Dr. Michelle McMurry-Heath Headlines Medtech Women Conference

We are very excited to announce that our Keynote Speaker this year will be Dr. Michelle McMurry-Heath, President & CEO of the Biotechnology Innovation Organization, who took over the CEO position at BIO in June, replacing Jim Greenwood. I’ve spoken to many of my former colleauges at BIO, who say she is a dynamic leader who’s hit the ground running. BIO recently annouced a new diversity & inclusion program, The Right Mix Matters, so we’re thrilled that she will close our event this year!

 

Dr. Michelle McMurry-Heath

President & CEO
Biotechnology Innovation Organization

Michelle McMurry-Heath assumed the leadership of the Biotechnology Innovation Organization (BIO) as President and CEO on June 1, 2020. A medical doctor and molecular immunologist by training, Dr. McMurry-Heath becomes just the third chief executive to steward the world’s largest biotechnology advocacy group since BIO’s founding in 1993.

The common thread in McMurry-Heath’s work across academia, government and industry has been her focus on broadening access to scientific progress so more patients from diverse backgrounds can benefit from cutting-edge innovation. Driven by her own past family experiences navigating clinical trials and funding uncertainties within the rare disease community, McMurry-Heath calls “the distribution of scientific progress the social justice issue of our age.”

She comes to BIO from Johnson & Johnson where she served as Global Head of Evidence Generation for Medical Device Companies and then Vice President of Global External Innovation and Global Leader for Regulatory Sciences. She was also instrumental in bringing J&J’s incubator, JLabs, to Washington, DC. She led a global team of 900 with responsibilities in 150 countries around the globe.

Prior to her time at J&J, Dr. McMurry-Heath was also a key science policy leader in government. The Obama-Biden transition team tapped her to conduct a comprehensive analysis of the National Science Foundation’s policies, programs and personnel. President Obama then named her associate science director of the FDA’s Center for Devices and Radiological Health under Commissioner Peggy Hamburg. In that role, she championed clinical trial evolution, the use of real-world evidence in product evaluation, and an embrace of the patient’s voice in health research so new medical products deliver outcomes that matter to them.

McMurry-Heath was the founding director of the Aspen Institute’s Health, Biomedical Science, and Society Policy Program, where she promoted personalized medicine and bolstered international preparation for pandemic disease threats. She received her early training in science policy from the Robert Wood Johnson Foundation and later served as Senator Joe Lieberman’s top legislative aide for science and health. In that role, she drafted legislation to protect the country from biological attacks.

McMurry-Heath received her MD/PhD from Duke’s Medical Scientist Training Program, becoming the first African-American to graduate from the

Allyson Bower-Willner succeeding Tiffany Wilson as chair of Medtech Women AdvanSE at Southeast Life Sciences

During the 2020 Medtech Women AdvanSE of Southeast Life Sciences (formerly Medtech Women@SEMDA) virtual event on September 8, 2020, Founder, Chair and GCMI CEO Tiffany Wilson will pass the gavel to Allyson Bower-Willner. Willner, Marketing Director for Strategic Accounts with Molynlycke Health Care, has served on the MW@S board since its inception in 2016.

“We founded Medtech Women to serve as a strong advisory network for mentoring and professional development for female professionals and innovators across the medical technology industry in the Southeast,” Wilson said. “There is a meaningful gender gap in the C Suite. We know this. At the same time we are seeing more female technologists — doctors and engineers — with their names on patents, but we are not seeing a corresponding jump in the number of women involved in medtech startups.”

“Our goal is to continue our work making the southeast a world-class region for the medical device industry,” Willner said. “Medtech Women can play an integral role in that mission by enhancing the opportunities for female inventors, entrepreneurs, and other industry professionals in the southeast.”

Since its inception, Medtech Women@SEMDA has evolved to include an advisory board of 20 medtech and life science executives, physicians and successful entrepreneurs. The group has added educational programs, webinars and is now positioned to expand its capabilities and reach in large part thanks to the merging of the Southeastern Medical Device Association (SEMDA) with SE BIO in the new combined entity Southeast Life Sciences.

“The convergence of medical technologies, including devices, with bioscience technologies including drugs, data, digital and combination products necessitates the convergence of these entities,” former SEMDA Executive Director and now Southeast Life Science Executive Director Jason Rupp said. “In order to respond to the combined needs of stakeholders in both ecosystems, the time arrived for SEBIO and SEMDA to come together under one roof.”

