The consulting agreement should include incentives such as royalty payments for major contributions to the medical device or the project. A consultant may even create intellectual property for a company and preserve ownership of its rights, if that was what…   Read more»

Many of the objectives stated in this forum are examples of requirements that companies should measure when approving and evaluating service suppliers for consulting or legal work. Documenting these requirements, as well as the evaluations of approved services, contributes to…   Read more»

Verbal agreements can be acceptable when there is evidence to support that one or both parties were providing services and benefiting each other. Records such as emails, meeting minutes, or purchase orders can be used to enforce a verbal agreement….   Read more»

Using the company’s mission and vision statements to decide on a structure is a good starting point. If a company emphasizes helping others and innovation, then its organizational structure can aid in fulfilling those goals or values. The size and…   Read more»

Multiple project deadlines and meetings can be better handled with management that has the right characteristics. A matrix organization allows for more people to have a say on what should be prioritized. Therefore, management should be more understanding and sensitive,…   Read more»

 I prefer the matrix organization due to the openness and collaboration. I would be able to acquire knowledge that I would not have learned in school otherwise. The ability to work for more than one boss has its advantages because…   Read more»

Risk management can be applied to supply chain efforts, considering that supply chain disruptions are usual in manufacturing at any time. The likelihood of supply chain disruption is higher, and the severity may be significant or severe depending on the…   Read more»

FMEA is a recommended tool for identifying potential failures early in the development phase, as well as their effects and the recommended actions to be taken. Global organizations such as the Six Sigma Institute recognize FMEA as a critical tool….   Read more»

Certain risks in medical device development can be mitigated but not eliminated. After the risk management plan is executed, the risk management team must measure the effectiveness of their plan. Residual risk refers to the remaining risk after strategies have…   Read more»

Yes, a smaller startup can benefit from efficiently using design controls. The advantage can start as early as the design planning and scope management phases. A smaller startup may be more likely to develop and execute a more custom project…   Read more»

Design transfer and process validation are closely related processes that require careful management from the right personnel. The design transfer must be completed so that the manufacturing stage can start. To prevent any issues or limitations, a contract review should…   Read more»

Even though validation occurs later in the design controls process, it is based on the user needs, which are determined at the start of the process. Therefore, it would be beneficial to consider the required validation methods as early as…   Read more»

The responsible persons have to research and collect data on user needs. They have to understand the user’s procedures and identify the risks & effects of the product. External factors like individual user performance can influence the product. This information…   Read more»

Medical device companies conduct internal audits to ensure compliance with regulations or standards. It is a great way to identify nonconformities before they become greater risks or to find ways for improvement. It is recommended for companies to conduct internal…   Read more»

Medical device development takes several years to complete, and drug development can take over a decade to complete. The clinical trial process has become more complex and expensive, as mentioned. Challenges include the need for more procedures & tests, longer…   Read more»

For the protection of human research subjects, regardless of the type of research, there is 45 CFR 46, which pertains to the Department of Health and Human Services. This regulation was also adopted by other agencies and departments, which is…   Read more»

Including as many factors as possible into a clinical study to support or even improve a treatment is beneficial for the study. Both placebo and nocebo effects are helpful to understand chronic and mental illnesses, especially. A placebo effect can…   Read more»

Two companies, Kimberly-Clark and Halyard Health, were found guilty of fraud eight years ago for the medical gowns they sold. The gowns were marketed for disease protection and claimed they met AAMI level 4 standards. However, the defendants concealed data…   Read more»

Yes, storytelling can help people understand medical devices better. The importance of clear and clever communication is found in sales as well. Hospitals depend on purchasing departments to acquire medical devices, equipment, and services. They are searching for ways to…   Read more»