14 mins read

Leveraging Partnerships in Medical Devices Innovation

Ann E Holder, the CEO of Odonata Health Inc., on her executive career at leading medtech companies, leveraging military-gained leadership skills and industry partnerships with world’s top health providers in pursuing her mission to bring innovative AI-based technology to the market to ensure better maternal and fetal health outcomes.

You really need to know the right people and you’ve got to know where to go for compliance, regulatory and quality assurance advice. I know enough about those areas to be dangerous, but I am by no means an expert. And when you’re bringing medical technology to the market, it’s a critical component of the work that you’re doing.

– Ann E Holder

Interview with Ann Holder

In this “For Women by Women” story, I interviewed yet another fabulous woman whose extraordinary life experience and achievements have inspired me to share her story with you. As an introduction, before we hear more about her current mission, I’d like to share a recommendation I found on her LinkedIn profile, given by her junior colleague at that time, which pretty much sums up her amazing charisma, leadership skills, and professionalism.

Ann is one of the most amazing people I have ever known both from a business and personal perspective. She is a phenomenal leader who puts the needs of her team before her own. Her employees gravitate toward her knowing she is there for them whether it’s trying to close a quarter or the passing of a relative. She is the type of leader who doesn’t try to solve your problems rather she helps you solve them. She has helped me grow professionally by putting me in positions where I may have doubted myself but she never did. I feel fortunate to work for Ann. But, that’s just her professional persona. She is active in her community and with her husband Rob they have done some amazing things to help at risk youth through athletics. She has done all of this while still fulfilling her obligation as a mother raising some amazing and accomplished kids.

– Chris Bulger

Vice President of Sales & Marketing USA, LindaCare

Chris has known Ann on a much deeper level than I do and it felt right to let him introduce my guest, Ann E Holder, the CEO of Odonata Health, a leader, an entrepreneur, and a mother of 4! In two words, a wonder woman!

While “sheltering in place”—me in San Francisco, Ann in the Twin Cities, Minneapolis—we chatted about the past, present and future of Ann’s life and career, which seems to have always been focused on helping and supporting others (Ann has 4 kids too), but especially lately, since she ventured into entrepreneurship with her startup in the domain of AI-empowered, wearable medical devices called Odonata Health, fulfilling her mission to help women and clinicians measure and monitor key vital parameters of a fetus and the mother, during pregnancy, labor and delivery. Heart rate and rhythm are interpreted using proprietary artificial intelligence algorithms developed in partnership with some of the best cardiologists, OB/GYNs, researchers and clinicians in the world at the Mayo Clinic.

For many of us, this mission is as clear and as relatable as it gets—Odonata products provide insights into a woman’s health profile and biometrics, allowing pregnant women and their caregivers to make informed decisions. This remote health monitoring is especially valued in the Covid/Post-Covid world where every visit to a doctor may present potential danger in itself.

Notably, medtech is one of the most challenging industries for startups and innovation. No space for beginners or sensitive hearts, it is the field where only weathered medical technology executives can respond to the fundraising challenges and regulatory pressures, but even then it is a windy path that requires a strong network of support and a clear product market strategy.

In the interview, we explore what brought Ann to the point in her life where she feels confident that she can lead the medtech startup in its fight for better medical outcomes for women around the world, who’s helping her bring this new technology to the market, and how they intend to empower clinicians and women with solutions that will make decision making process easier and more informed through data and AI. More than 350K babies are being brought to the world every day. Ann is not intimidated by the path ahead of her, on the contrary, she is more confident than ever that her purpose is the one worth fighting for.

Professional formation through transformation

Ann’s professional career starts after she graduates from the U.S. Military Academy at West Point with an engineering degree and joins the U.S. military forces which had her stationed in Germany during the Gulf War. This was the crucial forming period in her career when she truly learned how to rely on her intuition and resourcefulness to help move things forward.

