Episode 88-The benefits of a customer and patient centric approach in women's health care innovation with Kerry Rupp of True Wealth Ventures

Terri talks with Kerry Rupp of True Wealth Ventures about how True Wealth Ventures views women’s health, the opportunities and challenges in the space, and how innovators need to have a more customer-centric approach earlier in the innovation cycle.

Who is Kerry Rupp?

Kerry Rupp is General Partner at True Wealth Ventures, an early-stage VC fund investing in women-led businesses in consumer health and sustainability. She teaches for the NSF I-Corps program, mentors startups, and consults on innovation and strategy. Kerry was previously CEO at DreamIt, a Top Ten US startup accelerator and VC fund. She founded Holiday Golightly, a group travel service for women.  Kerry holds an MBA from Harvard Business School and a BA from Duke.
 

Show Highlights

·      Kerry shares why women’s health is interesting to her from an innovation and a funding perspective, her path into venture capital, and what True Wealth Ventures is all about

·      Kerry talks about True Wealth Venture’s focus on the broad definition of women’s health and how little research and emphasis has been on women and women’s bodies and brains

·      Kerry and Terri share the view that awareness, research and innovation in women’s health are critical right now

·      Kerry shares what she is excited about in women’s health and both Terri and Kerry talk about the difficulty in choosing the ones to invest in

·      Terri and Kerry talk about the gap between the startup innovation and the healthcare providers and how to bridge the gap

·      Kerry shares how to connect with her and Sara at True Wealth Ventures if you have a startup within their investment thesis

Terri’s Key Takeaway

We need to be doing more to bring together the healthcare providers and healthcare innovators earlier in the process. 

References in the Podcast

·      DreamIt Ventures:  https://www.dreamit.com

·      True Wealth Ventures: https://truewealthvc.com/

·      Sara Brand: https://www.linkedin.com/in/saratbrand/

·      Lisa Health:  https://www.lisahealth.com/

·      Genneve:  https://genneve.com/

·      Mighty Menopause: https://www.mighty-menopause.com/

·      Pandia: https://www.pandiahealth.com/

·      Lemonaid Health: https://www.lemonaidhealth.com/

·      Braincheck:  https://braincheck.com/

·      Katie McMillan:  https://www.linkedin.com/in/katie-donohue-mcmillan-mph/

·      Springboard: https://sb.co/

Contact

Kerry can be reached through LinkedIn  www.linkedin.com/in/kerryrupp or her website www.kerryrupp.com.   

You can follow Terri on Twitter at @terrihansonmead or go to her website at www.terrihansonmead.com or on Medium:  https://medium.com/@terrihansonmead. 

Feel free to email Terri at PilotingYourLife@gmail.com.

To continue the conversation, go to Twitter at @PilotingLife and use hashtag #PilotingYourLife.

Episode 87-removing the stigma and normalizing the conversation for women around stress incontinence.

Terri talks Allison Conti of Watkins-Conti Products about her personal experience with stress incontinence that led to the creation of a medical device for women as an alternative to surgery and other uncomfortable and invasive solutions.

Who is Allison Conti?

Allison Conti is an Oklahoma-based entrepreneur who was raised in an entrepreneurial environment where she witnessed the formation and creation of sustainable businesses. The industries ranged from oil & gas exploration and development to retail, cattle ranching and commercial real estate. Allison began her professional career in print media marketing and advertising. She then transitioned to a successful career in the radio and television industry. Allison also owned and managed a small business in the construction trades.

In 2015, as a mother of three, she conceived a solution for involuntary urine leakage, an issue that affects over 498 million women, worldwide.  The passion and drive for this venture is based on personal experience. She designed, patented, engineered and manufactured this non-invasive, comfortable and easy to use solution that is entering the FDA approval process. 

Allison is dedicated to the innovation and development of affordable, effective solutions for common life-altering difficulties faced in today’s environment.  Recently named Top 20 under 40 in Business Times Magazine!

