Medical Device Courses | Kiana Butler | Activity

Kiana Butler replied to the topic "Non Compete Agreement" -

Mon, 17 Apr 2023 17:53:05 -0400

I have worked as a contractor for major pharmaceutical companies and remember signing a non-disclosure agreement (NDA). I could not share any information with any other biopharma companies if I were to be employed by them. However, that never discouraged… Read more»

Kiana Butler replied to the topic "For those that work in a matrix based organization:" -

Mon, 17 Apr 2023 17:31:10 -0400

@sseal98 I work in the biopharmaceutical industry as well, and I am never bored also. During certain times of the year, there can be overwhelming situations when you have to meet a deadline for a lot of project teams and… Read more»

Kiana Butler replied to the topic "Organization Types: Which one benefits you?" -

Mon, 17 Apr 2023 17:22:56 -0400

I currently work in a matrix organization in the biopharmaceutical industry. I don’t mind working in a matrix organization since it allows me to support different teams and learn what each department is responsible for. Working for a matrix type… Read more»

Kiana Butler replied to the topic "Benefits of post-market surveillance" -

Wed, 12 Apr 2023 13:40:00 -0400

Post-market surveillance can give pharmaceutical and medical device businesses more knowledge about the natural history of the disease, the performance of their product in comparison to other marketed goods, and the natural history of the condition. The sponsoring firm can… Read more»

Kiana Butler replied to the topic "Dealing with risk" -

Wed, 12 Apr 2023 01:24:32 -0400

If there is a low level of severity and low probability of the risk occurring, I think it is worth accepting the risk associated with the medical device. In this scenario, the reward outweighs the risk of the device’s intended… Read more»

Kiana Butler replied to the topic "Risk management and Labels" -

Wed, 12 Apr 2023 00:58:20 -0400

When it pertains to the use of painkillers, it is up to the consumer to follow the instructions that are on the label. Drug companies do a great job at fully listing the directions of use and possible side effects… Read more»

Kiana Butler replied to the topic "Corporate Responsibility?" -

Tue, 04 Apr 2023 19:53:04 -0400

For the most part, corporations do a pretty good job of designing and releasing good products. Since we are in a huge capitalist society, companies put a lot of effort into their products to turn a large profit. Designing something… Read more»

Kiana Butler replied to the topic "Minutes for meetings" -

Tue, 04 Apr 2023 19:42:49 -0400

Meeting minutes are an important part of the design control process. There should be an assigned person to take meeting minutes for every meeting, and that person should send the minutes to everyone who attended and missed the meeting. To… Read more»

Kiana Butler replied to the topic "Design Verification & Validation" -

Tue, 04 Apr 2023 15:54:46 -0400

Design verification ensures that your design outputs match your design inputs. To put it another way, did you design the device correctly? Validation is establishing that the device’s design fulfills the user needs and intended usage.

Kiana Butler replied to the topic "Incentives for Clinical Trial Participants" -

Fri, 31 Mar 2023 01:21:17 -0400

Money will always be the main incentive for people to participate in a clinical trial. Another option would be to offer a more helpful non-monetary incentive. If the participants in the study are college students, the organizers of the research… Read more»

Kiana Butler replied to the topic "Clinical Studies" -

Wed, 29 Mar 2023 15:38:48 -0400

There are many advantages and disadvantages when it comes to clinical trials and studies. Advantages – Development of new drug with a high efficacy rate – Vast range of individuals (sex, gender, age, race, etc.) can participate and provide results… Read more»

Kiana Butler replied to the topic "Informed consent: What if Henrietta Lacks checked No for research use?" -

Wed, 29 Mar 2023 15:18:38 -0400

If Henrietta Lacks had checked “No” for research use of her cells, scientists would have still figured out a way to develop treatments for various diseases without her cells. There are dozens of treatments that were developed without her DNA,… Read more»

Kiana Butler liked forum post "Informed consent: What if Henrietta Lacks checked No for research use?" -

Wed, 29 Mar 2023 01:04:31 -0400

Kiana Butler replied to the topic "Digital Marketing" -

Thu, 23 Mar 2023 18:56:01 -0400

The internet has changed marketing by allowing a person’s product to be advertised on various platforms (Tiktok, FB, IG, Twitter, YouTube, etc.) and reach more demographics than traditional marketing strategies. We can now purchase something from our smartphones with the… Read more»

