Today's Medtech Snapshot episode features Seth A. Kaufman, MSHCA as he shares his insights on the best way to land a great clinical research organization (CRO) partner - before you need their help! Hear how Seth outlines his engagement process, things to watch out for and ways to approach your trials with your new partnership. Interested in listening to our past episodes of Medtech Snapshot? Check out our growing library archives at https://www.sqr1services.com/white-papers/category/snapshot #CRO #clinicalresearch #clinical #medicaldevice #medtech #outsourcing #trials #snapshot #partnership The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering. Learn more about how we can solve your work and project problems today to get you back on track!
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One of the biggest challenges professionals face when starting a new job is how they navigate ingratiating themselves into the new company and culture they’re now surrounded by. No two companies are alike, which also means practices, processes and procedures can vary wildly from one company to another. How a new employee, including new management, sorts through this can make or break their ability to be received well by their fellow colleagues while having a good career at their new employer. Imagine you’re in your second week of employment and you begin to uncover a variety of compliance issues like a lack of regulatory understanding throughout the company, poor or missing documentation, insufficient training, little to no post-market surveillance processes or a dinosaur quality management system (QMS) that’s holding the company back. Any of these shortcomings can be problematic for an operation, but the presence of several can be detrimental to the company’s short- and long-term success. It can be a precarious situation to come in as the new ‘gal or guy’ and start changing things right away. In fact, this typically doesn’t bode well for those who take the scorched earth strategy making big changes right out the ‘new hire’ gates, regardless of those changes being warranted. So the question begs to be asked – what do you do if you start a new job and quickly uncover problems within the company’s operations, especially if those problems are compliance related? Taking a measured and strategic approach to your new job and how you will handle the current business practice issues you are experiencing is key to your success. Consider the following process:
Remember that every organization is different, and your approach to addressing poor practices will depend on the specific circumstances. Your ultimate goal should be to contribute positively to the organization's growth and improvement while maintaining your professionalism and integrity. The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering. Learn more about how we can solve your technical work and project problems today to get you back on track.
In this Medtech Snapshot episode we cover strategies for supplier management and maximizing operational efficiencies when it comes to getting work done. Listen in as Todd Abraham, medical device chief operating officer, explores creative outsourcing, commodity-based decision making and practical manufacturing operation considerations. Need help making a decision on which tasks to keep internally versus to consider outsourcing? Todd has developed the above decision matrix to help guide the process of identifying when it is appropriate to outsource versus insource a particular task. The more we use tools like this to help in our decision making process the better chance we will have of making the right decision, first time around. #suppliermanagement #operations #medicaldevice #medtech #outsourcing #commodity #manufacturing #operations #snapshot The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering. Learn more about how we can solve your work and project problems today to get you back on track!
At the forefront of the medical device new product development (NPD) process we typically find a list of considerations we’re trying to address within our product all while coming up with a solution which meets marketplace needs. Talk to anyone in R&D, or downstream marketing for that matter, and you’ll commonly hear the list of ‘needs’ for a new product can seem never-ending. What you may find surprising is how often design for manufacturability (DFM) is not considered in the beginning of the development process. DFM is an important, and often overlooked, part of product development which involves designing a product in a way which makes it easier and more cost-effective to manufacture commercially. While embedding DFM into the process early seems like a logical part of the process, what plays out in reality is an NPD process that is focused on creativity and validating a technology yet can lack appreciation for the future state of the product and it’s foray into the market. So why is it companies may overlook incorporating DFM into the development process? For starters, many of us who design products on the front end, have little perspective, or perhaps no perspective on what it takes to actually produce a scalable product on the back end. Unless you’ve worked on a manufacturing floor or you’ve walked through an entire new product introduction (NPI) cycle, it’s easy to misunderstand all which goes into producing a product to bring to market. The design process also requires creativity and ingenuity in order to find new approaches, break common perceptions of technology capabilities, etc. It’s about ideation! Unfortunately thinking down the road about how it will be built for commercial purposes is “someone else’s problem”. To illustrate this point let’s look towards the automotive industry at a product we all know, which also happens to be a heavily regulated industry, like the medical device industry. If you have ever been to a large-scale automotive show, like