Author: Jason Rupp

Around 18 percent of all heart attack victims will wind up readmitted to the hospital within thirty days. For twenty-five percent of all heart attack victims, it is not their first experience with myocardial infarction (MI). This is costly to all concerned, most vitally the at risk patients, but also to the economic health of the hospitals that care for them who are at risk for being penalized for readmission rates over certain levels.

RCE Technologies, winner of the 2019 SEMDA PitchRounds competition, is following a commercialization pathway to reduce those events and costs via remote monitoring that “non-invasively detect[s] protein biomarkers in the blood, and extract[s] a 3D representation of the electrical conductivity of the heart. Continuous streams of critical data points wirelessly enable our cloud based AI models in detecting characteristic learned patterns of heart morphology changes, that affords the cardiologist in making an instant early assessment and proactive intervention”

“We have shown high velocity bringing concept to product in nine months, viable clinical alignment and a needed, reimbursement ready opportunity, RCE Technologies’ CEO Atandra Burman told Write2Market VP of Healthcare Paul Snyder. “We believe we have a very clear path forward to de-risking and commercializing our technology.”

Atandra shared with us a few of the insights gained from SEMDA 2019 and some pieces of advice for other early stage medtech innovators and company leaders.

Beyond the “win” what was most valuable about your participation in SEMDA PitchRounds?

Watching the late stage companies gave us a clearer view of our roadmap unfolding. What’s needed to weather the first, or next, round of challenges? Clinical studies and demos. All of the late stage PitchRounds companies had a clear path on reimbursement strategy, regulatory pathways and channel partnerships identified along with optimized operations for production and distribution. One hinted at a clear exit strategy. This I thought was most valuable, because it gives you the end goal, and helps you work backwards from that – time and cost wise, and those are important variables for me as an operator to run a startup and hit within time and budget.

What did you hear from prospective investors?

Are there other markets or monitoring product reimbursement codes for our technology? What we heard inferred a high level of synergy. Our technology is viable and multiple supporting elements exist.

What are the top questions young medtech & device companies need to answer?

Has there been any kind of clinical validation done? This assumes the technology works and the product functions as anticipated towards better patient outcomes. Next, understand your health economics. How will you get paid? Is the hospital paying, is there a reimbursement code? Basically, think beyond the bench. Think economics, exit path and ROI potential at an early point in your journey. That enables a better gauge on a MVP path to market.

What advice would you give young companies considering applying for SEMDA PitchRounds next year?

While working on functionality, you must also work on payer economics. You must be able to explain how your technology is going to make money in time. Furnishing an exit strategy is another important aspect, that keeps young companies focussed, and on target for what is needed. Expect curveballs from investors and strategics. You need to be on top of it to give perspective on how it will work.

We hear more and more that investors, particularly large strategics, are more frequently requiring products in which they invest be 100% de-risked? How accurate is that?

If you are revenue positive and cost effective, that shows some level of viability for strategics to bet on startups/early stage. Sometimes, we might see them engage in M&A with companies in pre-commercialization and clinical trials. An example is Boston Scientific’s acquisition of Millipede for $325 million in structural heart. Millipede has accomplished a great deal on their pathway to commercialization, but haven’t finished their clinical trials. But then, Boston Scientific’s strategy is clear towards innovation in cardiovascular devices, and if there are ones that have clinical viability, commercialization can be addressed effectively by these large strategics.

What’s next for RCE? 

Our goal in 2019 is clinical validation and submit to FDA this fall. As our pilots materialize towards key insights, we look forward to setting up 2020 for commercialization efforts.

What do you need?

As a fast moving business, we are currently raising $800k to support our immediate needs in completing our compliance testing and FDA sub, as well as supporting clinical pilots for 2019.

In parallel, we are evaluating channel partners, and contract manufacturers, to bring our at scale costs down enabling production lines for goto market.

Congratulations again to RCE Technologies. We look forward to seeing how far you’ve come by the SEMDA 2020 Medtech Conference.

With Shyam Parekh, Ph.D., Director, Strategy & Business Development, Avanos Medical. Inc..

Shyam Parekh’s role, as part of the Avanos’s corporate strategy group is to support the senior leaders in their strategic alliances and technology acquisitions needs. In other words, this gentleman would play a leading role on the team evaluating the value and suitability of your MedTech innovation if you wanted to sell it, or your company, to Avanos.

Shyam describes his role as focused more on open innovation and pre-revenue opportunities. Here’s what Shyam told Write2Market VP of Healthcare Paul Snyder during a recent visit to Avanos’ Alpharetta, Ga., headquarters.

