So if Lilly’s CEO John Lechleiter says Indiana needs to establish a world class research institute for life sciences, should resources in the state make it happen?
I’m still thinking about this, to be honest. Should Indiana play in the life science research space? Does the state have the right resources to make this successful?
You can read more of his comments at MedCity News.
Seems like a knee jerk reaction to me. But I’m just a medical device guy–not a pharma guy.
Pete Yonkman of Cook Medical speaks about the impending 2.3% medical device tax and its impact on Cook. He also shares some thoughts about the potential affects of increased regulation.
UPDATE: I just came across another interview with Pete Yonkman on this topic and thought I’d share:
July 31 is approaching quickly but still not here yet. That means you still have time to submit your application to the BioCrossroads Venture Competition. This is a contest for emerging life science companies and technologies.
You do not need a complete business plan to apply. In fact, the application process is pretty straightforward and does not take make time at all (I know because we applied for UniDoc).
If you are selected as a finalist, you will have to submit a business plan by August 24, 2012. The winners will be announced at the October 22, 2012 Indiana Life Sciences Summit.
Is it worth applying? First prize $25K. Second is $15K and third $10K.
There are quite a few interesting medical device related events throughout the Midwest, many in Indianapolis, in the month of July.
Check out the CQ Events page for all the details.
Do you have a great med tech idea and need someone to fund it? Perhaps BioCrossroads can help you with your venture.
BioCrossroads Inc. has raised an $8.25 million seed fund in its second attempt to help fledgling life sciences companies grow to the point where they can attract venture capital or a corporate funder. The Indiana Seed Fund II LLC was kicked off in late 2010 when Eli Lilly and Co. agreed to invest. Also chipping in are Indianapolis-based health insurer WellPoint Inc., Indiana University’s Research Technology Corp., Purdue University, the University of Notre Dame, the Richard M. Fairbanks Foundation and BioCrossroads’ own for-profit arm.
“It takes a long, long time in many cases to get these companies where they need to go,” says BioCrossroads President and Chief Executive Officer David Johnson. “This fund is designed to coax researchers who have always wanted to do this, to think big, to take a big risk and know there are going to be other people there to meet them halfway and invest in the company they’re trying to get started.”
“The market can be a very cruel place, and there are a lot of good ideas that wind up dying for lack of funding,” says Joe Hornett, leader of the Purdue Research Foundation (PRF), which funds the school’s research efforts, ”I hope some of those good ideas that, otherwise, might wind up on the laboratory floor now make their way into the marketplace, and indeed, into the lives of consumers—particularly in the life sciences market, where health is improved and lives are saved. It’s absolutely critical.”
So, no more excuses. If you have a great idea, there are people who are willing to help you make it a reality.
Bloomington, Indiana, has one of the most significant clusters of medical-device and life-science companies in the nation. Bloomington is home to industry giants such as Cook Medical, the world’s largest privately held medical device maker, which specializes in minimally invasive surgical devices that allow doctors to operate on patients who are too high-risk for major surgery.
Also in Bloomington is the startup Morris Innovative, which has designed an FDA-approved medical device that uses a futuristic new bio-tissue (created by Cook Biotech) to help patients heal faster.
Other examples of innovation abound: Indiana University pediatric surgeon Mark Rodefeld has invented a tiny pump that keeps a newborn’s blood oxygenated while surgeons repair the heart of a child born with a single ventricle. Aeon Imaging has developed a laser-scanning digital camera that uses near infrared light to see past cataracts and detect underlying eye diseases.
I live only 20 minutes from Bloomington, and have lived here for most of my life, and I am ashamed to admit, I had no idea.
Indiana’s longest running networking and informational forum for topics across the life science spectrum.
Click here for more details.
In my quest to understand product development, I thought I would start at the beginning, literally, with startups. I recently did an interview with Tiger Buford. Tiger has over 25 years of medical device product development experience.
What makes a startup successful?
Lise, this is a big question, but I’ll give it a try. There are many many ingredients to a successful Medtech startup. It’s like a complicated gourmet dish. If any one ingredient is wrong it will bring the entire meal down. From my experience, all of the successful startups have practiced some or all of these principles:
What is one piece advice you would give to a startup company?
The most important ingredient is the management team. VCs are known to invest in teams, not technology. The management team should be made up of people who can wear many hats and who thrive in chaos and uncertainty. And also, having startup experience with either a success or failure (it doesn’t matter which), is a big plus.
What are some of the challenges that startups face?