the LA Auto Show in Los Angeles, CA, what you’ll see are concept cars on display to wow the eyes and entice the senses. Ironically, if those same concept cars ever got to production, you’ll find their characteristics which made the vehicle look incredible are often diluted down to features and benefits which consumers will accept and are cost efficient to produce. Case in point, the two images below shows a 2010 Chevy Volt electric vehicle. The top image is the concept vehicle – sleek, sophisticated, sharp lines, aggressive character and eye catching. Almost resembles a sports car. The bottom image is the production vehicle – commuter extraordinaire with features which are dull, less angular and more consistent with a car which will be manufactured by the hundreds of thousands. Concept vehicles have their place though – mostly to show off a company’s capabilities and satisfy egos. They just aren’t practical on scale. The truth is if Chevy produced at volume the concept version the average consumer wouldn’t be able to afford it. As a result, they round out the features, slap some plastic on it and Walla you’ve got a commuter vehicle fit for the masses at a price point which coincides with high volume sales. The medical device industry is no different. While industrial design is playing a much larger role today with device design, the fact of the matter is our industry struggles at times with over engineering products just like the auto industry. This can lead to a company losing sight of what the end user needs and wants, as well as if it can actually be manufactured to meet reimbursements. It’s for these reasons it’s important to consider design for manufacturing from the very beginning of the design process. If you do so, you stand to experience the following:
Considering DFM from the beginning of the design process is crucial for optimizing the manufacturing process, reducing costs, improving product quality, and ensuring a smoother path to market. It ultimately results in a more competitive and successful product with potential less risk downstream. The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of medical device technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering. Learn more about how we can solve your work and project problems today to get you back on track!
Medtech Snapshot is back as we talk with Rohullah Latif who shares his insights on how artificial intelligence (AI) is changing the face of medical device manufacturing. Hear how AI is helping operations become more proactive, while reducing assembly errors. #artificialintelligence #AI #manufacturing #medtech #medicaldevice #snapshot The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering. Learn more about how we can solve your work and project problems today to get you back on track!
In this week's #medtech #snapshot we're joined by Michelle Caulfield, VP Global Quality, as we talk about medical device data protection and regulatory standards from a cybersecurity perspective. Hear about the considerations for the October 2023 deadline for section 524B, Ensuring Cybersecurity of Devices.
Check out our library of Medtech Snapshot episodes at https://lnkd.in/gFwF9GYN Want to learn more about FD&C Act section 524B, go to: https://lnkd.in/gDeumUcb #cybersecurity #medicaldevice #qualityassurance #qualitycontrol What does it really take?
Today's episode of Medtech Snapshot features our managing director Travis N. Smith as he covers the outcome of an online survey we hosted to learn what people thought 'is the most important characteristic a medical device start-up management team needs in order to successfully take a product to market'. So, the question remains - what does it really take for a management team to bring their product to market? Listen in and find out! If you're enjoying our Medtech Snapshot 3-minute digests be sure to check out our other episodes at https://www.sqr1services.com/white-papers/category/snapshot #medtech #snapshot #medicaldevice #startup #commercialization #product #marketplace #square1engineering #management The world around us is ever-changing and constantly evolving, and for those of us who are leading teams, projects or companies this presents a daily challenge. One area in the business world where we commonly run into change, or scope creep as many of us like to call, is in project work. It doesn’t matter if you are running an internal project, or if you are a consultant operating externally, change in work and projects alike seems constant. If you are new to the term, scope creep is defined as “changes, continuous or uncontrolled growth, in a project’s requirements, at any point after the project begins.” Simply put, it’s a change in plans that was unplanned for after the starting point of a body of work. While complete prevention of scope creep might be unreasonable, employing strategies at the forefront of your project and throughout are vital to ensure you stay on track with as little change along the way. Strategies like the ones listed below also allow the project to ebb and flow so that some change can be accommodated while other changes, which could derail a project, are held off at the proverbial gates. Below you are some strategies to help you prevent scope creep on your next project: 1. Clearly Define the Scope Up Front Have a detailed project scope statement that outlines the project's objectives, deliverables, boundaries, and limitations. Make sure all stakeholders agree on the scope before starting the project. Special note – want to get approval quickly for your project? Make sure the project and intended outcomes align with the company’s mission and primary objectives while clearly showing a good return on investment (ROI). 2. Engage Stakeholders From the Beginning Involve key stakeholders in the scope definition and planning processes. Their input and feedback can help identify potential scope creep early on and ensure that their expectations align with the project's scope. 