Upon her return to America with her husband and their first child, Ann starts looking for ways to build a career that will enable her to combine the skills she gained in the military with her technical college degree. The quest lands her a job at General Mills, a food production corporation, where she works in a plant on a cereal process design. Working in production, however, she realizes early on that her passion lies in working with people and takes a leap into operations, quickly growing her responsibilities from managing a single production line to managing full manufacturing facilities and finally taking up the roles where she manages the manufacturing and logistics of a whole region.

From there, Ann moves to the medical devices field where she takes on high level corporate sales and finance positions at world leader medical devices company and startup, respectively, Medtronic and ImpediMed, building up on her technical and leadership skills which were already very broad and distinctly valued in business.

Looking back on her roles in corporate America compared with the military experience and education, Ann singles out two factors that have impacted and shaped her entrepreneurial and leadership persona she draws upon today. The first one is discipline and second one is the attitude of “expect the unexpected and be ready to take on the challenge of a new day, take the good with the bad and embrace the day without worrying too much about the future”.

Having a really well-rounded and diversified professional background across verticals, she learned how to manage people, stress, finances and operations to reach the goals and inspire people around her to reach their full potential. Today, Ann is grounded in her belief that she has the skill set needed for making a global success as an entrepreneur with Odonata health (and helping women and babies in the most important moments in their lives).

Discovering the issue with pregnancy outcomes

Despite all technological advancements, it’s a disturbing fact that the number of deaths from complications in pregnancy or childbirth is increasing from year to year. In the U.S. alone, 700 to 900 women die each year, while a great number of women end up with severe maternal morbidity or unnecessary C-section deliveries.

Working for medical initiatives and corporations starting at Medtronic, then moving to ImpediMed, which is the world leader in the development of medical devices utilizing bioimpedance spectroscopy, then B2H Consulting Group, a Service Disabled Veteran Owned Small Business (SDVOSB) focused on providing medical supplies and technology to the VA and DoD hospitals and clinics, and finally partnering with one of the top providers in the world and #1 clinic in the US, Mayo Clinic, as an Entrepreneur in Residence, Ann has had the opportunity to learn about the challenges with outdated medical technology and fetal health monitoring from probably the best diagnostic cardiologist in the world, Dr Paul Friedman, Chair of Cardiology at the Mayo Clinic.

Ann recounts her beginnings at Medtronic in California, where she gets the opportunity to take high level sales and finance positions from where she advances to doing field work supporting Medtronic’s strategic partners in solutions and business development. This role required her to meet with startups to discuss their products and get acquainted with new technologies being developed, as well as the challenges related to them. Understanding that this is where the real innovation is happening and being the player that she is, Ann starts thinking about the possibility of joining the medical technology startup world where she could help develop IP into a commercial product. And, that’s when she transfers from Medtronic to ImpediMed.

Embarking on the entrepreneurial journey

Through her engagement with both Medtronic and ImpediMed, Ann has developed a relationship with Mayo Clinic. After years of successful collaboration mostly in the area of cardiology, she was presented with an opportunity to be contracted by Mayo Ventures for their Entrepreneur in Residence Program to help them bring new technology to the market. Now, this is where our story begins.

In parallel to joining Mayo Ventures, Ann applies for the Veterans in Residence accelerator program, operated by WeWork in conjunction with Bunker Labs. The program focuses on founders with military experience. Ann describes it as a phenomenal experience and a source of very much needed support in the early stages of her entrepreneurial journey.

I was surprised to learn from Ann about a strong history of veteran entrepreneurship in the U.S. which started after WWII. At that time, many veterans have used their intrepid self-driving personality to start businesses in those years and move American economy to the next level, the tradition that has kept until the present day making it a large community of veteran entrepreneurs with a strong support structure.

One woman in particular stands out, a Navy veteran, now a member of the Minnesota Technology Association with focus on government grants, who has helped Ann in many ways, but most importantly, in understanding the process to garner non-dilutive funding to develop technology companies.