“We have given Medtech Women life and validated its reason for being: creation of opportunities for women in medtech and life sciences for growth, leadership and professional development,” Wilson says. “Shifting from start-up mode into growth mode and maturity is an exciting time for any organization, particularly in an ever evolving industry like medtech and the life sciences.” 

“Thanks to the chair and the board’s leadership to date, and the remarkable environment in which we all find ourselves, the impact potential for Medtech Women AdvanSE is high,” Willner said. “We encourage all members of the southeast life science ecosystem to engage with us. Registering for the 5th annual Medtech Women AdvanSE virtual conference is an excellent place to start.” 

 

Those interested in serving on a committee like programming, conference, sponsorship or other should contact Jason Rupp at jrupp@southeastlifesciences.org or (202) 438-4960

On the frontline of connecting patients to their providers via blockchain: a quick catch up with Patientory Founder and CEO Chrissa McFarlane

As we recently recognized in a conversation with Florence Hudson, there is a LOT to unpack when it comes to blockchain in health care. But the industry has definitely taken notice of Patientory, whose team and distributed ledger technology is starting to revolutionize EHRs and the way doctors and patients interact with each other and their data.

You may recall Patientory was the winner of the 2018 SEMDA Medtech Conference PitchRounds competition.

After raising $7.2 million in mid-2017 through its ICO (initial coin offering), Patientory launched its consumer-facing app in late 2018. But what’s needed to accelerate blockchain technology deployment in the healthcare continuum?

“We need brave, forward looking health systems for use cases in large patient populations,” Patientory founder and CEO Chrissa McFarlane told us. “We need to see an adoption by a large company on a day-to-day basis that includes 1 million covered lives. The space is filled with great startups, but adoption and implementation is the next mountain to climb.”

Beyond an individual’s EHR, blockchain for healthcare can improve processes in supply chain management of medical devices or opioids or even claims processing and adjudication. But large scale adoption in highly centralized provider IT networks is unlikely in the short term given clinical workflow disruption and technical proficiency ramp up requirements.

“There are payer and provider CIOs or IT architecture leads fluent in blockchain, but very few of them,” McFarlane says. “Ultimately the end users, the patients, physicians and their bosses will drive systemic adoption of secure, distributed ledger technology that enables them to truly own and access individuals’ electronic health records. This is why the launch of our app was so important.”

As tech giants like Google and Apple wade deeper into the healthcare pool collecting more and more personal health data, will blockchain be the technology that carriers and secures it?

“It’s inevitable,” McFarlane says. “Blockchain’s potential spans the entirety of the continuum, which tends to cloud its greatest value potential: securely placing patient data in the right hands at the right time to improve outcomes while reducing cost.”

What’s next for Patientory?

“We remain focused on our core deliverables from our 2017 product roadmap including the enterprise distributed application solution and the PTOYNet storage network,” McFarlane says. “We are also eager to analyze the results from our ongoing pilot programs to learn what works, what doesn’t and what’s needed next to place millions of lives under care through the Patientory platform. Do they have a long term tech strategy to incorporate distributed ledger technology into their stack?

“We need more market validation and to learn more about health systems’ financial structures and operations along with their perception of the emerging opportunities and potential for blockchain in healthcare.”

Ms. McFarlane will share further thoughts on the future of blockchain in healthcare during a panel conversation following Florence Hudson’s keynote on Wednesday, April 9th at the 2019 SEMDA Medtech Conference. Register today!

Where are they now? Our 2019 deep-dive Q&A with SweetBio CEO & Co-founder Kayla Rodriguez Graff

Three years, two rounds and one ‘market reprioritization later,’ SweetBio is poised to enter the $10 billion wound care market this year. While FDA work continues on a first in kind pre-implant dental application of its Manuka honey and collagen derivative membrane product Apis, the company has pivoted to a planned, but previously secondary market. Why? A faster regulatory pathway and larger addressable market.

SweetBio Co-founder and CEO Kayla Rodriguez Graff was kind enough to share nearly an hour with Write2Market VP of Healthcare Paul Snyder. They talked about the company’s progression, ‘market reprioritization,’ learnings and more in the nearly four years since we first featured them following SEMDA 2015.

