S2 E2: Demystifying Medical Device and System Development with Alan Cohen

This podcast episode features an in-depth conversation with Ying Liu CEO of BlueLake Packaging, a seasoned expert in hardware product development and the sustainable packaging industry. Drawing from her extensive experience, including building Apple's supply chain infrastructure in China, Ying shares valuable insights onoutsourcing vs. insourcing,establishing strong supplier relationships,the importance of quality in product development,the challenges of scaling production andthe critical role of sustainability in manufacturing.Ying emphasizes the need for financial prudence, leveraging community support, and the importance of assembling a competent team. Through practical advice and personal anecdotes, this episode offers hardware entrepreneurs a comprehensive guide on bringing their innovative ideas to market, maintaining high standards of quality, and making sustainable choices in their manufacturing processes.Please don't forget to share, rate and like the podcast on your favorite podcast platform!Music by: Tom Stoke (in addition to royalty-free music provided by Descript)DISCLAIMER Please be aware that "The Builder Circle by Pratik" and "Pratik Development LLC" are entirely independent and are not affiliated with, sponsored by, or endorsed by any other company or any of its subsidiaries. The views, opinions, and content expressed in our podcast are exclusively those of "The Builder Circle by Pratik" and "Pratik Development LLC" and do not reflect the views, opinions, or policies of any other company or any associated entities. The content provided in this podcast is for informational purposes only and should not be construed as professional advice. Pratik Development, LLC., the hosts, guests, and producers of this podcast are not engaged in rendering legal, financial, or other professional services. Listeners are encouraged to seek the advice of qualified professionals regarding specific issues related to their business, product development, or any other matters discussed in the podcast. Listeners are responsible for conducting their own research, due diligence, and making informed decisions based on their specific circumstances. Please note, the information presented in this episode is for educational and informational purposes only and does not constitute legal advice. We strongly advise consulting with a professional legal advisor for any intellectual property concerns. By accessing and listening to this podcast, you acknowledge and agree that the hosts, guests, and producers of the podcast shall not be held liable for any direct, indirect, incidental, consequential, or any other damages arising out of or in connection with the use of the information presented in the podcast. Listeners are advised to independently verify any information presented and consult with appropriate professionals before making any decisions or taking any actions based on the content of this podcast. By continuing to listen to this podcast, you indicate your understanding and acceptance of this disclaimer.

Quality or sustaining engineering sound like big initiatives that only exist in big companies like GE or P&G but this is a common misconception in the startup world. Having a quality mindset and culture should come into play the first day of product development.I am excited to have Matthew Lipsitz, Head of Quality at Formlabs on to discuss exactly this. Formlabs started as a startup and scaled right in front of our eyes but quality was always front-in-mind. We talk about;defining #quality,applying quality from day 1, how to create a low-touch and non-burdensome quality infrstructure in a startupand much more!Music by: Tom Stoke (in addition to royalty-free music provided by Descript)DISCLAIMER Please be aware that "The Builder Circle by Pratik" and "Pratik Development LLC" are entirely independent and are not affiliated with, sponsored by, or endorsed by any other company or any of its subsidiaries. The views, opinions, and content expressed in our podcast are exclusively those of "The Builder Circle by Pratik" and "Pratik Development LLC" and do not reflect the views, opinions, or policies of any other company or any associated entities. The content provided in this podcast is for informational purposes only and should not be construed as professional advice. Pratik Development, LLC., the hosts, guests, and producers of this podcast are not engaged in rendering legal, financial, or other professional services. Listeners are encouraged to seek the advice of qualified professionals regarding specific issues related to their business, product development, or any other matters discussed in the podcast. Listeners are responsible for conducting their own research, due diligence, and making informed decisions based on their specific circumstances. Please note, the information presented in this episode is for educational and informational purposes only and does not constitute legal advice. We strongly advise consulting with a professional legal advisor for any intellectual property concerns. By accessing and listening to this podcast, you acknowledge and agree that the hosts, guests, and producers of the podcast shall not be held liable for any direct, indirect, incidental, consequential, or any other damages arising out of or in connection with the use of the information presented in the podcast. Listeners are advised to independently verify any information presented and consult with appropriate professionals before making any decisions or taking any actions based on the content of this podcast. By continuing to listen to this podcast, you indicate your understanding and acceptance of this disclaimer.

