microfluidics

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:

Microfluidics is an exciting field of science that has the potential to change the way we do drug trials. 

Today's speaker Susi Seibt is keen to explore the future applications of this teeny tiny science. 

Microfluidics is an exciting field of science that has the potential to change the way we do drug trials. 

Today's speaker Susi Seibt is keen to explore the future applications of this teeny tiny science. 

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

For most MedTech devices, the path to development starts with defining a market need, then creating a technology to fill that need. But sometimes innovation lies in finding a new application for an existing technology. And sometimes the inspiration can come from a totally unexpected place.

Such was the case for Venk Varadan, indie film producer-turned MedTech CEO of Nanowear, a wearable diagnostic device for cardiac patients. Nanowear adapted a unique sensor technology originally designed to provide data-rich sonar for submarines and high-flying aircraft, to create a cloth nanotechnology, which captures and transmits 85+ dimensions of clinical-grade biomarker data from basic skin contact. The fabric has a suede-like texture, which comes from billions of tiny vertical sensors.

Nanowear’s SimpleSense™ is an FDA-cleared wearable A.I.-based remote diagnostic platform.  The non-invasive smart fabric collects a variety of metrics including ECG, heart rate variability, respiratory rate, actigraphy, impedance cardiography, thoracic impedance, and cardio-phonography. 

Nanowear is one of a handful of ways to track heart rate, blood pressure, and other vital signs for long periods of time. But the big plus is that it’s non-invasive and can be used at home, facilitating patient compliance and, through telehealth, expanding the geography of high-quality care in rural markets. 

Andy Rogers of Key Tech gets to the heart of the matter as he talks with Venk about the journey from lab to marketplace.

Need to know:

• Decide who you’re going to be. Early on, Nanowear chose to go into MedTech, when they could have easily applied their technology to sports or wellness markets. 
• Don’t be afraid to re-think. Nanowear was originally two products: a tank top for men and a bra for women. The realities of sizing and inventory forced a change to a unisex shoulder sash.
• Know what you don’t know. Become an information sponge.
• Start small, stay small. After seven years, the Nanowear team is still only 30 people, recruited mainly from family (Venk’s father, Vijay, developed the fundamental technology), friends, and colleagues.
• Look at the angles. Consider the viewpoints of all your stakeholders: investors, clinicians, patients, and your own staff. 

The nitty-gritty

The primary factors that drive the application of nanosensors in healthcare are their non-invasive ease of use, high signal fidelity, and continuous monitoring capability.  Nanowear’s shoulder sash is an easy-to-use multi-metric diagnostic system with state-of-the-art embedded wireless network devices that feeds data to a smartphone, a laptop, or directly to a remote server. This in turn enables a closed-loop digital system for specific machine-learning algorithms built on terabytes of patient data.

Right now, Nanowear is focusing on monitoring congestive heart failure, which affects over 5 million patients in the U.S. With this versatile undergarment, doctors can remotely monitor patients and hopefully reduce expensive hospital visits. For patients, it’s a comfortable, easy way to stay on top of their condition. 

The SimpleSense™ fabric is the first cloth that’s FDA 510-cleared, but pioneering the cloth technology was only the beginning. The next challenge was dealing with the “firehose of data” that it generated.

Collecting more data. Nanowear sensors capture 85+ medical grade biomarkers directly from the skin and provide accurate, continuous, real-time assessment of the heart, lungs, and upper vascular system: a more comprehensive picture of patient health. 

Managing more data. The cloth technology produces exceptionally high-quality raw signal data. To analyze millions of data points per patient per day, Nanowear had to create proprietary software. 

Retaining more data. With machine learning algorithms, Nanowear can track trends in a patient’s cardiovascular health over time, providing clinicians with a tool that enables much more accurate decision-making.

Before any med-tech entrepreneur can bring a product to market, he or she must prove the technology will work reliably. Transforming a nascent technology like digital microfluidics into an intuitive product is not easy. But it doesn’t take a seasoned engineer to understand that you’ll need to evaluate multiple iterations of the device in order to develop a system that will work as intended.

