A good way to make verbal contracts binding would be to send follow-up emails right after discussions. The follow-up emails can summarize everything discussed over the conversation in writing. Once all the details, including any agreements reached, are written in an email and confirmation sought from the other party, then confusion can be cleare…[Read more]

The key to an effective project team is in understanding the goals and the required skills to get the job done. It’s very tempting to want to work with people that you get on well with, but it’s about the…   Read more»

To make single person decision making work better, setting up a “predecision consultation” process can help. This means the decision maker holds short meetings with key team members to gather different ideas and expertise. After making the final decision, they…   Read more»

For medical device companies to succeed in the value-based healthcare marketplace, their strategies have to be put in line with patient-centric and cost-effective solutions. A very effective strategy would be co-creation strategies through collaboration with healthcare providers and patients in…   Read more»

Risk management is not only crucial in medical devices where patient safety is a top priority. It not only ensures compliance with regulations such as ISO 14971 but at the same time, it is also important for a company’s reputation…   Read more»

I completely agree that proper training is critical to avoid mistakes with biohazard protocols. For example, take the case of a newcomer in a biology lab who is assigned to sterilize re-useable pipettes that have been used for non-pathogenetic but…   Read more»

I agree, after learning about verification and validation this week, I’ve gained so much knowledge about the safety and reliability of the medical devices we use. It definitely makes me feel much more confident in its safety and reliability.  Verification…   Read more»

Design control is a sensitive and important task in medical device manufacturing companies. The protocol to undergo design control and review can be considered a milestone in meeting regulatory norms and standards. This helps with product failure, rejection, mall function,…   Read more»

Enhanced Data Security and Patient Privacy:  Likewise FDA, medical companies have to follow HIPAA regulations. If the device is connected to a software operation, software validation protects the patient’s sensitive and personal information. Software validation and authentication guards prevent patients’…   Read more»

Medical device manufacturing companies have more crucial and sensitive responsibilities than other corporate sectors. Medical devices have a direct impact on the health and wellness of society. Despite medical companies abiding by FDA or ISO standards, new or small companies…   Read more»

Payment gives recognition to the participants’ time and risks, which enhances the recruitment process, and boosts diversity. On the other hand, ethical concerns regarding coercion arise. Financial incentives may lead the most vulnerable people to participate in studies for the…   Read more»

A double-blind study design is crucial in clinical trials to eliminate biases that can distort results. The fact that a single-blind study reduces participant bias does not account for the influence of the investigators themselves. If the researchers are aware…   Read more»

I would say, product development focuses on creating new products through research and innovation and mainly turning ideas into real solutions or prototypes that meet one’s customer needs. On the other hand, product management looks over a product’s life cycle…   Read more»

I agree that sales and marketing are fantastic fields for people who enjoy working with people. Although I haven’t directly worked in these areas, I see how essential they are for any business. marketing creates brand awareness through various channels,…   Read more»