How to Get a Federal Grant for Your Medical Device Startup

What is the best way to get a federal grant for your medical device startup?  Considering that the success rate for companies seeking federal loans hovers only between 11 and 15 percent according to Bhramara Tirupati, of BBCetc, an Ann Arbor, Michigan-based business consulting group, it is best to do everything you can in order to get one of these loans.  She shared these four tips with Brandon Glenn from MedCity News for startups looking to acquire the elusive federal funding:

Determine if you’re eligible.  SBIR and STTR grants are open to for-profit companies with fewer than 500 employees that have a U.S. location.

Follow the money.  Eleven different government agencies issue SBIR and STTR grants. Think of each one of those 11 as a separate program, as each has different interests, deadlines and requirements.

Exert some influence.  Agency scientists and engineers typically author “topics” that indicate the types of projects the agency is looking to fund. Find a topic that mentions technology similar to what you’re developing and contact the author.

Get a letter of support.  Some agencies, such as the National Science Foundation, accept letters of support from third parties that help make the case for an applicant’s technology.

Even though it may seem the odds are not in your favor, it is definitely worth it to check out this funding which could be a lifeline for your business.

 

 

Bloomington- Who Knew?

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.

A New Way to Fund Your Medtech Startup

I came across an article entitled “Is crowdfunding a viable option for medical technology startups?” I had no idea what crowdfunding was,  but I thought it sounded interesting.  I actually had to look up the definition of crowdfunding on Wikipedia.  For those of you who are as out of the loop as I am, crowdfunding  describes the collective cooperation, attention and trust by people who network and pool their money and other resources together, usually via the Internet, to support efforts initiated by other people or organizations.

According to Brandon Glenn, for some medtech startups, particularly those with simple medical devices that have already done some research and developed a prototype, crowdfunding could represent a realistic option.  A provision of the JOBS Act enables startups to raise as much as $1 million through crowdfunding and award equity to nonaccredited investors, which is likely to make crowdfunding more attractive to medical technology companies.

Is it worth it to have the hassle of having to deal with hundreds or even thousands of investors? “Crowdfunding will be more successful for biomedical companies if they look to raise a fairly small amount of money to help with technology validation or testing after an early prototype has been created. Before looking to crowdfunding, an entrepreneur should first invest in early development and seek grant funding,” Solomon Nabatiyan, a Northwestern University researcher who co-founded recently launched crowdfunding site TechMoola, said.

I checked out TechMoola, which focuses on technology projects.  It works like this: People sign up for a TechMoola account, put money in their account, look for projects that they like on the site, and then use money out of their account to fund the projects (starting with as little as $5).  I did find a medtech company posted.  Cervia Diagnostic Innovations has their cervical cancer test listed.  According to the stats, it had a total of $548 pledged so far.  From a business owner’s standpoint, it seems to me like trying to fill a gallon jug using a medicine dropper, but I suppose every little bit helps.

 

The Medical Device Industry in Memphis is Moving Mountains

According to the Greater Memphis Chamber more than 70,000 people work in the life science industry in the Memphis area.  However, most of the local residents aren’t even aware of the bounty of technical jobs that exist there.  Some in the industry are hoping to change that.  “Many of the students don’t necessarily know what kinds of careers are ahead for them if they focus on math and science in middle and high school”, said the Memphis Academy of Science and Engineering’s executive director, Harold Wingood.  But its mentoring program with Memphis medical device maker Smith & Nephew is helping to light the way.

“It’s not just engineers that make the bioscience sector move,” said Gibson “Sunny” Morris with the Mid-South Community College’s Arkansas Delta Training & Education Consortium.  ”You can have all the engineers you want, but if you don’t have production workers to make that plant run, it’s not going to be very effective,” Morris said. To that end, his school offers an array of advanced manufacturing programs to help students learn to weld and run machines, among other things.

Also, a work group of medical device companies, university groups and the Bartlett Area Chamber of Commerce are working on a possibly $4 million facility with the up-to-date equipment used in medical device manufacturing to train locals on the specific skills they need to work in the industry.

So, perhaps the mountain is moving to Mohammed instead of Mohammed having to go to the mountain.

