Posts Tagged Clinical data
Medical Device industry has been facing enormous and unprecedented challenges during the last several years. Only now it is emerging from the dark tunnel of funding dryout, layoffs, and lackluster job scenario. The 2014 Wilson Sonsini Medical Device Conference reflected some cautious optimism based on recent uptik in the industry. The challenges are not gone but companies have learned to work with the complexities. The conference this year focused on understanding the challenges still facing the Medtech startups and the new strategies that are emerging as response to these challenges. The conference was a sold out event with 600+ attendees that included CEOs, venture capitalists, investment bankers, market analysts, and industry strategists. Below are the highlights from one of the panels.
Funding Strategies for Entrepreneurs
Dried up funding continues to be a challenges for medtech start-ups. This panel was moderated by Casey McGlynn, Partner, Wilson Sonsini Goodrich & Rosati. McGlynn said he is increasingly seeing companies getting funded, even PMA projects are getting funding. One of the strategies for PMA is to have a believable path to an existing market in Europe that will adopt the product. Building product is not the challenge, but for these, the regulatory approval process in the US, becomes a big hurdle. For bite size consumer facing, wearable type, or health IT projects, crowdsourcing could be a good strategy, said McGlynn.
The panelists included CEOs who shared their experiences in search for capital. The panelists also discussed how interests of the investors are changing.
Laura Dietch, President and CEO, BioTrace Medical, shared about the technology that emerged from the Stanford BioDesign program. BioTrace is developing a temporary cardiac pacing device to treat reversible symptomatic bradycardia, during general surgery for percutaneous valve procedures. This is a 510K device. BioTrace raised $3.5M from 5 investors. Dietch’s advice to the entrepreneurs? “You have to be tenacious, have good target partners, be willing to take a lot of rejections, be organized, and be creative. She also advised entrepreneurs to stay lean, whenever possible, have a physician on the team, and be clear from the beginning regarding the exit strategy.
Qool Therapeutics offers patented cooling technology to induce therapeutic hypothermia. This minimally invasive technology has applications in stroke, cardiac arrest, traumatic brain injury, sports injuries and so on. President and CEO, Beverly Huss shared how the company raised $1.5M from small investors that included COO at American Airlines, General Counsel at EBay, an executive at Dish Network and so on. She said these relationships were developed over the years. “Early stage investing is a labor of love and can come from people who believe in your ability to deliver on a technology they like”, said Huss. She also advised that entrepreneurs be relentless and follow every path and see where it takes them, and be open to learning the lessons from each path they pursue. What has changed is how we are bringing therapeutics devices to a consumer market, said Huss.
Dr. Daniel Burnett, President and CEO at TheraNova also talked about how the climate has changed. With his first company, they raised funding without any animal or human data; next company required huge clinical data and since then most companies need some human data, before money can be raised. TheraNova turned to corporations and also had 4 SBIR grants. Since 2006, Burnett raised or helped raise, over $95M for six venture-backed TheraNova spinouts, BAROnova, Novashunt, Velomedix, EMKinetics, Channel Medsystems, and Potrero Medical. For Channel MedSystems, he partnered with Mir Imran’s Venture Health Crowdsourcing platform. His advice to entrepreneurs was to be lean and mean and to focus on both cost saving and improved outcome. Burnett said he avoids PMAs. Angel investors have been beaten up badly and still recovering but he advised that entrepreneurs can go to crowdsourcing platforms like Venture Health or DealLabs.
Doug Wall, Managing Director, Volcano Capital talked about some of their portfolio companies. All in all, market for early stage investors is pretty lonely, said Wall. There was virtually no competition from 2009 to 2011 but that is now changing. There are some VC funds now taking an interest in early stage deals. Most successful companies are the ones that think outside the box. Answering the question regarding what would be more important market or people, Wall said, “we are flexible on market size, but most important thing to us is the management team, and then we look to see if the milestones are thoughtful, and if the team shares the strategy to be capital efficient”. He said, they avoid PMS entirely to mitigate the regulatory risk factors.
Posted by Darshana V. Nadkarni, Ph.D. in Big Data -Cloud -IoT-Software -Mobile -Entrepreneurship, Biotech - Medical Device - Life Science - Healthcare on February 27, 2014
Al Gicqueau, CEO & President at Clinovo talked about Cloud-based eClinical Systems to make clinical trial process more efficient and cost-effective, at www.bio2devicegroup.org event.
