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»

[quote data-userid=”24129″ data-postid=”22166″] I would enhance what is already in place rather than initiating a system that would take more time. The QMS would adhere to FDA & ISO standards as well as the company’s mission and quality policy. A…   Read more»

I would enhance what is already in place rather than initiating a system that would take more time. A thorough review of the QMS would include revising sections that need to be improved on so that they reflect the current…   Read more»

QA should conduct an investigation if an adverse event occurs or if post surveillance data detects an issue with the medical device. As per most quality management systems, a complaint should be opened to handle an adverse event experienced by…   Read more»

Nasal spray is a combination product because a drug is prepackaged in a delivery system that enters the nose. The pump can be specialized to deliver a precise dose consistently. The primary mode of action is from the drug. For…   Read more»

People in medical device regulations need to handle changes set by different regulatory bodies. Many companies also want to sell abroad or work with other vendors or sellers which have their requirements. Entropy is a natural occurrence in the medical…   Read more»

In terms of general reform or changes, what came to mind was the Medical Device Amendments of 1976. Similar medical devices already sold in the country from 1976 or prior are typically considered Class 1 and are likely to be…   Read more»

Medical containers and trays that are used to store surgical instruments benefit from stability testing. The regulatory requirements for these medical devices are less demanding than medical devices that are in direct contact with patients. Many of the container systems…   Read more»

Another aspect to consider when preventing adverse reactions is proper placement of the medical implant by the medical professional. Adequate medical training and manufacturer instructions are required for doctors in order to use the implant on a patient. Instructions can…   Read more»

I have some industry experience in a small laboratory setting. What I did to expedite the progress was online research because I did not have much knowledge on instrument chemistries and sterilization practices at the time. This meant using credible…   Read more»

Conducting preclinical studies is beneficial in risk identification and evaluation during project development. Many of the processes in industry need to be written procedures to prevent errors and increase data accuracy. Forms that are required for records need to be…   Read more»

This post highlights the significance of project roles, especially the project leader or manager role. A project leader may also be a stakeholder, or the stakeholder may be upper management, a vendor, or a customer. A successful project leader and…   Read more»

The planning phase of project management determines the required tasks in order typically using a work breakdown structure. Depending on the project, a lot of these tasks may be connected to each other and require specific charts or diagrams to…   Read more»

AI can be a useful tool in the medical device industry if used appropriately. I hope that AI can continue to drive sustainability efforts in the healthcare and medical device industries. Common challenges that AI can address include managing inventory,…   Read more»