Has your perception of what makes a young medtech company ‘investable’ changed recently?

“Not significantly. The strength of your IP, the quality of your people, your credibility, and the presence of other reputable investors all increase investability in young companies. Now, in the early-stage exploratory work we do, human data is another significant advantage.

“A key question for us is whether a company has sufficiently considered available versus addressable versus currently served market. If a startup tells us, ‘It’s a billion dollars market opportunity,’ they can lose credibility fast. Credible investors will do their own diligence. Those financial data will never be, and do not need to be, anywhere near as precise as any claims. Any market potential numbers will be taken as guidance only. They need to be ‘directionally correct and precisely inaccurate.’

“Also, be prepared to validate your addressable market. This needs appropriate exposure to considerations a large strategic [MedTech company] has. When you say health economic impact is in the tens of billions of dollars for diabetics on injectable insulin regimens, that is not a questionable number. If your widget is automated and portable, then what’s the addressable market? Just as important, how large is the available market versus the market already being served?”

Where are your top areas of innovation interest?

“Pain management and nutrition delivery. We look at investment or acquisition opportunities two ways. Is it a procedural enhancement or is it outcomes improving? From a procedural standpoint, where can technology help with placement confirmation, short of direct visualization for nasal gastric tubes, for example?

“For outcomes improvements, how can devices reduce the number of days a patient stays on a ventilator? Then, once in the home care environment, how can medical technology reduce, or improve, underlying conditions or exacerbations that accompany COPD, chronic bronchitis or emphysema for example?”

How many investments might you make this year in young companies?

“We have publicly stated we are open to innovation acquisitions and are looking for disruptive solutions that are consistent with our value proposition in acute and chronic pain management and digestive health.”

What advice would you give a young company when preparing for an event like SEMDA?

“Keep your pitch crisp.

“Provide a high level of clarity on what are you doing and why is it better.

“Know your audience. Are you talking with true investors or am I talking with intermediaries? Are the people in the audience technology scouts or are they actually investors? In many cases, innovators will find themselves presenting to marketers, researchers or associates of a corporate innovation entity.

“Another question is, how are you changing my health economic equation? We look at that closely. If that isn’t the case and the story isn’t crisp, a pitch for investment in a young medtech company or startup does not score high.”

Does a device have to generate data to be investible?

“Data is becoming central to all, but if data doesn’t change outcomes or drive decisions, data for the sake of data has no bearing, particularly when looking at a quick procedural intervention.

“If you are leveraging diagnoses as evidence generation for reimbursement support, those data are valuable.”

The SEMDA 2019 Medtech Conference – where the Southeast Medtech Ecosystem Connects

The SEMDA 2019 Medtech Conference is April 8 – 10 in Alpharetta, Georgia. Register today to join hundreds of investors, entrepreneurs, researchers and representatives from large strategic companies like Avanos whose CEO, Joe Woody, will deliver the opening keynote on Tuesday, April 9 at 9:30 a.m.

Follow SEMDA on Twitter and LinkedIn for the latest.

“It isn’t about greed, it’s about quickly and securely sharing data to improve health outcomes.”

Blockchain, or, more generically, “digital ledger technology” is going to impact a very large, highly educated army of doctors and clinicians, IT professionals, cybersecurity specialists, organizational leadership, federal regulators, patients and more.

“Ultimately, blockchain for healthcare isn’t about greed, it’s about quickly and securely sharing data to provide valuable content and context to improve outcomes,” says Florence Hudson, a former IBM vice president and chief technology officer and current founder and CEO of advanced technology consultancy FDHint, LLC.

But the sharing of data without a centralized authority (digital ledger technology) brings security and provenance questions that haven’t been answered. Yet. In advance of her SEMDA 2019 Medtech Conference keynote which intends to unpack the current state, goals and opportunities for digital ledger technology in healthcare, Ms. Hudson shared with us the following.

Q: How would a seed stage investor begin to evaluate a healthcare blockchain startup?

A: The investors will need to engage a technologist to examine the startups’ technical risk. What is the true immutability of the company’s offering? Are they creating a central authority or are the data truly distributed? Do not be wowed by the blockchain. It must work in a significantly different way in healthcare than in the financial system.

If a young company is espousing a valuable blockchain for healthcare technology, they must be able to convincingly answer how they have architected and enabled TIPPSS – trust, identity, privacy, protection, safety and security. How are they entrusting that it is actually the doctor accessing an implanted, data-generating device and the ledger? Is that doctor still with the same institution? Are they still credentialed for example? Satisfying TIPPSS is a LOT to achieve, so beware and engage experts for evaluation.

