Digitizing the operating room - James Domine, Avail Medsystems : 23

Blackbird Labs is a life sciences accelerator with a mission to develop Baltimore’s biotech startup ecosystem. Funded by the owners of the Baltimore Ravens, Blackbird’s focus is on bridging the gap between research labs and clinical trials.

In Episode #32, Andy Rogers of Key Tech talks with Blackbird Labs CEO Matt Tremblay about Blackbird’s integrated initiative to foster life science and biotech research in Baltimore.

Need to know

Building Baltimore’s biotech infrastructure — The Baltimore area is home to some of the nation’s top biotech research institutions with lots of mid-career talent, but a relatively underdeveloped investor ecosystem compared to Silicon Valley.

Building a thriving ecosystem — With a mission to foster entrepreneurship and reduce Baltimore’s opportunity gap, Baltimore Ravens owner Steve Bisciotti’s family foundation wants to develop the region’s biotech innovation.

Blackbird Labs gets innovations out of the lab — A $100 million founding grant will let Blackbird Labs accelerate life sciences innovation by helping promising research cross the gap separating the lab from the market.

Blackbird Bioventures moves startups towards the market — Making seed-stage investments and cultivating a network of investors, advisors, and leaders will help biotech startups shift from research to clinical trials.

The nitty-gritty

Blackbird Labs and Blackbird Bioventures address a significant hurdle preventing novel therapies and technologies from reaching the market. A laboratory discovery is too risky for investors. There are too many open questions concerning safety and efficacy.

“When a new therapeutic is identified,” Tremblay explains, “we can’t just immediately go into a clinical study.”

Blackbird Labs attacks the problem from one end by funding research at universities and contract labs that no longer fits within the academic systems of publications and grant-making.

“What you may need is another one to two years of very focused research to create the data that will then draw in investors that can support the development of this technology all the way to market.”

That is when Blackbird Bioventures enters the picture. Startups need capital to prepare for and enter clinical trials, which Blackbird’s early seed investments and investor networks help provide. Since its launch last November, Tremblay’s organization has already awarded grants to six research teams and invested in four existing startups. 

Data that made the difference:

“An important element of our business model is syndicating with other investors but also strategic partners like Big Pharma,” Tremblay says. “We have a few different layers of challenges to overcome. We’re not just looking at… commercial potential, but we also have to look at the feasibility on a one to three-year timescale.”

The goal is to generate what Tremblay calls “prudent principal data” to excite potential investors. This data must meet two criteria. First, is there a strong mechanistic underpinning for therapy’s efficacy? Second, can the project generate clinical data on a meaningful timescale to show that the therapeutic works?

Blackbird’s data and investments, Trembly explains, “is a signal to the market that this is an important technology. The goal is then to bring investors from within the Baltimore ecosystem — but importantly from outside of the mid-Atlantic —folks that are investing in very high-quality companies in Boston and San Francisco to look at what we’re building here.”

MicrofluidX is an early-stage developer of cell and gene therapy manufacturing platforms that aims to streamline the transition from laboratory research to large-scale GMP manufacturing.

In Episode #31 of the Speed to Data podcast, Key Tech hosts Andy Rogers and Director of Strategy Lei Zong speak with Dr. Lindsey Clarke, MicrofluidX Vice President of Commercial, about the company’s solution to advanced therapy commercialization.

Need to know

Cell and gene therapies are revolutionizing medicine — Since the 1990s, these therapies have opened new avenues for curing once-terminal conditions like cancers and heart disease.

However, the field is far from industrialized — Skilled operators produce these living medicines in small batches using systems sourced from a complex supplier ecosystem.

Scalable manufacturing is part of the solution — MicrofuidX is developing a scalable bioreactor that speeds time to insight and accelerates commercialization.

The nitty-gritty

Cell and gene therapies allow the patient’s body to cure itself with a single dose. “When I first started in this industry,” Dr. Clarke explains, “we didn’t know if these therapies were going to work, then they started working, and then literally in the last five years, we started saying ‘curing.’ To have seen that in my career is incredible for me.”

Researchers are now developing therapies for chronic conditions like epilepsy, rheumatic diseases, and diabetes.

