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.

 

 

How to Succeed with Medical Device Product Development

How do you ensure you give your medical device the best chance for success? Jessica Urban, Director  of Program Management at Stratos Product Development suggests five factors to success in product development:

1.       Wait Until the Technology is Really Ready

2.       Choose the Right Team

3.       Use a Systems Approach

4.       Use a Risk-Based Approach

5.       Dedicated Project Management

For an in depth look at Jessica’s strategies, check out her article Five Factors To Success In Product Development.

 

 

 

Is Social Media More Important than Medical Technology?

Did you know that the seven big Facebook holders, including Mark Zuckerberg, Dustin Moskovitz, and Sean Parker, hold shares totaling $25 billion?  By comparison, all the 12 health care billionaires on last year’s issue of the Forbes 400 Richest People in America had a combined net worth of a measly $28 billion.

Forbes’ Matthew Herper concludes, “There’s not really much doubt: if you want to reach the upper echelons of wealth, creating a social networking site is a better bet than inventing a drug.”  Sound depressing?  Never fear, He had some suggestions as to how the medical device industry could change so that entrepreneurs might break through the glass ceiling and enter the upper stratum of the mega wealthy:

  1. De-emphasize drugs. Right now research in medicine is often centered around medicines. Leland Hartwell, the Nobel laureate who used to run the Fred Hutchison Cancer Institute, used to complain that we could make more progress in cancer by focusing on diagnostics.
  2. Innovate toward disruption: Right now it might cost $2 billion or more and a decade to invent a drug that’s ready to give to people, but does that have to be the case for every drug?
  3. Make more research “pre-competitive:” Too much of the science done at drug companies is locked up inside the silo of a single drug giant, not allowing the free exchange of ideas that leads to real innovations.
  4. Change the way patents work: In the tech business, a device can be protected by hundreds of patents. In the drug industry, you’ve really only got one, and it has a twenty-year life span.   Often, by the time it hits the market, half the patent life is gone. In many cases, the true usefulness and the side effects of a medicine are not apparent until after it becomes generic.

I personally love facebook.  I use it every day.  I post pictures and videos of my kids and keep in touch with people that I probably never would know how to contact if it weren’t for facebook.  However, it seems to me that saving lives and making things that improve people’s quality of living should be worth more than the convenience of being able to share a picture of your kid in his Halloween costume with someone you haven’t seen since high school 25 years ago.

May 24, 2012- MWDG Presents Play the Process Validation Game

ASQ-Biomedical Division
MWDG Presents Play the Process Validation Game

Univ of Indianapolis Schwitzer Student Center Building #7 Room #013 Indianapolis, IN 46227

Thursday, May 24, 2012 5:30 PM  – 7:30 PM

Details

The MWDG of the ASQ Biomedical Division Presents: Play the Process Validation Game-A Team ExerciseThursday, May 24, 2012, 5:30pm to 8:00pm  

Attendees will be broken into teams. A deck of cards will contain the major steps and tasks of process validation. Each team will have identical decks of cards. Each player of the team will take cards and then sequence them in the proper order. There will also be cards that contain “Punishment” & “Reward” cards to slow down or speed up the teams’ progress. The goal of the game is to design and implement a process validation process by placing the cards in the proper sequence. The team must have the right process sequences to win.

 

Howard Cooper will introduce the project.  He is currently the chairman of the ASQ Midwest Biomedical Discussion Group.

 

 

Location: Univ of Indianapolis, Schwitzer Student Center Building No.7 Room No.013 (on lower level)

 

Food: Hot Buffet Dinner, Beverage and Dessert. 

ASQ Members $12.50-, Non-members $15.00- (0.3 R.U.s Awarded) Walk-ins welcome for $15- cash only at the door, however food and seating can not be guaranteed. To encourage interaction, seating is limited to the first 40 registrants, so sign up soon!   For more information, contact: Ann Stankiewicz at ann.stankiewicz@roche.com

(317) 521-2980

As volunteers in a not-for-profit professional organization ASQ Biomedical, MWDG (Midwest Discussion Group) is committed to providing low cost high value events for biomedical professionals and the local community. We are able to keep our costs low by utilizing a registration system that incurs minimal administrative overhead expenses and minimizes excess time and effort spent by our volunteers to bring you these events. Please help us continue providing low cost quality programs to you by using the system that works well for us. 

This Roundtable Discussion will utilize the synergy of our well-versed Subject Matter Expert along with your Regional Industry Peers.

