Are you considering a career move to project management?

 Are you considering a career in project management? If so, you're in good company.

Project management is a rewarding and exciting field that offers a range of opportunities to help companies achieve their goals.

Whether you're just starting out in your career or looking to make a change, here are some things to consider as you explore project management:

1. What does a project manager do?

Project managers are responsible for planning, executing, and monitoring projects from start to finish. This includes defining project goals, creating a project plan, managing resources, communicating with stakeholders, and ensuring that the project is delivered on time and within budget. Project managers are also responsible for managing risks and resolving issues that arise during the project.

2. What skills do you need to be a successful project manager?

Successful project managers have a range of skills, including strong communication, leadership, and problem-solving skills. They are also highly organized, able to manage multiple projects and deadlines at once. In addition, project managers need to be able to work collaboratively with stakeholders and team members, and to adapt to changing circumstances as the project evolves.

3. What education or certification do you need to become a project manager?

While there is no one-size-fits-all answer to this question, many project managers have a bachelor's or master's degree in business, engineering, or a related field. In addition, many project managers pursue certification through organizations such as the Project Management Institute (PMI), which offers the Project Management Professional (PMP) certification.

4. What industries employ project managers?

Project managers are employed in a wide range of industries, including construction, engineering, healthcare, information technology, and more. Project management is a highly transferable skill, which means that project managers can work in many different roles and industries throughout their careers.

5. What are the benefits of a career in project management?

A career in project management offers a range of benefits, including the opportunity to work on challenging and exciting projects, the ability to make a significant impact on an organization, and the potential for career advancement and growth. In addition, project management is a highly valued skill in today's job market, which means that project managers are in high demand.

If you're considering a career in project management, there's no better time to get started. Whether you're just starting out or looking to make a change, project management offers a rewarding and challenging career path that can help you achieve your professional goals.

If you want to learn project management, here are some good starting books to read

 No one really starts in school with project management in mind as a career path, so many PMs end up as transfers from other career starting points such as majors in science, business, marketing, finance, etc.  So I get asked a lot what books to recommend for people starting out in the PM field or interested in advancing their basic PM skills.

Some books I find that I continue to recommend again and again are:

1. "The Project Management Body of Knowledge" by Project Management Institute (PMI)
2. "A Guide to the Project Management Body of Knowledge (PMBOK® Guide)" by Project Management Institute (PMI)
3. "Getting Things Done: The Art of Stress-Free Productivity" by David Allen
4. "Crucial Conversations: Tools for Talking When Stakes Are High" by Kerry Patterson, Joseph Grenny, Ron McMillan, and Al Switzler
5. "The Lean Startup: How Today's Entrepreneurs Use Continuous Innovation to Create Radically Successful Businesses" by Eric Ries
6. "Scrum: The Art of Doing Twice the Work in Half the Time" by Jeff Sutherland
7. "The 7 Habits of Highly Effective People: Powerful Lessons in Personal Change" by Stephen Covey
8. "The One Minute Manager" by Ken Blanchard and Spencer Johnson
9. "Managing Successful Projects with PRINCE2" by AXELOS
10. "Critical Chain" by Eliyahu M. Goldratt

These books cover a wide range of topics in project management, from the basics of project management methodologies and processes (particularly 1, 2, and 9 above) to specific techniques for increasing productivity and managing stakeholders. I think 3, 4, and 7 are great reads for any business person and are applicable far beyond project management.

What are the best project management software solutions?

I get asked a lot what the best PM software solutions are there to use. There are many project management software tools available in the market, each with its own unique features and benefits. Here are some of the most popular and highly recommended project management tools:

1. Trello: Trello is a visual collaboration tool that uses boards, lists, and cards to organize and prioritize tasks. It is easy to use and highly customizable, making it a popular choice for teams of all sizes.

2. Asana: Asana is a web and mobile application designed to help teams track and manage their work. It offers features such as task management, project management, collaboration, and reporting.

3. Jira: Jira is a popular project management tool that is often used by software development teams. It includes features such as issue tracking, project management, agile boards, and reporting.

4. Basecamp: Basecamp is an all-in-one project management tool that includes features such as task management, team communication, and file sharing. It is designed to be easy to use and highly customizable.

5. Microsoft Project: Microsoft Project is a comprehensive project management tool that offers features such as task scheduling, resource allocation, and budget tracking. It is often used by large organizations and project management professionals.

