Joining me for episode #106 was Mr. Naveen Agarwal, the Founder at Creative Analytics Solutions.

If you’re in Med-Tech, & you browse LinkedIn, chances are you’ve seen some of Naveen’s content, especially centered around Risk.

Naveen comes to the show with over 25 years industry experience. He’s worked for well known organizations like Kimberly-Clark as a Research Scientist and for J&J in Business Analytics & Quality Management.

Over the last 7 years or so he has led Creative Analytics which is a consulting firm providing Quality Systems expertise to Medical Device organizations through it’s trademarked platform called Exceed Innovative Quality Solutions Platform across 4 broad areas (Customer Experience, Regulatory compliance, Risk Management & Quality Culture)

Some of the highlights we discussed:

-Biggest pitfalls when it comes to device manufacturers risk management programs

-What are some low hanging fruit teams can go after when it comes to improving risk management safeguards?

-Regarding the new QMSR , from a risk perspective, what will be the biggest challenges for companies when it comes to implementation ?

...and so much more!

Naveen Agarwal on LinkedIn:

https://www.linkedin.com/in/naveenagarwal/

Naveen's Substack:

https://naveenagarwalphd.substack.com/about

Creative Analytics Solutions:

https://www.linkedin.com/company/exeedqm/

Mitch Robbins had the pleasure of hosting Mr. Jason Gorman, the Vice President of Regulatory, Quality & Compliance at Propeller Health for episode #105. Jason comes to us today with over 25 years of experience across the Med-Tech industry. He has a proven track record for developing & implementing Quality Management Systems, Risk Management strategies & Regulatory Compliance processes to meet the highest standards of excellence in customer satisfaction. Prior to working for Propeller Health, Jason spent over a decade working for Accuracy. For those unfamiliar with Propeller Health, now owned by Resmed, it's a precision digital health company on a mission to uplift every person living with chronic disease so they can take control of their health and live a better life. The Propeller Platform includes FDA-cleared & CE Marked medical devices, consumer apps support & coaching and secure access to clinical data for provider monitoring.

Some highlights:

-Jason's journey into Quality & Regulatory

-The evolution of his interest & responsibilities related to privacy & security

-Cybersecurity's disruption to Med-Tech in relation MDR & QMSR changes

-Jason's prediction for the evolution of Reg Affairs & Quality roles with regards to Cybesecurity

-The relationship between Quality Management Systems & Information Security Management Systems

-Cybersecurity vs AI....what is the common thread?

...and so much more!

Jason Gorman on LinkedIn:

https://www.linkedin.com/in/jason-c-gorman/

Propeller Health on the web:

www.propellerhealth.com

For this episode, I had the pleasure of hosting Ms. Jennifer Mascioli-Tudor, Founder & Principal of JMT Compliance Consulting.

In this episode, we discussed:

-Jennifer's transition from corporate to consulting

-The challenges and rewards of consulting

-The importance of community, and the need for vulnerability and connection in the industry

....and so much more!

Takeaways

• Transitioning from corporate to consulting requires a willingness to embrace uncertainty and risk.
• Building a community and fostering connections is essential for success in consulting.
• Being vulnerable and taking risks in reaching out to others can lead to valuable connections and opportunities in the industry.

About Jennifer Mascioli-Tudor:

Jennifer comes to the show today with over 23 years experience in Med-Tech Regulatory & Quality. Having worked in a variety of different capacities for many organizations…. Companies like J&J, Medtronic, Boston Scientific, Outset Medical & GE Healthcare have all been graced by her talents.

She’s currently an instructor at UC San Diego & simultaneously runs her consulting practice. Jennifer holds her bachelors of science degree in Physiology/Chemistry & French from Eastern Michigan University & her MBA from the University of Phoenix

https://www.linkedin.com/in/jennifermascioli/

About JMT Compliance Consulting:

JMT Compliance Consulting helps organizations navigate the quality and regulatory landscape providing coaching, mentoring & foundational business support. Where appropriate the team also provides COO & CQRO leadership to support growing businesses.

www.jmtcompliance.com

Mitch Robbins had the opportunity to host Mr. Garth Conrad, the VP of Quality for Flex Health Solutions. Garth shares his career journey and insights on leadership and building a strong company culture. He emphasizes the importance of relationships, curiosity, and drive in achieving success. Conrad also highlights the role of mentors and coaches in career development. He discusses the differences between individual contributor and managerial roles, as well as the qualities that separate top performers from the average. Conrad stresses the significance of aligning values, beliefs, and behaviors to create a positive company culture. He encourages professionals to gain experience in different functional areas and to actively solve problems. Near the end of the show Garth humanly shares the vision for the legacy he hopes to leave behind.