“I think that’s hugely exciting if, from a technology perspective, slightly concerning that there’s really big numbers of patients at the end of these. Do we have the tools that will enable us to get to that scale?”

R&D pipelines translate manual laboratory processes into automated, scalable commercial production. A challenge for chemistry is more complex for cell and gene therapies that depend upon living cells where, as Dr. Clarke points out, small changes can have big impacts.

She contrasts feeding cells in production, where automated incubators maintain perfect conditions, to a lab where a human operator moves a flask to a hood, removes the cap, adds media through a pipette, replaces the cap, and returns the flask. These steps introduce stresses and temperature variations that won’t exist in manufacturing.

“We don’t measure it,” Dr. Clarke says, “We don’t know what impact it really has, but it could be having an impact. So you’re having to go through an optimization phase that is involving large scale technology.”

Data that made the difference:

MicrofluidX balances complexity with simplicity. The company’s core technology is a bioreactor with automation, control, and sensor layers that let this single platform scale from milliliters in the lab to liters in production. Dr. Clarke explains, “It means that you can really start to optimize processes in small volume, understand it, and then drive it to where you need it for manufacturing.”

Listen to the market early. Letting potential customers shape the development path can optimize your product-market fit. “If you’ve already got something that’s ready for the market, it’s too late,” Dr. Clarke says. Qualitative discussions identify issues when you have time to change.

Make engineers talk with people. Asking engineers, whether they want to or not, to join these customer conversations is “really good for them,” Dr. Clarke says. Engineers ask different kinds of questions that directly impact development.

Diversity and inclusion (D&I) are essential to sustainable business cultures, nowhere more so than in the MedTech industry, where a product’s success can depend on its acceptance within a variety of communities.

In Episode #30, KeyTech’s Andy Rogers and Senior Mechanical Engineer Danica Mackesey sat down with Sarah Hassaine, ResMed’s Head of Global Inclusion and Diversity, about fostering environments where multiple voices get heard.

Need to know

Changing lives globally —ResMed is a global manufacturer of CPAP systems for at-home sleep apnea treatment and ventilator solutions for out-of-hospital care settings.

Diversity as a strategy — Hassaine’s team coordinates ResMed’s efforts to bring diversity and inclusivity to the employee experience, business practices, and product development.

Giving ResMed communities a voice — ResMed employees participate in Employee Resource Groups where women, veterans, neurodiverse, and other communities contribute their perspectives to the company’s D&I strategies.

The nitty-gritty

A large part of Hassaine’s role is fostering D&I within ResMed — quite a challenge, considering the company has over ten thousand team members supporting customers in over 140 countries! At the same time, the core challenges will be familiar to small companies and startups.

“The first part is for people to understand themselves,” she explains. “People have their own intrinsic opinions, thoughts, biases…. Building in that ability to understand and find value in people’s differences is the hardest part.”

Diversity and inclusivity also need to be part of the product development cycle. “Some communities are not comfortable talking about sleep,” Hassaine says. “It is a very personal experience. We have seen that struggle with getting some communities to even get sleep-tested.”

People from disparate communities — Women, people of color, veterans, older people — have differing attitudes towards doctors, the healthcare system, and personal health in general. These differences, however, are not well understood.

“Our medical affairs team is doing more research on the social determinants of health and access to health care. We're making sure that everyone gets access to a sleep test if needed.”

Data that made the difference

ResMed’s D&I team collects qualitative and quantitative data to understand the state of diversity and inclusion within the company. In addition to surfacing perspectives through Employee Resource Groups, her team generates quantitative insights from hiring, promotion, and attrition data as well as from employee surveys.

“It does take time, especially in the inclusion space, to address data and see improvement,” Hassaine says. “I’m finally now having a story to tell three years later.”

Hassaine and Danica addressed how diversity data plays is crucial in medical device development. Danica brought up the “importance of understanding who’s going to use the device because there’s some really potentially dangerous impacts.”

“We're really taking that into consideration,” Hassaine agreed. The success of sleep apnea treatments often depends on the fit of a CPAC system’s mask. A key question Hassaine brought to ResMed’s product teams: “Are we making sure we have enough diversity to test our products so that we're… accommodating all face types or all heights or all body types?”

