Archive for category Biotech – Medical Device – Life Science – Healthcare
JP Morgan & #BiotechShowcase #Healthcare events 2023 – Major themes for the decade ahead
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on January 13, 2023
During JPM 2023 week, I attended #BiotechShowcase and observed and mingled at many receptions. I met incredible professionals in pharma, biotech, medtech, digital health and almost anyone working with anything to do with health or healthcare. I met VCs, CEOs, and others, witnessed all sorts of deal making conversations, sat in as attendee in investor panels and listened to media roundup.
From these observations, panels and conversations, here is my assessment from very inexperienced eyes – (please take it with a spoonful of salt).
Looking at the decade ahead after the transformational, post-pandemic phase……
- There is capital available for serious players in the field. Easy seed money may have dried up somewhat but there are many sources of funding available to entrepreneurs who can protect their IP, tell a good story, and back up their claims with data. There is still a great deal of hype and every entrepreneur claims to be working on the next company worth $4+ billion. But many investors want to see some serious revenue stream before putting down a check.
- I heard some discussions about the cost of healthcare. We spend a lot of money on healthcare and yet among developed nations, the USA lags behind. There will be continuing increased focus on providers to uplevel care. There was also discussion that we have had fewer curative solutions. My sense is that all these conversations means the industry is seriously focused on solutions that will elevate the quality of healthcare and indeed quality of life.
- Real winners in the decade ahead will be patients. Interesting innovations are happening in challenging areas of oncology to chronic diseases. In oncology, previously the focus was mainly on prolonging life by a few months, there are now discussions for more curative solutions. From diagnostics to transformative therapeutics, quality of life will be better for patients and longevity with better quality of life looks very likely.
- The innovation that is happening is fast paced and on the cusp of several disciplines. The advantages in technology and participation of previously non traditional medtech players like artificial intelligence and machine learning is enabling biotech, medtech and healthcare and facilitating these slower disciplines to evolve rapidly. Remote work, collaborations via zoom and other technologies have broken down silos even further and have facilitated for people from diverse disciplines to come together with ease and without many hurdles.
- Mental health will be a serious aspect of overall healthcare. However, mental health offers an entirely different set of challenges. I will mention three challenges here – insurance reimbursement, objective markers of mental health, integrating service with solutions – 1) The insurers need to step up reimbursement for mental health. Advantages of good mental health in reducing overall costs are increasingly becoming clear and savvy entrepreneurs have been making that case. The payors have yet to step up to impact innovation, although VA is leading in innovation in the mental health arena. 2) Companies may need to come up with objective markers of good mental health – for instance, differences in behaviors, voice, routine maintenance etc. Markers for health are easy – a patient’s blood sugar or BP goes down or does not. However, objective markers of mental health are not yet clear and that clarity will enable more payors to step up for reimbursement. 3) There is also difference in therapeutic solutions. For instance, for a patient with diabetes, once a solution is provided, a patient can be counted upon for measuring blood sugar levels and taking necessary medication. Even then adherence is sometimes an issue. But among mental health patients, that can be much more challenging. Frequently, patients fall off the routine and then have epileptic seizures, repeat attacks of psychosis and during those times, they cannot be counted upon to administer the medications themselves. So companies working on drug therapies for instance, may increasingly need to integrate service with therapeutic solutions and bridge the gap.
- We may likely see foundational changes among regulatory agencies like FDA and in the regulatory framework. As mentioned above, increasingly innovation is happening on the cusp of various disciplines. Much of the regulatory framework has not kept up with these changes and in the years ahead we may likely see brand new, better, tech savvy regulatory agencies and frameworks.
Time to fasten seat belts and get ready for some of the most exciting changes yet to impact quality of life for patients, increase longevity and offer better quality of life overall.
How Deception Technology is changing the rules of the game against cyber security attackers
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on September 9, 2022
Tushar Kothari, CEO of Attivo Networks will be speaking with moderator, Naveen Bisht, at TiE Silicon Valley’s #MyStory event on September 13 at 6:30 pm where Kothari will share his inspiring journey as an entrepreneur in the game changing world of Cyber Security and Identity Threat Deception technology.
The term “game changing” is used frequently in the sometimes over hyped, entrepreneurship world. But as attacker become more creative, fast and increasingly malicious, cyber threats can cause unprecedented levels of damage and cyber deception technology literally changes the rules of the game, gaining an upper edge on the attackers.