Kayla Rodriguez, MBA – Co-founder & COO, SweetBio

Paul: “What drove your reprioritization from a first in kind dental implant regenerative product to wound care in general?”

Kayla: “Our baseline technology, which we call MXTECH, is a true platform. While the first manifestation of MXTECH was a regenerative membrane for dentistry, we quickly discovered the direct translatability and extreme market demand in adjacent markets, including wound care. As honey has never been cleared for use in dental, the regulatory pathway became more difficult. Because we had already examined the wound care market and heard from early customer discovery that our product is ‘exactly what they have been looking for,’ we were confident in this pivot.

“We were grateful to be working with world renowned wound care clinicians, including Dr. Lillian Nanney and Dr. Jeffrey Davidson at Vanderbilt University, who provided incredible feedback as we prepared for the wound care industry. Because of the background work completed on the safety and efficacy of MXTECH, and because there are currently over a dozen Manuka honey wound care products commercially available, we were able to translate our dental regulatory documentation into over a 1,000 page wound care 510K application in just 40 days. We expect to our first product to enter the $10 billion wound care market – with solid, existing reimbursement opportunities in place – this year.”

Paul: “SweetBio recently closed a new funding round. What messages resonated most with your investors?”

Kayla: “A $10 billion market and an investable opportunity with high growth return potential. There is also strength in our multiple bottom line message. We are able to demonstrate a proven record of delivering on dollars received including spending plans, accountability, clear messages and consistent communication with our investors. We are an investable company with high growth potential and a diverse, woman-led company.  

“Because we stand for better healing, everyone has a relatable story, which usually involves witnessing a painful healing experience with an aging loved one or even a beloved pet. We are also tackling a problem with an on-trend natural solution without having to sacrifice performance for ingredients.”

Paul: “What have you learned about the FDA process that could be useful to very early stage innovators – like yourselves three years ago?”

Kayla: “First, understand your claims and pathway. Word choice is monumentally important. Just one or two words in your claims can push a 510k to a PMA. Next, find the right partner, especially regulatory consultants that are experienced in your product class and FDA branch to communicate that word choice. Then, finalize your product design in a way that enables you to manufacture at scale with economics that make sense. The last thing you want to learn is that you have $100 product COGS that can only retail for $20.

Paul: “What would you do differently?”

Kayla: “Hire full-time, high quality consultants up front. Pay them to work every day as early as possible with complete focus on, and enthusiasm for, what you are doing. Conversely, move faster on removing bad partners. They might not be bad people, but if they are misaligned with your vision, remove them swiftly.”

Paul: “What makes clinicians (potential customers) more likely to engage with a pre-FDA healthcare startup?”

Kayla: “Referrals are the way we get early interest from clinicians. We don’t succeed at cold calling. Even clinicians follow the common diffusion of innovation curve – people are either innovators, early adopters, in the majority or laggards. Understand your value proposition for each group, then find early adopters willing to try something different and are excited about it. The value proposition and strategic alignment with innovators or early adopters lies in an existing interest in innovation and industry leadership, which includes being part of the research and publishing.

Paul: “How did you get to be part of Prudential’s ‘State of Us’ commercial happen?”

Kayla: “That was absolutely amazing. Their own team picked cities with statistics that drove unique financial decisions. They picked Memphis due to its massive increase in the number of  women owned businesses. We had no contact with them prior to being asked to participate. I believe that our visibility in the entrepreneurial and life sciences ecosystems, serving on boards including Epicenter and New Memphis Institute, participating in community activities as mentors, our mission and diversity helped them find us. After eight rounds of interviews, we got the gig!

Paul: “What’s the lesson there?”

Kayla: “When you serve, good things happens. What happens outside of your office or lab is equally as important as what happens inside of it. You won’t see immediate results. Do it from a different place, a place of service. In our case, our commitment to our community and service ultimately helped raise money, connect to clinicians, gain access to more boards and other resources like our new office at the University of Memphis CommuniTech Research Park initiative.”

Paul: “What has been most surprising about your journey to date?”

Kayla: “How my role has changed. Each day, I focus on identifying the right work that aligns with strategic objectives and putting the right people on that right work. It has shifted from putting processes in place for projects with more partners and help the business run more efficiently. Axel Strombergsson, our new chief operating officer, was built for that. With Axel on operations and myself on the future activities of the company, it frees up our co-founder and Chief Science Officer, Dr. Isaac Rodriguez, to soar at his strengths – reinforcing the scientific credibility of SweetBio. The culture of our company is strong and I am proud of it – we each have the opportunity to soar at our strengths while we drive incredible progress for the company.