Show Highlights

·      Allison talks about what stress incontinence is, who it impacts, and why don’t women don’t want to talk about it, and why she is passionate about creating a better solution for women. 

·      Allison shares the other options available to women and why she developed YoniFit as another alternative for women.

·      Allison talks why women would be willing to participate in the clinical trial at NYU. 

·      Allison created LeakyLady.com to make the topic easier for investors to discuss and for women to share their stories to remove the stigma around stress incontinence.

·      Allison talks about the team bringing this product to market and surrounding herself with an experienced team.

·      Terri asks about Allison’s fundraising experience and the reactions from investors.    

·      Allison talks about protecting her technology through patents and trademarks and expanding into global markets. 

·      Allison shares her personal story around her condition, how many women are affected by this condition, and how it has changed her life and how she wants to change the lives of other women as well. 

Terri’s Key Takeaway

So much of how we have approached women’s health has been about what is wrong with our bodies and with shame and we need to start talking about the conditions affecting so many women to remove the stigmas, shame, and get to better solutions. 

References in the Podcast

·      Leaky Lady:  http://www.leakylady.com/

Contact

Allison can be reached via email at Allison@watkinscontiproducts.com.  You can follow on Instagram @YoniFit.  Read stories from other women and share your own at www.leakylady.com and sign up for email updates. 

You can follow Terri on Twitter at @terrihansonmead or go to her website at www.terrihansonmead.com or on Medium:  https://medium.com/@terrihansonmead. 

Feel free to email Terri at PilotingYourLife@gmail.com.

To continue the conversation, go to Twitter at @PilotingLife and use hashtag #PilotingYourLife.

Episode 86-Improving healthcare solutions for women by pairing technology with Health

Terri talks Katie McMillan of Duke Health about why she is interested in women’s health, why we are seeing an explosion in women’s health solutions, and why she sees technology as the answer to some of our healthcare issues for women.

Who is Katie McMillan?

For 10 years, Katie D. McMillan, MPH has dedicated her career to imagining and building technology to improve healthcare for patients and providers. Her experience spans multi-national global health organizations, lean software start-up companies, and large academic medical centers. Katie’s latest venture is the creation of the Mobile App Gateway at Duke University Health System. Launched in the summer of 2017, the MAG serves as the hub for digital health at Duke and provides product consulting services to clinicians and researchers, monthly events and workshops, and content exploring the many facets of the health tech industry. Katie has been involved in the ideation and creation of over 75 apps. In her free time, Katie microblogs at her Well Made Health account on Instagram (@wellmadehealth exploring creativity, digital design, and Fem Tech.  
 

Show Highlights

·      Katie shares how she developed an interest in women’s health and FemTech

·      Katie talks about how she’s seen women’s health and technology change over the last 10 years

·      Katie shares why we are seeing an explosion in technology for women’s health and why she started micro-blogging under Well Made Health with #FemTechFriday

·      Terri asked Katie about evidence-based solutions for women’s health and talks about matching up FemTech companies with researchers to generate clinical device and inform the science around the solutions

·      Terri raises the issue of the price point and focus on middle class white woman for these solutions and the importance of making available to a broader group of women

·      Katie is highlighting Lemonaid Health this week on @WellMadeHealth for #FemTechFriday

Terri’s Key Takeaway

We women hold different roles in our lives and have different seasons in our lives which is very different from men and therefore our healthcare needs are very different as well. 