Q: How do buyers in this technology evaluate its potential or utility?

A: What is the technology’s value proposition? Can it ensure data provenance without a central authority? Let’s look at sample data tracking of biomarkers for cancer care. Labs, patients, hospitals and providers, CROs, payers and regulators will all need to access and understand how a distributed ledger technology benefits them. Is it financial, risk reducing, efficiency generating? Will you be able to track those data and process them more easily? That could be a powerful value proposition.

Q: Where are the top immediate needs and potential startup opportunities for blockchain in healthcare?

A: Secure data sharing via blockchain moving us toward precision medicine and precision oncology, blockchain for the pharmaceutical supply chain, as well as blockchain for clinical trials are at or near the top of the list. In a clinical trials scenario, imagine a distributed ledger that could synchronize a pharmaceutical manufacturer’s clinical trial development process with regulators and providers, then connect to a public blockchain for patient advocate groups to increase the number of participants in the trial. The manufacturer of course wouldn’t share proprietary details of the chemical compound(s), but it may more effectively make the trial and benefits known to the concerned community. If we can streamline the clinical trial process, we could accelerate drugs to market and improve healthcare outcomes.

There are clear opportunities for hospitals and connected devices, data sharing for precision medicine and personal patient medical records. If you could securely acquire data from a contextual history (i.e. multiple family members), connect with permissions to them, then connect to those with similar DNA, who knows what we could do?

Ms. Hudson will unpack all of this further and dive into important issues not addressed here, like IEEE prestandards work for clinical IoMT and data in blockchain, existing partnerships and deployments and more in a keynote at the SEMDA 2019 Medtech Conference April 8-10 in Atlanta. Register today!

A health tech startup born at Georgia Tech may end “pay and chase” for health insurers’ special investigations units.

Healthcare fraud in the United States is estimated to cost the system $270 billion every year. Scams are constantly evolving. Current detection techniques and whistleblowers only uncover a small fraction of this.

Founded in March 2017, FraudScope is the brainchild of Georgia Tech alum Musheer Ahmed, Ph.D. The company’s AI-based SaaS platform origins can be found in Dr. Ahmed’s dissertation on applying cybersecurity concepts in healthcare. Fraudscope is commercializing the patented AI-based technology to detect fraud, waste and abuse (FWA) in health insurance claims data from his dissertation.

“Every health plan has a special investigations unit (SIU) to identify FWA in health insurance claims,” says Dr. Ahmed,FraudScope CEO, CTO and Founder. “When plans receive a claim for payment, they have a limited number of days to make that payment. If initial, simple checks for validity discover nothing suspicious, they pay the claims and then further examine for anything potentially fraudulent, wasteful or abusive. If this further examination uncovers patterns of FWA within paid claims, insurers have to chase the money for recovery which is difficult and costly to attain.”

How then do you optimize the use of limited special investigation unit resources to maximize savings?

FraudScope brings sophisticated AI-based technology currently absent in the FWA detection realm for insurers to identify those claims before payments are made. And because the machine learning capabilities aren’t rules-based like most existing solutions it can adapt to new scams at very high speed with low false-positive rates. The days of playing ‘pay and chase’ for insurers, their audit teams and special investigations units may be nearing an end.

Dr. Ahmed says that every health insurance plan that has seen a demo of FraudScope has signed on to pilot the technology. FraudScope’s pilots have identified a significant amount of claims containing FWA that were paid at those plans. The company’s target market is currently commercial payers, though they will target public payers such as CMS and the VA in the future as well.

FraudScope announced a $1.5 million seed fund round shortly after its founding in April 2017. Among the investors and now principal advisor to FraudScope are former UnitedHealthcare COO of Shared Services Patrick Stamm. The company plans another funding round later this year to expand its sales and engineering teams. The goal: acquire more customers and rollout additional products such as pharmacy/drug claims and workers compensation FWA detection.

When asked what FraudScope needs from the southeast medtech community, Dr. Ahmed said, “More interactions with health insurance plans to make them aware of what we can do, especially SIU directors, audit teams and payment integrity officials at health plans.”  

When asked what advice he would share with other innovators or engineers who believe they may have a technology ripe for commercial development, Dr. Ahmed said, “Because there is so much potential for improvement in healthcare, connect with foundations and apply for commercialization grants. Healthcare innovation, including the insurance space, moves more slowly than almost any other industry. Be prepared for a longer sales timeline than you might anticipate.

