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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!
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 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!
Sanjay Shrivastava, Ph.D. joins us on Medtech Snapshot to talk about medical device contract manufacturing partners - when to strategically engage them, especially if you are a startup, and the importance of "keeping the end in mind" throughout the process. Interested in catching up on our past Medtech Snapshot discussions? Visit #medicaldevice #medtech #snapshot #contractmanufacturing #contractmanufacturer #outsourcing #startup 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!
 Selecting the right medical device contract manufacturing partner is a critical decision that can significantly impact the success of your medical device development and production process. There are many advantages which come with working with a contract manufacturing partner, chief among them is it can potentially help you get out to the market quicker without having to go vertical, building up your own production system internally. The right partner can also offer cost savings as a result of their established supply chain partners, ability to scale and expertise in developing similar products. While those advantages can indeed be a blessing to a maturing business, landing the wrong partner can also be a curse. For this reason its vital device companies utilize a strategically planned process for how they are to approach and select a new contract manufacturing partner. The more due diligence one can do on the forefront the better the likelihood will be you will see success on the back end. Here are some important criteria to consider when evaluating potential contract manufacturing partners: 1. Experience and Expertise: Look for a partner with experience in manufacturing similar medical devices. Their expertise in the specific type of device, materials, processes, and technologies is vital to ensuring a smooth production process and high-quality output. 2. Capabilities and Facilities: Evaluate the contract manufacturer's facilities, equipment, and technological capabilities. Make sure they have the necessary infrastructure and resources to meet your manufacturing needs and scale as your project progresses. (HINT - learn about their employees. If they have high turnover with their internal staff this could create problems for you in the future) 3. Supply Chain Management: A robust supply chain is crucial for consistent component availability and cost-effectiveness. Assess the manufacturer's ability to manage the supply chain efficiently, including sourcing components, managing inventory, and handling potential disruptions. 4. Flexibility and Scalability: Consider the partner's ability to adapt to changes in project scope or production volume. A flexible partner can accommodate adjustments in design, production, and scheduling, which is important in the dynamic field of medical device development. MEDTECH SNAPSHOT: CONTRACT MANUFACTURING In this episode we are joined by Innova Vascular's CEO Sanjay Shiravastava who takes us through several pointers on when to consider finding a medical device contract manufacturing partner to aide in your go to market strategy. Here from Sanjay on why it's "important to begin with the end in mind". 5. Regulatory Compliance: Ensure that the contract manufacturer has a solid understanding of regulatory requirements, such as FDA (or equivalent) regulations, ISO standards (e.g., ISO 13485 for medical devices), and any other relevant local or international regulations. They should have a track record of successfully producing devices that meet these requirements. 6. Quality Management: A strong quality management system is crucial for medical device manufacturing. The partner should have established quality control processes, including inspection, testing, documentation, and corrective action procedures. They should also have a history of adhering to quality standards and maintaining good manufacturing practices. Their data and practices should be transparent and they should be open to you reviewing this information. 7. Geographical Location: The location of the contract manufacturer can impact shipping costs, lead times, and the ease of visiting the facility for inspections or meetings. 8. Intellectual Property Protection: Ensure that the contract manufacturer has protocols in place to protect your proprietary information and intellectual property throughout the manufacturing process. Do they work with a competitor of yours, if so how will they ensure your IP and product is protected? 9. References and Reputation: Research the manufacturer's reputation in the industry. Seek references from other companies they have worked with and review their track record to gauge their reliability, performance, and commitment to quality. 10. Cost and Pricing: While cost should not be the sole deciding factor, it's important to have a clear understanding of the pricing structure, including setup costs, unit costs, and any additional charges. Pricing should be clearly laid out and defined in your contract; stay away from partnerships where things seem murky and or inconsistent from a pricing perspective. 11. Long-Term Partnership Potential: Consider whether the contract manufacturer is interested in building a long-term partnership and is willing to support your future projects and iterations. 12. Employees and Training: Be mindful of how their employees are treated, trained and managed. High turnover at a contract manufacturer may mean you find yourself constantly involved int he training process to ensure the operators and assemblers working on your product are working as expected. The more turnover that occurs the more training that will need to take place, which means your partners training methods and consistently is critical to your success. High turnover and poor training will inevitably lead to yield problems. Before making a final decision, it's advisable to visit the contract manufacturer's facility, meet their team, and discuss your project in detail to ensure alignment and understanding. Taking the time to thoroughly assess potential partners will increase the likelihood of a successful and fruitful collaboration in medical device manufacturing. 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're joined by Terry Vick, Director Program Management at Shockwave, as we dive into the activities people in project management, program management and leadership need to be aware of and consider upfront in the project planning phase into order to limit scope creep on the back end. Hear how Terry discusses the importance of having an internal project sponsor.
Enjoying these quick 3-minute discussions? Be sure to check out our past Medtech Snapshot episodes HERE. #medtechsnapshot #medtech #snapshot #projectmanagement #programmanagement #medicaldevice #healthcare #scopecreep In this episode of Medtech Snapshot we're joined by SPARK Neuro COO Marinela Gombosev as we sort through the opportunities and challenges in adopting machine learning (ML) and artificial intelligence (AI) technologies in the medical device space. Listen in as Marinela provides additional perspective on the considerations for adopting this technology within our current health system and its stakeholders like the FDA, clinicians, etc.
Enjoying these quick 3-minute discussions? Be sure to check out our past Medtech Snapshot episodes at https://lnkd.in/gFwF9GYN #medtechsnapshot #medtech #snapshot #AI #machinelearning #medicaldevice #artificialintelligence #fda #healthcare About the AuthorTravis Smith is the founder and managing director of Square-1 Engineering, a life sciences consulting firm, providing end to end technical project services to companies which design, develop and or manufacture products in Southern California. He successfully served the life sciences marketplace in SoCal for over 15 years specializing in engineering services, consulting, project outsourcing and leadership development. In 2019 he was recognized as a ‘40 Under 40’ honoree by the Greater Irvine Chamber of Commerce as a top leader in Orange County, CA. Archives
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