I'm joined by Dennis Lenard, design expert and CEO of Creative Navy, as we explore the critical role of evidence-based design in creating successful medical devices and interfaces. With 15 years of experience in medical interface design, Dennis shares insights on how startups can leverage design to compete with incumbents and create better user experiences in healthcare.

In this episode, we breakdown:

The Evolution of Medical Device Design

→ Origins of ergonomics in medical devices

→ Why incumbents often struggle with GUI design

→ How design can level the playing field for startups

→ The intersection of function and aesthetics in medical interfaces

Evidence-Based Design Framework

→ The three pillars: gathering facts, decision-making process, and culture

→ Why invalidation trumps validation in design

→ Using complexity analysis to improve interfaces

Starting Design Early in Product Development

→ When to begin thinking about GUI design

→ Low-fidelity prototyping techniques

→ The iterative nature of interface development

→ Balancing functionality with user experience

Competing with Incumbents Through Design

→ Why large companies struggle with innovation

→ How startups can exploit design opportunities

→ The importance of user-centered development

→ Breaking through market barriers with better design

Practical Design Implementation

→ Managing interface complexity

→ Making decisions about icons versus text

→ International considerations in GUI design

→ When to bring in professional design help

Best Quotes:

"Design is a death trap if you don't do it right... design actually means doing something on purpose in a particular way to achieve a desired effect."

"We create designs with the intent of destroying them, just like in science where you formulate the theory and then try to disprove it. You're not validating it... nobody has ever validated anything, you can only invalidate something."

"Beauty without meaning is nothing... if you have meaning in something, it evokes an emotional response, it makes people bond with it."

Want more insights on medtech innovation?

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

FIND DENNIS LENARD ON SOCIAL

LinkedIn: linkedin.com/in/dennislenard
Creative Navy: https://www.linkedin.com/company/creative-navy/
Website: https://creative.navy/work

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 Dennis Lenard and Creative Navy
2:04 - Dennis's journey into medical interface design
4:20 - State of the Medtech market and incumbent challenges
7:40 - The importance of early design concepts

14:40 - How design helps compete with incumbents
21:00 - The fundamentals of evidence-based design
27:30 - When and how to start thinking about GUI design
38:00 - Using AI and tools in the design process
41:46 - Making decisions between icons and text
43:30 - What to prepare before engaging design services

Join Spencer Jones as he sits down with Brad Shirley, Founder and Principal of DCMS Solutions, to explore the nuances of medtech innovation both within large corporations and startups. Drawing from his extensive experience at Cook Medical, Cook Regentec, and Maruho Medical, Brad shares invaluable insights on navigating product development, managing R&D teams, and driving successful innovation in different organizational contexts.

In this episode, we break down:

Corporate Innovation vs Startup Agility

→ Challenges of innovating within large corporate structures

→ How Cook Regentec operated as an innovation incubator

→ Balancing corporate advantages with startup speed

→ Managing relationships between incubator and parent company

R&D Leadership and Capital Stewardship

→ Strategies for managing R&D budgets effectively

→ Importance of being good stewards of capital

→ Prioritizing projects and making tough decisions

→ Focusing on critical features in product development

Customer Discovery and Market Validation

→ Leveraging corporate networks for customer access

→ Different approaches for startups vs large companies

→ Building relationships with sales representatives

→ Strategies for effective physician engagement

Product Management Excellence

→ Transitioning from engineering to product management

→ Cross-functional leadership and relationship building

→ Career growth opportunities in product management

→ Balancing technical and business responsibilities

Quality Systems and Innovation

→ Managing quality requirements in different environments

→ Streamlining documentation processes

→ Building appropriate quality systems for different stages

→ Balancing innovation speed with compliance

Best Quotes:

"It's like I want to go stay in the in-laws' mansion but I don't want them to be there... like I want to take the good, leave the bad." - On managing corporate relationships in innovation

"As my 10-year-old would say, let them cook... you've already got the green light, let them go." - On empowering development teams

"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?

Subscribe to unpack hot takes and insider tactics from the trenches of medtech startups.