There are pieces missing in everyone’s first-time startup discovery. Despite having a largely diverse background when it comes to different facets of running a business, Ann’s business acumen was missing the startup financing piece—understanding the rounds of funding and how to approach investors.

Another important challenge, from a corporate perspective, was not having a business support structure in terms of having different teams manage certain parts of the business (marketing, finance, legal, etc.) and relying on colleagues to help on projects. Ann had to manage all aspects of the business by herself. If you’ve ever been a part of an early stage startup, then I’m sure you know exactly what this means.

Vital partnerships for developing medical startups

You really need to know the right people and you’ve got to know where to go for compliance, regulatory and quality assurance advice. I know enough about those areas to be dangerous, but I am by no means an expert. And when you’re bringing medical technology to the market, it’s a critical component of the work that you’re doing.

Being located in the Twin City, the center of medical technology development in the U.S., has proven to help. Ann was able to find a mentor, Kathy Tune, who became the lead investor in her seed round and is now the chairman of the company’s board. Kathy works with her on a daily basis in bringing Odonata to the market. Kathy is another superstar business woman with more than 25 years of healthcare executive and investing experience. She now also owns and manages her own healthcare investment firm Fourth Element Capitalfocusing primarily on medical device technology, diagnostics and connected devices.

Combining their experience and connections, the two of them have managed to ensure vital partnerships for Odonata and to successfully navigate the relationship with clinicians at Mayo Clinic, other hospitals and technology partners.

Speaking of technology partners, the reason I can speak with Ann today is that our team at HTEC is developing Odonata’s maternal ECG device. When I heard about an amazing story behind this partnership, I reached out to Ann for the interview. The story about how she connected with HTEC is interesting and why she trusts us to navigate her product development going forward.

The story goes like this…

Telehealth solution innovation with Orbital Research and HTEC

To create a frictionless and wearable ECG device, Odonata is partnering with a company called Orbital Research, which has developed pioneering FDA-approved dry electrode sensors, a revolutionary technology for measuring ECG signal without the need for electrolytic gel and aggressive skin preparation. The company has already done extensive research of their technology application in fetal monitoring and has created several successful patents around it. NASA even mentions Orbital sensors in their research paper on dry electrodes.

When Odonata and Orbital teams set out to build the first product’s prototype, the president of Orbital research introduced Ann to my colleague Srdjan Jovanovic, who at that time was leading our medical devices R&D group with one of the programs in the domain of ECG monitoring and diagnostics. HTEC is one of the pioneers in the world to ever use Orbital dry electrodes in a complete telehealth solution our team has developed in collaboration with the leading electrophysiologists and cardiologists, called HUMEDS, which measures and analyzes ECG to provide precise diagnosis of cardiac arrhythmias and send alarms and notifications to doctors and patients.

The legend has it that just before Ann asked Fred whether he can recommend a technology development partner for Odonata, someone who has already worked with the technology and implemented their sensors successfully in a wearable device, Fred had just received HUMEDS device from our team and he was able to show the product to Ann. As per Ann, HTEC was everything Ann was looking for.

I was specifically looking for the company with very very technical expertise in firmware and hardware development, signal processing, AI and algorithm development. And what HTEC brought to the table was everything I needed. Oh, and also to include the software platform.

Ann goes on to explain that there is a sense of urgency in bringing this product to the market since there is a gaping hole when it comes to fetal and maternal health technology products. The technology used hasn’t been updated for more than 50 years and the interest and support among medical and general community for Odonata products is noticeable, especially with Covid-19 situation. Taking all this into account, Ann admits that she couldn’t find a better skilled team to help her develop the product at a desired velocity because the sensors are not standard and they require a very specific expertise that only HTEC can provide.

So, why did Ann choose to work with the most innovative dry sensors technology?