 

 

Registration

Please indicate the quantity you would like for each type of registration shown below. Then click on “Continue” to confirm your order selections and total. After that we will ask for your name and address information and your payment information to complete your order on our secure server.
ASQ members
Order at $12.50 each
Price: $12.50 Processing: $0.00 Total: $12.50
Non member
Order at $15.00 each
Price: $15.00 Processing: $0.00 Total: $15.00

 

Activity Questionnaire

ASQ-Biomedical Division has requested that its customers provide the following information to better help it fulfill your order. Required questions must be answered in order to complete your order.
You may submit on-line questions for discussion at the event.

  

ASQ-Biomedical Division Purchase/refund policy: The default refund policy is to provide full refunds up to 14 days before the event, and future credits after that time. Individual events may have different refund policies, and these will be noted on the registration page. Normally, the $15-$25 discussion group meetings are non-refundable. ASQ Biomedical Division reserves the right to cancel, reschedule any event, or to change speakers. Please be advised that ASQ Biomedical Division or ASQ Headquarters is not responsible for any airfare penalties, or hotel charges that may be incurred due to sold out, cancelled, or rescheduled events.Acteva’s Purchase/refund policy: Refunds and cancellations are provided only at the discretion of the organization hosting or sponsoring this event. Acteva issues credits only when directed to do so by the sponsoring organization. Contact refunds@acteva.com or the sponsoring organization for further details.

One Person Can Make a Difference Against the Medical Device Tax

We’ve talked in a couple of blogs lately about the No2point3 medical device petition that is attempting to stop the medical device tax.

Last week, CareFusion CEO Kieran Gallahue lent his support to no2point3.com. Gallahue, an AdvaMed board chairman, sent an email to U.S.-based CareFusion employees to consider signing the online petition which launched on April 17, 2012. Nearly a quarter of those contacted responded, putting CareFusion atop the site’s “Corporate Leaderboard,” and ahead of fellow California-based companies NuVasive (with, at present, more than 700 signatures) and Volcano Corporation (nearly 400 signatures).

No2point3 founder Joe Hage puts Gallahue’s effort in perspective. “750 petitioners signed the day I launched the site to the 100,000-member Medical Devices Group. Kieran’s one email to his employees generated more signatures in one day than I could with 15 times the reach!”

I checked as I was writing this, and CareFusion had 1,450 signatures.  The total number of signatures on the petition was 6,136.  The goal is 25,000 signatures by July 18.

It just goes to show that one person can make a difference.

See our other blogs about No2point3:

2.3% Medical Device Tax – Will It Really Kill American Jobs?

Making a Difference Against the Medical Device Tax

Are We Too Hard on the FDA?

One title in particular jumped out at me when I researching for my blog this week: Advice from a VC to startups: Speak no evil about the FDA.  What?!?  OK, so perhaps I have been trashing the FDA a bit lately, but not without cause… Right?  Here’s a bit of an excerpt from the article:

After a short complaint about the FDA coming from another panelist — John Ryan of Onset Ventures — Juliet Bakker, founder and managing director of Longitude Capital, said that her advice to portfolio companies is to be always be respectful of the FDA.

“After all, they are here to protect us,” she said.

Bakker added that on many occasions companies and regulatory consultants don’t ” bother to answer the questions that the FDA has asked” or give the answers that they want to give. That, she said, creates delays. And delays are anathema to the venture capital and startup community eager to see a return on investment.

Are we too hard on the FDA? Should we be more sympathetic to their cause?  What do you think?

 

Ways Startups Can Stretch Dollars

It may seem impossible to get investors interested in your medtech startup when the trend seems to be that venture capitalists prefer later stage medical device companies, overseas ventures, or Web-based or digital media companies.  Not to mention that the current economic climate is not exactly conducive to anyone who is trying to secure money for their projects.

Charlie Chi, PhD, suggests using a capital-efficient business model and to accomplish as much as you can with as little cash as possible.  She offers some great tips for medical device startups:

  1. The Right Team- Getting the right team in place is one of the main pillars of a capital-efficient business model because doing so can save both time and money.
  2. Time is of the Essence-The goal of any emerging medical device company should be to out-innovate larger competitors, as well as get one’s product to market before other start-up companies can do so.
  3. Choosing a Sound Regulatory Strategy-Start-up companies need to determine the various regulatory options and develop capital and time efficient business strategies that include both the United States and other countries.
  4. Growing Carefully Through Strategic Marketing-  Start-ups following this model should not ramp up sales and marketing teams or launch their products nationally too far in advance of revenues and market validation. In contrast, it will be more important for them to focus on local or regional markets initially to validate their products.
  5. Outsourcing Non-Critical Business Functions- Emerging medical device companies should focus on their core technology, such as research, design and innovation, and outsource non-critical business functions, such as payroll, accounting, HR, and IT.
  6. Compensation for Sales Team-For start-ups operating with limited cash and resources, hiring and supporting a permanent sales team is extremely expensive; paying commissions is much more cost-effective.