In Episode 21 Andy Rogers and Key Tech Senior Computer Engineer, and Partner, Lei Zong talk about creating test platforms that will collect essential raw data and turn it into useful information to speed up the product development process.

Need to know: 

• Is this thing going to work? – the fundamental, elemental, do-or-die question.
• While de-risking, look ahead to the long-term - could the test bed lead to a potential system higher-level architecture, or just be a dead end?
• Be greedy about data. Get as much as you can with the test bed in order to understand system boundaries.
• You don’t know what you don’t know. So the flexibility of test beds is paramount.

The nitty-gritty:

Medical devices often have humble beginnings. Some may start out in pieces, with off-the-shelf components cobbled together into a benchtop system that simply demonstrates the proof of concept. This is a great shortcut that helps non-software engineers get up and running quickly. But as with any shortcut, there are caveats. Holding off for custom design and testing until later in development isn’t always cost-effective.

Consider this example: you have a PCR test fixture, like those used in COVID tests, to drive a thermal profile with a consumable, and you want to know what’s happening within the platform itself, both with fluid and temperature. You need feedback from the system and software to capture the data. Generally, you have 3 options:

1.      Off-the-shelf software, which may lack necessary functionalities or may not be compatible with certain test bed components.

2.      A customizable solution such as Key#™ (Key Sharp), a solution that can drive the system and be configured to collect, process, and display the data you need.

3.      Develop your own application, which requires time and deep, deep pockets. What’s more, the PC app won’t have any practical commercial use, since you’ll likely need a custom UI to control the product.

The customizable Key#™ solution gives you the most flexibility, budget-wise and performance-wise. Key#™ lets you quickly build the architecture you need with the functionality you want. It allows you to leverage a flexible framework with existing command libraries and gives you the ability to easily add new or custom commands. From there, the user can build scripts to run system protocols and collect data throughout the product development process.

This customizable setup allows the user to easily adjust and test a variety of ranges and performance parameters to make testing fast, reliable, and easy. The user can tweak every parameter at a granular level: control modules, pumps, sensors, temperature ramp rates, and more.

In addition to allowing users to control components at a granular level, the custom message protocol provides a clean and intuitive UI to enable more team members and manufacturing partners, to test devices.

Let’s say you need to control six motors and optical sensors – with Key#™, you can set parameters and go! A program such as Key#™ can give users a graphic image of what the system looks like while collecting and processing hundreds of real-time data points from firmware (such as fluid movement, the temperature at various points in the system, and so on).

As prototypes progress and include more custom features, programs like Key#™ can progress with the prototypes. Key#™ can provide pedigree verification along the way and can also continue running as the foundation for firmware while you enhance the UI. Core functionality remains the same, but the end-user interface is much “dressier.”

To learn more about Key#™, check out our blog “Key Sharp – Key Tech’s Custom Software Tool” or contact us to discuss further.

Everybody likes to feel warm and cozy, but we all know someone that can’t keep themselves warm. This is a particular problem for women who have undergone preventive or therapeutic mastectomies. The implants used in reconstructive surgery often feel cold, literally chilling women to the core.

Kristen Carbone designed Brilliantly Warm, a wearable technology to solve a problem that she had herself: keeping warm following a preventive double mastectomy and implant reconstruction.

A former museum curator, Kristen had no background in engineering or business, but she had a powerful idea. She started with a prototype that was connected to a drill battery, and now has a low profile, wearable technology that delivers safe, natural-feeling warmth to the body. 

The device slips easily into any bra and is controlled by an app, making it an almost invisible solution for women who want to feel warmer and more comfortable. Brilliantly Warm was initially designed for mastectomy patients, but since its launch, Kristen discovered it’s also being used by nursing moms, for menstrual cramps, and people with chronic conditions who constantly feel cold.