References in the Podcast

·      Atlantic article: The Doctor Doesn’t Listen to Her but the Media is Starting To: http://bit.ly/DoctorDoesntListen

·      PitchBook article: Why Women Investing in Women Matters: http://bit.ly/WomenInvestingInWomen

·      Duke Health: https://www.dukehealth.org/

·      Marketwatch article:  http://bit.ly/WomensHealthTherapeuticMarket

·      Genneve: https://genneve.com/

·      Willow Pump:  https://shop.willowpump.com/

·      Hello Jessie:  https://www.hellojessie.com/

·      Qurasense: https://qurasense.com/#/site/home

·      Pumpspotting: https://www.pumpspotting.com/

·      Mahmee:  https://www.mahmee.com/

·      Maven Clinic Blog:  Back to Work:  The Billion Dollar Opportunity for Companies:  http://bit.ly/MavenClinicBillionDollarOpportunity

·      Tara Health Foundation: https://tarahealthfoundation.org/

·      Lemonaid Health: https://www.lemonaidhealth.com/

·      Icon Undies:  https://www.iconundies.com/

·      Thinx: https://www.shethinx.com/

Contact

Katie can be reached via email at wellmadehealth@gmail.com , on Twitter @KatieDMcMillan  @Wellmadehealth and DukeMobileApps  and on Instagram @Wellmadehealth.

You can follow Terri on Twitter at @terrihansonmead or go to her website at www.terrihansonmead.com or on Medium:  https://medium.com/@terrihansonmead. 

Feel free to email Terri at PilotingYourLife@gmail.com.

To continue the conversation, go to Twitter at @PilotingLife and use hashtag #PilotingYourLife.

Episode 85-What is new and exciting in Women's Health and Digital Health after the JP Morgan conference

Terri talks with Jacqueline about what she learned and who she met at the JP Morgan Life Sciences conference in SF including innovations, digital health, and opportunities in women’s health.    

Show Highlights 

• Terri talks about what the JP Morgan Life Sciences conference is all about, what she learned, who she met, and some of the trends and innovations in women’s health.  

• Terri talks about the importance of normalization language and conversations around women’s health and wellness, including sexual health and wellness.   

• Terri and Jacqueline talk about changing the norms around aging, especially around body image, and taking charge of our health in our midlife in setting ourselves best for life after 65.   

• Terri is excited about how digital health is being embraced within biotech and pharma in various areas including medication adherence, better patient targeting, better clinical trial design, and better leveraging of data to optimizing drug development and delivery.   

• They talk about data and data ownership being a big topic in 2019 and the ramifications of deals like 23andMe and GSK.   

• Terri and Jacqueline discuss the $8.1B invested in digital health in 2018, and what is included in digital health including the blurring of lines between health and wellness.    

Terri’s Key Takeaway 

We need to normalize the language and conversations around women’s health, wellness, and body parts.   

References in the Podcast 

• TechCrunch article on CES / female sex-tech:  https://techcrunch.com/2019/01/08/ces-revokes-award-from-female-founded-sex-tech-company/?sr_share=facebook&utm_source=tcfbpage 

• More Men Named Michael Present at JP Morgan (2018):  https://www.statnews.com/2018/01/07/jpm-gender-diversity/ 

• JP Morgan Life Sciences conference: https://www.jpmorgan.com/global/healthcareconference 

• Panty Prop: https://www.pantyprop.com/ 

• RESI: http://www.resiconference.com/ 

• Startup Health: https://startuphealthfestival2019.splashthat.com/ 

• Healthcare Innovation Popup: https://medium.com/humble-ventures/teaming-up-with-mount-sinai-co-lab-for-open-innovation-in-healthcare-pop-up-ec3852b4bcb5 

• Humble Ventures: https://humble.vc/ 

• Ogilvy: https://www.ogilvy.com/ 

• Biotech Showcase: https://ebdgroup.knect365.com/biotech-showcase/ 

• Springboard: https://sb.co/ 

• True Wealth Ventures: https://truewealthvc.com/ 

• Lisa Health: https://www.lisahealth.com/ 

• Genneve: https://genneve.com/ 

• Mighty Menopause:  https://www.mighty-menopause.com/ 

• Madorra: http://www.madorra.com/ 

• Pulse: https://lovemypulse.com/ 

• B8ta: https://b8ta.com/ 

• Astarte Medical:  http://www.astartemedical.com/ 

• Watkins-Conti Products:  http://www.watkinscontiproducts.com/ 

• Prima-Temp:  http://www.prima-temp.com/ 

• Ceek Women’s Health:  https://ceekwomenshealth.com/ 

• JLabs:  https://jlabs.jnjinnovation.com/ 

• Saama:  https://www.saama.com/ 

• Rock Health article on digital health: https://rockhealth.com/reports/2018-year-end-funding-report-is-digital-health-in-a-bubble/ 