6. Monday.com: Monday.com is a visual project management tool that uses boards, timelines, and calendars to help teams track and manage their work. It offers features such as task management, team collaboration, and reporting.

Ultimately, the best project management tool for you and your team will depend on your specific needs and preferences. It's important to research and compare different tools before making a decision. Fortunately, some of those listed above have free trial options so make sure to take advantage of several if you can and stick with the one that works best for you.

You can easily find these project management tools by searching their names on any search engine or by going to their respective websites.

Here are the websites for the project management tools I mentioned at the time of writing:

1. Trello: https://trello.com/
2. Asana: https://asana.com/
3. Jira: https://www.atlassian.com/software/jira
4. Basecamp: https://basecamp.com/
5. Microsoft Project: https://www.microsoft.com/en-us/microsoft-365/project/project-management-software
6. Monday.com: https://monday.com/

Always be searching for Positive Optionality in Life, Business, and Investing

Take action in your life (career, relationships, investing) that are highly skewed in favor of positive expected outcomes for you relative to negative expected outcomes

Key questions to ask in each situation:

What is the upside (positive) benefit if I am right?

•  be careful to avoid overoptimism bias
• Great reads:
• Misbehaving by Richard Thaler
• Nassim Nicholas Taleb's risk management "trilogy"
• Fooled by Randomness
• Black Swan
• Antifragile

What is the downside (negative) affect if I am wrong?

•     be careful to never take a risk that will "end the game" for you if you lose (physically, emotionally, financially)
• Great read for entrepreneurs: Great by Choice by Jim Collins (especially recommend the chapter on "Luck")
• Great read for investors: Unknown Market Wizards by Jack Swagger (highly recommend the his other Market Wizards books, as well)
•     make sure to check your assumptions (What am I missing?  What am I not seeing?)
• Great read for entrepreneurs: The Road Less Stupid by Keith Cunningham

What are the probabilities that I'm right/wrong?

• avoid confirmation bias (only seeing/believing evidence that supports what you want to believe)
• use base case assumptions to level set your expectations
• great read: Thinking Fast and Slow by Daniel Kahneman
• Adjust your assumptions to avoid overconfidence and uncertainty risk to your assumptions
• recommendation: Learn about the "Kelly Criterion" and the method that many gamblers/investors recommend of betting "half kelly"

What is my decision/choice?

• Take those actions that have a large skew (preferably 2x or greater) of positive expected value versus negative expected value
• remember that "expected value" is the product of multiplying the probability X outcome.  Yes, a winning lottery ticket has a very high positive outcome, but it's expected value is very low when you multiply the outcome by it's probability of occurrence.
• Minimize the negative expected value
• in investing, this could be done by placing a "stop loss" order or buying an option rather than the stock itself.
• in business, this could be buying insurance (e.g., worker's compensation, fire, life, etc.)
• Size your commitment/investment according to the level of positive optionality
• Investment example: if you are buying 2 stocks and one has a high likelihood of tripling in five years while the other has a chance of doubling, you would better off investing more in the one more likely to triple rather than equal weighting them in your portfolio.  This seems obvious, but is very often not done as investors sometimes seek too much diversification in their portfolio
• Great investors to learn from regarding this:
• George Soros
• Stanley Druckenmiller
• Charlie Munger
• Great read: Charlie Munger by Trents Griffin
• Career example: If you have 2 side hobbies with one that keeps you entertained (e.g., playing a sport) while the other is something that you'd like to become a second career that could provide you with greater long term happiness, you should probably be allocating much more of your available time towards the career-changing opportunity.
• Good read: The Compound Effect by Darren Hardy

When does your medical device testing need IRB approval?

Medical Device studies need Investigational Device Exemption (IDE) determination from an Institutional Review Board (IRB) when:
• Data is being collected on safety and effectiveness regardless of whether or not the results are intended for FDA submission
• New disease or condition
• New intended use
• New patient population
• Significant design changes
• Significant use changes

HOWever, SOME MEDICAL DEVICE USAGE IS EXEMPT FROM

21 CFR PART 812 (IDE):

Medical Device Sponsors and Clinical Investigators may be exempt from 21 CFR Part 812 regulations regarding Investigational Device Exemption (IDE) requirements (meaning that they need neither FDA nor Institutional Review Board (IRB) approval) if the medical device is:

• used in accordance with its legally marketed labeling,

• testing only consumer preference (i.e., no safety or efficacy tests),

• testing a modification that:

(1) is not for the purpose of determining safety or efficacy and

(2) does not put subjects at risk,

• intended solely for veterinary use, or

• a diagnostic that:

• complies with 809.10(c) labeling requirements and

• the testing

• is noninvasive;

• does not pose a significant risk;

• does not introduce energy into a subject; and is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure

Doing a Medical Device Clinical Trial?....Know Your Device's Risk Significance

When submitting your medical device clinical trial documents to an Institutional Review Board (IRB), you must know if your device is considered Significant Risk (SR) or Non-Significant Risk (NSR).