If all else fails, take heart in the fact that not all venture capitalists are only interested in late stage development companies. Mike Carusi, general partner at California venture capital company Advanced Technology Ventures, is a firm believer that you can strike gold by investing in early stage companies.  He goes so far as to say, “Many of these late-stage deals are  crap,” to an audience gathered at the Medtech Investing Conference in Minneapolis. His confidence stems from the fact that Advanced Technology Ventures’ philosophy of investing in younger companies helped it see pay day in two major deals.  He believes that investors focused on late-stage companies are missing out on these types of deals.  ”The reason they are late-stage companies is because no one was interested in them.”  Take that, all you naysayers out there…

 

June 5, 2012- The State of STEM Education In Indiana: Challenges Today and Strategies for Future Success

Hello,

Please join us for our next Frameworx session on Tuesday, June 5 at 8:00 a.m. – The State of STEM Education In Indiana: Challenges Today and Strategies for Future Success. In this session, Vince Bertram, CEO of Project Lead the Way, will start the discussion with a quick overview of the current state of science technology engineering and math (STEM) education in Indiana, the U.S. and throughout the world.

The keynote will be followed by a panel of STEM education experts representing Woodrow Wilson Fellows, New Tech High School, Conexus, National Math and Science Initiative, Indiana Department of Education, I-STEM Resource Network, Eli Lilly and Company, and Teach for America. The group will present the success of current programs as well as share the challenges and possible strategies for future success in Indiana.

D’Amore 48th floor, Top of Chase Building

Register here

Event Sponsors: Eli Lilly and Company and Cook Group

Printing Sponsor for the Series: Miles Printing

Is the Color of Your Medical Device Important?

Did you ever stop to consider the color of your medical device and how it may appeal to your consumer?  I know it sounds a bit crazy, but perhaps it is worth considering.

CMF, or color, materials and forecasting design, is a design expertise which is becoming more and more prevalent. As products and markets become more complex the need for specific knowledge about color, materials, surface finish and trends has increased.

Medical devices can be given a personal and sophisticated competitive edge when we work with color pallets beyond navy blue, black and silver and with high quality manufacturing techniques and sophisticated finishes.  Thoughtful and careful color, materials and surface design create more accepted, appreciated devices which are a natural part of users’ daily lives.

I actually pulled up a website of a company called Fairings that makes specialized coverings that surround an existing prosthetic leg. The site states:

Fairings infuse the individual’s lifestyle and taste into the design from the start. But to make this an even more personal part of the prosthetic leg, Fairings can be enhanced with patterns, graphics, and materials—including leather, ballistic nylon fabric, chrome plating, and even tattoos. By creating a unique custom form that presents the individual, Bespoke Innovations hopes to change the way the world thinks of prostheses.

Am I suggesting that you take your already stretched budget to go out and hire expensive designers to investigate the recent hip trends and somehow transform your product into the new “it” device? I really don’t think anyone wants leopard print surgical tubing, pastel circuit boards, or even leather prosthetic legs for that matter, but CMF certainly is something to keep in mind if you want your product to stand out in today’s market.

May 23, 2012- 2012 FDA Regulatory 101 Course

2012 FDA Regulatory 101 Course Wednesday, May 23, 2012

Approved for 5.3 Hours of CLE Credit

Presented by a host of Indiana Medical Device Manufacturing Sector Experts

Sponsored by Samco & Associates, Inc.

Stericycle ExpertRECALL

2 Sponsorships Available (Sponsorship includes promotions, signage at the event as well as a shared table for materials distribution. Sign up at the bottom of the Registration Form)

Program Agenda

8:30-9:00 am Registration / Continental Breakfast / Networking
9:00-9:15 Welcome Ralph Hall, Counsel, Faegre Baker Daniels
9:15-10:00 Clinical Trials and IDEs   21 CFR 50, 54, 812   Roles and responsibilities   FDA submission process   Informed consents, IRBs, etc.   European Issues Keli Hankee, Manager, Clinical Affairs, Biomet, Inc.
10-00-10:15 Break
10:15-11:15 Submissions   PMA requirements   Submission contents   Process and issues   510(k) requirements   Process and requirements   513(g) Russell Gray, Sr. Regulatory Consultant The Anson Group
11:15-11:45 Combination Products Suzanne O’Shea, Partner Faegre Baker Daniels
11:45-12:15 Complaint Handling/Corrections and Removals Part 806, Part 7   Part 803 Dale Miller, Manager, Regulatory Affairs Zimmer, Inc.
12:15-1:15 Lunch and Networking
1:15-2:15 QSR Overview   820   Design controls   Management responsibility   Process controls   Adverse Event Reporting   Other QSR topics Chris Kilander Regulatory Affairs Manager Cook, Inc.
2:15 Break
2:30-3:15 Advertising and Promotional Controls Danelle Miller, Global Regulatory Counsel Roche Diagnostics
3:15-4:00 Enforcement / Wrap Up Administrative, civil and criminal   Other Provisions (qui tam, 1001, 371) Ralph Hall, Counsel Faegre Baker Daniels

 

Register Online Now! Use your username and password to expedite registration by prefilling the registration form!