Deception technology actually entices attackers to interact with false IT assets and helps security teams to detect, analyze and defend against advanced threats. These technology solutions deceive attackers with traps and decoys and lures them in with an aim to collect information about their tactics. Until now, most solutions have aimed to minimize damage after the attack. However, deception technology helps improve preventative security controls in real time.
Kothari says, at Attivo, “we are are a company focused on detecting threats in a network with particular focus on lateral movement and privilege escalation detection and prevention. We have the industry’s best deception fabric, end to end. We can project decoys throughout the network in a very effective way and we have added focus on credential and identity protection.
Three key pillars of Attivo technology are, to provide visibility to their customers on all credentials and identity from endpoint and active directory throughout infrastructure, help customers reduce the attack surface, by eliminating exposures, and to help protect them if someone goes after an identity threat. Attivo claims to have the most comprehensive and effective portfolio in this area.
This will undoubtedly be a fascinating discussion. Register free of cost at the link below https://hub.tie.org/e/my-story-featuring-tushar-kothari and more see more information at http://www.tie.org .
Our universe may be about to transform – With Metavarse, NFT, Cryto, Web3
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on April 28, 2022
While many of us are still trying to wrap our heads around the new terms that have multiplied in the last few years like blockchain, data, IOT, artificial intelligence, and machine learning, our lexicon is about to expand much more significantly. With words that are rapidly gaining significance like Web 3, Metaverse, NFT and crypto, it is not just our lexicon that is changing but a huge transformation is looming on the horizon that can well impact every aspect of our lives. We can safely assume that in the coming couple of years, we could be laying some new foundations transforming how we buy, sell, trade and conduct every aspect of our business.
At TiEcon 2022, an entire track dedicated to Web 3, Crypto, and NFTs is guaranteed to give us fascinating insights into the industry in which Venture Capital has invested over $50B in 2021.
The track at TiEcon will begin with fireside chat with Randi Zuckerberg, former director of market development and spokesperson for Facebook and as of 2014, founder and CEO of Zuckerberg Media. She is also editor-in-chief of Dot Complicated, a digital lifestyle website, and creator of Dot, an animated television show about a young girl who uses technology to enhance her education experiences as well as her recreational activities. At its simplest, Dot is an entertaining guide to understanding how technology and social media influences and informs our lives online and off. At its more complex level, we need to understand metaverse and NFTs. Broadly speaking, Metaverse is a graphically rich virtual space where people can work, play, shop and socialize and can interact through NFTs or non fungible tokens. Non-fungible meaning unique and can’t be replaced with something else. For instance, while bitcoin is fungible and one can be replaced with another, NFT is non fungible – kind of like a unique trading card. That is as much sense as I can make. Besides, I am not about to give my readers a headache. We will leave it to zuckerberg to demystify it further.
In another fireside chat, Sandeep Nailwal, co-founder of Polygon will talk about “building a Web 3 decacorn”. Web 3 is an idea for a new iteration of World Wide Web based on blockchain technology. Arguments have been made in favor of Web 3 that it will provide increased data security, scalability and privacy. And on the other side, concerns have been raised about possible increase in proliferation of harmful content, in an environment of low moderation. Polygon tagline says, it’s for everyone who wants to contribute to a decentralized future! Let us hope he helps us further in coming up to speed on what may be a fast approaching future.
After attending Harvard and Stanford, serving in finance roles at the Federal Reserve and Goldman, managing P&Ls at two consumer startups, and founding two startups of her own, Mercedes Bent joined LIghtspeed Venture firm in 2019 and now scouts funds and invests in early stage companies that are “unlocking wealth creation for underserved individuals and regions through crypto, fintech, career mobility, or the creator economy”. She will share her insights as a track keynote.
Exciting panel with Lorien Gabel, co-founder and CEO of Figment, Shiva Rajaraman, VP of product at Open Sea, Raghu Yarlagadda, co-founder & CEO of FalconX and moderator Rashmi Gopinath, General Partner at B Capital Group will talk about the next era of Web 3. It sounds like the future of the future that we will get to learn about.
“Gaming and the next billion Web 3 users” is the topic of another fireside chat where Justin Kan, co-founder of Fractal (formerly co-founded and sold Twitch) will share his insights on how Web 3 is poised to transform the gaming ecosystem.