In this podcast, TBC host and Pratik founder Sera Evcimen has a discussion with patent attorney Troy Grabow about the importance of intellectual property (IP) strategy for hardware startups. They explore the differences between patents and trade secrets, the complex process of filing and maintaining patents, and the potential costs involved,the strategic decisions startups need to make regarding patenting their inventions or keeping them as trade secrets,underline the significance of clear agreements on IP ownership in co-development and supplier relationships. Troy emphasizes the value of IP as a startup's principal asset in the early stages, and advises startups on managing related costs, risks of overseas operations, and the importance of employee IP education.You can find Troy's company here: https://www.grabowlaw.com/Resource Highlight: Hardware Meetup (an informal project) is a global community of over 25k hardware professionals that meet in cities around the world to network, share insights, and find collaborators, investors, and partners. With 30 chapters and growing, and partnerships with recognizable hardware brands like Google X, Tesla, Solidworks, and Onshape. Attend a local IRL Hardware Meetup for an invite! Find your city chapter at hardwaremeetup.comMusic by: Tom Stoke (in addition to royalty-free music provided by Descript)DISCLAIMER Please be aware that "The Builder Circle by Pratik" and "Pratik Development LLC" are entirely independent and are not affiliated with, sponsored by, or endorsed by any other company or any of its subsidiaries. The views, opinions, and content expressed in our podcast are exclusively those of "The Builder Circle by Pratik" and "Pratik Development LLC" and do not reflect the views, opinions, or policies of any other company or any associated entities. The content provided in this podcast is for informational purposes only and should not be construed as professional advice. Pratik Development, LLC., the hosts, guests, and producers of this podcast are not engaged in rendering legal, financial, or other professional services. Listeners are encouraged to seek the advice of qualified professionals regarding specific issues related to their business, product development, or any other matters discussed in the podcast. Listeners are responsible for conducting their own research, due diligence, and making informed decisions based on their specific circumstances. Please note, the information presented in this episode is for educational and informational purposes only and does not constitute legal advice. We strongly advise consulting with a professional legal advisor for any intellectual property concerns. By accessing and listening to this podcast, you acknowledge and agree that the hosts, guests, and producers of the podcast shall not be held liable for any direct, indirect, incidental, consequential, or any other damages arising out of or in connection with the use of the information presented in the podcast. Listeners are advised to independently verify any information presented and consult with appropriate professionals before making any decisions or taking any actions based on the content of this podcast. By continuing to listen to this podcast, you indicate your understanding and acceptance of this disclaimer.

In this episode, Kristine Barnes shares her extensive experience in the world of complex systems, straddling the fields of nuclear power and automotive engineering. She hails from General Motors and an executive member of Society of Women Engineers. At the end of the episode you will walk away with knowing:how to proactively start writing requirements for your complex system,how to effectively conduct a DFMEA (design failure modes effects analysis),risk managing,strategizing product focus and,executing development for a successful complex system launch.Hey! If you liked this episode you should also listen to: https://open.spotify.com/episode/2GZlF2JUCAhCh2xYc8XpN2?si=819b2bc4bd11490aTime Markers:38:46 Podcast break01:08:11 TLDLDISCLAIMER Please be aware that "The Builder Circle by Pratik" and "Pratik Development LLC" are entirely independent and are not affiliated with, sponsored by, or endorsed by General Motors or Society of Women Engineers or any of their respective subsidiaries. The views, opinions, and content expressed in our podcast are exclusively those of "The Builder Circle by Pratik" and "Pratik Development LLC" and do not reflect the views, opinions, or policies of General Motors or Society of Women Engineers or any associated entities. The content provided in this podcast is for informational purposes only and should not be construed as professional advice. Pratik Development, LLC., the hosts, guests, and producers of this podcast are not engaged in rendering legal, financial, or other professional services. Listeners are encouraged to seek the advice of qualified professionals regarding specific issues related to their business, product development, or any other matters discussed in the podcast. The information, opinions, and recommendations presented in this podcast are based on the personal experiences and expertise of the hosts and guests. However, they do not guarantee the accuracy, completeness, or effectiveness of any information shared. The hosts and guests disclaim any liability for any errors or omissions in the content or for any actions taken based on the information provided.It is important to note that every situation is unique, and what may work for one individual or business may not work for another. Listeners are responsible for conducting their own research, due diligence, and making informed decisions based on their specific circumstances.By accessing and listening to this podcast, you acknowledge and agree that the hosts, guests, and producers of the podcast shall not be held liable for any direct, indirect, incidental, consequential, or any other damages arising out of or in connection with the use of the information presented in the podcast. Listeners are advised to independently verify any information presented and consult with appropriate professionals before making any decisions or taking any actions based on the content of this podcast. By continuing to listen to this podcast, you indicate your understanding and acceptance of this disclaimer.

