Chirag Patel, PMP

Too many times in my career I have experienced the traditional project planning and management approach result in frustrated project teams and frustrated leadership. Consider a change of mindset and bold approach that requires trust, elimination of fear and transparency. I’ve found a few key mindset shifts can produce big shifts in team attitude and behavior. 1. Commit as a team to finish the project as quickly as possible. Commit to speed, not to completion dates. 2. Set goals for completion dates with a clear mission driven why! The why needs to be crystal clear. 3. Negotiate the strategy to achieve the goal, not the amount of time it will take. The strategy can change to meet the goal. 4. Set the expectation of a dynamic, flexible and agile plan. Don’t be afraid to change, pivot, and renegotiate the strategy. 5. Motivate through mission and purpose, a unifying common ground, not fear. Follow for more content like this.

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Overcoming the Challenge of Creating Repeatable Excellence through Standard Work One of the greatest challenges in any organization is taking the expertise and talent of individuals and translating it into standard work that can be repeated by others. It’s not just about capturing the knowledge—it’s about creating a new baseline that elevates the entire team and ensures consistent, high-quality results. The key to overcoming this challenge lies in collaboration and documentation. Here’s what I’ve found effective: • Involve experts in the process of creating standard work. They know the nuances and potential pitfalls, and their input is critical to building something that truly reflects best practices. • Refine the standardized process. No standard work is perfect from the start—trial it with different team members and gather feedback to ensure it’s truly scalable. • Continuous improvement is crucial. Once you have a baseline, keep evolving it. Encourage team members to suggest improvements to keep the process agile and adaptable. Building standard work from expertise doesn’t just make operations smoother—it’s a way to spread excellence across the organization, allowing everyone to perform at a higher level. How do you capture and standardize expertise in your organization to build a foundation for repeatable success?

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According to recent statistics, women make up only 13% of the engineering workforce in the U.S., but their impact is significant and growing. Female engineers often excel in fostering diverse perspectives and solutions, which are critical for the development of cutting-edge technologies and advancements in our industry. For more statistics and information on women in engineering, check out this article by Fictiv: https://ow.ly/eOor30sEsmb #WomenInEngineering #EngineeringExcellence #DiversityInTech #WomenInSTEM

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🚀 Exciting News! 🚀 I’m thrilled to announce that I’ll be attending the MD&M Minneapolis Conference (https://lnkd.in/gTWX3Wyv ) this week! 🏭🌐 This is one of the premier events in the advanced manufacturing space, where the best minds in medical device innovation and manufacturing technology come together to discuss the latest trends and breakthroughs. As someone deeply invested in cybersecurity, robotics, and disruptive technologies in advanced manufacturing, this is a golden opportunity to connect, collaborate, and exchange ideas with industry leaders and innovators. If you’re passionate about scaling disruptive technologies in the world of manufacturing or simply looking to explore what’s next in medical devices, let’s connect! 👥 Let’s explore how we can shape the future of the industry together. 📅 Will you be attending? Drop a comment or DM me—I’d love to meet up and exchange ideas on how we can drive innovation! #MDMMinneapolis #AdvancedManufacturing #MedicalDevice #Cybersecurity #Innovation #DisruptiveTech #Networking

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Give me 15-20 seconds and read the attached post if you are involved in the #Manufacturing & #ProductDevelopment world in any capacity.

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CS Lifesciences at Project Medtech Startup Symposium! Join us on November 19th and 20th at the Project Medtech Startup Symposium. Don't miss Angela Paterson's insightful session on navigating complex regulatory pathways, understanding the competitive landscape, and achieving successful market entry in the USA. Learn about common pitfalls that startups encounter and how to avoid them. 𝗖𝗦 𝗟𝗶𝗳𝗲𝘀𝗰𝗶𝗲𝗻𝗰𝗲𝘀 - 𝗬𝗼𝘂𝗿 𝗧𝗿𝘂𝘀𝘁𝗲𝗱 𝗣𝗮𝗿𝘁𝗻𝗲𝗿 𝗶𝗻 𝗥𝗲𝗴𝘂𝗹𝗮𝘁𝗼𝗿𝘆 𝗖𝗼𝗺𝗽𝗹𝗶𝗮𝗻𝗰𝗲! We look forward to connecting with new and existing partners at the symposium. Let's explore how we can help bring your regulated products to market. Connect with us at [email protected]. #medicaldevices #USmarket #FDA #Medtech #Innovation #startups #regulatory #Quality #Clinical #510k #presub

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Risk Management is not something to forget.

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Practical approach to use the resources obtained in the moon to build a moon base.

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Keeping the audience in mind is important when preparing a presentation and the 10/20/30 rule below helps consider the audience and making your message more impactful.