Lastly, a panel will discuss funding and founding Web3 Startups. Moderated by Asha Jadeja, founder of Motwani Jadeja Foundation, the panelists Avichal Garg, Co-founder of Electric Capital, and Elena Nadolinski, founder/ CEO of Iron Fish will share insights, and discuss opportunities and challenges and tools one may need to navigate this fast-evolving decentralized world.
Register ASAP for #TiEcon2022 at www.tiecon.org and avail of the opportunity to listen to the entire conference virtually on zoom.
Sustainability & Profitability can co-exist with Entrepreneurial Creativity
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on April 21, 2022
Wendell Berry had said, “the earth is what we all have in common” and sustainability isn’t a debate anymore, it isn’t a choice either; increasingly, acting on it with urgency is an imperative. On this #EarthDay2022, it needs to be mentioned that if we act on it with urgency then that the future of our planet may look green in more ways than one. Sustainability is emerging as a big business opportunity, attracting hundreds of billions of dollars in startup and investment capital and in 2022, growth is likely to accelerate.
The topic of climate crisis will be tackled head on at #TiEcon2022, the largest virtual #entrepreneurship conference to take place in May, 2022. Register ASAP to avail of free registration for the entire exciting conference. Opening keynote for sustainability track will be given by Dr. Ali Nouri. Dr. Nouri leads the Office of Congressional and Intergovernmental Affairs as an Assistant Secretary in the U.S. Department of Energy. Following the previous climate crisis denying President, Nouri as part of Biden-Harris administration, will lead the charge on tackling the climate crisis and helping shape policies towards building a clean energy future. It will be exciting to hear his thoughts and to know what we can anticipate in terms of new climate policies.
After working as Climate Editor at Tech Crunch, Johnathan Shieber has joined FootPrint Coalition as chief editor and venture partner. In fireside chat, we hope to hear from him many creative ideas on the planet’s various challenges, including getting microplastics out of the ocean, reducing pollution and more. FootPrint Coalition backs a wide array of projects to promote the development and adoption of technologies and services aimed at solving some of these kinds of most pressing problems. With both its non-profit initiatives and for-profit arm, FootPrint seeks to change the trajectory of our society through creative storytelling. As companies are discovering that sustainable change towards the planet’s sustainability must consider the economy, society, and the environment, we will be required to think outside the box and tackle the challenges with creativity and resourcefulness and I can’t wait to hear his thoughts.
Chief Product Officer at Turntide Technologies, Brad Surak will share his thoughts on how creative use of technology can not only help sustainability and do good for the world but can also help decrease the company’s carbon footprint and operating costs and can open up new revenue opportunities.
Sustainability track’s closing keynote will be by Dr. Jennifer Holmgren, CEO of revolutionary carbon recycling company LanzaTech. The company’s process converts carbon waste from industrial smokestacks, agriculture and landfills into ethanol that is used by its partners to make a slew of products from packaging to perfume to dresses. Over its dozen years, LanzaTech has grown into a carbon recycling powerhouse and with its recent announcement to go public, the company is valued at around $2.2 billion.
Don’t miss this exciting track. Register at @TiEcon for #TiEcon2022 virtual conference. Some free registrations are available, thanks to the sponsors.
Data Readiness in Healthcare to Unlock AI Potential
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on April 16, 2022
What Is Data Readiness? In simple language, it consists of all the tasks required to ensure that artificial intelligence (AI) platforms learn from reliable and relevant data sources.
What is the state of data readiness in healthcare? According to a recent report, lack of data readiness is preventing healthcare leaders from driving rapid, effective, measurable and sustainable transformation and this impedes their ability to execute.
Over 90 percent of healthcare executives mention prepping for data readiness as their top priority. A vast majority of them are planning to invest in technologies designed to improve data readiness and support systemic interoperability. According to the report, in addition to financial issues and staffing capacity crunch, interoperability is another issue that is blocking innovation. Interoperability is key for a seamless transition achievable through unlocking the full potential of artificial intelligence (AI) in healthcare.
As in financial, auto and other industries, AI is expected to have a huge impact on health care delivery, access and on financial and clinical outcomes in health. Healthcare as an industry transitions to newer systems at a much slower pace. Tendency is to pour money into older technologies that tend to create more data silos, as remarked by Abhinav Shashank, co-founder & CEO of Innovaccer.
The crisis is so acute and the promise of closing the data readiness gap to realize the full potential of digital transformation is so immense that it is imperative to act on it.
