Check LED Medical Diagnostics. Its a good example for a medical device start-up that is growing.
http://www.ledmd.com/

Give BAROnova a call. They are located in Goleta, CA and were just named as one of FierceMedicalDevices 2013's Fierce 15 device and diagnostic companies.

Carl Lincoln Thanks so much for all of your comments and kind offers to talk more. I will be in touch when I get back in the office on Monday.

Atomo Diagnostics out of Australia is a great example. They have developed an amazing fully integrated Point Of Care lateral flow blood test that improves usability and time to result. No, I don't work for them but am very impressed with the device.
http://atomodiagnostics.com/

Helen K Check out U-Heal Com. Operating out of Mineapolis and Florida. Helen K.

Our company, FMI Medical Systems, is a start up in CT/PET scanner devices. We are in Akron Ohio. Look us up. www.fmimaging.com

Carl,

That is a loaded question! Here in Minneapolis, known as a medical device hub, we have a number of med device companies that have gotten funding and are doing well. I also know of a number who are having to work a bit harder to get that investment and are self-funded in the meantime. If you need more specifics, feel free to send me a message!

Christianna Finnern
Medical Devices Group Advisory Board
www.winthrop.com/finnern

Richard Brautigam You might want to speak to our founder, Alex. www.newwavesurgical.com . We raised money over the past seven years in an environment I would still consider very challenging. Good luck with your article.

We would love to see some of these great companies at the 7th Annual OneMedForum in San Francisco, Jan. 13-15, 2014! OneMedForumSF runs concurrently with the JP Morgan Healthcare Investor Conference in SF so it is a great opportunity to reach a global investor audience and network with leaders in the medtech industry. Please visit the conference website to learn more and apply to present. http://www.onemedconferences.com Hope to see you there!

Hi Carl,

I think that you should look at a little start up just across the Channel in France called One Fit. The founder Sébastien Henry will be more than happy to discuss with you.

CreatiVasc, located in Greenville, South Carolina, is a terrific example. They are in late-stage clinical trials with a novel hemoaccess valve for arteriovenous grafts, were one of three technologies named to the FDA's first-year FastTrack program, and they recently closed a $5M funding round. I think the CreatiVasc team represents the best of medical device start-ups with their technology, path forward, and feisty "can do" attitude. And no, I do not work for the company. Thanks for throwing this inquiry out there.

HI,
If any of the start-ups in Medical devices and Diagnostics would like to joint venture or collaborate with Malaysian or Indian Companies, please contact me at pgbagali@geneflux.net.my We recently received a Biomedical Excellence Award in Biomalaysia 2013. Earlier, we have received recognition from Frost & Sullivan in 2010 and 2012 as the fastest growing molecular diagnostics company in Asia Pacific.

Victor Torres Great into and insight from various locations...

A question for the group, maybe looking at it form a more narrow focus - which are the top medical device startups in the Bay Area?

Take look at this company - http://www.biocartis.com/

Well funded and a great product.

Being biased I would have to say Aurora Spine, based in Carlsbad, CA...we started with angel investors but like your comment raising money in today's environment is very challenging so we went public on Sept 10th. Look us up at www.auroraspine.us

Hi Carl, I would suggest that you look at LLTech www.lltechimaging.com.

LLTech develops and sells optical biopsy imaging systems (FDA class 1) and endoscopes for biopsies qualifications (prostate, lung) and cancer surgery guidance. The devices enable real time in depth, direct, high resolution (cellular level) tissue imaging and qualification with no preparation. By providing real time tissue architecture on a digital image, physician are able to make immediate clinical decision ( take an other biopsy, assess a sentinel node...)

LLTech has several published clinical results on various tissues (lung, prostate, breast...) and collaborates with largest cancer institutions (MD Anderson, J Hopkins, Institut Curie)

Since beggining LLTech was funded by angels, many grants. ($4 M) and $1.5M sales. LLTech is currently on a crowd funding platform www.angelmd.co

Have a look at www.opsens.com
Experts in optic-fiber based pressure transducer, they used their revenues from oil drilling to develop a revolutionary new pressure-wire to be use to assess coronary stenoses...
Waiting to do FIM soon

Michael Sinsheimer Carl,

There are many medical device "start-ups" that intentionally stay under the radar screen as it takes 7-10 years to come to market often so the figures used in the public press don't necessarily reflect this action. My portfolio companies at MedTech Catalyst typically get funded when they cross milestones and decrease risk of commercialization. With that said, please check out www.mobiusimaging.com which just gained FDA Clearance and has a commercial partner in Brainlab. The product is called Airo. I'm glad to connect you with our technical co-founder and CEO if you want to speak with him.