Here in Episode 20, Key Tech’s Andy Rogers talks with Brilliantly Founder and CEO Kristen Carbone about the hows and whys of Brilliantly Warm and how data – or sometimes the lack of it – shaped the journey from idea to marketplace. 

Need to know:

• Feel the need. Kristen understood the need for the product from her personal experience.

• Get a lawyer and accountant you love. Find people who focus on start-ups, who can help you make deals, and help you stay compliant with regulations.
• Take the fastest track to the market. Brilliantly Warm is sold directly to consumers. For them, it was a quicker way to ROI. And because it’s a consumer product, Brilliantly Warm is not subject to FDA med-tech regulations. 
• Work the web. Brilliantly has a robust website that sells the product and also offers content to help address some of the issues cancer survivors face: sexual dysfunction, medical bills, talking to kids about hereditary cancer, and living well after treatment.
• Start small.  Brilliantly began with small product runs, so the company was not sitting on large inventory. That gave them the flexibility to make improvements along the way based on customer feedback about product size, shape, and even color. 

The nitty-gritty

Breast cancer affects about 1 in 8 women in the U.S., and those women who have had a mastectomy and reconstructive surgery often feel cold because implants will actually act as a heat sink and pull heat away from the body’s core.   

Until now, women have had to create D-I-Y warming solutions, such as using chemical hand warmers or electric heating pads; these can result in discomfort, burns, and even melted implants, necessitating additional surgery. Therefore, safe temperature control was a critical product requirement for Brilliantly Warm. Once a setting is selected in the app, the wearable warms up, with three temperature settings and a built-in thermometer that ensures it never exceeds 111 degrees F. 

In the earliest stages of development, Kristen found herself in a data desert. There was virtually no market research about breast cancer survivors, no research to support the product for investors or even much research on women-founded businesses. * So she did what any enterprising entrepreneur would do: she built a database herself. Through what she terms “shameless networking,” Kristen talked to hundreds of women who had similar experiences and assembled enough anecdotal information to convince investors and customers and get the product off the ground. 

Turn anecdotes into science - by assembling a large body of anecdotal information and seeking constant feedback from the breast cancer survivor community, Kristen created compelling evidence of market need.

Use what you got – among the few nuggets of data that Carbone could find was that women have a 30% slower metabolism than men, that 80% of people are willing to use wearable technology, and that feeling warm and comfortable improves productivity, all of which strengthened her case.

Create a data feedback loop for your customers. Kristen talked to hundreds of breast cancer survivors and previvors. Through those conversations, she confirmed the need and recognized that the opportunity to help women feel better was much bigger than a single product. Through a wide range of content on the Brilliantly website, Kristen is connecting with the community of women navigating life after breast cancer with a curated resource of products, services, and information.

After a jump-start into the direct-to-consumer market, Kristen and her team are now three years into R&D with its flagship product, Brilliantly Warm. Though the company is still in the VC stage, the product is approved for HSA and FSA expenditures. Now, they’re exploring the efficiencies of the B2B market and insurance reimbursement.  And working on new applications for warming technology.

This is an inspiring story of by-the-bootstraps entrepreneurship. Give it a listen here <LINK>. You’ll be happy you did. 

*According to a February 2021 article in Harvard Business Review, only 2.3% of venture capital funding goes to start-ups founded by women.

Each year, millions of people in the U.S. require some sort of neurosurgery due to injury, disease, or genetic condition. They often undergo multiple procedures and face long, painful recoveries. This inspired Jesse Christopher to start tinkering with his kid’s toys in his garage, which was the beginning of Longeviti Neuro Solutions.

Starting from this humble beginning, Longeviti pioneered the development of a low-profile intracranial device platform in 2016, in partnership with Johns Hopkins: the first customizable platform to address a growing need for patients undergoing complex brain surgeries. Today the company is pioneering new solutions for brain surgeries and has brought several FDA-cleared implants to market.