The sensors used in the solution are dry which means that there is no need for the extensive skin prep necessary for other sensors. A pregnant woman’s skin is already very stretched and thin so the additional scraping of the dead skin cells and irritation that comes with it is something to be avoided. Another reason is that these sensors provide outstandingly clean and precise fetal ECG. Odonata is very focused on making every little detail right when it comes to building a perfect product for future mothers.

Odonata products are for clinicians or consumers, or both?

Odonata aims to enable clinicians and women to monitor vital health parameters during pregnancy and delivery. Several companies have tried the space without notable success. How does Odonata differ from the rest in its technical and business approach?

In the development of the product very consistent fetal and maternal heart rate is being captured. Current focus is to gather and analyze large amounts of biometric data in collaboration with clinicians, in hospitals, during prechecks, labor and delivery in order to reach the point of high clinical credibility. Only after the clinical trust is established and the product is endorsed by the hospitals and FDA can it potentially reach a wider consumer market to help mothers track their health at home and notify their doctor through the app.

In the future, when large amounts of cases have been collected and analyzed, the solution may well become completely AI-based and independent. But this is still a faraway future. Current focus is on getting the first tier FDA-approved products out so that they can measure the impact and success of the solution.

Do FDA procedures limit innovation?

Medtech is possibly one of the most challenging industries for startups and innovation. Shrouded by regulatory and legislative ecosystems that govern medical devices, many innovators break at the point of FDA approvals. Although we’ve seen some relaxation in this regard recently, it’s still one of the highest hurdles for startups partly because investors are often reluctant to invest in a product before it is FDA approved. I was curious to hear about some of the challenges that Odonata products are facing in this regard.

As someone who has spent most of her career in the medical devices space, Ann believes that

FDA is there for a reason. They’re there to protect the patients and may ensure that the products do what they say they do. I am a significant supporter of this strategy. I don’t believe that it limits innovation, it does slow it in some cases depending on the product and how much clinical data you need, but it’s also, I think, necessary. Having a product that needs an FDA clearance limits the types of investors that you go after because there is a perception that there’s too much inherent risk involved.

Although Ann does not see the FDA approval and regulatory process as something that prevents innovation, it is clear that it is one of the significant hurdles one has to pass in addition to ever increasing privacy requirements including but not limited to HIPAA and GDPR compliance. Luckily, the Odonata story, the experienced leadership and the actual existing value and perceived need for their products is so great that many investors feel that it’s worth the risk.

That being said, Ann is certain that the associated risk is significantly lower than it may seem from the outside, especially when you plan the things carefully from the start, working with professionals in every aspect of the business.

We can expect the first few Odonata products to show on the market early next year.

Does being a woman help in entrepreneurship?

Our previous guest in FastForward stories was yet another amazing woman executive, entrepreneur and investor, Maya Migotti, who mentioned that she only invests in and supports women-led startups because women tend to focus more on real life problems that go along with her heart. I have to say I agree with Maya on this, and Odonata’s mission is the one with which every hu/wo/man can relate to, where technology truly serves a deeply human purpose.

Ann seems to be one of those leaders who is able to attract attention and get support from other women, but also many other groups and communities that recognize the quality of Odonata products and the value of their mission. It is worth noting, however, that some of the most prominent investors and supporters of the company are women, including Kathy Tune and Shelly Lanning, both experienced healthcare investors and executives who are also on the board of directors actively helping Ann through the process and adding substantial value to the company.

In the end, as a woman, I personally feel proud to work at the company which is helping Ann deliver Odonata products to hopefully solve important issues and eliminate the worry during one of the most beautiful but at the same time very stressful periods of our lives. On behalf of the whole HTEC team, I can say that we are excited to see how Odonata products will reduce the growing global healthcare challenge of maternal mortality and morbidity and to quote Ann herself:

We are eager to offer clinicians a non-invasive, cost-effective solution for identifying early signs of distress which enables early intervention to avoid costly hospitalizations and unwanted outcomes.

Thanks Ann for building a better future for us!