Another self-serving recommendation: www.mobisante.com - Ultrasound imaging on a smartphone or tablet. We've been around since 2009, were the first FDA-cleared device based on a smart phone and have done both angel funding as well as a series A round.

We are company based in India , I would like to have distribution of medical equipments in India or Asia, Is there somebody to help me
Dr. Swarn Singh

Check out valvexchange.com Currently in Series B Round anticipating CE Mark

Carl Lincoln Once again, thank you so much to all of you. Your willingness to help has amazed me!
I have sent personal messages to each of you however in the interests of continuing the discussion (and for those that are yet to comment) I would like to ask: My initial question mentioned funding and regulation however these are of course very broad areas and so it would be great to know what specific barriers today's start-ups are experiencing?

Scott Spinka I have a medical device start-up company which has developed a game changing business model, Home Patient Hospital Care™, that may provide a significant solution to acute care hospital fiscal challenges, rising healthcare costs, and Baby Boom generation healthcare needs. We are seeking an existing medical device company strategic partner to help us. It is a $B+ opportunity. Call me at 919 923 9522.

Joe Zott Certainly funding and medical device regulations are big issues for startups. Those aren't new and you just have to plan the business around them. There are always things affecting market conditions, but current market conditions are especially uncertain. This isn't a positive or negative comment on the affordable care act, but the act did create uncertainty and that is difficult to plan for. I will also do the self-serving thing and throw AccuVein into the ring as a top medical device startup.

Lindsey D. Alexander Carl, I might suggest MedCity's startups report, where we feature the most innovative and most popular (on our site) medtech, biotech and digital health startups: http://medcitynews.com/2013/10/october-index-four-healthcare-startups-will-change-morning-routine/

Please be sure to update this group when you've finished the piece--there's so much innovation here, I can't wait to read the article.

Carl Lincoln Never fear all! I will definitely post a link once the article is written! Just an FYI for all of you; this discussion has sparked a lot more interest than I had expected and so the article is probably going to evolve from my initial idea and may even become a series of pieces.

Michael Sinsheimer The time horizon to exit is often the biggest barrier which ties into the regulatory burden and capital required. With all the noise around ehealth and prospectively quicker times to market, the comparison sometimes is negative for device and diagnostic companies. The thing I think people miss sometimes including investors is the fact that entry barriers are usually dramatically lower for ehealth companies which means competitive pressures can more likely undo these businesses. With medtech, it's much more possible to have intellectual property protections built in. With that said, medtech investors and others tied to a medtech early-stage company need to be patient and execute lowering the risk factors along the way.

Jim Osborne- FACHE Acell.com

Carl Lincoln Out of interest, will anyone here be at MEDICA next week? If so, perhaps those that have offered to speak further would like to arrange a meeting?

Cinde Waller TempOrthotics just incorporated and recently acquired our CE Marking for EU distribution. We are proudly manufactured in the US. as well as proud sponsors of the Rocky Mountain Dental Convention. Still rolling!

CareAline Products, LLC We are a medical device/garment start up. We have a needed product and funding was a no brainer for our investors. Our products were developed out of necessity because the hospital did not have a solution. That does make it a bit easier, however it still takes time. Interesting article.

cheers

David de Mena I will be at MEDICA making a presentation of the Home Care Telemonitoring System that Primum Health (www.primum.es) has developed. (Nov. 23 at 2.30pm - AppCircus at the Health &IT Forum, Hall 15). It would be a pleasure to have a personal meeting also.

Robert Edelstein Great list of companies. Our company Millennium Surgical Corp. focus is specialty surgical instruments. We continue to add instruments to our offering and develop new ways of helping our customer which include hospitals, surgical centers and other device companies. Growing in this market takes work and the right products and staff.
When surgical instruments are needed head to www.surgicalinstruments.com.
Best growth areas are in Spine and Ortho but ophthalmology still pays the bills.