In this deep-dive episode, Greg Paulsen, Director of Applications, Engineering and Marketing at Xometry, discusses the complexities and intricacies of physical product development. He highlights the importance of understanding different manufacturing methods and the potential biases they can introduce in the design process. The episode delves into the pros and cons of various 3D printing technologies such as filament-based, powder bed fusion, and resin-based methods. Greg also points out the potential pitfalls of not considering scalability when developing prototypes. He underscores the need for clear communication regarding design requirements and having in-depth discussions about the design and manufacturing processes for successful product development.This episode is NOT sponsored by Xometry however they have provided a perk for TBC listeners:Take $25 off an order of over $100 through Xometry's Instant Quoting Engine® using the promotion code BldCirPod2024. Limit one use per customer. This offer expires on June 30, 2024._____________________________________________________________________________Music by: Joel Caffey and Tom Stoke (in addition to royalty-free music provided by Descript)DISCLAIMER Please be aware that "The Builder Circle by Pratik" and "Pratik Development LLC" are entirely independent and are not affiliated with, sponsored by, or endorsed by Xometry, Inc. or any of its subsidiaries. The views, opinions, and content expressed in our podcast are exclusively those of "The Builder Circle by Pratik" and "Pratik Development LLC" and do not reflect the views, opinions, or policies of Xometry, Inc. or any associated entities. The content provided in this podcast is for informational purposes only and should not be construed as professional advice. Pratik Development, LLC., the hosts, guests, and producers of this podcast are not engaged in rendering legal, financial, or other professional services. Listeners are encouraged to seek the advice of qualified professionals regarding specific issues related to their business, product development, or any other matters discussed in the podcast. The information, opinions, and recommendations presented in this podcast are based on the personal experiences and expertise of the hosts and guests. However, they do not guarantee the accuracy, completeness, or effectiveness of any information shared. The hosts and guests disclaim any liability for any errors or omissions in the content or for any actions taken based on the information provided.It is important to note that every situation is unique, and what may work for one individual or business may not work for another. Listeners are responsible for conducting their own research, due diligence, and making informed decisions based on their specific circumstances.By accessing and listening to this podcast, you acknowledge and agree that the hosts, guests, and producers of the podcast shall not be held liable for any direct, indirect, incidental, consequential, or any other damages arising out of or in connection with the use of the information presented in the podcast. Listeners are advised to independently verify any information presented and consult with appropriate professionals before making any decisions or taking any actions based on the content of this podcast. By continuing to listen to this podcast, you indicate your understanding and acceptance of this disclaimer.

Scott Miller is back again on the Builder Circle! A true hardware veteran, in this episode we will be privileged enough to talk with him within the realm of his professional sweet spot: how to properly scale your manufacturing with a focus on injection molding! The episode will dive into:When should a product team know to convert to injection molding? From a technological readiness level, unit economics and supply chain strategy perspective.More specifically, how many units should companies be aiming to produce for injection molding to make sense?What are some other manufacturing techniques that work at scale? What are some considerations for each technique?And many more!A hardware startup and interested in getting advice from our host, Sera Evcimen? That's exactly what Pratik is for! Contact us at [email protected] with information on your product and what you need help with and let's get started!Don't forget to rate the episode and share it with your network for a broader reach and positive impact in the hardware world! Thank you for your support :)All disclaimers mentioned in previous episodes hold true for this episode. Please visit the first 10 episode notes for details. Thank you!