Registration Only: 8:30 am Program: 9:00 – 4:00 pm Location: Montage Catering Facility, 8580 Allison Pointe Blvd., Indianapolis, IN 46250
Members: $195 per person (Member discounts apply when registering more than 4 attendees at the same time)
Non-Members: $275 per person For more information or to join the IMDMC, please contact Blake Jeffery at IMDMCoffice@ameritech.net.

IMDMC.logo.gif Click here to join the IMDMC!

 

Footer1.jpgFooter2.jpg

May 18, 2012- GIIRT Breakfast: Make Organizational Change Happen with the “Patterns of Innovation”

May 18 GIIRT Breakfast: Make Organizational Change Happen with the “Patterns of Innovation”
Where:

Suite D 40 Executive Dr. Ste D Carmel, IN 46032 Driving Directions

When: Friday May 18, 2012 from 8:00 AM to 9:30 AM EDT Add to my calendar
Overcoming organizational stagnation is exhausting and difficult…. unless you know how to make small changes in the right places.
It’s all about recognizing the “Patterns of Innovation,” key triggers and symptoms that are common among effective, innovative workplaces.  Instead of expending energy by fighting an uphill battle, you can use tipping point leadership and a “heads up” mindset to create lasting, effective change.  Dr. Jan Byars will help May GIIRT attendees understand these patterns and begin utilizing simple techniques that begin turning ordinary individuals into agents of change.

 

The event will take place on May 18th from 8:00-9:30AM at Suite-D in Carmel. Registration costs $20 per registrant and includes breakfast, relevant learning, and access to some of Indianapolis’s most innovative minds.

 

 

Get more information
Register Now!
I can’t make it
If you have any questions about the Greater Indy Innovation Roundtable or want to learn more about student or non-profit pricing, please call (317) 814-5294.

 

We appreciate your interest in GIIRT and we look forward to seeing you at our next event!

 

Sincerely,

 

Doug McColgin
Greater Indy Innovation Roundtable

BioCrossroads Has Money For Life Science Startups

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- 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.

What Does That Mean?

FDA, PMA, SAE, V&V, CPT…  I see acronyms tossed around all the time when researching for my blog and have no clue what most of them mean.  I have never dared mention my lack of understanding to anyone for fear that I might come across as dim-witted, but last week I saw an article in MedCityNews that made me feel like maybe I was not alone. The author lists the above acronyms as the Top 5 Anxiety Provoking Med-Tech Acronyms (APMAs).  In case you are as clueless as I was, here’s the rundown:

Food and Drug Administration

Pre-Market Approval

Serious Adverse Event

Verification and Validation

Common Procedural Technology

Is there an acronym that really makes you PO’d?

Add your (least) favorite med-tech acronyms to the APMA Hall of Shame by clicking here.

I think I am going to form my own support group called PWDUAAAAI.  (People Who Don’t Understand Acronyms and Are Afraid to Admit It)

Grow Up, FDA

The medical device review process adopted by FDA has won many critics for years for being too complicated, vague and slow, especially when compared to the European device approval process. In an internal report, the U.S. Food and Drug Administration is defending its approval process for medical devices, while trashing some of the regulatory practices used by its European counterparts.  FDA officials are critical of a number of EU standards, noting that European regulators seek less evidence and allow “private, for profit companies” to sign off on product approvals in member countries.  Even if the EU system is quicker, it is far from better, the report argues. U.S. companies have repeatedly argued that they lose valuable time and money waiting for FDA approval as they seek to improve the lives of patients they serve.

I am reminded of when my two sons get in a fight.  I am usually alerted to the battle when someone screams, “He hit me!!” to which the other one replies, “Well, he kicked me first!” as if that negates any responsibility he had in the altercation. Whether or not the EU has an effective process really has nothing to do with the FDA’s efficiency.  I believe the FDA needs to take care of their own problems and not worry about what the Europeans are doing, or, as I tell my sons, “take responsibility for your own actions and keep your hands and feet to yourself.”