An exciting panel at @TiEcon2022 moderated by Chris Waugh, Chief Innovation Officer at Sutter Health with panelists Prat Vemana, Chief Digital Officer at Kaiser Permanente and Abhinav Shashank, Founder & CEO at Innovaccer will address the challenges and opportunities of data readiness in healthcare and the promise it holds in enhancing industry collaboration to improve outcomes and reducing costs.
Register ASAT at www.tiecon.org to avail of early bird incentives.
Science making the impossible, possible!! Albert Bourla – grand keynote at #TiEcon2022
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on April 12, 2022
I am eagerly looking forward to the opportunity to hear Dr. Albert Bourla give a grand keynote on Day 2 at #TiEcon2022 in May at Santa Clara, CA.
As Chairman and CEO, since 2019, Dr. Bourla has led Pfizer through one of its greatest challenges when the world was looking to scientists and pharmaceutical companies for answers to the sudden calamity represented by covid. In a rare mode of cooperation and unprecedented speed, scientists began furiously working for a vaccine. However, their work was also proceeding against a backdrop of political drama that was unfolding in the USA.
Very likely scientists and leaders of pharmaceutical companies had no interest in maneuvering the political minefield and yet it became unavoidable when Mr. Trump predicted a breakthrough vaccine before Election Day. News of Pfizer’s success however, only arrived right AFTER the election was called for Joseph Biden. The story of Pfizer and its research partner, the German firm BioNTech, both of who declined the money from the federal effort, “Operation Warp Speed” and Moderna who accepted the money from the Government that was led by science denying President Mr. Trump, unfolded against the backdrop of politics, science, and incredible high stakes for humankind. The resulting accomplishments by these companies and others are as fascinating as they are impressive. Bourla was awarded the 2022 Genesis Prize for his leadership in the development of the Pfizer-BioNTech Covid 19 vaccine.
During his 25+ years at Pfizer, Bourla has emphasized his commitment to help ensure equitable healthcare access to medicines and patients. However, Bourla also opposes government interference in pharmaceutical pricing, which he has argued would hamper spending on development of new drugs. As per a recent RAND Corporation report, US prescription drug prices are higher than in most other countries. The Biden Administration released a plan to decrease prescription drug costs covered by the Medicare program, and later dropped the initiatives, after objections from some key Democrats. Bourla has observed that drug prices are in fact going down and more importantly, drug prices are only a small portion of the overall US healthcare spending.
It will be fascinating to hear Mr. Bourla speak on these and other health and healthcare related issues at TieCon2022. During covid challenges, when many prayed as never before for the lives of their loved ones, world also realized that besides the divine, our next best hope for better life rests in the hands of #science.
Register ASAP for the #TiEcon2022 conference at @TiEcon www.tiecon.org to access early bird incentives.
Armon Dadgar, CTO – HashiCorp: Enabling Innovation
Grand keynote: Armon Dadgar, CTO- HashiCorp – Enabling Innovation
Preparations are in full swing for #TiEcon2022 at Santa Clara, CA in May, 2022. Among an exciting lineup of speakers and panels at this largest entrepreneurship focused conference will be Armon Dadgar, CTO & co-founder of HashiCorp giving a grand keynote on day 1.
HashiCorp is one of the fastest growing tech companies in the cloud and DevOps space. With its open source tools, Hashicorp supports the development and deployment of large scale service oriented software installations and enables companies to deliver applications faster. Each tool focuses on specific stages in the life cycle of a software application, with a goal towards automation.
With a range of products like Terraform, HashiCorp Vault, HashiCorp Nomad, and HashiCorp Consu, it has truly emerged as a company that enables innovation. Highly respected by the developer community, Hashicorp is a prominent open-source promoter and is also a leader in all remote working practice.
Armon Dadgar says, as CTO at Hashicorp, he combined his passion for security and distributed systems and their applications to solve real world problems, through the world of DevOps tooling. In early childhood, when children were still leaving cookies for Santa, Armon begged his parents to get him a coding book for Christmas. His parents also gave him a box set of .NET kit and he used it to build games like Tetris and Tic-Tac-Toe.
The secret of Dadgar’s success seems to be in the way in which he puts himself in the shoes of the user community. Speaking of the transition from writing code to managing people, Dadgar says, “making the shift from IC-land to manager land was a tough one”, but it helped to internalize that “I can only be so effective with just two hands at a keyboard. But if I can train 10, 20 other people to think the way I do, or to apply the same design principles, then it’s like I have 20 hands at the keyboard”.