In Episode 19, Andy Rogers talks with Longeviti Founder and CEO, Jesse Christopher, about the journey from garage to CEO’s office, and the data that helped along the way.

Need to know:

• Advocacy groups can guide innovation. Listen to physicians and patients to keep the user front-of-mind during development.
• Embrace the grind. Founding and operating a startup takes fortitude and trust.
• “Lean in” to the FDA. They’re receptive to questions, and can provide great insights, and resources. Also, check out FDA preceptorship programs. 
• Plan. Plan. And plan some more. Set a calendar each year so that planning is visible to all, while being mindful of this wisdom from heavyweight Mike Tyson, “Everybody has a plan until they get punched in the face.”

The Nitty Gritty

Longeviti’s Clearfit® disc implants are designed to reconstruct the skull’s natural contour after surgery, and allow for post-operative imaging using ultrasound, instead of more costly MRI or CAT scan procedures. Their InvisiShunt™ supports location and orientation while restoring the natural contour of the cranium for patients with conditions such as hydrocephalus. InvisiShunt is a single-use, sterile implant made to fit different areas of the skull. 

These devices are “windows into the brain” that allow doctors to monitor tumors, observe fluid drain, and to use ultrasound instead of more costly MRI or CAT scans for diagnosis and easy access monitoring (ultrasound imaging is not possible on an adult because of the attenuation abilities of the skull).

Of course, a lot of hard data went into the engineering and manufacture of these devices, including material selection, contour, and manufacturing specs. But the secret to Longeviti’s success so far lies in how the company has been able to manage” soft” data.

Market knowledge – before starting Longeviti, Jesse had 20 years’ experience in the field with a Fortune 300 company.

Company culture – in any start-up, you’re flying by the seat of your pants. But establishing a culture that fosters creativity, accountability, and open communication helps build a strong cohesive team. Humility helps.

Education – as with any new technology, real success lies in the ability to educate people about the use and the advantages of your device. Longeviti relies on several pillars:

• On-brand initiatives
• Physician courses, society meetings, and conferences
• Working with hospitals to “follow the dollars” 
• Patient advocacy groups, whose feedback can guide innovation

It’s a marathon run, gathering data to hit critical mass. But these grassroots efforts pay off in real-world terms: research that points to statistical significance, achieving standards, and getting all-important reimbursement codes. 

Investor relations – a start-up can’t survive without regular infusions of capital. So keeping investors happy–and focused on a success that may be years in the making–is critical.  Communication and transparency are the rules. It’s just as important to understand their need for revenue. Show them a path to profitability. Create multiple plans for success. Tell them where you see opportunities for growth. And toot your horn when you find pockets of success. 

Longeviti is a great story that truly captures the med-tech entrepreneurial spirit. And the discussion is chock-full of great info. 

Helpful Links:

 www.longeviti.com

www.hydroassoc.org/hydrocephalus/

Coagusense developed the first point-of-care prothrombin time/Internationalized Normalized Ratio (PT/INR) monitoring system for cardiac patients to help them maintain warfarin dosage within a therapeutic range. In the latest version of their device, they actually removed connectivity features to accommodate the needs of their older, less-tech-savvy self-testers. Therefore, they had to go back to the FDA with more bench data for re-approval. 

Andy Rogers talked with Mike Acosta, EVP/Head of Compliance at Coagusense, and later recapped some of the lessons learned with Senior Electrical Engineer Jake Cowperthwaite. Andy and Jake have an informative discussion about how to define performance requirements when you’re aiming for FDA approval.

Need to know:

• Make sure the performance requirement is objectively verifiable by a measurable test result, functional demonstration of performance, simulation analysis, and/or visual inspection.

• Plan for the number of prototypes you’ll need to create confidence in your statistics. Large companies may have their own internal mechanism to create a plan. Startups can consult with the FDA. 

• Understand the regulatory considerations for seamless FDA approval.  It’s a good idea to meet with the FDA prior to submission to outline your requirements. The earlier you have regulatory buy-in, the better.