Rivanna Medical is a Virginia-based developer of ultrasound imaging technologies. Accuro, the company’s first product, is a “stud finder for the spine” for more accurate needle placement during spinal and epidural procedures.

In Episode #29, Andy Rogers of Key Tech talks with Rivanna’s Chairman, CEO, and Co-founder, Will Mauldin, Ph.D., about the role of data in his company’s AI-powered product.

Need to know

• Three million vaginal and caesarian births in the United States require anesthesia injected into the epidural space around the spinal cord.
• Twenty million patients receive epidurals during surgery or as part of a treatment program for chronic pain.
• However, there are complications. For example, post-dural-puncture headaches occur when a needle punctures the dura and fluid leaks from the spinal canal.
• First-attempt success rates are around forty percent in challenging populations, such as obese patients or those with spinal abnormalities. 
• Success rates with Rivanna’s Accuro ultrasound imager approach seventy-five percent.

The nitty-gritty

Although physicians have used general-purpose ultrasound imagers to scout needle placement, most anesthesia providers don’t have the skills to make it common practice. By focusing on one indication, distinguishing epidural tissue from bone, Rivanna designed a simple handheld device that uses AI-powered software to streamline needle placement.

Accuro’s small size and integrated screen make identifying and marking the needle insertion site easier. In addition, the device’s transducers interact with bony tissue better than general-purpose devices designed to image soft tissue.

A focused value proposition also lets Rivanna use neural network algorithms to automate the identification of bone and epidural tissue and guide needle placement more accurately.

Data that made the difference:

Conversations with obstetrics anesthesia providers let Mauldin identify the value proposition. “It became pretty clear from those qualitative market research interviews,” Mauldin says, “that the problem is just where do I place the needle to begin with and on what trajectory?”

Rivanna launched Accuro in 2015, but medical societies like the American Society of Anesthesiologists need more data to recommend ultrasound image-guided epidural procedures. Mauldin explains that Accuro’s next iteration requires identifying “what kind of endpoints would move society guidelines to point to an image-guided standard of care? What clinical evidence do we need to support in order to allow the societies to make that determination?”

A new product line required gathering even more data. Today, seven percent of emergency department (ED) patients have suspected wrist or ankle fractures. The U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) is concerned that terrorist attacks could overwhelm EDs with hundreds of fracture patients. Rivanna received BARDA funding to design a portable ultrasound bone tissue imager.

“We made it through the base segment,” Mauldin explains. “That was about gathering data. We interacted with 180 different emergency physicians, emergency department directors, orthopedists, and radiologists to answer the question: is there a market here for the indication of bone fracture bedside assessment? Fortunately, the answer was yes.”

Uterine cancer rates in the United States are rising. Yet uterine exams rely on expensive, difficult, and painful procedures developed decades ago. North Carolina-based Luminelle has developed an office-based alternative that could revolutionize women’s health.

In Episode 28 of the MedTech Speed to Data podcast, Andy Rogers of Key Tech talks with Allison London Brown, Luminelle’s Chief Executive Officer, about her company’s innovation journey. 

Sometimes, it takes direct experience to understand the value of innovation. Born out of personal crisis, Luminoah is developing a solution to enteral nutrition, or tube feeding, that will dramatically improve patient quality of life.

In Episode #27 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers talks with Luminoah CEO Neal Piper about bringing much-needed innovation to in-home care.

Need to know

Tube feeding is extremely common — Every year, half a million new patients, from infants to geriatric patients, can’t swallow solids or liquids and require an alternate means of nutrient supply.

Enteral nutrition lets patients live at home — A patient with long-term needs has a gastric feeding tube inserted through their abdomen into their stomach so they can leave the hospital.

Yet the current standard of care is bulky — Patients must manage an IV pole, peristaltic pump, replaceable nutrient bags, and two meters of tubing.

Slow pumps limit freedom further — Patients become defined by their illness, unable to go to work or school.

Current products do not track data — Because tracking nutrient consumption is difficult, many patients are readmitted to the hospital for malnutrition.

