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 on

• outsourcing vs. insourcing,
• establishing strong supplier relationships,
• the importance of quality in product development,
• the challenges of scaling production and
• the 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 startup
• and 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.com

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 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=819b2bc4bd11490a

Time Markers:

38:46 Podcast break

01:08:11 TLDL

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 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 hello@pratikdev.com 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 launch
• The mindset shift between research and productization
• Finding your unique value in the value chain
• Effective ways to set up your board and board meetings

And many many more! Some resources that were mentioned in the episode:

• Book recommendation: Pasteur's Quadrant: Basic Science and Technological Innovation
• Article Recommendation on Systematic Hiring utilizing Skill Matrices: Finding the Right Balance: Hiring or Outsourcing for Your High-Potential Startup Team

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!

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 Background
• 00:58 Guest Introduction: Alan Cohen
• 01:32 Alan Cohen's Background and Experience
• 02:37 Challenges in Medical Device Development
• 05:40 Identifying a Hardware Medical Application Need
• 07:48 Understanding Reimbursement and Business Models
• 09:32 Regulatory Bodies and Compliance
• 12:50 Risk Assessment in Medical Device Development
• 21:22 Fault Tree Analysis vs Failure Modes and Effects Analysis
• 27:48 Balancing Documentation and Process in Medical Device Development
• 33:01 Understanding Development Process Standards
• 33:19 Importance of Following Your Process
• 33:42 Inspection and Audit Procedures
• 34:16 Balancing FDA Requirements and Lean Operations
• 35:13 Testing and Validation in Medical Device Development
• 36:43 Navigating FDA and Institutional Review Boards
• 40:02 Challenges in Medical Device Innovation and Funding
• 47:16 Podcast Break
• 47:29 Podcast break
• 56:02 Navigating Supply Chain and Manufacturing Challenges
• 01:04:09 Understanding FDA and EU Regulatory Differences
• 01:07:00 Final Thoughts and Advice for Medical Device Startups
• Ending 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.