Cloud has been a big buzz word, significantly impacting the economy, in the last few years. Cloud is growing 3X faster than traditional internet infrastructure, said Gicqueau. Worldwide public cloud services market will total to over $73 billion, by 2017. There is also simultaneous cloud-bashing. According to Citrix research, majority of the Americans don’t understand it and over 51% think it has something to do with the stormy weather. Most also believe they have never used it but over 95% of us have used cloud based services.
It is therefore important to understand what constitutes cloud based services. There are 5 essential components of cloud based services.
Self Service, On Demand: Cloud based services are available, when the consumer needs them. Further, for the most part they are autonomous and the user can perform the actions without going through the IT department. They are easy to use and on-site training will increasingly become a thing of the past. Any training required has to be available on-line and has to be very short and for the most part the service has to be intuitive and should not require training.
Broad Network Access: Cloud based services provide a broad internet access. For instance, consider gmail. It can be accessed through desktop, laptop, tablet, smart phone etc. Cloud based services enable an ability to easily synchronize information over multiple devices.
Resource Pooling: Amount of traffic over the internet is rapidly growing. Because of the distributed nature of the internet, there is no single point of measurement for total internet traffic. But it is a fact that the total global IP traffic will pass the zettabyte threshold by the end of 2015. By the year 2017, the total internet traffic is expected to reach 5.3 zettabytes. To put it in perspective, if the 11 oz coffee on your desk equals one gigabyte, a zettabyte will have the same volume as the great wall of China! Cloud based services enable customers to pool their resources and save cost.
Rapid Elasticity: In the world of internet activity there are lot of peaks and valleys. Cloud can scale based on demand peaks, without incurring penalty for the period of low traffic.
Measured Service: Cloud offers and ability to pay as you go. People can pay for the internet infrastructure as they pay for electricity.
Some of the examples of cloud based services include, SalesForce, Netflix, Gmail and Amazon.
Clinical Data Trends
Spiraling costs have been a grave concern in healthcare. Typically, efficiency has not been very high in the area of healthcare. Costs of clinical trials is likely to increase even more significantly, in future, on account of increasing costs of medical research and changing and tightening regulations, among other things. Increased costs for clinical trials will push the cost of drugs higher. On the other hand, there is strong public criticism of higher costs of medicines and there is a lot of pressure on drug companies to contain costs. Companies have pressure to cut the middle layers and manage clinical trials on their own. Citing CISCRP (Center for Information & Study on Clinical Research Participation) study, Gicqueau said, currently, only 6% of clinical trials are completed on time, whereas 72% run late by over a month.
Compliance issues and regulations specified in 21 CFR, part 11, prohibit use of public cloud, for clinical data. Clinical data has to be stored in a private cloud. Clinovo’s ClinCapture is a cost-effective EDC (electronic data capture) system. It is tailored to specific clinical studies teams and offers intuitive navigation and one-click access to routine functions. It reduces time for data entry. ClinCapture is also flexible and can be customized and deployed rapidly. “We validate our software like medical devices are validated”, said Gicqueau.
Mobile is next major trend, as more data entries are happening through tablets and smart phones. Tables are also very useful in remote regions of the world where cell phone reception may be spotty or non existent, where information can be easily synchronized later. Data entries can also be structured by getting patients involved. Data integration is another big challenge. Everyone hopes to make sense of the data and make meaningful use of the data. However, making sense of the data and putting it to good use remains expensive. Gicqueau said, meaningful data integration is another promise of the cloud.
Clinovo is launching CloudClinica, next generation, cloud-based eClinical platform. With its easy to use, pay as you go platform, CloudClinica will eliminate IT dependency and allow small companies to manage clinical studies in a sophisticated manner, without high level programming skills. About 30% of cost and 60% of time associated with clinical trials is about data management, and almost 80% of clinical trials are still conducted on paper, said Gicqueau. Paper has many pitfalls. Paper can get lost, it is inefficient, there is challenge of mis-reading someone’s handwriting, it has regulatory risks and other hidden costs. CloudClinica is FDA compliant and it can scale.
Clinovo had revenues of over $4 million in 2013 and raised $500,000 from business angels over the last few months to execute on their business strategy. The company is profitable, and has 30+ clients that include Gilead, Roche and others. Clinovo is now targeting small to mid-size companies, said Gicqueau. Current market of $2.3 billion can be rapidly growing in the coming years. MediData and Oracle are two dominant players but are relatively more pricey. Clinovo’s CloudClinica will fill in the gap and broaden the use of eClinical systems and will empower and bolster the biotech, pharmaceutical, and medical device companies, said Gicqueau. The event was followed by Q&A.