The nitty-gritty

Neal’s decision to enter the enteral nutrition sector was not the result of market analysis or laboratory research. “It came out of a personal need for my wife and I when my son, Noah, turned three years old. He started choking on his saliva and food.” 

Doctors at the UVA Children’s Hospital discovered a tumor in the base of Noah’s skull that prevented him from eating or drinking. Noah rang the bell and ended his therapy after 18 months of chemotherapy.

“Fortunately for us, we had a really positive outcome,” Neal said, but the experience opened his eyes to the challenges kids and adults face in similar situations. 

“Everyone says, don’t obsess about the solution, obsess about the problem, and that’s what we did.”

After interviewing GI surgeons, nutritionists, distributors of feeding solutions, and many patients, Neal confirmed that Noah’s experience was not unique. “The major challenge that patients are dealing with is a lack of portability, an unintuitive approach, and not being able to track and be empowered with data.”

Data that made the difference:

Understanding the problem can justify a research program, but it does not explain how Luminoah could raise $1 million seed and $6 million Series A rounds in a tough investment climate. 

Noah explained how his team pressure-tested what he calls the 5 P’s of business development:

Product Validation: Can you design a manufacturable product that solves the problem?

Plan: What’s your go-to-market strategy? What does the financial model look like? 

Patent strategy: Can you protect the technology?

People: Can you find experienced people to drive the project forward?

Pathway: Can you get from development through 510(k) approval?

“Three and a half years in, we’re about a month away from design three,” Noah explained. “We’ve got a working device we’re submitting to the FDA for 510(k) approval with clearance anticipated in 2024.”

Learn how the Charlottesville, Virginia, biotech ecosystem and a community of enteral feeding patients supported Luminoah’s journey in the full video here:

Many conditions can elevate or depress the intracranial pressure (ICP) of fluid pushing on the brain, potentially seriously impacting patient health.

However, the only ways to measure ICP require specialized invasive techniques that are too risky for most patients.

In Episode #26 of the MedTech Speed to Data podcast, Key Tech’s Andy Rogers talks with Ryan Myers, CEO and Co-founder of CranioSense, about developing portable, non-invasive ICP measurement technologies.

The National Institutes of Health spends about $42 billion on medical research each year, but less than one-eighth of that money is spent specifically on women’s health. That may come as a bit of a shock, given that women make up a majority – about 51% – of the population. This underserved market is a huge economic opportunity for med tech companies.

That’s what Holly Rockweiler discovered as a Fellow at the Stanford Byers Center for Bio Design. So she put her background in biomedical engineering to work and started Madorra Medical, developing solutions to improve the vaginal atrophy and dryness that women experience after menopause or breast cancer. Madorra’s flagship product is a handheld home-use device that uses ultrasound to rekindle the body’s natural moisture-producing capability. The FDA has granted it breakthrough device designation 

The first randomized trial has been published, and a second one is on the way, and the company is now working toward the next set of data. Here in Episode #24, Madorra CEO Holly Rockweiler and Andy Rodgers talk about how that data is helping to blaze new trails in women’s health. 

Need to know:

• There was a commercial about menopause in this year’s Super Bowl (Astellas Pharma). That simple fact signals a new era in women’s health. 
• Fundraising can be the most difficult part of bringing a new product to market, and it never goes away. Investors want to know what data has been collected, what payer requirements are, and to see a clear path to market.
• Piggyback on existing data when you can. For Madorra, there was substantial literature and technology using ultrasound in other therapies, data on vaginal blood flow from sexual arousal studies, and existing ultrasound devices that could be modified to show proof of concept.

The nitty-gritty:

Vaginal dryness resulting from vulvovaginal atrophy (VVA) affects over half of post-menopausal women and is also common among breast cancer survivors due to treatments that cause estrogen levels to drop. Symptoms include soreness, irritation, pain, increased urinary tract and yeast infection rates, and pain with sexual intercourse. 

Today, the standard treatment for menopausal symptoms is estrogen therapy. But that comes with risks: breast cancer, heart attack, and stroke. The quandary for doctors and patients alike is whether the benefits of pharmaceutical treatment outweigh the risks. For some patients, the risks are too significant and estrogen therapy is not recommended.   