From leveraging your ecosystem to building your product roadmap and from managing your board to determining who to hire and why, this episode has it all. Pete Blake from Sapphire Steel is a fellow All-Star Mentor at Techstars. In this episode we dive deep into:How to strategically incorporate your ecosystem in hardware development and launchThe mindset shift between research and productizationFinding your unique value in the value chainEffective ways to set up your board and board meetingsAnd many many more! Some resources that were mentioned in the episode:Book recommendation: Pasteur's Quadrant: Basic Science and Technological InnovationArticle Recommendation on Systematic Hiring utilizing Skill Matrices: Finding the Right Balance: Hiring or Outsourcing for Your High-Potential Startup TeamDon't forget to rate the episode and share it with your network for a broader reach and positive impact in the hardware world! Thank you for your support :)All disclaimers mentioned in previous episodes hold true for this episode. Please visit the first 10 episode notes for details. Thank you!

This episode features a conversation between host, Sera Evcimen, and Alan Cohen, author of 'Prototype to Product: A Practical Guide for Getting to Market'. They delve into the complexities, misconceptions and opportunities in medical device development. The discussion includes the importance of generating good requirements, handling regulatory requirements, and conducting risk analysis. They also highlight the value of hiring experts conversant in both engineering and regulatory matters to guide a startup through navigating the FDA and EU approval processes.You can find his consultancy at www.alancohen.com.Rundown of Episode for easy navigation to topics of interest:00:00 Introduction and Host Background00:58 Guest Introduction: Alan Cohen01:32 Alan Cohen's Background and Experience02:37 Challenges in Medical Device Development05:40 Identifying a Hardware Medical Application Need07:48 Understanding Reimbursement and Business Models09:32 Regulatory Bodies and Compliance12:50 Risk Assessment in Medical Device Development21:22 Fault Tree Analysis vs Failure Modes and Effects Analysis27:48 Balancing Documentation and Process in Medical Device Development33:01 Understanding Development Process Standards33:19 Importance of Following Your Process33:42 Inspection and Audit Procedures34:16 Balancing FDA Requirements and Lean Operations35:13 Testing and Validation in Medical Device Development36:43 Navigating FDA and Institutional Review Boards40:02 Challenges in Medical Device Innovation and Funding47:16 Podcast Break47:29 Podcast break56:02 Navigating Supply Chain and Manufacturing Challenges01:04:09 Understanding FDA and EU Regulatory Differences01:07:00 Final Thoughts and Advice for Medical Device StartupsEnding with TLDL!Music by: Tom Stoke (in addition to royalty-free music provided by Descript)DISCLAIMER The content provided in this podcast is for informational purposes only and should not be construed as professional advice. Pratik Development, LLC., the hosts, guests, and producers of this podcast are not engaged in rendering legal, financial, or other professional services. The hosts and guests disclaim any liability for any errors or omissions in the content or for any actions taken based on the information provided. By accessing and listening to this podcast, you acknowledge and agree that the hosts, guests, and producers of the podcast shall not be held liable for any direct, indirect, incidental, consequential, or any other damages arising out of or in connection with the use of the information presented in the podcast. Furthermore, the hosts, guests, and producers of this podcast make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability, or availability of the information, products, services, or related graphics contained in the podcast for any purpose. Listeners are advised to independently verify any information presented and consult with appropriate professionals before making any decisions or taking any actions based on the content of this podcast. By continuing to listen to this podcast, you indicate your understanding and acceptance of this disclaimer.

