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»

A company with a motivating mission statement and a vision that encompasses a bigger or more inspiring goal can effectively distinguish itself from competitors. A unique or modern purpose can secure stakeholders and boost employee morale. The value of these…   Read more»

My previous response was intended for your other discussion on public versus private companies, which I added there. However, I want to add to this discussion about cash flow versus profit. Understanding why cash flow is important can start with…   Read more»

The medical device industry is diverse and compromises of both public and private companies. Privately owned companies benefit from reasons that you mentioned such as faster and more flexible decision making. A private medical device company gives the owners more…   Read more»

The medical device industry is diverse and compromises of both public and private companies. Privately owned companies benefit from reasons that you mentioned such as faster and more flexible decision making. A private medical device company gives the owners more…   Read more»

Evaluating financial ratios can determine if a company is capable of investing for returns that come later. A balance between short term financial goals versus long term investment can depend on the product line which can evolve over time with…   Read more»

Challenges during auditing can appear in the investigator’s audit report especially when they are QMS deficiencies. Negar and Natalie provided examples of frequent problems that can arise. As a result, the company needs to respond back with a plan to…   Read more»