FIND BRAD SHIRLEY ON SOCIAL

LinkedIn: https://www.linkedin.com/in/brad-shirley/

DCMS Solutions LinkedIn: https://www.linkedin.com/company/dcms-solutions/

Website:https://dcmssolutions.com/

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 and Brad's Background
5:00 - Corporate Innovation and Cook Regentec
12:50 - Managing R&D Budgets and Resources
23:00 - Customer Discovery Strategies
27:00 - Product Management Journey
31:00 - DCMS Solutions and Future Plans

In this episode, I'm joined by Paul-Lukas Hoffschmidt, Founder and CEO of Alpha Sophia, who's revolutionizing how medtech companies find and engage their customers. Coming from the world of retail analytics, he brings a fresh perspective on using data to drive commercial success in healthcare.

From hyper-personalization at scale to building trust through content, we unpack the new rules of medtech commercialization.

Episode Breakdown:

The Evolution of Commercial Analytics in MedTech

→ Why medtech lags behind other industries in commercial analytics

→ Building a single source of truth for market intelligence

→ Democratizing data access for early-stage companies

→ How retail analytics expertise translates to healthcare

Market Research and Customer Discovery

→ Start commercial planning 1-2 years before regulatory approval

→ Focus on deep market penetration in smaller segments

→ Build relationships through scientific/clinical education

→ Creating multiple touchpoints with target customers

Omni-Channel Marketing in MedTech

→ Creating content that resonates with busy physicians

→ Leveraging video for trust-building and engagement

→ Testing and analyzing different marketing channels

→ Balancing short-term and long-term marketing strategies

Building a Data-Driven Go-to-Market Strategy

→ Hyper-personalization at scale through data

→ US market becoming primary launch target globally

→ Traditional sales strategies becoming less effective

→ The importance of standing out in a crowded market

Key Lessons for MedTech Innovators

→ Do extensive customer discovery before building

→ Focus on going deep before going wide

→ Create compelling, personalized stories

→ Don't wait for perfect scalability - do what works now

Want more insights on medtech innovation?

🚀 My FREE 5-day email course to learn how to go from Vision to Funded medtech startup: https://xomedtech.com/free-course

Get actionable insights on:

→ Zeroing in on your billion-dollar problem

→ Navigating the regulatory maze like a pro

→ Mastering lean product development

→ Crafting your healthcare economics value story

→ Building a thriving medtech company

🎯 Join our exclusive community where medtech innovators build together: https://xomedtech.com

FIND PAUL-LUKAS ON SOCIAL

LinkedIn: https://www.linkedin.com/in/paul-lukas-hoffschmidt

Alpha Sophia: https://www.alphasophia.com

Episode Timestamps:

0:00 - Introduction to Paul-Lukas and Alpha Sophia

10:20 - Market research and customer discovery

18:30 - Sales and marketing cheat codes

23:00 - Content marketing and brand building

28:30 - Trends to win in medtech

36:52 - Closing thoughts

F Javier Perez from MedTech Digest and I are joined by David Narrow, Co-founder and CEO of Sonavex, where we explore the journey of building innovative medical devices, navigating regulatory approvals, and transforming dialysis care.

In this episode, we break down:

The Journey from Academia to MedTech Entrepreneurship
→ Spinning technology out of Johns Hopkins University
→ Building the right team and securing early validation
→ Transitioning from biomedical engineering to business leadership

Revolutionizing Dialysis Care with AI-Enabled Ultrasound
→ Understanding the critical need for better vascular access
→ How EchoMark and EchoSure work together to improve outcomes
→ Reducing catheter dependency from 7 months to weeks

Navigating CPT Codes and Reimbursement
→ Starting the process at the right time with clinical trials
→ Building relationships with specialty societies
→ Understanding the non-meritocratic nature of coding approval

Securing $24M in Funding During Tough Market Conditions
→ Working backwards from potential exits
→ Building comprehensive data rooms and economic models
→ Maintaining relationships with investors through milestones

Platform Technology and Future Applications
→ Expanding beyond initial use cases
→ Development of needle guidance technology
→ Leveraging grants for new product development

Best Quotes:

"It's not about how much you know, but how well you can apply, test, and iterate on that knowledge in the real world."