I tend to see many companies going through the funding process, as our team becomes pretty involved by aligning independent contract reps - compensated on sales results. A solid roll out plan for market penetration utilizing a pay-for-performance sales team can ultimately result in increased potential for funding. We have been building independent rep teams for nearly 15 years and we are very aggressive with placing sales channels.

MedCepts is an industry leader supporting innovative, flexible and out-of-the-box performance based compensation within a relationship-based culture. Simplified, Creative Compensation packages for who you know and what you know! Whether a company seeks funding or acquisition, a sales force with sales results, can certainly have an impact!

Presently, we happen to be preparing to introduce the First Regulatory Compliant Marketplace for Healthcare..... a highly targeted, influence-based, sales channel (50,000 experienced medical sales agents) and a prescriber - driven, on demand empowerment channel (320,000 physicians). Think Facebook or LinkedIn on a regulatory compliant platform for MD's, manufacturers, sales reps.... wow (talk about out-of-the-box) - then add a marketplace (sales) piece, high end training modules, access to CRM and an array of additional free tools the big companies utilize. http://www.medcepts.com/pages/rimedio.html

I look forward to the results of your work, Carl, and welcome further communications on results driven sales teams utilizing out-of -the-box compensation packages as an entity to one's business plan for funding purposes.

Anyone here working on a new OCT for ophthalmology?

Javier Miguel Cabrera Contreras With the National Health Sercice in UK banning the implant of metal on metal total hip prosthesis due to high failure rates (known for decades) . a new panorama for medical device manufacturers has appeared to invest in new methods, using modern biotechnology and minimal invasive surgery.
Osteoarthritis by definition is a progressive destruction of the joint, due to the lack of a definitive treatment of the initial lesion, especially in the articular cartilage..
My patent GB2344290 "A device for replacing or repairing a joint" describes a method to reach the hip joint avoiding the capsule in a single portal entrance for new arthroscopic devices, in order to reshape and resurface the hip joint with biomaterials, stem cellls etc..This method avoids the need of total hip prosthesis by preventing the destruction of the joint.
We should treat osteoarthritis of the hip and other major joints just like dentists do with dental caries avoiding its deterioration and removal.
A new era of biotherapy and minimal invasive surgery has now been opened to treat osteoarthritis..
Any manufacturer who can present this kind of innovate treatment will have a big advantage in this market, taking into consideration that osteoarthritis is increasing worldwide. See: www.biototalhip.com

"

Malcolm Wootton BSc MBA Have a look at what we're doing at www.fliuk.com

Christopher Scorzelli, MD Look up Minnesota companies, there are several that have raised capital. To name a few Sunshine Heart, NxThera, CV Rx, they're just busy using it to move their product forward, and not bragging about it.

Karen Lunde We would love to help some of these great companies get CE approval for European sales of their new products! CE approval is often easier to get than FDA approval, and post-market clinical follow-up of the success of your devices in Europe could help you acquire FDA approval. Since 2005, all medical devices for which we did clinical evaluations have gained CE approval, that's 100% success. If you need a clinical trial in Europe, we can run it, as a full-service provider, or by providing just the help you need. If you need a literature-based clinical evaluation, we can write it. Please visit the our website to learn more http://www.clinical-evaluation.com Hope to see your devices on sale in Europe soon!

CareAline Products, LLC As a new company bringing a medical garment to market, the first year has been though. Based on my research, it can take a few years to really get a product introduced into the market. We are told we are ahead of the curve because we just signed a distribution contract and in the process of signing two more. . What are your thoughts on how long it takes to get new products to market?

Greg Smith Good question Micheal

There are many things that can slow a product getting to market; inadequate market awareness leading to wrong specification, lack of adequate funding for development and commercialisation, an inexperienced design team, transfer into manufacture if design and manufacture is not an integrated process, or a lack of good distribution.

For medical devices I think that you’re probably talking 15 – 18 months to get something ready for the market. That would include gaining regulatory approvals, but 510(K) submissions might add more time; as would clinical trials if required. It’s very difficult to say, but 2 years isn’t unrealistic for a more complex programme.

A lot of these issues can be overcome by using an experienced team and the best way to do this for a start-up is to keep overheads low and outsource.