Elecia White has worked on DNA scanners, inertial measurement units for airplanes and race cars, toys for preschoolers, a gunshot location system for catching criminals, and assorted other medical and consumer devices. She is the founder of Logical Elegance, an embedded systems consulting company based in San Jose and the host of the Embedded FM podcast. Elecia has strong skills in signal processing, hardware integration, complex system design, and performance. Having been through FAA and FDA certification processes, she understands the importance of producing quality designs and how they lead to quality implementations.In this episode we answer the questions:What is firmware and why is it important for a hardware to have a very robust firmware system architecture?Could you walk us through a typical firmware build out/development process? How long does it often take? How many iterations are there usually?How should a startup decide to either insource or outsource firmware specifically?What are common misconceptions around firmware? What do people get wrong when planning?What are the most common firmware pitfalls for startups and how could they be avoided?What is the best way ME, EE and SW teams could interface with firmware teams?What are the more critical tests to do to ensure the firmware risks are mitigated?The Hardware Resource Spotlight for this episode is ScaleForClimatetech, a NYSERDA supported program that provides resources to climate tech entrepreneurs to scale up their technologies, to learn more visit: www.forclimatetech.org/innovator-services. Application deadline to be a part of this upcoming cohort is December 4th.Music by: Tom Stoke (in addition to royalty-free music provided by Descript)DISCLAIMER The content provided in this podcast is for informational purposes only and should not be construed as professional advice. Pratik Development, LLC., the hosts, guests, and producers of this podcast are not engaged in rendering legal, financial, or other professional services. The hosts and guests disclaim any liability for any errors or omissions in the content or for any actions taken based on the information provided. By accessing and listening to this podcast, you acknowledge and agree that the hosts, guests, and producers of the podcast shall not be held liable for any direct, indirect, incidental, consequential, or any other damages arising out of or in connection with the use of the information presented in the podcast. Furthermore, the hosts, guests, and producers of this podcast make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability, or availability of the information, products, services, or related graphics contained in the podcast for any purpose. Listeners are advised to independently verify any information presented and consult with appropriate professionals before making any decisions or taking any actions based on the content of this podcast. By continuing to listen to this podcast, you indicate your understanding and acceptance of this disclaimer.

Orin Hoffman is a seasoned hardware veteran and VC investor passionate about enabling hardware through capital. In this episode we dive into two main questions:How does a hardware entrepreneur strategically source capital to have a successful hardware product?What are the common pitfalls and failures hardware teams do when building their capital stack?Don't have time to listen to the full episode? Totally understandable, scroll to the end to get the key takeaways and summary during the TL;DL (too long didn't listen) segment!Music by: Joel Caffey and Tom Stoke (in addition to royalty-free music provided by Descript)DISCLAIMERThe content provided in this podcast is for informational purposes only and should not be construed as professional advice. Pratik Development, LLC., the hosts, guests, and producers of this podcast are not engaged in rendering legal, financial, or other professional services. Listeners are encouraged to seek the advice of qualified professionals regarding specific issues related to their business, product development, or any other matters discussed in the podcast.The information, opinions, and recommendations presented in this podcast are based on the personal experiences and expertise of the hosts and guests. However, they do not guarantee the accuracy, completeness, or effectiveness of any information shared. The hosts and guests disclaim any liability for any errors or omissions in the content or for any actions taken based on the information provided.It is important to note that every situation is unique, and what may work for one individual or business may not work for another. Listeners are responsible for conducting their own research, due diligence, and making informed decisions based on their specific circumstances.By accessing and listening to this podcast, you acknowledge and agree that the hosts, guests, and producers of the podcast shall not be held liable for any direct, indirect, incidental, consequential, or any other damages arising out of or in connection with the use of the information presented in the podcast.Furthermore, the hosts, guests, and producers of this podcast make no representations or warranties of any kind, express or implied, about the completeness, accuracy, reliability, suitability, or availability of the information, products, services, or related graphics contained in the podcast for any purpose.Listeners are advised to independently verify any information presented and consult with appropriate professionals before making any decisions or taking any actions based on the content of this podcast.By continuing to listen to this podcast, you indicate your understanding and acceptance of this disclaimer.