 

Medical Device Startups (Interview with Tiger Buford)

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:

  • Focus, focus, focus on the unmet clinical need that you are trying to bring a unique solution to.  Regularly test the market to make sure that your technical solution solves the unmet need.  Taking your eye off the unmet need is certain startup death. 
    • Be frugal.  Spend the company’s money like it’s your personal money.  If you burn $15K per day, then you have to ask if you have created $15K of value for the day. 
    • Fail fast. Eliminate business risks and technical risks as fast as possible and as cheaply as possible. I have seen startups spend $20M to find out that the technology doesn’t actually work, when it could have been tested faster and cheaper. 
    • Stay in stealth mode as long as possible.  There are more downsides than upsides to telling the world what you are doing.
    • Knowing who your investors are and their intentions is more important than the amount of the investment
    • Don’t drink your own Kool-Aid.  Deal in facts and objective reality. 
    • KISS.  Simple IP, simple legal, simple structure, simple.  This may be obvious, but simplicity gives the team the best use of time, complexity robs time from the team. And time is everything. Time = cash burn = available life.

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…

How do You Market Medical Devices?

So, you’ve developed a great medical device that’s going to revolutionize the industry and save thousands of lives.  How do you market it?  Sure, you can show up at your potential client’s workplace with your briefcase and product sample, but then what?

I came across an interesting article by Gavin Finn that looks at the options for presenting and demonstrating medical device products to prospects. He covers everything from who might be present at the meeting and how to market to them, to creating a compelling experience through audience involvement and demonstrations, to using virtual and interactive technologies.

Finn states, “Fortunately, today’s sales and marketing toolkit includes a number of options for presenting and demonstrating products to prospects—even in the absence of a physical product. In a traditional selling process, buyers often play a passive role—listening to sales presentations, watching case study videos, etc. They have no interaction with the product whatsoever. These traditional selling methods don’t provide the information necessary to make a truly informed buying decision, and that can lessen or kill chances for a sale, or make for a far longer sales cycle.”

“When it comes to sales, who you’re talking to is as important as what you’re talking about. It’s not unusual to have five or more departments involved in the buying process, and each may have different requirements and decision-making influences. For this reason, sales and marketing professionals need to customize their messages with an experiential focus that addresses each decision-maker’s requirements. The customer experience should concisely articulate those benefits in an engaging and memorable way.”

When I was a kid in the 70’s, a neighbor of ours was a Rainbow vacuum cleaner salesman. One day my parents, out of the goodness of their hearts, let him come over to demonstrate his merchandise. I remember as a child that I was quite impressed with the cool demonstrations that he did to highlight his product- dumping dirt on the carpet and vacuuming it up to show the suction ability of his machine and adding scented oil to the water inside the apparatus, thus infusing the house with a pleasant odor.  It seems, even with today’s technology, salespeople haven’t come that far from their roots.  You still have to market to the right audience, get and maintain their attention, and impress them with the abilities of your product (even if that only entails the power to suck up dirt and make your house smell nice).  If it makes any difference, my parents ended up buying a Rainbow that day, even though we weren’t in the market for a vacuum.  So, it must work…

J & J to Get Out of Heart Stent Business

Some big news from Johnson & Johnson was announced this week.

Johnson & Johnson is getting out of the heart stent business.

The diversified healthcare company said Wednesday it no longer will develop its Nevo heart stent and will stop production of its Cypher stent as it pulls back on a segment of its cardiovascular business that has suppressed earnings in recent years.

Analysts believe J&J’s decision to leave the stent market ultimately will benefit the New Brunswick, N.J.-based company by allowing it to focus on higher-growth divisions such as Biosense Webster, which develops and markets electrophysiology navigation systems and ablation therapy devices. Annual Cypher sales had reached $2.6 billion, but the stent was on track to earn merely $400 million this year, according to Gabelli & Co. analyst Jeff Jonas. Its current sales amount to about 1 percent of company profit.

J&J executives said the company’s new focus will revolve around access, diagnostic and therapeutic products for cardiology procedures, products to diagnose, access and treat lower extremity disease, and the Incraft Stent-Graft System, an investigational device for treating abdominal aortic aneuryisms.