“There is a great deal of lot of support in the Atlanta local and regional startup ecosystem. The ecosystem has matured significantly in the past few years. Young companies should be confident that there is sufficient local and regional support for their journey without needing to court Silicon Valley.”

Connect with the entirety of the Southeast Medtech Ecosystem at the 2018 SEMDA Medtech Conference May 2-4, 2018 in Greenville, SC!

Without a doubt, one of our favorite aspects of the SEMDA conference is meeting scores of young, investible companies that attend and pitch to the whole of the Southeastern medical device ecosystem. On day two of the conference, five startups pitched their companies reinforcing the strength of the technologies coming out of the Southeast. Congratulations to each of our PitchRounds finalists Myolyn, SweetBio, Patientory, Demore MUSC, and Contego Medical. The competition was exceptionally tight but at the end of the day, Patientory claimed the top prize.

Accepted as the first healthcare transformer in Boomtown’s Healthcare Accelerator, in partnership with Colorado Permanente Medical Group, Patientory is the first and only distributed blockchain cybersecurity technology for healthcare. They combine the power of rapid and secure medical record access with a patient community platform to reduce healthcare data breach and provide a centralized patient record depository- connecting the provider with the entire patient history to enable better chronic care management.

As we all know, patient history storage is fragmented. Each healthcare provider has their own Electronic Medical Record (EMR) vendor and platform. Those systems do not speak to other hospitals, practices, or specialists making it difficult for all parties to achieve care coordination. Patientory changes that by utilizing blockchain technology.

Patientory CEO, Chrissa McFarlane, recently shared with us a few insights about the company’s SEMDA 2017 experience.

What was your experience at SEMDA 2017 like?

“SEMDA proved to be a very worthwhile experience. Not only did our team feel a real sense of validation upon winning the SEMDA PitchRounds $10K cash prize and invitation to attend AdvaMed 2017, we were able to meet many industry leaders and investors which made our time at the conference an experience of high value. Let me say, it was an overwhelmingly positive experience.

I have presented our company during multiple pitch competitions but SEMDA was by far the most healthcare focused I have experienced. It was amazing to explain Patientory’s solution without needing to explain the current state of healthcare or the dated standard of EMR keeping. And because SEMDA is THE place for medtech leaders in the SE, I received quality feedback from industry mavens that are well versed in the space- SEMDA was a valuable experience for our team.”  

What were the results?

“Everyone I spoke to following the PitchRounds and throughout the entire conference were savvy healthcare leaders who could see right off the bat that we were meeting a real need. We had meetings with multiple investors and vendors during SEMDA- and the connections we made during those two days are continuing to evolve.”

What advice would you give medtech startups considering attending?

“Definitely utilize the resources provided by SEMDA and take full advantage of the annual conference as a place to meet vendors and potential partners. SEMDA is a great networking opportunity and by far the premier medtech event in the Southeast. I know SEMDA is an event that we will continually attend in the years to come.”

The company recently announced a raise of $7.2 million in an “initial coin offering” crowd sale. WOW! Driven by 1,728 investors, the company reached it’s funding goal in three short days- changing the game and utilizing an innovative funding model. The funds raised will be used to officially launch the Patientory platform.

Congratulations and thank you, Chrissa! We can’t wait to see Patientory grow and what you will have in store for us at SEMDA 2018 and beyond!

We are already counting down the days until SEMDA 2018 in Greenville, SC. In the meantime, follow SEMDA on LinkedIn and Twitter to stay up to date with the latest southeastern medtech news and events like our Medtech Women@SEMDA conference.

At SEMDA, our industry partners and sponsors are the ones that make it possible to advance our collective mission: accelerating device development and achieve commercial success with access to funding, education, and networking opportunities for medical device companies, inventors, physicians, investors, tech transfer offices, universities, sponsors, and service providers interested in growing the medical device industry in the Southeast.

We know we also have an obligation to provide value to our partners. Courtney Warren, consultant for the Marsh & McLennan Agency shared with us how SEMDA meets that obligation.

How does SEMDA drive value for your investment?

“Our mission at Marsh & McLennan Agency (MMA) is to help clients by delivering smarter, local knowledge and world class solutions in employee benefits and risk management. Our partnership with SEMDA allows us to engage with the entire Southeastern medtech and medical device ecosystem. As such, we gain a better understanding of industry issues.  We have the opportunity to give back to the community through leadership, making us better equipped to connect clients with valuable contacts – capital investors, suppliers, or other business partners. SEMDA provides key connections and resources to bring innovation to market.”