Kiana Butler replied to the topic "The Four P's" -

Mon, 20 Mar 2023 17:29:33 -0400

@jbdoddo1 I thought I was the only one playing devil’s advocate by saying placement is the most important of the four Ps. As someone with over 15yrs of retail and customer service management experience, I can say that where you… Read more»

Kiana Butler replied to the topic "Accepting job based on company." -

Mon, 20 Mar 2023 17:08:36 -0400

@ronakmandaliya You made a great point about choosing a start-up over an already-established company. I think the decision is totally up to the individual and what their long and short-term goals are with the company and personally. A start-up company… Read more»

Kiana Butler replied to the topic "FDA on Recalled Items" -

Fri, 17 Mar 2023 22:50:00 -0400

The FDA instructed all makers of surgery mesh goods used for pelvic organ prolapse (POP) repair to cease advertising and marketing their goods throughout the United States instantaneously in April 2019. Since the FDA reclassified these devices in class III… Read more»

Kiana Butler replied to the topic "Combination Product" -

Wed, 15 Mar 2023 19:20:29 -0400

Combination Product: Trulicity Trulicity is a once-weekly injectable glucagon-like peptide-1 (GLP-1) receptor agonist that has been approved for use as a supplement to diet and exercise in persons with type 2 diabetes to enhance glycemic control. It helps patients’ bodies release… Read more»

Kiana Butler replied to the topic "Examples and ways to improve quality assurance" -

Tue, 14 Mar 2023 16:19:21 -0400

A corporation will build and manage a quality assurance (QA) system to make sure that the products and services it offers are of a continuously high standard and adhere to legal and organizational requirements. QA supports employees in achieving quality… Read more»

Kiana Butler replied to the topic "Animal Diversity in Pre-clinical Research" -

Wed, 08 Mar 2023 21:22:31 -0500

I believe animal diversity can have a very positive influence on the pre-clinical trials of any drug or device. Since many of the animals used in research, such as pigs, rodents, and rabbits, are similar in physiology and genetic make… Read more»

Kiana Butler replied to the topic "Animals used for research and for food" -

Mon, 06 Mar 2023 19:02:16 -0500

I believe that animal research is viewed negatively because many organizations believe that animals are treated inhumanely in experiments. Possibly, it is because the animals are subjected to certain chemicals, drugs, and diseases for extended periods. In contrast, animals used… Read more»

Kiana Butler replied to the topic "Ethics of Animal Testing" -

Mon, 06 Mar 2023 02:49:25 -0500

Animal testing in my opinion is ethical depending on the animal that is the subject. For example, it is unethical to perform experiments on dogs and cats as they can be emotional support and service animals to humans who suffer… Read more»

Kiana Butler replied to the topic "Which feature is the most important for a project manager?" -

Thu, 02 Mar 2023 22:14:07 -0500

I believe the most important features a project manager should have are communication and coaching. A project manager should be efficient in communication to deliver important detailed information to their team members and higher-level leaders. The coaching feature is important… Read more»

Kiana Butler replied to the topic "How to Avoid Scope Creep" -

Thu, 02 Mar 2023 21:51:36 -0500

To stay on course and avoid scope creep with any project, a detailed plan needs to be formed before it project commences. Within that plan, there should be allotted time to address any unexpected hiccups that may occur during the… Read more»

Kiana Butler replied to the topic "Leah Banks - Merging Lanes for Medical Devices and Communication" -

Wed, 01 Mar 2023 20:15:36 -0500

I understand the disconnect between people in underrepresented communities and new technologies in medicine, and that is one of the many reasons why I wanted to become a scientist. Communication, to bridge the gap, has to happen between the doctor… Read more»

Kiana Butler replied to the topic "People in a Project" -

Wed, 01 Mar 2023 20:05:03 -0500

In every team/group environment, there has to be some great chemistry between all group members. The team/group leader should be able to identify every member’s strengths and opportunities to make sure everyone is in a position to be successful and… Read more»

Kiana Butler replied to the topic "Professions in Academia and the Industry" -

Wed, 01 Mar 2023 15:45:58 -0500

I currently work as a mammalian cell culture scientist for Johnson & Johnson utilizing a robotic cell culture device, and it has been one of the most rewarding experiences thus far. Although I graduated in 2006 with a B.S. in… Read more»

Kiana Butler replied to the topic "Professions in Academia and the Industry" -

Wed, 01 Mar 2023 15:45:58 -0500

@sromemsm-edu Definitely look into applying to the many biopharma companies and affiliates that make medical devices. I work in the research and development sector for Johnson & Johnson, and scientists use tons of lab equipment daily for experiments that are… Read more»