"What blew my mind was that 1% of the entire federal government budget is spent on dialysis care."

"An organized oligopoly is essentially a monopoly."

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

📈 Ready to accelerate your medtech journey? Join XO Medtech - the #1 network for medtech innovators: https://xomedtech.com

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

FIND DAVID NARROW ON SOCIAL LinkedIn: https://www.linkedin.com/in/david-narrow Sonavex LinkedIn: https://www.linkedin.com/company/sonavex Sonavex: www.sonavex.com

FIND F. JAVIER PEREZ ON SOCIAL
LinkedIn: linkedin.com/in/francisco-javier-perez-cfa
MedTech Digest: https://themedtechdigest.com/

Episode Timestamps:
0:00 - Introduction to F. Javier Perez
3:45 - The Academic to Entrepreneur Journey
6:00 - Understanding the Dialysis Market
12:45 - Navigating CPT Codes and Reimbursement
14:45 - Fundraising Strategy and Market Access
24:20 - Study Details
31:32 - Future Applications and Pipeline Development

I'm joined by Steve Maxson, a 20-year medical device manufacturing veteran and Innovation Lead at US Extruders, as we explore the future of balloon-based therapies and the evolution of medtech manufacturing. Steve shares insider knowledge on emerging technologies that are transforming cardiovascular care and reshaping how we think about medical device development.

In this episode, we breakdown:

The Next Wave of Balloon-Based Technologies

→ How integration of electronics and balloons is revolutionizing treatments

→ Why new energy delivery methods are attracting billion-dollar acquisitions

→ Deep dive into cryo, RF, and pulse field ablation approaches

→ The engineering challenges of combining soft materials with electronics

Mastering Medical Device Manufacturing

→ Critical collaboration strategies between contract manufacturers

→ How metallization on balloons is changing the game

→ Breaking down technical barriers in profile reduction

→ Why design for manufacturability can make or break your startup

Navigating Contract Manufacturing Relationships

→ Why transparency trumps secrecy in early development

→ Common pitfalls startups face when selecting partners

→ The hidden advantages of mid-sized manufacturers

→ How to structure your RFQ process for success

Market Insights & Future Trends

→ Why neurovascular is the next big frontier

→ How outpatient migration is driving innovation

→ The evolution from cardiovascular to neurovascular applications

→ Emerging opportunities in visualization and sensing

Building Technical Credibility

→ The power of specialized technical content

→ Why depth beats breadth in medtech marketing

→ Building trust through expertise sharing

→ Engaging with sophisticated audiences

Best Quotes:

"Adding sensors to balloons, adding cameras to balloons... you're going to see more and more devices mounted to the body of balloons. It really is next level."

"Don't try to be too cute on the timeline... these aren't investors. Just be completely honest, be like 'yeah this is our timeline.' If it's fundraising dependent just tell them that - they understand, they're running businesses."

"I am much more in the hack and harvest camp where you're like 'hey let's see if we can get some stuff, cut it open, glue it together, make it work' because I feel like it's such an application - nothing's static, balloons are moving, they're flexing, they're bending, they're inflating."

Key Insights for Innovators:

• Start with hack-and-harvest prototypes before full-scale development
• Share therapy details early with manufacturing partners
• Consider mid-sized manufacturers for better startup support
• Build design for manufacturability into early development
• Focus on scalability in initial designs

Want more insights on medtech innovation and development? Subscribe for weekly deep dives with industry leaders.

FIND STEVE MAXSON ON SOCIAL LinkedIn: linkedin.com/in/stevemaxson1 Steve’s podcast: www.youtube.com/@stevemaxson1

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

Episode Timestamps:

0:00 - Introduction & background

2:15 - Balloon-based energy delivery deep dive

7:00 - Clinical use cases

14:08 - Contract manufacturing collaboration examples

18:35 - Future market trends discussion

23:50 - Technical content marketing insights

27:35 - Advice for medtech startups

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.”

Want more insights on medtech quality and regulatory strategy?

Subscribe to unpack hot takes and insider tactics from the trenches of medtech startups.

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