. For medical device manufacturers, the precision and accuracy… Read more»

td256 replied to the topic "FDA rules too strict?" -

Mon, 30 Sep 2019 00:51:43 -0400

Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation.During AIDS epidemic, late 1980s, different activist organizations accused the FDA of unnecessarily delaying the approval of medications to fight HIV which caused lost… Read mo…[Read more]

td256 replied to the topic "Discussion Topic: Android app for measuring blood glucose" -

Mon, 30 Sep 2019 00:40:24 -0400

I am going to talk about few apps that connect to the glucometer without wire.1. BG Monitor Diabetes : It is an app that logs everything at one spot. It tracks blood glucose, insulin and carb intake. If target numbers… Read more»

td256 posted a new topic "Talking about animal research" -

Mon, 23 Sep 2019 02:49:17 -0400

When it comes to animal research there are various constraints we need to keep in mind. One of them is animal rights. A lot of animal rights group are against this. Recently there are few news about extremist groups who… Read more»

td256 replied to the topic "This vs That" -

Mon, 23 Sep 2019 02:43:08 -0400

I will choose to work in academia over industry. Biomedical has a huge scope for research and development. I would like to work on the devices that no one can think of. Yes, it is mostly for curiosity, but I… Read more»

td256 replied to the topic "Academia vs. Industry Research" -

Mon, 23 Sep 2019 02:32:44 -0400

In research lab in academia, we perform animal testing till we are satisfied with the result. This costs time and money. As this is solely for research purpose, the constraints are less strict than industry. In industry it is fast… Read more»

td256 posted a new topic "How do you identify or become a good project manager?" -

Sun, 15 Sep 2019 23:14:24 -0400

I have no work experience in working in the industry. I am studying about project management and trying to learn how to be a good project manager. For a person like me, I can only learn in theory but to… Read more»

td256 replied to the topic "Multiple Project Managers for one project" -

Sun, 15 Sep 2019 22:46:44 -0400

I am a master’s student with no prior experience of working in the industry. My knowledge of project and project leader was limited to final graduation project or summer research program. I have always seen and experienced classes between team… Read more»

td256 replied to the topic "project management" -

Sun, 15 Sep 2019 22:33:45 -0400

Starting a project always have an end goal. It may or may not be achieved partially or totally, but to reach the goal it follows a path. This path may not be exactly similar for every project, but we can… Read more»

td256 replied to the topic "Discussion Topic: Practical vs. Informational courses" -

Sat, 07 Sep 2019 19:13:38 -0400

Hello,I am a master’s student following biomedical instrumentation track and have chosen thesis option. As of practical vs informational courses I think for masters student it is more important to learn about the practical side. Mostly in undergrad we learn… Read more»

td256 replied to the topic "Discussion Topic: Academia vs. Industry" -

Sat, 07 Sep 2019 18:57:21 -0400

Hello,Currently I am pursuing MS in BME. I did my undergrad in Instrumentation engineering. I have chosen thesis option. I have started my master’s right after my bachelors. So I have no industry experience. Now that I have choose between… Read more»

td256 replied to the topic "Thoughts on BME degree, "a little of everything"" -

Sat, 07 Sep 2019 18:17:22 -0400

Hello,I agree to the part where you have said in BME we learn a little bit of everything. When we start BS no matter what your major is we learn a little bit of everything. By the time we reach… Read more»