Money and Time. This is a double whammy because they are directly affected by each other. Today, Medtech startups are requiring more money and time to reach value-adding milestones because of longer regulatory pathways, smaller funding increments, and longer horizons to exit. Since the credit constriction in 2008, we have all seen the available investment funding shrivel up. There is less investment available for the same number of Startups. Keep in mind that startups don’t have income, but they have a finite barrel of money. The sole purpose is to reach a value-creating event (e.g.: regulatory approval, First-in-Man, etc) before the barrel is dry. If the event is reached, more incremental funding may be available.
Regulatory approvals. Under this administration, the FDA has become unreasonable, unpredictable and not driven by objective science. This unpredictable behavior by the FDA is challenging the business plans of Medtech startups and VC investors. More years are added to the FDA path each year for the same technology. Experts estimate that a startup must spend $90M to get through PMA approval for a Class III device today. Few VCs have the tolerance for this.
By contrast, the EU Regulatory bodies are reasonable and predictable. Therefore, all startups pursuing Class III devices are going to Europe first for regulatory approvals and clinical studies. Many Class II device startups are going to Europe first also. I really wish someone would document the number of Medtech companies fleeing to Europe, because there is a silent exodus happening right now.
Tell me about some of the startup situations you have been involved with.
I jumped into the startup world in 2008, after a successful career in three large Orthopedic device companies.
My first startup experience was VC-funded startup called NovaLign Orthopedics in Memphis. NovaLign was spun out of an incubator in Atlanta called The Innovation Factory. I was the 2nd hire and had a large voice in the business. The technology that the company was based on was “dead on arrival”. So, in my first month on the job, with the Board’s blessing, the CEO and I scrapped the technology and started over. 12 months later, I had saved the company with a completely different technology and IP that addressed the same unmet market need. During this 12 months, I also transitioned the company from outsource R&D to insource R&D as hired the engineering talent.
My second startup experience was Angel-funded startup called Active Implants with the corporate offices in Memphis. I was brought into to lead the Israeli-based team from a Research-focus to a Development-focus. They did a great job in bringing a game-changing polymer meniscus replacement from Research, through Development, and into Manuf8acturing and Clinical Studies in Europe. After a CEO change, the company is now moving its headquarters to Europe. I am helping out during the transition.
Thanks for sharing your information and experiences, Tiger. This certainly helps me to better grasp what is involved with “starting up” a medical device company.
Stay tuned for further blogs on the product development subject as I continue my research…
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I’m new to the medical device industry, and the more research I do, the more I find out I don’t know. Did you know that Indiana’s medical device industry is the fifth largest in the U.S. according to a report recently released by BioCrossroads? According to the report, the medical devices industry is one of Indiana’s most valuable economic assets employing over 20,000 people, and generating more than $10 billion of annual economic output. The medical devices sector accounts for more than 40 percent of the jobs in the state’s life sciences industry placing Indiana as the fifth largest state in percentage of medical technology industry employment.
What amazes me is the fact that I was basically oblivious that this industry existed until I became involved with a medical device product development company. I was born in Indiana and raised here until I went off to college, at which point, I lived in South Carolina for awhile, and then Maine. When they found out where I was from people would say to me “I’ve driven through Indiana, but I never actually stopped there.” Folks would often ask me, “Why would you want to live in Indiana? Is there anything to do there?” At the time, I really didn’t have an answer for them. That was the same point in my life where I swore I would never move back to Indiana. Somehow, fate brought me back here sixteen years ago, and now I can’t imagine living any place else. Besides family and friends, now I understand that, although many people may picture the state as a giant cornfield with little to do but tip cows, go to tractor pulls, and hang out at the mall, we really do have a vibrant industrial sector that people from around the country are proud to become involved with.
Worried you’re going to retire and have nothing to do? Perhaps you can pull yourself up to the computer and whittle away the hours…
Researchers from North Carolina State University’s Gains Through Gaming laboratory have found that playing the massive multiplayer online video game World of Warcraft (WoW) appeared to boost cognitive functioning in older adults. The researchers hypothesized that playing a cognitively complex game such as WoW, which requires multitasking and extensive use of a number of cognitive skills such as map reading, planning and tracking of multiple status indicators, could boost the cognitive performance of the elderly.
My mom spent the last six years of her life in assisted living facilities and nursing homes. It seems that the inhabitants, including my mom, spent most of their time sitting around and staring into space or sleeping. It makes sense that it would be more productive and beneficial for them to be engaging in an activity in which they have think and plan. Although, I am left to ponder, do I really want grandma to be “witnessing zeppelins flying over smoldering battlefields, facing the mighty Dragon of Blackrock Spire, and cleansing the undead from the looming ziggurats of Stratholme?”