“We plan on doubling our team in next 12 months while ensuring we’re operating in a way that’s energizing. I’ve been spending and enjoying more time focusing on the team and our culture – different and surprising for me – and I’m highly energized by it.”

Paul: “What do you need next?”

Kayla: “Two things. First, interview around 100 wound care experts for customer discovery. Second, identify and learn from business mentors who have done what we are hoping to do: to build, launch and scale a company both nationwide and globally.”

Paul: “What are you interested in learning from the collective ‘medtech’ community?”

Kayla: “The New Memphis Institute, a community leading nonprofit in Memphis, does a ‘speed mentoring’ event. I’m interested in more one-on-one knowledge sharing from the Randy Scotts and Bob Crutchfields of the world in a low-risk environment. There are always questions about reimbursement, resource recommendations and what are the top questions to ask distributors in contracts? Having access to mentoring from these inspirational leaders can be company altering for a scale-up company.”

Follow SweetBio on LinkedInTwitter and Facebook.

SweetBio uses SEMDA as springboard to medical device startup growth

Kayla Rodriguez, MBA – Co-founder & COO, SweetBio

Three weeks before SEMDA 2015, SweetBio wasn’t even incorporated. Six months later, Innova and MB Venture Partners co-led a $900,000 seed round to support FDA 510(k) clearance and commercialization of the company’s Guided Tissue Regeneration Membrane (GTR).

A graduate of ZeroTo510, listed among TechCrunch’s Top 20 U.S. Accelerators, SweetBio has created a patent-pending dissolvable membrane that uses honey to encourage healing and produce better outcomes. While currently used in hospitals to treat ulcers and burns, SweetBio is the first company to leverage this naturally antibacterial and wound-healing ingredient in oral procedures.

SweetBio COO Kayla Rodriguez recently shared with us a few insights about the company’s SEMDA 2015 experience and plans for SEMDA 2016.

Why did you decide to invest in SEMDA 2015?

“A few weeks before SEMDA 2015, I was in San Francisco and we hadn’t even settled on a name for the company. When we heard about SEMDA, we realized it would be the perfect opportunity to determine if our pitch, our business model and our value proposition are worth something.

“In less than 3 weeks, we incorporated the company, put our first investor pitch deck together, practiced, practiced and practiced some more to get ready for PtichRounds.”

What was your experience at SEMDA 2015 like?

“It was the most wonderful experience. Gaining insights and feedback from David Huizenga, Chris Hooper, Randy Scott and others helped shape our company. They also introduced us to dozens of colleagues including other investors that have been instrumental in SweetBio’s growth. Having the undivided attention of seasoned medtech investors in a low-risk environment is something I had never experienced before attending the SEMDA conference in 2015.”

What were the results?

“We got to know more about who we are as a team. And while we don’t have all the answers, we have the grit and grind. Our experience at SEMDA 2015 helped refine our strategic direction, improved our pitch, opened new doors and helped validated our business.”

What advice would you give medtech startups considering attending?

“If you are not planning on pitching, no matter how early or young your company or idea, get it ready and just go pitch. Do whatever you can to take steps forward. Redefine winning. Winning PitchRounds is not all about coming in first. Winning PitchRounds is also in relationship building. Allow yourself to be social, be bold. The collective crew at SEMDA is most welcoming.”

What are your goals for SEMDA 2016?

“We are participating in PitchRounds again and we are treating it as a benchmark. We are proud of our progress, and this is a perfect opportunity to do a ‘temperature check.’ Having just celebrated our first year as a company we need to ensure we are focused on what’s critical to our continued development: de-risking our marketing plan and de-risking our trials plan.”

“We hope the investors will challenge us and poke holes in our pitch, so that in year two we focus on initiatives that continue to add value – especially to our go-to-market strategy.”

Thank you, Kayla! We can’t wait to see you and what you have in store for us at SEMDA 2016 and beyond!

Applications for PitchRounds at SEMDA 2016 open through May 2, 2016

PitchRounds and its corresponding online platform connect medical device startup companies with venture capitalists and angel investors who are seeking new investments. If you have a medical device or health IT company and you’re looking for venture funding, PitchRounds is for you.