“With the removal of a large, ‘troubled’ player from the market, we’re inclined to think industry dynamics—like pricing—might improve on the margin as well,”  Leerink Swann LLC analyst Rick Wise wrote in a note to investors. “We also view the news positively for J&J, as the Cordis restructuring…should further drive positive operating leverage and better allow the company to focus on the business’ other, higher-growth divisions like Biosense Webster. All this should set the stage for J&J to drive better sales and operating in 2012 and beyond.”

It will certainly be interesting to see how this development affects Johnson & Johnson as well as its rivals.

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New Tenant at Purdue Research Park Offers Drug Delivery System

A company that specializes in developing devices to deliver injected freeze-dried drugs, diagnostics and vaccines has become a tenant in the Purdue Research Park.

LyoGo, founded in 2009 by Rush Bartlett, Arthur Chlebowski, and Peter Greco, has developed patent-pending technology that stores a lyophilized, or freeze-dried, drug in one chamber and liquid diluents in the other. David Giddings, a medical industry veteran with more than 30 years of experience, is CEO. Charles Haywood, business development adviser, also is president and CEO of Mansfield-King, a contract manufacturer of personal-care products that was the fifth-fastest growing company in Indiana in 2010.

LyoGo was formed for the purpose of developing innovative drug-delivery systems. LyoGo is focused on engineering delivery systems which offer a superior user experience, are intuitive to use, improve safety and sterility, and substantially reduce or eliminate the need for refrigeration at room temperature, which improves drug storage and distribution. LyoGo develops systems for delivering drugs that are intentionally designed to easily fit into the established drug-filling processes of leading pharmaceutical companies.”

This is cool technology because freeze dried drugs don’t necessarily require refrigeration and can be kept for years at room temperature instead of a few hours. (Case in point- I have a jar of Folger’s Freeze Dried Coffee Crystals of which I only use a couple of tablespoonfuls once a year to make Christmas cookies.  I have had the same jar for years, and my cookies still taste great- ask my husband…) Drugs like this can be used for stockpiling vaccines and for diabetes and cancer drugs.  This is an excellent addition to West Lafayette’s life science industry.

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Ideas vs. Execution

I came across this blog by Seth Levine in which he encourages usage of some of the same principles that we try to persuade you to instill with our Building The Business Case document.

Mr. Levine states, “Ideas are great. But they’re not as valuable as most people make them out to be, and by correlation, execution is almost universally underrated and in hindsight taken for granted as a given once a company has become successful (and rarely given the credit it deserves).”

I was especially interested when, in referring to what we consider market leaders, he states “Many weren’t the first or only ones to come up with the idea that made their company. What separated them from their competitors was their ability to out execute everyone else in a way that took a good idea and made it a great company. Often, in fact, another company was the early market leader only to have their leading position overtaken by an upstart who was hungrier, more nimble, and more focused on the basics of executing a great business.”

He ends with, “My point isn’t that ideas aren’t important. It’s just that execution of those ideas is far more critical. And it’s worth thinking about that as you consider the operations of your own business.”

This is where Building the Business Case can really make a difference.  Keeping the principles we discuss in mind will “keep you focused on the basics of executing a great business” and therefore help to ensure that your business becomes and remains successful.

I remember when I was in elementary school one of the girls had a Cricket doll instead of a Barbie doll.  Mr. Levine’s musings got me to wondering, “Whatever happened to Cricket?” I’m sure Cricket was basically the same unrealistically perfectly proportioned, flawlessly coiffed doll as Barbie.  Perhaps poor Cricket didn’t have the advantage of having people behind her who were focused on executing a great business. Otherwise she too might still be popular and successful after over fifty years.