What have the results been related to your SEMDA investment?

“SEMDA serves as the central connecting hub for the Southeast medtech community. We have met new companies at SEMDA that are now MMA clients. Through our involvement with SEMDA, we have been able to connect our clients with investors, suppliers, and specialists to help their business succeed.”  

What’s most needed in the Southeast medtech and medical device ecosystem?

“Industry advancement happens in small groups. Beyond the annual conference, we need vehicles that foster more in-depth conversations. Every member of the ecosystem offers a unique perspective, which we would like the opportunity to learn about in order to innovate our business strategy for our clients and the community.  Our work with companies developing medical devices and technologies is enhanced by input from CPAs, legal, and regulatory consultants.

“Knowing the right time to pull each other into the mix is a high-value proposition to ensure the best use of scarce resources. The better we know each other and our unique talents, the faster the right person will come to mind when we need help to advance our business and our clients’ objectives.”

If you would like to know more about how SEMDA drives value for our partners, email Executive Director Jason Rupp – jrupp@semda.net

Access the entirety of the Southeast medtech ecosystem in a ‘one stop shop’ at SEMDA 2017, April 26 & 27 in Atlanta.

Depending upon your study of choice, medication non-adherence creates between $100 and $400 billion in wasted U.S. healthcare spending every single year. Yes, pill bottles have a child-proof lid, but that does nothing to make adults accountable when dosing medication or taking it on time. What about people who think two pills are better than one? That’s not always the case with regards to medicine, and that is almost always a step into the pitfall of addiction.

Intent SolutionsTM created a solution to help improve medication adherence and also to combat the notion that more is better when medicating. Their principal device is TADTM— “Take As Directed.” It is a smart medication dispensing device that is designed to markedly improve the monitoring and management of medication adherence.

“TADTM was born from the idea that we could invent a technology that would help people take their medicine as directed to prevent misuse, abuse, and addiction,” says Ashley Hancock, Co-founder and COO of Intent Solutions. “With this device we are tackling the broad spectrum of non-adherence as well as the misuse of prescription drugs: a market that encapsulates more than $300 billion, $72 billion of which is attributable to direct abuse or misuse.”

Hancock is a long time supporter of SEMDA. His involvement spans 10 years including service as the Executive Director from 2011 to 2013. The story of Intent SolutionsTM begins at the SEMDA conference and develops through the ongoing engagement with the experts and resources that make SEMDA a ‘must go to’ conference year after year.

Preventing the next “accidental addict”
After overcoming an addiction to prescription pain medication following a severe hip injury, Martin Mclean, Director and Co-Founder of Intent, teamed up with entrepreneurs whose relationships can be traced to SEMDA: Dr. Van Crisco and Ashley Hancock.  Later, Sam Zamarripa and Lou Malice, a SEMDA regular, joined the team.

“Intent’s existence is directly attributable to our relationship with SEMDA,” Hancock acknowledges. “We continue to leverage the connections made through the conference: from relationships with seasoned advisors to the people we will contact for future investment.”

Today Intent is a company that might be able to prevent the next “accidental addict” and take a bite out of hundreds of billions of dollars in wasted healthcare spending.

“The Conference is a must-go in my opinion,” says Hancock. “SEMDA holds a wealth and depth of medtech and medical device industry knowledge. When creating a med-tech company you need advisors, consultants, and fund raisers. The conference makes it possible for an innovator to make connections with these individuals that they would not be able to make in a single event elsewhere in the region, if not the nation.”

Intent finalized a $1.5 million seed round in November 2016 and is eyeing a Series A in 2017. In addition to the current inclusion of Intent Solutions’ TADTM adherence product within an NIH study at Johns Hopkins University, Hancock says an announcement involving a study with another leading university hospital involving TADTM is eminent.

Advice from Ashley Hancock on how to make the most of SEMDA as a newly formed medical device company

• Take advantage of the partnering platform: understand who is a part of SEMDA and how you can meet them.
• Attend and pay attention during the educational programs. The panelists can become great resources for connectivity, consulting, and ultimately partnering relationships.
• As a startup you never have enough money, bandwidth, or people so once you attend SEMDA, leverage your new connections to create future success.

“Some go to the conference just for the investor forum, and some go for the educational track; we go for both,” says Hancock. “It gives you access to the advisors and consultants that may even some day be a part of your team.”