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jbh8 replied to the topic "Hazard, Hazardous, Harm" – 1 year, 4 months ago
A patient is fitted for their first back brace following a scoliosis diagnosis. However during that fitting, the prosthetist/orthotist had incorrectly written the waist measurement to be significantly smaller than the patient’s true waist size. The back brace now poses… Read more»
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jbh8 posted a new topic "Design Matrix Content" – 1 year, 4 months ago
The Design Matrix is an extremely useful tool to get a fuller picture of the design process. It compiles inputs, specifications, validation, and verification information. It is a spreadsheet with each information type in its respective column. Do you think… Read more»
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jbh8 posted a new topic "Validation Study Success Defined" – 1 year, 4 months ago
Validation is how companies confirm there is objective evidence demonstrating that their processes consistently produce either a result or product that fulfills its predetermined specifications. A successful study must be clearly defined and fixed to avoid moving target success criteria…. Read more»
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jbh8 posted a new topic "Benefits of Software Validation" – 1 year, 5 months ago
Software validation is an important tool in ensuring the device software and software operations are of desired quality. There are several long-term benefits such as decreased failure rates, less recalls and needed corrections, and lowered risk. There are many more… Read more»
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jbh8 replied to the topic "Different Standards for Design Controls" – 1 year, 5 months ago
I think one factor that influences how a company interprets these guidelines are previous product documentation that were used in successful products (products that were approved and performed well in the market). This previous documentation could serve as reference to… Read more»
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jbh8 replied to the topic "Design Controls Component" – 1 year, 5 months ago
Of the nine components, the three most interesting ones are: inputs, design history file, and planning. Inputs are essential to the overall success of a product. This phase pushes manufacturers to address the product as an attainable device that fulfills… Read more»
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jbh8 posted a new topic "Design Input Requirement Categories" – 1 year, 5 months ago
Design input requirements typically can be sorted into 3 categories. These requirement categories are: functional, performance, and interface. Functional requirements specify what the device does, which includes its operational characteristics, and input processing and resulting outputs. Performance requirements specify use… Read more»
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jbh8 posted a new topic "Clinical Trial Participation" – 1 year, 5 months ago
Clinical trials enable improved and/or emerging medicines and medical devices to be developed and later available to a wide consumer population. Patient participation makes clinical trials possible. Without them, clinical trials cannot be conducted to fulfill regulatory requirements and knowledge… Read more»
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jbh8 replied to the topic "Balancing Scientific Rigor and Ethical Considerations in Clinical Trials" – 1 year, 5 months ago
One consideration taken should be the benefit-risk ratio. Researchers should determine whether the benefits outweigh the risks by asking whether risks have been minimized and benefits maximized to their full potential. Have all the possible steps been taken to ensure… Read more»
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jbh8 posted a new topic "Diversity and Inclusion in Clinical Trials" – 1 year, 5 months ago
Clinical trials are an important step in evaluating product performance to determine its appropriateness as a commercially available product to the wider population. It’s essential to understand all of the potential effects the product can have on humans. Therefore, it… Read more»
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jbh8 replied to the topic "Scenarios if internal & external environments" – 1 year, 5 months ago
A medical device company based in Florida launches a novel commercial IUD with a biodegradable polymer coating. The company had hired subject matter experts on polymers to consult on the IUD development. Their expertise contributed to the final design in… Read more»
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jbh8 replied to the topic "Digital Marketing" – 1 year, 5 months ago
Although the internet has definitely widened its customer reach through digital marketing, the digital divide should be considered. The digital divide essentially describes the gap between demographics and regions that have information and communications technology, and have limited/no access. The… Read more»
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jbh8 posted a new topic "Modern Promotion of Medical Devices" – 1 year, 5 months ago
“Push marketing” is in decline as customers have gained more control over what marketing they interact with. Therefore, modern marketing requires more direct interaction from marketing with customers. This goes hand in hand with promotion. Types of promotion include: viral… Read more»
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jbh8 replied to the topic "Ethics of Corporation considered as an entity" – 1 year, 5 months ago
As previous replies had stated, the corporate veil’s purpose is to separate the corporation and their shareholders; it essentially protects shareholders’ personal property. Initially, I would have been more inclined to say the corporate veil is not ethical as it… Read more»
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jbh8 posted a new topic "Business Courses for Engineering Students?" – 1 year, 5 months ago
At NJIT, currently BME and other engineering students are required to take one semester of an engineering management course. The class covers the fundamentals of engineering economics and project management. The class delves into the business side of product development… Read more»
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jbh8 replied to the topic "80% margin" – 1 year, 5 months ago
Like previous replies, I also believe it is unethical life-saving technology potentially may be disregarded if the profit margin is under 80%. A few replies had mentioned government intervention in the form of incentives such as tax breaks and special… Read more»
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jbh8 replied to the topic "QA/QC Audits" – 1 year, 6 months ago
In a way, the audits performed by regulatory agencies are a way to measure the performance of the QA and QC departments. However, I would also argue the regulatory department within that same company is observing the QA and QC… Read more»
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jbh8 posted a new topic "FDA Advisory Panel Member Requirements" – 1 year, 6 months ago
When a novel product (whether it is a medical device, drug, or biologic) seeks FDA approval, it can go to panel. A panel involves a certain group of experts under each FDA center that will meet to approve the PMA… Read more»
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jbh8 replied to the topic "Items Affecting Quality" – 1 year, 6 months ago
While working as an intern for a commercial technical operations team, I was exposed to the change control process. The company I worked for had been aiming to expand the scope of their biologics developments. The amount of site locations… Read more»
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jbh8 replied to the topic "FDA vs EMA drug approval rate" – 1 year, 6 months ago
I agree with points made above by previous users including the difference in review process. I particularly want to expand on the point regarding the difference in protocol for review of data. Each agency has different standards for determining data… Read more»
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