3. Set Realistic Goals Establish achievable project goals and objectives. Unrealistic expectations can lead to scope creep as stakeholders try to add additional features or requirements. If you can’t get agreement on the goals of the project this should cause you to pause before moving forward. Remember, each person involved may have a different perspective of what is needed based on their own biases. 4. Create a Change Control Process Develop a formalized process for requesting and approving changes to the project scope. I like to use the engineering change order (ECO) process on our projects as it formalizes changes and requires approval from stakeholders before the changes are enacted. All changes should go through this process, involving the evaluation of their impact on time, cost, and resources before being accepted. Speaking of scope creep, in this episode of Medtech Snapshot Terry Vick, Sr. Director Program Management at Shockwave Medical out of Santa Clara, CA talks about some of the strategies in this list which we need to be aware of and consider upfront in the project planning phase into order to limit scope creep on the back end. Plus, the importance of having an internal project sponsor. Back to our list of strategies to help you prevent scope creep… 5. Prioritize Requirements Use techniques like MoSCoW (Must have, Should have, Could have, Won't have), Five Whys or the Analytic Hierarchy Process (AHP) to prioritize project requirements. This helps in focusing on what's essential and avoids unnecessary additions. 6. Track Progress Against Scope Regularly track project progress against the defined scope. Tools like Microsoft Project which build out real-time Gannt charts are incredibly helpful to visualize tasks and progress. This also helps identify any deviations early on and allows for timely corrective actions. 7. Communicate to Your Team Consistently & Clearly Ensuring all team members and stakeholders understand the project's scope and the implications of scope changes is paramount to the success of the project. Effective communication can help prevent misunderstandings that might lead to scope creep. 8. Document Changes to the Project Keep a detailed record of all changes to the project scope, including their rationale and impact. This documentation helps maintain transparency and accountability. 9. Manage Expectations by Providing Project Updates to Stakeholders Continuously manage stakeholder expectations by providing regular updates on project status and any changes to the scope. This can help prevent unrealistic demands and last-minute additions. 10. Institute a Review and Approval Process for Scope Change Institute a formal review and approval process for scope changes. All changes should be evaluated by relevant stakeholders and approved based on their impact. 11. Stay Firm but Flexible While it's important to resist unnecessary scope changes, be open to valid suggestions or changes that genuinely enhance the project's value. Just ensure that these changes go through the proper evaluation and approval processes. If you can’t readily identify the ROI of the change it probably isn’t a good change to consider. 12. Conduct Regular Project Reviews Conduct regular reviews with stakeholders to ensure that the project is meeting their expectations and to address any concerns before they escalate. When facilitating meetings, try to employ Jeff Bezos’ ‘Two Pizza’ rule when it comes to meeting attendees. 13. Manage Dependencies to Avoid Unintended Cross Functional Impact Understand and manage dependencies between project tasks and deliverables. Changes in one area can often impact other parts of the project. Remember that while complete prevention of scope creep might be challenging, these strategies can significantly help to reduce its occurrence and impact on your project. Regular vigilance and proactive management are key to avoiding scope creep from taking over your project. The quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering. Learn more about how we can solve your work and project problems today to get you back on track! In this episode of Medtech Snapshot we hear from Karen Polkinghorne, President of Network Partners Group, on her three strategic considerations for improving your chances of gaining approval with management on the new project, program or initiative you're trying to get under way. Learn how the companies vision and mission, as well as the return on investment (ROI) for your project, plays an important role in the approval process. #medicaldevice #medtech #snapshot #approval #project #program #management #returnoninvestment #vision #mission Get Medical Device Project Support TodayThe quickest way to overcome a business challenge is to get help from those who are experienced in besting your beast! The team at Square-1 Engineering is comprised of a variety of technical and project management professionals who are subject matter experts in the areas of NPD, Quality, Compliance and Manufacturing Engineering. Learn more about how we can solve your work and project problems today to get you back on track!
Last weeks' LinkedIn poll closed and the results are in! Our managing director Travis N. Smith shares the details of how Southern California's medical device industry got its start and the history which led us to present day! For a complete timeline of the evolution of SoCal's medical device industry click HERE. #medicaldevice #industry #southerncalifornia #medtech #USC #keck #baxter #history About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a medical device consulting firm, providing end to end engineering and compliance services. He successfully served the life sciences marketplace in SoCal for over 15 years and has been recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. Categories
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