• Sandstone Diagnostics: https://trakfertility.com/ 

• MyHealthTeams: https://www.myhealthteams.com/ 

Contact 

You can follow Jacqueline Steenhuis on Twitter @TipsyCopilot or through her website https://www.jacquelinesteenhuis.com/.   

You can follow Terri on Twitter at @terrihansonmead or go to her website at www.terrihansonmead.com. 

Check out Terri’s new Medium publication:  https://medium.com/terri-hanson-mead 

Feel free to email Terri at PilotingYourLife@gmail.com. 

To continue the conversation, go to Twitter at @PilotingLife and use hashtag #PilotingYourLife.  

Episode 63 -Terri explains how to set up a technical project for success

Terri talks with Jacqueline about her process for planning a technical project to set the project up for success and be able to objectively evaluate the success at the end of the project.   

   

Show Highlights 

• Terri talks about having to complete her professional education hours for her PMP (project management professional) certification.  She talks about writing some blog posts and putting on a webinar on planning a technology project which is covered in this episode.  

• The presentation Terri provided covers the following areas (link in references): 

• Project charter 

• Project document 

• Project plan 

• Agreements 

• Preparing for kick off 

• Terri talks about how she is assuming that the lead candidate has been identified and the system is either business critical, a major enterprise project, or needs to be validated to meet 21 CFR Part 11 requirements.   

• Terri shares that she is a believer in right-sizing the planning of a project.  

• Terri talks about starting with a project charter to get the stakeholders on the same page regarding the project and shares details about what goes into the charter.   

• Terri talks about creating a project document for the larger projects she works on which is the guidebook / playbook for the project.   

• Terri shares why it is important to establish the acceptance criteria and success criteria for the project at the beginning of the project to be able to objectively assess the success of the project at the end of the project.  

• Terri explains to Jacqueline why a project plan is wrong as soon as it is generated but you need to start someplace when it is good enough.  

• Terri emphasizes the importance of NOT signing agreements with vendors until the project is planned.   

• Terri talks about the practical aspects of managing and planning the overall project and the importance of understanding the motivations of all of the stakeholders.  

• Terri shares her concerns about SaaS solutions and the assumption that they are plug-and-play without taking into account the integration within the business processes.  Terri is concerned about operationalizing the new system and associated processes.   

References in the Podcast 

• Link to the Presentation:  https://bit.ly/2t7VeG4 

• PMP:  https://www.pmi.org/certifications/types/project-management-pmp 

• PMBOK: https://www.pmi.org/pmbok-guide-standards/framework 

Contact 

Jacqueline can be reached through her website at https://www.jacquelinesteenhuis.com/ or via Twitter at @andYoureaGirl.  

You can follow Terri on Twitter at @terrihansonmead or go to her website at www.terrihansonmead.com or on Medium:  https://medium.com/@terrihansonmead.  

Feel free to email Terri at PilotingYourLife@gmail.com. 

To continue the conversation, go to Twitter at @PilotingLife and use hashtag #PilotingYourLife. 

Episode 60 - IT compliance and IT strategy consulting for biotech, medical device, diagnostic, and digital health companies with Terri

Terri talks with Jacqueline about her work consulting with biotech, medical device, diagnostic, and digital health companies providing IT strategy and IT compliance services.     

Show Highlights 

• Terri and Jacqueline start out with some discussion about end of school year and the beginning of summertime.   