Initially, Dadgar says he felt he knew the system better than anyone else, that he would think about edge cases, he could be the code reviewer, but at some point, he realized it wasn’t practical. Then a new realization set in that after all software is malleable, it can be fixed, it’s not set in stone. That seems to be a key leadership skill that is constantly called for when one leads and manages people.
Register for TiEcon2022 at @TiEcon at www.tiecon.org .
Future of Capitalism where People Matter
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on March 15, 2022
At #TiEcon2022 the largest #entrepreneurship conference taking place in Silicon Valley, the theme this year is Imagination Unleashed. After all entrepreneurs are visionaries and dreamers who take tiny grain of an idea and often grow it to unleash a force for something much bigger and often better. As in previous years, this year also there will be opportunities to listen to incredible speakers, panelists and thinkers like the amazing 2021 keynote speaker, Adena Friedman. She once said, “new products, new markets, and new ways of doing things are the lifeblood of growth” and no one would know it better than Adena Friedman, currently serving as the President and CEO of Nasdaq Inc. It is worth repeating the known fact that on the world’s first electronic exchange global marketplace for buying and trading securities, most of the world’s technology giants are listed on Nasdaq and at least half of the American adult population invests directly or indirectly in the stock market through brokerage accounts, retirement or savings vehicles.
After graduating from Vanderbilt University, Friedman’s professional journey began at Nasdaq in 1993, where she served as the Head of Data Products and Chief Financial Officer. She left Nasdaq and joined the reputed private investment firm, The Carlyle Group as CFO and MD in 2011 and then returned to Nasdaq in 2014.
In 2019, Friedman gave a TED talk titled “What’s the future of capitalism?” Capitalism is an economic system where private citizens own industries or companies, rather than the Government. And in that way, it is the will of the people that decides the fate of commercial ideas, worthy of investment. Friedman asserts that capitalism is intricately tied to our freedoms.
While capitalism has indeed done a great deal for humankind, capitalism is also blamed for many financial disasters and inequities. According to a recent Edelman report, persistent and rising inequality can unbalance a society over a long term, as people lose trust in the institutions and experience a sense of injustice. And in the end, capitalism doesn’t work for anyone if it doesn’t work well for the working middle class. More recently, ideas have emerged to alter capitalistic systems in varying forms such as “conscious capitalism”, “inclusive capitalism” and more.
Friedman asserts that capitalism works well in lock step with healthy governance that fosters, a) healthy competition through regulations and incentivizing small businesses, b) prioritizes societal benefits like clean energy through regulations and c) government itself makes investment in areas of societal benefits like broad based education, healthcare, defense. Friedman further asserts that in a well balanced system, capitalism offers a platform for the buyer and seller to come together for “price discovery” through a dialog, in an efficient manner. She believes that if we can level the playing field then we can create markets of tomorrow for people, with people and for the benefits of more people.
Exciting keynotes, speakers and panels are lined up for #TiEcon2022 – Please register at www.tiecon.org .
EO Sterilization for Medical Devices
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on March 2, 2022
A panel at www.bio2devicegroup.org discussed Ethylene Oxide (EO) Sterilization of Bio/Medical Devices on Tuesday, March 1, 2022. The panel consisted of Denny Christensen, CEO of Sterilization Validation and Consulting, Michael Anderson, Site Director at Infinity Laboratories, and Sam Sohal, President of Test-O-Pac Industries and EO Sterilization.
EO sterilization was discovered in 1928 and used as an insecticide in hospital rooms. In the 1940s, EO began to be used to sterilize spices and food preservatives. However, in 1948 it was found that EO could potentially cause cancer and that rang some alarm bells. But it was eventually found that the risk was miniscule in the amount used.
Currently EO sterilization is used in 50 percent of medical devices. In fact, EO has become a dominant method for sterilization of all disposable medical devices. FDA has been investigating alternative gas methods for sterilization but we are not closer to finding anything that can replace EO in the short term.
EO is a valuable compound and is very versatile. Over 17 million tonnes of EO is produced annually, worldwide. EO is used in antifreeze, heavy machinery, acrylics, plastics, glue, paper, fabrics, carpets, polyester, cosmetics and more. EO also plays a massive role in sterilization of medical devices. There are two primary factors that drive its usage for medical devices. First, EO is consistently compatible with the majority of other materials and second, it can be performed at low heat. Other vaporized gas materials are often not compatible with cellulose, paper etc. For many medical devices, sterilization with Ethylene oxide may be the only method to effectively sterilize a device without causing damage. Medical devices made from certain polymers (plastic or resin), metals or glass or those that have multiple layers of packaging or hard to reach places like catheters are likely to be sterilized with ethylene oxide. Additionally, other gas alternatives are challenging to scale up because they can’t be effectively packaged in cardboard and shipped to various locations, with ease.
