The Quality Mindset: Unlocking Medtech Success with Kyle Rose

In this episode, Spencer is joined by Kyle Rose, CEO of Rook Quality Systems and expert quality and regulatory consultant, to explore the critical role that quality management plays in medtech innovation and startup success.

Key topics covered:

1. 
   The Importance of Early Quality Integration

→ Why quality shouldn't be an afterthought in product development

→ Finding the right balance between speed and compliance

→ How quality processes can actually accelerate innovation

1. 
   Quality Management for Resource-Constrained Startups

→ Tailoring quality systems to startup needs vs. large company approaches

→ Leveraging external expertise and scalable solutions

→ How to efficiently achieve strong compliance

1. 
   The Impact of Quality on Exits and Acquisitions

→ How acquirers evaluate a company’s quality during due diligence

→ Planning for international expansion with quality processes

→ Avoiding post-acquisition quality headaches

1. 
   Evolving Quality Management Systems

→ The shift from paper-based to electronic quality management systems (eQMS)

→ Pros and cons of different QMS approaches for startups

→ Leveraging technology without losing human expertise

1. 
   Building a Culture of Quality

→ Involving the whole team in quality processes

→ The founder's role in championing quality

→ Extending quality mindset to manufacturing partners

Best Quotes:

"We don't want to slow down development or engineering, we want to keep [you] moving fast… let us handle the quality side and not slow you down.”

“My personal pet peeve is having to go back and redo work - having a quality mindset really prevents that.”

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Find Kyle Rose and Rook Quality Systems: Website: https://rookqs.com/ LinkedIn: linkedin.com/in/kyle-rose-rook

Find Spencer Jones on social: LinkedIn: https://www.linkedin.com/in/spencer-jones-5a008672/ XO Medtech LinkedIn: https://www.linkedin.com/company/xo-medtech

Episode Timestamps:

0:00 - Introduction to Kyle Rose and Rook Quality Systems

3:30 - What is elite quality management?

7:45 - The importance of early quality integration in medtech startups

11:45 - Kyle’s recommendation for early-stage companies

18:02 - Quality management horror stories and lessons learned

25:32 - The evolution of quality management systems and eQMS solutions

30:43 - Rook’s secret sauce

33:33 - How quality impacts exits and acquisitions in medtech

I'm joined by Mark Norton, former Apple Manufacturing Manager and now Founder and CEO of Adele Health, as we explore the journey from tech giant to medtech startup and the challenges of building an innovative diabetes management solution.

In this episode, we breakdown:

1. 
   The Apple Manufacturing Experience

→ Transitioning from oil rigs to the cutting edge of tech manufacturing

→ Insights into Apple's meticulous approach to product design and quality

→ Lessons learned from managing global supply chains during unprecedented events

1. 
   Applying Big Tech Principles to Medtech

→ Translating Apple's attention to detail into medical device development

→ The importance of user-centric design in healthcare technology

→ Balancing aesthetics with medical-grade reliability and accuracy

1. 
   Navigating the Medtech Startup Landscape

→ Challenges of developing FDA-regulated devices vs. consumer electronics

→ The critical role of regulatory strategy in product development

→ Importance of aligning incentives with suppliers and partners

1. 
   Building Adele Health: A New Approach to Diabetes Management

→ Creating user-friendly glucose monitoring solutions

→ Leveraging AI and machine learning for personalized insights

→ Balancing privacy concerns with data-driven health management

1. 
   From Concept to Market: The Medtech Journey

→ Importance of early regulatory planning and pre-submission meetings

→ Strategies for iterating on hardware and software designs

→ Building a team that bridges the gap between engineering and healthcare

Best Quotes:

"When your products are used every day, almost all the time… you have to have that elegant usability, the ruggedness, the durability, the reliability."

"We have a phrase we keep using: we'll just figure it out. And I think that's startups to a tee. You just figure it out."

"Always have a second source of supply. Never be sole-sourced."

Want more insights on medtech innovation?

Press the subscribe button to unpack hot takes and insider tactics from the trenches of medtech startups.

📈 My FREE 5-day course for Medtech Innovators to create successful ventures: https://xomedtech.com/free-course

🤝 Join the #1 network for medtech innovators on the internet. Become a member to accelerate your journey, collaborate and build valuable ventures. Try 7-days completely free: https://xo-medtech.circle.so/checkout/xo-membership

FIND SPENCER JONES ON SOCIAL LinkedIn: https://www.linkedin.com/in/spencer-jones-5a008672/ XO Medtech LinkedIn: https://www.linkedin.com/company/xo-medtech

FIND MARK NORTON ON SOCIAL LinkedIn: https://www.linkedin.com/in/mark-norton-adele/ Adele Health: https://adelehealth.com

Episode Timestamps:

0:00 - Introduction to Mark Norton and his journey

2:54 - How to Strategically Approach Product Design

8:38 - Applying Big Tech Principles to Medtech

13:42 - Navigating the Medtech Startup Landscape

18:03 - From Concept to Market: The Medtech Journey

I'm joined by Samantha Wagner, Business Development Manager at Medical Murray, as we explore the journey from R&D engineer to medtech business strategist and the challenges of bringing novel devices to market.

