Leadership in the Realm of Employee Motivation
Lots of people talk about leadership – including us if you review other blog posts we’ve made on www.Waddellgrp.com. People talk about how you get your team members to do what you need them to do. How closely should you manage? How should you give difficult feedback? This article will approach leadership from a different perspective: What motivates your team members to do their best? We’ll start by going down a historical lane and examining what one ancient general believed motivated people to go to war. While not the whole…
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Project Management in the World of Trump
For a bit of fun, we took a look at our current President and his project management prowess in light of our previous work on hierarchies of teams… i.e., would he be a great project manager???? Different leadership styles, creating high energy and success President Trump is known for his confrontational style of negotiation and high energy. As a business leader who enjoys competition and a need to win, he emulates another President, Teddy Roosevelt. Both men are marked by wanting to do great things and leave their mark on…
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How to increase profit through rightsizing your Quality System
This is a series of blogs geared around accelerating product development through clinical study (animal, cadaver, or FIM). Successful medical device companies have been developing products for decades but along the way, some have developed quality systems no longer adequate to achieving competitive speed to market in the current landscape. There are many reasons for this: additions due to internal issues, embracing all FDA “suggestions” for improvement, general institutional scope creep inside the best-intended methodologies of creating safe, effective, and approvable medical devices The results have yielded quality and…
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Hierarchy of Teams
Abraham Maslow theorized that we as humans have a hierarchy of motivation that transcends from getting our basic human needs met to stay alive all the way through self-actualization. As a team of project managers, we see the same kinds of dynamics at play in the hierarchy of what a project team needs. Waddell Group segmented four levels of team quality and identified the qualities of each. Further, we have identified attributes of these stages to enable identification of the level or stage at which your team operates. The categories…
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Being a Great Team Member
October 30, 2017 Leadership Development, Project Management/Leadership There are multitudes of articles and books that contain advice on how to be a great leader. But what if you’re like most of us and not at the top of the food chain? In most teams, there is one leader and a team of people doing the work. While we like to place the responsibility for a project’s success or failure on the leader, every team member has ownership and influence on how a project turns out. Your contribution to the project must…
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MEDDEV 2.7.1 Rev 4, and what it means to you
If you manufacture a medical device that is CE marked, you are required to comply with the latest MEDDEV 2.7.1 publication. This revision is a major rewrite from the previous publication of Rev 3 as the authors sought to bring clarity and layout stricter expectations for Clinical Evaluation Reports (CERs). Compliance expectations ultimately fall on the manufacturer, and the Notified Bodies are being given greater responsibility in enforcement as they perform audits. Rev 4 is 50% larger than its predecessor because of the level of detail. Fortunately, the document was…
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Where to Start With Medical Device Compliance Changes
Begin with the End in Mind: This is the second habit Steven Covey lays out in his famous book, The Seven Habits of Highly Effective Sales Leaders. The reason this habit is so important is that it aligns all tasks, projects, and talent toward a single purpose. This habit also provides a framework to eliminate tasks and projects that will not help accomplish the end goal. With major regulatory shifts occurring in the medical device industry it is imperative that device manufacturers know exactly which “end” to keep in mind.…
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MDSAP – The Beginning of a 3 Year Debacle For Medical Device Companies
The Notified Bodies are already very busy and our medical device manufacturing clients are already seeing increased audit times. Several European Notified Bodies are no longer taking new clients with the onset of MDSAP (inclusive of ISO13485:2016), MEDDEV 2.7.1 Rev. 4 & MDR. This is the beginning of a 3-year debacle for medical device companies. These substantial regulatory reforms are now underway and will be required over the next 3-5 years: MDSAP will become the mandatory replacement for the CMDCAS certification to support Canadian device approvals on January 1, 2019…
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How to Execute your Medical Device Regulation (MDR) Plan
The stakes seem high and the risk is real, but in a very large sense executing your MDR project is just another project. This is the fifth blog post in a serious on the changing European regulations in Europe. The previous four discussed what MDR is and why it is a concern, how to prioritize your devices in preparation for the new regulations, what to be thinking about as you perform a gap analysis, and finally, how to build a plan. Phases of Project Management A normal development project will…
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Creating a Plan of Action for Medical Device Regulation (MDR):
This is the fourth blog post in a series on the changing European regulations in Europe. The previous three outlined what MDR is and why it is a concern, how to prioritize your devices in prep for the new regulations, and what to be thinking about as you perform a gap analysis. Building A Plan of Action This blog post concentrates on how to build a plan of action. If you need a refresher, please see the other posts or reach out to us and we can discuss how these…
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