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nda4 replied to the topic Written Agreement v/s Verbal Agreement in the forum Consultants and Legal Basics 8 years, 4 months ago
Just to add to what’s been stated, In my opinion I would prefer a written agreement instead of verbal. I believe that whenever there is a mutual understanding of what is decided, then legal issues can be prevented or least have documented evidence when there is an infraction. Writing a formal agreement involves the review and assistance of legal…[Read more]
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nda4 replied to the topic NDA vs Patents in the forum Consultants and Legal Basics 8 years, 4 months ago
It’s also important to note that a NDA is a contract. And contract law is an entirely separate field from patent law. How contracts are interpreted is a matter of state law, and interpretations vary from state to state.
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nda4 replied to the topic Alternatives dispute resolution in the forum Consultants and Legal Basics 8 years, 4 months ago
In addition to what has been stated, I’d like to add:
Neutral Evaluation
In neutral evaluation, each party gets a chance to present the case to a neutral person called an “evaluator.” The evaluator then gives an opinion on the strengths and weaknesses of each party’s evidence and arguments and about how the dispute could be resolved. The…[Read more] -
nda4 replied to the topic Alternatives dispute resolution in the forum Consultants and Legal Basics 8 years, 4 months ago
In addition to what has been stated, I’d like to add a few more:
Case Evaluation
Case evaluation is a non-binding process in which parties to a dispute present the facts and the issues to be determined to an experienced neutral case evaluator. The case evaluator advises the parties on the strengths and weaknesses of their respective positions,…[Read more]
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nda4 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics 8 years, 4 months ago
Hello everyone,
Although I understand Roberto’s perspective, I also agree that the restrictions are important and necessary. Effective January 2012, the Sunshine Act required that pharmaceutical companies and durable medical equipments suppliers report gifts to physicians in excess of $25. I think this is a fair amount, since like Andrew and…[Read more]
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nda4 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics 8 years, 4 months ago
Hello everyone,
Although I understand Roberto’s perspective, I also agree that the restrictions are important and necessary. Effective January 2012, the Sunshine Act required that pharmaceutical companies and durable medical equipments suppliers report gifts to physicians in excess of $25. I think this is a fair amount, since like Andrew and…[Read more]
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nda4 replied to the topic Restrictions for physician's gifts in the forum Consultants and Legal Basics 8 years, 4 months ago
Hello everyone,
Although I understand Roberto’s perspective, I also agree that the restrictions are important and necessary. Effective January 2012, the Sunshine Act required that pharmaceutical companies and durable medical equipments suppliers report gifts to physicians in excess of $25. I think this is a fair amount, since like Andrew and…[Read more]
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nda4 replied to the topic Organization types of medical devices? in the forum Organizational Development in Device Companies 8 years, 4 months ago
I will have to agree as well. I would prefer the matrix organization as it also allows for greater flexibility in terms of outsourcing. In my experience, some projects that can be done outside the company are easily contracted and the outsource personnel are expected to support whole functional areas. However, I must also add that in this…[Read more]
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nda4 replied to the topic Discussion Topic: Your organizational type in the forum Organizational Development in Device Companies 8 years, 4 months ago
In my current job, I work in a project based/matrix organization. Depending on the need, I am pulled into projects outside my direct functional therapeutic area as needed. I like the matrix structure since it allows for enhanced growth and career development. It is a great opportunity to work with diverse areas across the organization and continue…[Read more]
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nda4 replied to the topic Forming a Project Team in the forum Organizational Development in Device Companies 8 years, 4 months ago
I agree that project teams should consist of representatives from each function in order to receive contribution from all roles. I have noticed in my experience, that having a mixture of people with varying levels of expertise can be helpful especially in the case of learning. I think having good interpersonal skills is something that is a great…[Read more]
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nda4 replied to the topic Risk Management Mistakes in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Very interesting article, Khemraj. I agree with you. Just to add it is very easy for risk managers to become occupationally tunnel-visioned. However, the job is to manage risk, not to avoid it unnecessarily. Every business action involves risk. Even standing still and clinging to the status quo entails risk. Risk is inherent in business as in…[Read more]
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nda4 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
I like how you pointed out the importance of avoidance in high severity scenarios. It is also important to know in terms of cost, risk acceptance does not reduce any effects however it is still considered a strategy. This strategy is a common option when the cost of other risk management options such as avoidance or limitation may outweigh the…[Read more]
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nda4 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
I agree with you Luisa, I’d also like to add that risk transference is the involvement of handing risk off to a willing third party. In my opinion, in the case of low severity I think it is a good idea if a company outsources certain operations such as customer service, payroll services, etc. This can be beneficial for a company if a transferred…[Read more]
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nda4 replied to the topic Manage Risk in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
I agree with you Luisa, I’d also like to add that risk transference is the involvement of handing risk off to a willing third party. In my opinion, in the case of low severity I think it is a good idea if a company outsources certain operations such as customer service, payroll services, etc. This can be beneficial for a company if a transferred…[Read more]
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nda4 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Personally, I would hope the techs and surgeon’s are aware of what is in the label (such as the risks) prior to using the product. Perhaps through training taken in advance. I agree , that in the surgery example, it is hard to mitigate risk.
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nda4 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Personally, I would hope the techs and surgeon’s are aware of what is in the label prior to using the product. Perhaps through training taken in advance. I agree , that in the surgery example, it is hard to mitigate risk, but I would expect a warning label if it is needed.
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nda4 replied to the topic Risk management and Labels in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Personally, I would hope the techs and surgeon’s are aware of what is in the label prior to using the product. I agree , that in the surgery example, it is hard to mitigate risk, but I would expect a warning label if it is needed.
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nda4 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Great post. Just to add onto what has been stated.
Risk ranking and filtering is also particularly helpful in situations in which the portfolio of risks and the underlying consequences to be managed are diverse and difficult to compare using a single tool. Risk ranking can also be useful for management to evaluate both quantitatively-assessed…[Read more]
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nda4 replied to the topic Risk management methods in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
Great post. Just to add onto what has been stated. Another risk management tool is:
Risk ranking and filtering- This method is used for comparing and ranking risks. Risk ranking of complex systems typically involves evaluation of multiple diverse quantitative and qualitative factors for each risk. The tool involves breaking down a basic risk…[Read more]
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nda4 replied to the topic Risk analysis in real company in the forum Risk Analysis for Medical Devices 8 years, 4 months ago
I agree that the risk analysis is team based and involves checks along the way. The team should begin with a thorough identification of all potential and/or known hazards and develop an estimation of the risk(s) for each hazard. In a three-tiered version, the severity, probability of occurrence, and detectability of each hazard are evaluated,…[Read more]
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