Other blogs on Building the Business Case:

Building a Business- The First Step- Know Your Product

The Second Step to Building the Business Case- Know Your Market

Part Three of Building the Business Case – Location, Requirements, and Market Size

The Final Steps- Know Your Competitors

INpact Selects Miles & Brinson As Marketing Partner

FOR IMMEDIATE RELEASE

Contact: John Miles
Public Relations Director
MB2 Advertising
Phone: (317) 873-6655 x101
E-Mail: jmiles@MB2advertising.com

 

Wednesday, April 27, 2011

INpact Network Selects Miles & Brinson, Inc., As

Public Relations Agency of Record

 

 

Indianapolis, IN – Miles & Brinson, Inc., has been named the public information, communications and media relations’ agency of record for the INpact, Inc.

The goals and objectives of this business relationship will be to communicate and enhance public and community awareness of the growing Medical Device Manufacturing industry in the State, including the huge economic benefit of the quality sustainable jobs that this business sector is creating for Indiana’s workforce.
INpact Network was created to assist in the promotion and growth of the Medical Device Industry and its related support membership.  The Medical Device Industry is the catalyst for a strong new manufacturing base, positioning Indiana as a leader in attracting related business ventures to the State.
Jon D. Speer, President and Co-founder of INpact states “The members of INpact have a proven track record in supporting medical device product development and manufacturing. When we started INpact, these separate and sometimes competing companies agreed to come to the same table to help grow this industry in Indiana and the Midwest.”
Indiana’s Medical Device Industry is already successfully developing and manufacturing innovative products.  The results have already established a foundation for quality, sustainable jobs, providing a new source of economic industrial growth in Indiana.
About INpact:
INpact is a professional business network association comprised of Indiana-based medical device manufacturers, technology companies, and related service and support organizations.  This unified network exists to promote the Medical Device Industry and its membership throughout the State of Indiana.
INpact provides its membership with a variety of shared product development experiences and related industry support services, that are designed to assist in the successful growth of this emerging Indiana-based manufacturing industry.
For more information about INpact, visit:  http://www.inpact.org.
ABOUT MILES & BRINSON (MB2)
MB2 is a full-service marketing communications agency founded in 1995 and headquartered in Indianapolis.  The agency serves a diverse base of clients located throughout Indiana as well as in New York, Los Angeles, Miami and Chicago.
In addition to providing traditional advertising, interactive, public relations and media services, MB2 can provide its clients an array of advanced technology services.
This includes content managed dynamic websites, online marketing, enterprise email, social media, smart phone apps, QR code technologies, as well as digital video and photography.
More information about Miles & Brinson visit:  http://www.mb2advertising.com.

 

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Life Sciences in the Midwest

A new contract sterilization company locating near Warsaw hopes to capitalize on the existing strength of the “Orthopedic Capital of the World,” while also expanding into other areas. Canada-based Iotron Industries says Columbia City, located in the agricultural heartland between Warsaw and Fort Wayne, offers the perfect geography for its three-prong growth strategy to increase its business in medical devices, commercial defense and agribusiness.

The $15 million facility in Columbia City is the company’s first U.S. operation and will split the distance between two major industry clusters: Warsaw’s orthopedic sector and Fort Wayne’s commercial defense industry, in which plastics and composites are used in aircraft and aerospace applications.

Indianapolis-based Medical Animatics, a 3D animation company, is making a foray into the game business. The company will develop a game for kids ages 6-12 to help them learn safe behaviors at home, in their neighborhoods, at school or at a park. Medical Animatics will develop the game for Ohio-based Nationwide Children’s Hospital. Health games designed to be both educational and enjoyable are being developed by two other companies with Indiana ties—Bloomington-based Wisdom Tools LLC and Indianapolis-based Gabriel Entertainment, as well as by growing numbers of developers around the country. Medical Animatics also develops 3D animated instructional and informational materials for the health care, higher education and sports industries.

Northern Indiana’s Manchester College plans to begin work this summer on its new $18 million pharmacy school. School spokeswoman Jeri Kornegay said Thursday that a ground-breaking for the 75,000-square-foot building in Fort Wayne is expected early this summer, possibly in June. Until the building is complete in July 2012, the college’s School of Pharmacy will continue to occupy space at Parkview Hospital in Fort Wayne, about 30 miles east of North Manchester. The project is supported by a $35 million grant from Lilly Endowment that’s the largest gift in the college’s history. While pharmacy schools have opened on a rapid pace around the nation in recent years, Indiana is one of 18 states with a shortage of pharmacists. Manchester’s will be the third in Indiana offering doctorates in pharmacy, joining schools at Butler University in Indianapolis and Purdue University in West Lafayette.