By putting data to work, Madorra created an ultrasound solution that stimulates natural moisture production and eliminates these risks. Madorra’s hand-held external device, used on regular basis for 8 minutes, has been producing significant results in 1 to 3 weeks.  The device is shaped to be intuitive as possible to fit naturally and is used with disposable proprietary hydrogel. Safety is always a key issue, and the wide variety of literature on ultrasound therapies – including the fact that it’s used on pregnant women – has instilled confidence in patients and clinicians alike. 

Data that made the difference:

Market data from the Stanford BioDesign program helped Rockweiler learn to do an analysis of unmet needs, stakeholders, and market dynamics before taking the big leap.

An Institutional Review Board (IRB) feasibility study helped in initial development.

Pre-existing data on ultrasound showed that ultrasound therapy in other uses improved blood flow to treated areas. This key finding indicated that it might work on thin friable vaginal tissue as well.

Patient data revealed how the condition feels to patients and what they wanted in a product.

Bench studies and computer simulations proved invaluable in prototyping.

This story is not only compelling because of the ingenious device itself, but it also reveals a broader story about opportunities in the underserved market of women’s health.

Interesting links:

https://www.madorra.com/

https://www.ispot.tv/ad/1VAi/astellas-pharma-super-bowl-2023-whats-vms

Surgery is not usually considered a spectator sport, but an OR is often filled with the surgical team, colleagues, residents, and medical device clinical representatives, in addition to a patient and equipment. Now Avail Medsystems, based in Silicon Valley, has created a way to increase learning, collaboration, and idea-sharing in the OR – while reducing the headcount – by connecting physicians and care teams to remote experts and device industry representatives during medical procedures. 

The Avail surgical telepresence platform is a hardware and software platform that enables instant, two-way audio/visual communication with high-definition video, surgical imaging views, and even telestration capabilities. 

In Episode #23, Andy Rogers of Key Tech talks with James Domine, CTO at Avail MedSystems, about how data-driven surgical procedures are facilitating collaboration and creating better outcomes. 

Need to know:

• Understand the rules of engagement – the surgeon in the OR is ultimately responsible, so assist without hindrance and design redundancies for reliability, such as battery backup for power failure, etc.
• Take a Silicon Valley approach – strive for a constantly evolving product driving toward a user benefit.
• Internalize security upfront and consider different vectors of attack – healthcare has experienced the largest percentage increase of cyberattacks (it currently ranks 3rd among industries) and is increasingly the choice of bad actors.
• Build a moat – Domine says Avail’s best defense from the competition is being “the best platform on the market, with a custom system that integrates everything to provide the best intuitive UX, optimized for the OR environment.”

The nitty-gritty

The Avail platform connects inside and outside the OR and allows viewers to customize their own experience. This way, clinical specialists, additional physicians, residents, and advisors watching the surgery can be remote but still actively participating and sharing with the surgical team. Med-tech research and development teams can sit in on the action, too, enabling collaboration on device development and creating faster product design cycles.

The complete hardware and software package features a palette of high-tech features, including hi-def video, GigE Ethernet port, built-in dialing for calling remote contacts, and medical imaging. The system is on a wheeled cart, with a camera on a manual boom arm, so surgery can be viewed from various angles. The audio system streaming is custom-built for the OR to reduce background noise from machines and equipment.

Avail is a data nexus – not only capturing real-time data from the surgical procedure itself – but archiving and enabling machine learning to help improve subsequent procedures and outcomes.

Audiovisual data - the remote app works with an iPad or laptop. With two-way audio and video, it’s like being in the room — even if you’re thousands of miles away.

Digital data – the system enables digitization of the OR to guide physicians and allow machine learning.

Secure data - Avail is HIPAA-HITECH protected. To enhance security, designers purposefully avoided certain design patterns and third-party platforms.

User feedback - user input ensures that any new feature added will be used, and Avail generates data on reliability, which is logged on Splunk, a data analysis platform that seeks, monitors, and analyzes machine-generated data via a web-style interface. 

Through collaborating in real-time, sharing knowledge about surgical techniques, and accelerating the development of new products and procedures, data is connecting a world of medical expertise.

USEFUL LINKs
www.avail.io/

splunk.com