• Terri talks about her consulting work with Solutions2Projects and that she is still consulting, despite a recent comment by someone that they didn’t realize she was consulting.   

• Terri started her consulting company, Solutions2Projects, 13 years ago.   

• Terri does higher level IT strategic and compliance work within biotech, medical device, diagnostic, and digital health companies.  This has included IT strategy, IT compliance, IT system selection, IT project management, and vendor audits within life sciences companies.  

• Terri works with companies that have 30-300 people, moving towards or in Phase III clinical trials and/or getting ready for market approval and commercialization.  Terri likes to come in during Phase II to help the companies plan out their IT strategies in advance of when they need the systems in alignment with their corporate strategies.   

• Terri talks about how biotech companies outsource certain systems and processes early on and then later decide to bring in house and how the planning for this should be aligned with the corporate strategy.  

• Terri talks about computer validation and 21 CFR Part 11 (electronic records / electronic signatures) in an FDA regulated industry.   

• Terri works with systems and processes across an organization including clinical, regulatory, quality, financial, manufacturing, distribution, quality, HR, payroll, budgeting, business performance management, lab systems, etc.    

• Terri is a business person who understands technology and compliance.  Solutions2Projects’ value is in considering business, technology, and compliance requirements and needs.  

• Terri talks about the importance of data integrity in life sciences and how we use computer validation to demonstrate data integrity and control over the data and the systems.  

• Terri talks about the challenges associated with the introduction of SaaS in life sciences.  

• Jacqueline asked Terri about her first system selection and validation.  Terri talks about how she fell into life sciences a year after the 21 CFR Part 11 regulation was released (1997) and her first implementation and validation of JD Edwards at Coulter Pharmaceuticals following GAMP4.  GAMP5 has since been released and computer validation has evolved over the last 20 years.  

• Terri is a believer in taking a risk-based approach to computer validation and tailoring to each company’s risk tolerance and approach to the system.  

• Computer validation is all about defining what you want, testing to confirm you got what you wanted, training people to effectively use the system in a consistent manner, and then maintaining the system in a controlled manner.  To Terri, this makes good business sense.  

• Terri talks about the evolution of computer validation and some project and client stories.  

• Terri talks about GDPR.  

• Terri shares her concerns about potential litigation in the life sciences space between SaaS companies and life sciences companies because of computer validation and potential exclusion of data from regulatory submissions or complete response letters. She is starting to see more warning letters and 483’s around data integrity.   

• Terri talks about blockchain in the life sciences space.   

• Solutions2Projects is ideally suited for situations where this is an internal lead or project manager and Terri provides guidance, structure, and templates to help them with their processes.  Terri can help guide the business through the changes related to the new system implementations.   

• Terri has some project managers she likes to work with whereby she plans the project and then they are able to manage the projects with high level advisory and guidance from Terri.  

• Everything comes down to process and technology.  Terri’s favorite part of her work is to aligning corporate strategy with the system strategy.  When she can help life sciences companies see systems as business enablers and meet compliance requirements she is a happy camper.   

References in the Podcast 

• GAMP5:  https://ispe.org/publications/guidance-documents/gamp-5 

• GDPR:  https://www.eugdpr.org/ 

• Arena Solutions:  https://www.arenasolutions.com/slc/ 

• John English:  https://www.linkedin.com/in/johntenglish/ 

• Lisa Scotch:  https://www.linkedin.com/in/lisascotch/ 

• Lighthouse:  https://lighthouseis.com/ 

Contact 

Jacqueline can be reached through her website at https://www.jacquelinesteenhuis.com/ or via Twitter at @andYoureaGirl.  

You can follow Terri on Twitter at @terrihansonmead or go to her website at www.terrihansonmead.com or on Medium:  https://medium.com/@terrihansonmead.  

Feel free to email Terri at PilotingYourLife@gmail.com. 

To continue the conversation, go to Twitter at @PilotingLife and use hashtag #PilotingYourLife.