Indianapolis-based medical device maker NICO Corporation announced at the American Association of Neurological Society (AANS) annual meeting that it has received CE Mark approval for its automated minimally invasive brain tumor removal device, the NICO Myriad™. The approval allows NICO to sell the Myriad system in the 27 countries that make up the European Union. The device has been commercially available in the United States since 2009 with more than 1,000 procedures performed with adults and children, sometimes in cases that would have previously been considered inoperable.

On a sad note, Bill Cook, founder of the Bloomington-based medical equipment manufacturer Cook Group Inc., passed away this past week.  He was 80 years old.  Cook built Cook Group Inc. into a worldwide conglomerate, with 42 companies under its umbrella. The Cook Group employs about 10,000 worldwide with sales estimated at more than $1.5 billion.  Cook’s company is one of the largest employers in Central Indiana, with about 3,000 workers in the Bloomington area.

Who Are Your Competitors and How do You Protect Your Ideas From Them?- The Final Steps to Building The Business Case

This is the final installment of our Building The Business Case series.  We have been looking at the questions entrepreneurs need to ask themselves in order to Build a Business Case.

What are the competitive products / technologies / services currently available?:

It’s not enough to just design a great product; you also need to be aware of what other products are out there.  Take the time to do the research to see what other people are already offering.  Sure, the new shampoo you developed smells great and makes your hair soft, but were you aware that there are also 500+ other brands of shampoo out there that do the same thing?

Why is your product / technology / service better than competitive products?:

Once you discover what the other products are, figure out what differentiates your product from them. What do you have that they don’t?  If you can’t come up with an answer to this question, perhaps you shouldn’t be marketing your product.  Does your shampoo perhaps rinse itself, or automatically highlight one’s hair as it scrubs?

Can your product / technology / service be protected via patents and/or trade-secrets?:

This is important so that you get the credit for your idea and someone else doesn’t.   Remember, it’s not your idea to steal if it’s not patented.  Just because you thought of it first doesn’t mean it belongs to you.  Talk to a patent attorney if you aren’t sure if your product should be protected.  You might also want to conisder non-disclosure or confidentiality agreements if they apply to your situation.   It is important to note that once there is public disclosure of your idea, your ability to patent the idea may be compromised. In fact, once there is a public disclosure, your patent rights are gone in most of the world (you have one year from date of public disclosure to file a patent in the U.S.).

Previous blog posts on Building a Business Case:

Building a Business- The First Step

How Well Do You Really Know Your Market?

Location, Requirements, and Market Size

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I’m Your New Doctor . . .

. . . but I haven’t been to medical school. Okay, maybe this couldn’t happen.

However, I was recently introduced to someone who has been put in a somewhat specialized position but doesn’t have any experience in the field. It’s a little disturbing to me. Let me give you an example. Let’s say CQ decides to hire a new project manager, and the person we hire has little to no project management experience. Do you think it’s going to work?

What if we told our new project manager to read a couple books and meet Joe, an experienced project manager, for coffee sometime. Joe is really good; I’m sure picking his brain between sips of java will be all this person needs to get going. Do you think this will help our new project manager?

Neither do I. This is why this scenario is a bit of a head-scratcher for me. Why in the world would a company hire someone to fill a position who has no experience in this field?

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Getting Ready to Kick Off Big Ideas Competition

Creo Quality is getting ready to kick off its Big Ideas Competition for 2011 on April 15. This is a contest for anyone who has a business/product/technology idea that would help improve Morgan County.  Each participant submits their idea and a panel of judges reviews the submissions.  The winners receive cash prizes to help start their business, as well as access to business mentors and resources to help learn about business ownership and entrepreneurship. It also gives sponsors a chance to invest in their community by donating money that will go towards helping new businesses.

We are excited about this opportunity to improve the business and economic climate of our county and are looking forward the innovative ideas our contestants will come up with.

Look for more information in upcoming posts.

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