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“Develop success from failures. Discouragement and failure are two of the surest stepping stones to success.” — Dale Carnegie Every no brings you closer to the next yes. Every strike in baseball brings you closer to the next homerun. Always stride forward each and everyday. #contractmanufacturing #medicaldevice #medicalimplants #medicalinstruments #aerospace #industrial #candatool

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Selecting the right MedTech product design partner can significantly enhance your product development efforts. I started about 20 years ago as a project manager supporting new product development, and I've seen firsthand how multi-disciplinary expertise is so crucial. From concept to product realization at volume, every detail matters, including how software interacts with hardware, how components are designed, formed, and integrated into the final system able to perform complex processes. And all these need to come together in a repeatable and regulated fashion to support the clinical need. Key considerations include finding a partner with broad expertise, regulatory experience, and a deep team. Protecting IP and thorough reference checking are also essential. For more insights, read the full article below: https://lnkd.in/gVVzPEk5

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🫡 a win for the free market everywhere!! S/O to those who voted and made this happen. There’s definitely going to be legal challenges. Who knows how long this will get tied up in court. But I will give credit to the FTC for doing what they did. This is a complicated matter. It’s not as simple as banning non-competes across the board. There are some IP concerns at high high levels. I applaud them for their nuanced look at this policy. What will change? I don’t know. But what I do know is we are approaching a day in our industry where talent isn’t stuck in a bad situation because of a non-compete. This is a huge win! Now how do we get control of the credentialing companies?? 😂 #medicaldevice #medicaldevice #medtech #meddevice #ftc #sales #linkedin https://lnkd.in/g6Rgv8Ez

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As we approach 2025, I’m hopeful that the medical device industry will begin to recover. Over the past year, I’ve witnessed an increasing number of layoffs across companies, impacting many talented professionals. Conversations with colleagues and friends affected by these challenges have been a stark reminder of the uncertainty in our field. Now, with the elections behind us and the potential for interest rates to decline, I’m optimistic that we’ll see positive momentum in the industry. Here’s to a brighter and more stable year ahead for everyone in the medical device community. https://lnkd.in/ehawJiGS

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Sell Shovels. "More people got rich during the gold rush selling shovels than looking for gold." This quote brought me many insights this week. When I see people building companies, sometimes I wonder how they identified that opportunity? The answer is: there are buyers and there are sellers. 💸 Buyers, see a challenge and they try to "buy" the knowledge (from free online resources or by paying for a certificate or degree). 🧠 Sellers, might also "buy" the knowledge, but then "re-sell" it as a service for a specific niche. 💸 Buyers, see projects at work to make themselves shine and get a promotion or bonus. 🧠 Sellers, see projects as a way to find ways to support other's efforts and thrive in the process. In today's world, this principle is more relevant than ever. Whether in tech, real estate, or any other industry, providing the tools, services, and support that others need can be a path to immense success. What "shovels" can you offer in your field? Your next big opportunity might just be in equipping others to find their own gold. #StrategicFocus #Innovation #Entrepreneurship #Intrapreneurship

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Transitions - Life is full of transitions. Maybe it’s a new role or new job. Maybe it’s a big move. It could be having a child or them growing up and leaving the house. What we don’t realize is we often underestimate the impact these transitions have on us. Transitions require more of us physically, mentally, and emotionally. During these periods we need to build in extra time for rest and margin. We also need to give extra attention to how we are managing our emotions. Big changes can be tough, so make sure you give yourself a little more grace as well. If you have multiple significant transitions happening at the same time, take extra time to reflect and be self aware of how it’s impacting you. Transitions bring great opportunities, so don’t be afraid of them, but make sure you give them the respect they deserve.

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Engagement matters... How you treat your employees matters!

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I’ll be (virtually) presenting as part of Q1 Productions’ “QMSR Implementation & Quality Management Enhancement Professional Education Course” 17-18 June 2024 (link below). With the FDA’s QMSR ruling of 02 Feb this year, greater emphasis has been placed upon the needs of Risk Management for Medical Devices. This being one of my favourite topics for the importance within Medical Device development, Risk Management (alongside the Design Controls process) are often being treated and regarded as, ”those painful document deliverables we need to have…” rather than the tools they can and should be to drive the development process. But when to start them? ISO 14971:2019 (and ISO 13485:2016) define the life cycle (that the standards are applicable to) as “..from the initial conception…”, yet the FDA’s QS Reg wording from 1996 defined in the preamble a period of research, “creativity and innovation” that the FDA would not expect design control requirements. With the QMSR, “…the FDA does not expect manufacturers to maintain records of all changes proposed during the very early stages of the design process…”. Although many manufacturers appreciate this caveat, I’ll be describing the risks (pun absolutely intended) of missing important design knowledge during those early design iterations and using the analogy of Agile Project Management processes to show. With an emphasis on Risk Management and the Design Control Processes as tools for development, rather than the perceived documentation need, I believe that focus on the activity and effort for the two will aid to deliver safe, effective and high-quality Medical Devices. I’ll walk through a detailed (and colourful!) flow-diagram for how this all comes together.

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All set for another 3 years of experience and continuous learning. There are some excellent resources for further education on the PMI site. I particularily enjoyed "Intentional Leadership Styles: A Journey for ERG Leaders". It works through how to gain the mindsets, skills, and leadership styles necessary to fully appreciate and engage with the fundamental concepts of diversity, equity, and inclusion. #PMP #PMI #Leadership #Inclusion #Diversity #Equity #Belonging

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