In this episode, we breakdown:

1. Navigating the RFQ Process
   → Essential preparation steps for founders
   → Balancing technical details with business realities
   → The importance of communicating challenges and pain points

   
   

2. The Art of Manufacturer Partnerships
   → Building long-lasting relationships in the medtech space
   → The value of transparency and mutual success
   → How to handle funding cycles and financial constraints

   
   

3. From Concept to Creation: The Development Journey
   → Strategies for effective prototyping and proof of concept
   → Balancing cost, quality, and speed in product development
   → Aligning expectations throughout the process

   
   

4. Avoiding Common Pitfalls
   → Missteps in vendor selection and how to avoid them
   → The importance of on-site visits and thorough vetting
   → Preparing for the inevitable challenges in R&D

   
   

5. The COGS Conundrum
   → Why sharing cost targets is crucial for success
   → How COGS transparency guides development and ensures viability
   → Balancing honesty with business strategy

Top Quotes:

"It's super important to communicate specifics of what your pain points are, what your biggest challenges are... I think that's one part of the RFQ slide deck that you guys have that I think hardly any customer shares with us that I wish pretty much every customer did."

"We're constantly hacking up devices and buying used product or expired product and trying to apply it to new devices or new technologies. That's one of the most cost-effective ways, I think, to prototype.”

"R&D is challenging, and there will be issues. There's going to be unforeseen challenges that come up, and you're going to have to be prepared to overcome those."

Want more insights on medtech innovation?

Press the subscribe button to unpack hot takes and insider tactics from the trenches of medtech startups.

📈 My FREE 5-day course for Medtech Innovators to create successful ventures: https://xomedtech.com/free-course

🤝 Join the #1 network for medtech innovators on the internet. Become a member to accelerate your journey, collaborate and build valuable ventures. Try 7-days completely free: https://xo-medtech.circle.so/checkout/xo-membership

FIND SPENCER JONES ON SOCIAL LinkedIn: https://www.linkedin.com/in/spencer-jones-5a008672/
XO Medtech LinkedIn: https://www.linkedin.com/company/xo-medtech

FIND SAMANTHA WAGNER ON SOCIAL LinkedIn: [https://www.linkedin.com/in/samanthawagneria/

Medical Murray LinkedIn: https://www.linkedin.com/company/medical-murray/
Medical Murray Website: https://www.medicalmurray.com/

Episode Timestamps:

0:00 - Introduction and Sam's background

1:52 - Readiness essentials for the RFQ process

5:24 - Different approaches to development and manufacturing

8:27 - How to set yourself up for success

12:06 - Navigating relationships with suppliers and manufacturers

15:10 - Quality vs Cost

18:48 - Honest communication is key

23:55 - Common pitfalls in the RFQ process

29:06 - The importance of sharing COGS targets

I'm joined by Dr. Josh Ammerman, Founder and CEO of ComboSpine, as we explore the journey from practicing neurosurgeon to medtech entrepreneur and the challenges of building a successful startup in the spine surgery space.

In this episode, we breakdown:

1. The Physician Entrepreneur's Journey
→Transition from clinical practice to medtech innovation
→Importance of surrounding yourself with the right team and resources
→Recognizing the need for business skills beyond medical expertise

2. Navigating the Regulatory Maze
→Building strategic partnerships and avoiding common pitfalls
→The value of a holistic approach to product development
→Importance of considering market dynamics and regulatory constraints

3. Mastering Value Analysis Committees (VACs)
→Evolution of VACs and their impact on purchasing decisions
→Strategies for developing clinical champions
→Tailoring your approach to different hospital contracting models

4. Fundraising in a Challenging Climate
→The importance of storytelling and persistence in pitching
→Value of lead investors and maintaining investor relationships
→Balancing clinical expertise with business acumen in presentations

5. Building a Culture-Centric Startup Team
→Focusing on shared values and work ethic
→Importance of responsiveness and ethical behavior
→Extending company culture to distributors and partners

Best Quotes:
"As a physician entrepreneur, I have absolutely no training in anything but the surgical skills. No one ever taught me how to found a business, how to raise money, how to build a team, pursue intellectual properties, build a business plan. We don't teach doctors how to do that."

"First dollars are way harder than last dollars. Getting to the 50-yard line on your fundraising opens up all sorts of opportunities."

Want more insights on medtech innovation?

Press the subscribe button to unpack hot takes and insider tactics from the trenches of medtech startups.

📈 My FREE 5-day course for Medtech Innovators to create successful ventures: https://xomedtech.com/free-course

🤝 Join the #1 network for medtech innovators on the internet. Become a member to accelerate your journey, collaborate and build valuable ventures.Try 7-days completely free: https://xo-medtech.circle.so/checkout/xo-m...

FIND SPENCER JONES ON SOCIAL
LinkedIn: https://www.linkedin.com/in/spencer-jones-...
XO Medtech Linkedin: https://www.linkedin.com/company/xo-medtech

FIND DR. JOSH AMMERMAN ON SOCIAL
LinkedIn: https://www.linkedin.com/in/joshua-ammerma...
Combospine Linkedin: https://www.linkedin.com/company/combospine/
ComboSpine: www.combospine.com

Episode Timestamps:
0:00 - Introduction to Dr. Josh Ammerman and ComboSpine
4:45 - The Physician Entrepreneur's Journey
9:42 - Navigating the Regulatory Maze
14:55 - Mastering Value Analysis Committees (VACs) and selling into hospitals
23:45 - Fundraising in a Challenging Climate
31:32 - Building a Culture-Centric Startup Team