Significant Risk (SR) devices pose potential for serious risk to the health, safety, or welfare of a subject

Non-Significant Risk (NSR) devices are defined as those not being categorized as significant risk (SR)


This determination is important:
SR devices require both IRB and FDA approval before starting a clinical trial
NSR devices require only IRB approval before starting a clinical trial

Yes, that's right that you can initiate a medical device clinical trial without notifying the FDA if your medical device is a Non-Significant Risk device and you obtain IRB approval for your study.  That's a big difference from pharma studies where all drugs are considered high risk and require FDA approval before beginning a drug clinical trial.

So what defines an SR device?...

Under US regulation 21 CFR 812.3(m), an SR device means an investigational device that:

• Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
• Is purported or represented to be for use supporting or sustaining human life and presents a potential for serious risk to the health, safety, or welfare of a subject;
• Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject; or
• Otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.

The definition of NSR is by default.  Your device is Non-Significant Risk (NSR) if your device does not meet the above definition for an SR device.

But who makes the final decision on SR versus NSR categorization?

Your Institutional Review Board (IRB) does (21 CFR 812.66)

If you want to start a clinical trial and you feel that your device does not pose a significant risk to study subjects:

• You (the Sponsor) submit your clinical trial documents (e.g., protocol, device description, Informed Consent Form, etc.) to your IRB along with a statement of why your device trial does not pose a significant risk to study subjects

• If the IRB agrees that the clinical trial does not pose a significant risk and determines the trial device as an NSR, then, no FDA approval is needed before you start the trial. Your clinical trial can start under AbbreviatedInvestigational Device Exemption(Abbreviated IDE) requirements.

• If the IRB disagrees and they deem your trial to pose a significant risk, then your device is deemed SR and you must submit an Investigational Device Exemption (IDE) application to FDA for approval before starting your trial.

So if you are planning to start a medical device clinical trial, you need to know your risk significance (SR or NSR).  Note that this is different from your risk classification, which in the US, medical devices are also classified according to their risk (Class I devices are lowest risk; Class II devices are medium risk; Class III devices are highest risk).

It can be confusing to know how to distinguish risk classification from risk significance, but think of it this way:

• your medical device's risk classification is determined by the FDA according to your device's level of risk (Class I, II, or III) regardless of whether you are planning a clinical trial or not.
• when initiating a clinical trial, your IRB will assess the device's risk significance (SR or NSR) and that will determine if you need to go to the FDA and apply for an Investigational Device Exemption (IDE) before you can receive IRB approval for your clinical trial. If your IRB deems your device to be SR, then you will need to apply for an IDE from the FDA (got to love all those acronyms).

What is a medical device?

The US government has a definition of what a medical device is and this is important to know when your product meets this definition because if it does, you will need to comply with the US medical device regulations.  The definition below is for the United States, but there are similar definitions for European, Asian, and other North/South American countries.

Section 201(h) of the US Federal Food Drug & Cosmetic (FD&C) Act regulated by the Food and Drug Administration (FDA) defines a medical device as:

• an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,

• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

• intended to affect the structure or any function of the body of man or other animals, and

• which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. The term "device" does not include software functions excluded pursuant to section 520(o).

So what are some key takeaways from the above definition?

•  The definition clearly goes out of its way to capture a broad set of terms that could be used to describe a medical device (e.g., implement, machine, contrivance, etc.)
•  Note that the definition includes both "treatment" devices such as those that come in contact with the body (ex. an artificial hip) and "diagnostic" devices that do not contact the body such as a lab test that is used to determine if a person has a disease or not.
•  The definition applies for both human and veterinary medicine
•  The last bullet paragraph is what really distinguishes "medical device" from "drug/pharmaceutical" by stating that the primary intended purpose is not achieved through chemical action.