The nitty gritty:

Rule Number One is to make sure that the performance of the device is objectively verifiable. For example, simply stating “the device shall be easy to use” is vague and subjective and won’t cut it with the FDA. 

Write your requirement in a way that can be verified through: testing and measuring results, a functional demonstration of performance, analysis via calculations or simulations, or visual inspection. A well-written requirement is specific with clear criteria, for example if your product was a pump, a performance requirement could be: “the aspiration pump shall have X flow rate within Y bounds”. If it meets that requirement, you’re ready to move on. Don’t over-spec.

Three things the FDA is looking for:

1. Above all, efficacy and safety
2. Accuracy
3. Is your device novel technology or based on a predicate device?

At the test bench, start with a good understanding of how many prototypes you’ll need to have statistical confidence in your results. Sample size will depend on the data needed; an on/off switch won’t require a large sample size, but testing with different operators – as with in-home devices – will need a substantial data set.

In some cases, it’s possible to short-cut the process early in development by testing multiple variables at once. This will yield a lot of data, which can then be analyzed. You’ll find some variables meaningful and others not, but understanding these variables and their sensitivity early in product development has great value and can save money in producing fewer prototypes.

USEFUL LINKS

https://coag-sense.com/about-us/

https://www.greenlight.guru/

Sexually transmitted infections like chlamydial and gonorrhea are making a comeback, especially with younger demographics. Part of the problem is the stigma of examination and testing. These are not trivial infections, and can result in more complicated syndromes, which could include sterility or issues reproductive health. Early, discrete, confidential detection is key. Today's guest is Dr. Anna Dixon. She's the Chief Technology Officer of Binx Health. Her company has devised a lab-on-a-chip solution that provides fast and accurate diagnosis of specific infections in thirty minutes. Providing non-invasive, rapid and accurate, point-of-care detection can have profound roles in advancing patient care, as well as decreasing the incidence of disease in a population. 

There’s nothing like finding a partner with a map when you're exploring new territory.

CoaguSense developed the first point-of-care prothrombin time/Internationalized Normalized Ratio (PT/INR) monitoring system for cardiac patients who have been prescribed warfarin. Their Coag-Sense® device monitors blood clotting rates and helps patients maintain rates within a therapeutic range. It’s designed for both professionals and patient self-testers. As with any MedTech device, there were plenty of regulatory hoops to jump through. So they looked for outside help and found it with Greenlight Guru, a company that provides an out-of-the-box electronic quality management system specifically designed for MedTech companies. 

Listen in as Andy Rogers talks with Mike Acosta, EVP/Head of Compliance, CoaguSense, and Wade Schroeder, Medical Device Guru at Greenlight Guru, to learn how outsourcing can facilitate speed to data and get you to market more efficiently.

NEED TO KNOW:

• Understand the market by getting users' feedback—what they want/need versus “if you build it, they will come.” Go out there and get that information.
• An outside partner can provide a built-in knowledge base.
• In the med tech industry, quality for the sake of compliance is no longer enough.
• COVID pandemic challenges have delayed FDA review time.

THE NITTY-GRITTY:

According to the FDA, about two million people in the United States take warfarin to prevent blood clots and to prevent stroke in people with atrial fibrillation, heart disease, or artificial heart valves. 

So CoaguSense was poised to capitalize on a large market. But as a small company with a new technology, the path to regulatory approval could have been long, tortuous, and costly. 

Greenlight Guru came to the table with a purpose-built platform that could manage all the quality, regulatory, clinical, and product development activities across the entire device lifecycle. And having the design control aspect upfront helps all the way.

Coag-Sense is now a market leader, and they’re working on a 3rd Gen simpler version to meet the needs of their older patients. Every step of the way, data drove the decisions.

Fast data. The Coag-Sense® meter directly measures clot formation in seconds. 

Procedures and templates from Greenlight Guru were audit-ready to align with regulations, including ISO 13485 and FDA CFR Part 820, and provide a traceable source of truth. 