EO is regulated and controlled by FDA and EPA and shutdowns sometimes lead to shortages. There is a need for public information and there is need to balance use of EO with public and environmental safety. EO is an effective sterilization method and we will continue to need EO sterilization since there are fewer other efficient alternatives.
It is also important to understand how EO can be used more effectively in medical devices. Four active ingredients required to deliver a successful process are: heat, humidity or moisture, gas concentration and time. Achieving a high sterility level reduces the chance of microbes and resulting infections. Additionally, EO sterilization companies need to have open communication with the designers of medical devices. Earlier medical device companies start thinking about sterilization, the more they can take full advantage of optimum sterilization process that in the end saves time, resources and helps the public and environment by achieving optimum sterilization with less exposure.
In summary, it was mentioned that state of the art technology will continue to evolve and enable fine tuning of sterilization cycles. Additionally, better planning and early communication between device engineers and sterilizers and consideration of the sterilization process in the design phase will mean fewer sterilization challenges later. Also important is communicating to those handling the devices that thorough cleaning of these devices prior to sterilization is of immense importance in helping minimize risk of infection through unclean devices.
Making Surgeries Safer
Posted by Darshana V. Nadkarni, Ph.D. in Biotech - Medical Device - Life Science - Healthcare on January 30, 2022
Recently Dr. Stuart Mitchell gave a talk at www.bio2devicegroup.org zoom meeting on “Making Electrically Stimulated Surgical Devices Safer”. Electrically stimulated surgical devices are now ubiquitous, said Dr. Mitchell. Some of the large players in the electrically stimulated surgical device space are Ethicon holding the largest market share, followed by Medronic, Olympus, Hologic, and Conmed. There are many such devices in use but two of the most dominant types are RF devices and Harmonic devices. Radio Frequency or High Frequency devices are the most common type of surgical units on the market. They transform mains current into HF current. One such device Bovie is used to incise tissue, destroy tissue through desiccation, and to control bleeding by causing the coagulation of blood. The harmonic device is used to simultaneously cut and cauterize tissue by using ultrasonic vibration to generate mechanical friction at the active blade site.
Sharing the history of electrically stimulated surgical devices, Dr. Mitchell began with the fact that despite many hazards in the usage, surgical devices though not perfect, often make surgeries easier, faster and lead to lesser post surgical complications. It is an accepted truism in surgery that the time a patient spends under anesthesia, the better the outcome and electrically stimulated devices vastly lessen the time spent in the OR.
However, 33% of surgeries result in complications. In the USA alone 16M patients experience surgical complications and 49% or nearly half of those are avoidable complications of which 77% were due to technical errors. Nearly 1 out of every 200 uses of RF devices result in severe burns or fires and that number is as high as 80,000 patients per year. And sometimes this impact goes beyond the patients and affects medical personnel as well.
Of great concern, among the complications caused with these devices, are fires, burns, and smoke.
One out of 200 uses of RF devices result in severe burns or fires. That affects 80K patients per year. Sometimes the fires affect medical personnel. Sometimes smoke causes the images to get blurred and impairs the ability of the surgeons to see clearly. Smoke can also create other health hazards post surgery, including toxic gas buildup, viruses, bacteria etc. There are now smoke evacuators available. However, that becomes one more equipment to be used in OR and the compliance can be low.
Some surgeons simply refuse to use electric surgical devices for certain procedures, due to these complications.
Dr. Mitchell then shared about their company, Novuson’s range of surgical devices. Novuson’s Direct Therapeutic Ultrasound technology potentially can vastly improve surgical outcomes. DTU offers a range of next gen advanced emergency electrosurgical devices. These are electrically neutral, and they are effective in blood or liquid, cause no burning or charring, do not create smoke, and lead to considerably less thermal damage. Dr. Mitchell played a couple of videos showing how the device works. These devices can be used for all surgical procedures including for open, robotic, minimally invasive surgeries and lead to smaller scars, improve precision, speed and control and are far safer.
This exciting talk was followed by Q&A around the regulatory pathway ahead for various Novuson devices.