Takeaways

• Build strong relationships and value the people you work with
• Cultivate curiosity and a drive to understand the 'why' behind things
• Develop leadership skills by managing yourself, then a small team
• Establish a network of mentors and coaches for guidance and support
• Focus on making your people successful as a leader
• Create a positive company culture by aligning values, beliefs, and behaviors
• Gain experience in different functional areas to broaden your skills
• Be proactive in solving problems and taking initiative
• Build leaders within the organization and help others succeed in their careers

About Garth Conrad:

Mr. Garth Conrad comes to The Med-Tech Talent Lab with almost 25 years of industry experience across Med-Tech. He's worked for a variety of the large strategics like Medtronic, J&J, BD, etc. Garth holds a bachelors of science degree in materials engineering, an MBA, and he is also a Lean Six Sigma Black Belt.

Garth on LinkedIn:

https://www.linkedin.com/in/garth-conrad-38b3835/

About Flex & Flex Health Solutions:

Flex Health Solutions is a division of Flex which is a $30 billion dollar organization with about 170,000 employees worldwide. The company is a global supply chain and manufacturing solutions provider.

https://flex.com/resources/flex-health-solutions

In this episode, we talk with Mr. Mark Rhein, the Head of talent & Learning at Glaukos Corporation. Mark shares his experience in building a learning and development program at Glaukos, focusing on middle-level leadership development. He emphasizes the importance of prioritization and designing programs that provide the biggest value to employees. Mark also discusses the company's unique approach to performance management, which involves regular check-ins and feedback conversations. He shares insights on workforce planning and the need for flexibility in a rapidly growing organization. Overall, Mark highlights the importance of continuous learning and adapting to meet the needs of the business.

Takeaways

• Prioritize learning and development programs that provide the biggest value to employees.
• Design leadership development programs that focus on middle-level leaders, who have a direct impact on the majority of employees.
• Implement regular check-ins and feedback conversations as an alternative to traditional performance management.
• Streamline workforce planning and focus on critical roles and areas of expertise.

Chapters

00:00Introduction and Background

01:12Building a Learning and Development Program at Glaukos Corporation

05:01Focusing on Middle-Level Leadership Development

07:23Designing and Implementing Leadership Development Programs

09:16Expanding Learning Activities and Classes

11:15Balancing Time Constraints with Learning and Development

20:34Providing Feedback and Recognizing Achievements

22:09Streamlining Workforce Planning

32:27Lessons Learned and Advice for Building a Learning and Development Program

35:27Exciting Innovations at Glaukos Corporation

About Mark Rhein:

https://www.linkedin.com/in/mark-rhein-7b3944/

Mark has built a storied career over the last 25+ years building Learning & Development programs across industries. Deloitte, Sprint, Abbott, & now Glaukos are just some of the fine organizations Mark has contributed to. Mark’s expertise, which I know we are going to dig into today, lies in the areas of Organizational Development, Performance Management, Leadership Development across all levels & project Management.

Mark Holds his Bachelors degree in Enviornmental Design from the University of Missouri-Columbia & his Masters Degree in Executive Leadership & Organizational Change from Northwestern University.

About Glaukos:

www.glaukos.com

Glaukos Corporation is a ophthalmic medical technology & pharmaceutical company based out of Southern California that is focused on novel therapies for the treatment of glaucoma, corneal disorders & retinal disease.

Summary

In this episode, Mitch Robbins interviews Alan Beckman, the Vice President of Market Access at Blue Wind Medical. They discuss Alan's background, his transition from sales to market access, and the challenges and rewards of working in market access. Alan shares his insights on interviewing and hiring, the qualities of a successful market access professional, and the changes in market dynamics post-pandemic. He also talks about managing stress and maintaining a routine, his desired legacy, and the exciting developments at Blue Wind Medical.

Takeaways

• Market access is a complex and challenging field that requires a focus on patients and a willingness to navigate the intricacies of coding, coverage, and payment.
• Honesty and transparency are crucial in the interview process, both from the employer and the candidate.
• Building a strong network and seeking guidance from experienced professionals in market access can be invaluable for career growth.
• The gratification of helping patients and improving access to therapies is a rewarding aspect of working in market access.
• The post-pandemic healthcare landscape has presented new challenges for market access, including the need to partner with healthcare systems and address delayed procedures.
• Managing stress in market access involves maintaining a routine, focusing on family and patients, and finding ways to stay active and mindful.
• Success in market access requires tenacity, a patient-focused mindset, and the ability to navigate rejection and overcome obstacles.
• Blue Wind Medical is experiencing exciting growth and is poised to make a significant impact in the UUI space.

About Alan:

Alan received his Bachelors in Economics from Rutgers University & MBA from Fairleigh Dickinson University & comes to us today with almost 30 years of experience across Med-Tech & the greater LifeSciences having held positions in sales, progressive roles in sales leadership and for the last 14 years leadership roles overseeing Reimbursement, Market Access & Healthcare economics. Back in the day he worked for companies like Cephalon and Abbott Labs. More recently he was a Senior Director of Healthcare Economics & Reimbursement for LivaNova before joining BlueWind Medical in 2022 as the VP.

https://www.linkedin.com/in/alan-beckman-mba-abb5986/

About BlueWind Medical:

Bluewind Medical, is introducing a transformative new treatment for urgent bladder leaks. The company’s product, Revi, is a miniature device implanted near the ankle that sends signals up through the nerves to the bladder to help manage symptoms. With up to 95% patient satisfaction, Revi is a long-term solution designed to help calm and control your bladder symptoms.

https://bluewindmedical.com/

Joining us for this episode was Mr. Ken Mariash, the CEO at Sinaptica Therapeutics. For over 20 years Ken has been leading & growing new business ventures on both the 'Buy Side' and the 'Build Side.' He started his career in management consulting at Charles River Associates then jumped to industry at CLS, then Baxter BioScience (acquired by Takeda) and then Boston Scientific with leadership roles in marketing, strategy & corporate development. Ken holds degrees in both Biochemistry & Business Economics from Brown University.