The effects of stress on health have been a main focus area for public health research, but progress has been limited due to a lack of wearable sensors that can be worn effectively in the field, until now. Researchers at Ohio State University recently analyzed wireless, wearable sensors that are a part of a system developed by AutoSense. The system’s sensors effectively collect and processes cardiovascular, respiratory, and thermoregularity measurements that can inform about the general stress state of test subjects in their natural environment.
Will this change the way stress is analyzed in the future? Perhaps. However, I’d like to see it in a nice girl-cut t-shirt. I always say “A woman should never sacrifice fashion for comfort”, or in this case, stress management.
It defies explanation that an artificial heart that doesn’t actually beat would be functional. Even more amazing, one of these beatless hearts was actually implanted in a man who was dying from amyloidosis and had no other options. The operation saved his life, although by current medical criterion (he had no heartbeat) afterwards he was dead.
This short film titled “Heart Stop Beating” is truly amazing.
I’ll be the first to admit that I’m a conservative who obviously did not vote for Obama. Although I am not outspoken about my political beliefs like my ultra-conservative husband (you don’t want to get him started), this blog post by Shana on mddionline.com about the recent State of the Union Address caught my attention:
“The domestic medical device manufacturing industry, like many other manufacturing sectors, has suffered from devastating job losses, outsourcing to Asia, and a lack of skilled, high-tech workers in recent years. So, President Obama’s State of the Union Address hit pretty close to home. And while he skirted the issue of healthcare reform, Obama did lay out a blueprint for bringing manufacturing and high-tech jobs back to our shores that served up some serous food for thought to medical device OEMs.
‘In his speech, the President expressed the need to encourage more domestic manufacturing and keep jobs here in America. The first place he should looks is medical device manufacturing, which provides more than 35,000 jobs in Minnesota alone,’ Minnesota Congressman and co-chair of the Congressional Medical Technology Caucus Erik Paulsen said. ‘This American success story has come under assault from our own government and unelected bureaucratic agencies. As a result, American jobs are being forced overseas. We need to repeal the President’s new tax on medical devices and modernize FDA so we can keep innovation, manufacturing, and jobs here in the United States.’
If President Obama is serious about his commitment to high-tech American manufacturing, repealing the medical device tax would be a strong show of faith to the profitable medtech sector. But the chances of that happening are looking increasingly grim. As for Obama’s most-recent ideas, they’re inspired. Until Congress puts its money where its mouth is, however, they’re just pipe dreams. If the government is as concerned as it says it is about companies shipping jobs and manufacturing overseas, something needs to be done—and fast—as medical device companies continue to flee from burdensome taxes and what they view as innovation-stifling regulation.”
While I guess I can applaud the president’s apparent desire to promote manufacturing here in the U.S., is it all just empty rhetoric? Until I see something actually being done, such as repealing the medical device tax, I chose to remain respectfully disenchanted.
A new device called the Dynamic Ocular Evaluation System (DOES) can screen children’s eyes for abnormalities, while the kids watch a cartoon or play a computer game. What more could you ask for? DOES is low-cost, high-quality, and operator- and child-friendly. The test is done as the child watches a three-minute cartoon or plays a computer game. Infrared light is used to analyze the binocular condition and the assessment is reported on-site within a minute. Neither eye dilation nor verbal response is required.
At the beginning of the cartoon, a three-second comprehensive test screens for binocular refractive risks, high-order aberration, scattering, ocular alignment, and significant neural problems. The subsequent dynamic test searches for less significant signs of abnormal ocular alignment, neural responses, amblyopia, and—in the future—mental statuses that include dyslexia, attention deficit hyperactivity disorder, post-traumatic stress disorder, and autism. The images and results are digitally recorded and can be electronically transmitted to specialists for referral if necessary.”
If, in fact the DOES does do everything it claims to do, it sure would make things easier for us parents. My nine-year old sees a pediatric ophthalmologist for various problems with his eyes and he is always getting bored while sitting still for the interminable time it seems to take for them to run all the tests at each appointment. He also vociferously complains because they have to dilate his eyes. I know a quicker, more fun process would certainly go a long way towards making our trip to the eye doctor more pleasant. Perhaps I wouldn’t even have to bribe him with a trip to McDonald’s on the way home. A mom can dream, can’t she?