Independent diagnostic testing facilities (IDTFs) can be used to manage call-in results from self-testers, even if a device lacks connectivity. 

Developing a “downgraded” next-gen version without connectivity for elderly patients 

The Gen 3 version of Coag-Sense actually has fewer bells and whistles in response to the needs of older in-home self-testers who are less tech-savvy. Here are the hows and whys:

Consider elderly patients' desire for simple devices - Many older people don’t have computers at home or are not savvy with smartphones; they don’t want or need connectivity. These patients are more commonly managed by IDTF’s who can manage self-testers.  

Build in time for FDA reviews - First, a Gen 3 FDA review is more challenging than a Gen 2  review. You’ll need to show more performance data: FDA wants to see data comparing operator to operator. In addition, the classic 30-day review for 510k is now taking almost a year, with older reviewers retiring and new reviewers coming on board. 

Be ready with a plan for post-market surveillance - IVDR - Capturing post-market surveillance data is required now and will feed back for potential improvements.

Find partners who continually evolve – CoaguSense partnered with Greenlight for an out-of-the-box solution for QMS & documents, but just as important for keeping up with what needs to be reviewed in international markets and traceability mapping too. 

It all adds up to one interesting discussion. Listen in. 

USEFUL LINKS:

https://coag-sense.com/about-us/

https://www.greenlight.guru/

As medical devices keep advancing, the consumables used in testing and therapeutics are moving forward as well, far beyond grandpa’s diabetes test strips. New semiconductors, circuitry, and sensors, along with automated production, bring a whole new spectrum of functionality within reach for consumables. 

The burgeoning at-home market is driving demand and the growth of body-worn therapeutics and delivery devices. But with new functionality comes new risks, and among the biggest risks is human error. To paraphrase Murphy’s Law, “Anything that can be misused, will be misused.”  

Complex consumables are our topic du jour. Mechanical Engineers Will DeMore and Andy Rogers engage in a far-ranging discussion of the ins and outs of consumables development, how to avoid pitfalls, and how to engineer your way to success.

Need to know:

• The critical importance of interfaces
• How to “goof-proof” your system
• Why user experience drives design
• Common pitfalls that slow development and increase costs

The nitty-gritty:

Consumable products, whether they’re for in-home or clinical use, fall into two categories: single-use, such as blood-test strips, or multiple-use, such as CPAP masks. Each has its own special considerations. But regardless of whether your device is single-or multiple-use device, a therapeutic device, testing device, or drug delivery system, interfaces are the areas where your product will succeed or fail. 

Interfaces are where you’ll encounter the most constraints and most complexity in design. For example, a body-worn consumable in a home setting has an interface between the device and user, the device and electronics, the device and its physical space, as well as the device and the digital world, i.e., smartphone app. 

Keep the user experience topmost in your mind and your design. It pays to put some time into “poka-yoking” your product. (Poka-yoke is the Japanese term for "mistake-proofing.") It can be as simple as a “This side up” sticker, color-coding, or creating a plug-in that only works one way, a la Apple.

Consider number and types of sensors needed. If you’re dealing with gases or liquids, you’ll need a reliable seal to prevent backflow and cross-contamination – preferably with haptic feedback – so your user knows when the connection is secure. For multi-use consumables, factors like ingress protection, cleanability, and durability, come into play. 

Depending on the type of device, you can upgrade interfaces at development or add them later. The important thing is to take a risk-based approach in your design. Think ahead and design to assembly to reduce time and scrap. Think about the cost vs. benefit of upgrades. And, of course, safety first. 

The bottom line on complex consumables, whether starting from scratch or adding new functionality to an existing device, is to look for places to add value. Optimize the user experience. Add new data or new connectivity.  Prompt the user when it’s time to re-supply.  The more you succeed in simplifying a complex consumable for the user, the more successful your product will be.

HELPFUL LINKS:

https://sixsigmadsi.com/poka-yoke/