Today, Ken is leading the team at Sinaptica to advance their personalized closed-loop neuromodulation therapy for Alzheimers which has generated unprecedented Phase 2 sham-controlled clinical data that was recently published in the Oxford journal, 'Brain.' Sinaptica has FDA Breakthrough status for its novel proprietary approach which combines rTMS, EEG, and Neuronavigation with a sophisticated ML-derived personalization engine based on a novel brain target--the precuneus, the central hub of the Default Mode Network, a brain network involved in episodic memory. The company has completed all clinicals to date with non-dilutive funding and is now in-process of obtaining financing to complete the clinical product (SinaptiStim-AD) ** and prepare to initiate a pivotal study in one year's time.

Some of the major highlights we discussed:

-How Ken's upbringing shaped his early & future career days

-Pivotal roles that were instrumental in Ken's career development to becoming a CEO

-How Ken manages stress, especially during difficult times

-Ken's perspective on the toughest part of being a CEO

-Career advice for others coming up behind him

...and so much more

Key Takeaways:

• Early interests and experiences can provide clues to future career paths.
• Pivotal roles and responsibilities can shape a career and provide valuable skills and experiences.
• Opportunities and the belief of others can play a significant role in career progression.
• Being a MedTech CEO requires managing time and maintaining focus amidst numerous demands. Maintaining focus is crucial for productivity. Techniques like taking short walks, facing the sun, and prioritizing tasks can help regenerate focus.
• Managing stress involves letting go of outcomes, maintaining an optimistic outlook, and imagining a future where goals are achieved.
• Establishing a daily routine that includes meditation, setting intentions, exercise, and prioritizing sleep can contribute to mental and physical well-being.
• Building a high-performance team requires individuals with an all-in mentality, personal responsibility, and a focus on winning together.
• Culture is a system of unspoken values that determine the behaviors that get rewarded. Leaders must actively shape and reinforce the desired culture.
• Leadership involves pushing others to achieve their best, providing honest feedback, and being open to personal growth.
• Career and life advice includes becoming excellent in your area of focus, being curious and hungry to learn about other areas, and seeking new opportunities.
• The future of Synaptic and their work in Alzheimer's therapy is exciting, with promising data showing the potential for significant impact.

Find Ken Mariash on LinkedIn:

https://www.linkedin.com/in/kenmariash/

Sinaptica Therapeutics on the web:

https://sinapticatx.com/

Note: (SinaptiStim is a trade mark of Sinaptica Therapeutics)

In this episode, we were joined by Mr. Anthony Incontro, the Talent Acquisition Manager for Vertos Medical. We discussed the importance of creating a best-in-class candidate experience and how to streamline the application process. We also explored the challenges of collaborating with hiring managers and delivering tough feedback to candidates. Anthony shares insights into the growth and culture at Vertos Medical, a company focused on developing innovative treatments for lumbar spinal stenosis.

Takeaways

• Treating candidates with respect and transparency is key to creating a best-in-class candidate experience.
• Streamlining the application process by eliminating unnecessary steps can improve the candidate experience.
• Engaging candidates throughout the process and providing regular updates can help alleviate their anxiety and maintain their interest.
• Hiring managers should understand that hiring is a two-way street and that candidates have choices. Treating candidates with respect and valuing their time is crucial.
• Delivering tough feedback to candidates requires empathy and clear communication. It is important to provide constructive feedback that can help candidates improve.
• Company growth and culture play a significant role in attracting and retaining top talent.

Chapters

00:00Introduction and Background

01:16Importance of Candidate Experience

05:49Streamlining the Application Process

06:36Engaging Candidates Throughout the Process

09:32Managing the Hiring Manager's Role

12:14Delivering Tough Feedback to Candidates

Anthony Incontro on LinkedIn:

https://www.linkedin.com/in/aincontro/

Vertos Medical on the web:

vertosmed.com

About Anthony Incontro:

Anthony received his bachelor’s degree from Rutgers University in Labor Relations & Human Resources Management, and since 2005, he has been building his career in Talent Acquisition. Anthony’s had the opportunity to work across the LifeSciences ecosystem in both Pharma & Medical Device having worked for various organizations like Johnson & Johnson, Novo Nordisk, Alcon, Integra LifeSciences & Acadia Pharmaceuticals to name a few. Today, as I mentioned, he leads Talent Acquisition for Vertos Medical.