Thanks Greg very good advice

Serascience, who are part of the Abingdon Health Group in the UK, are a young company in the market place. They are going from strength-to-strength having launched a CE approved point-of-care test for multiple myeloma, Seralite®. They will be exhibiting at Medica (Hall1 F16) this week.

Michael Sinsheimer If something requires a 510(k) with clinical "trials", this can be 7-10 years to translate a concept to commercialization. I agree with Greg that an experienced team is the best way to do it and also agree generally with the outsourced perspective. We have served as fractionated management at MedTech Catalyst often in this capacity.

Burrell (Bo) Clawson Michael has it right in that whoever is doing it "right" now has already often spent the 7-10 years, so looking as successful companies now has NOTHING to do with current funding going on in VC & PE circles today.

A "top Med-Dev startup" is a company making profits and that occurs often years after starting sales. For some companies that can easily mean years added to the commercialization/startup time period.

David R. Leon Carl, Fierce Publicaitons put out a top med device company listing each year here is a link to the 2013 list you can research past years as required. http://www.fiercemedicaldevices.com/special-reports/fiercemedicaldevices-2013-fierce-15

Carl Lincoln Much appreciated, thanks David

Carl, GessNet (http://www.gessnet.com) should be one of them. It provides an unique and critical service to medical device companies, especially start-ups for their risk management and US FDA submission. It does not make medical devices per se, but make the life of "making medical devices" much easier.

Victor Torres Thanks David R. Leon for the link....very useful...

Carl Lincoln Theme number three:

I know there is an age-old debate around in-house v outsource however it would be interesting to hear what medical technology start-ups have chosen to do considering the economic climate and whether or not they feel they have made the right choice.

Michael Sinsheimer We typically outsource at our portfolio companies - helps us to get the expertise when we need it and not build infrastructure costs to help us remain lean so we can have a low burn rate while focusing most of our efforts on R & D. We have found this a very good way to translate technology to its commercial endpoint.

Carl Lincoln Thanks Michael, what areas would you be outsourcing if not R&D at the development stage?

Michael Sinsheimer Depending - CPA/Finance, Product Development, Regulatory.

Carl Lincoln And that would depend on what? I assume things like whether the company has in-house capabilities or if there is benefit to be gained from the experience/expertise of a 3rd party?

Michael Sinsheimer You are right Carl - depends on stage of company too.

I find the importance of a solid regulatory strategy and quality plan is typically overlooked, by founders and R&D teams of start-ups. Investors are aware of the need for FDA clearance/approval and CE marking, and that regulatory or clinical requirements can be a huge risk to an even stellar idea.

David R. Leon Agreed about regulatory & clinical one important addition "health economics"

Carl Lincoln Hello everyone. I have started going through my data in detail in order to tease out the key areas of interest and (as long as this won't annoy everyone) I'm thinking it might be good to get some discussion going around some of the topics rather than me simply asking people questions through a private medium.

Firstly I am interested to hear about people's experience when bringing something new to the market:

Have you found that your device was accepted or rejected initially and what were the reasons for this? Following from that initial reaction, how did you move forward?

Please let me know if you would rather I didn't keep posting my questions on here.

Carl Lincoln OK the second theme to have arisen is as follows:
When securing funding, did you have a strategy in place i.e. targeting specific investors, grants etc. or have you experienced a need for a more 'take what we can get' approach?

Once again, if there is a better way for me to ask these follow-up questions please let me know.

I completely agree Andrea - we at ITL often meet with clients who have a fantastic product or idea, but little understanding of the regulatory requirements in order to get it to market - I think my top tip to any start up would be to keep your finger on the pulse when it comes to regulatory requirements and have that plan solidly set up before over-investing in development. After all, the last thing anyone wants is to finish their product R&D and then find that they have another year and yet more funding needed in order to make it compliant when the problems could have been avoided at the very start of the project.

We are a relative new company who has invented the newest technology for hip protectors. (www.comfihips.com). This is a much needed product for our rapidly growing senior population. If I can help you with your article, please let me know.

Iris Onrot, CEO
Worldwide Ortho, LLC

CareAline Products, LLC Check out carealine.com Just signed another distributor in Australia and now looking to move into the EU. Our products were developed to help solve a problem in the PICC and Central LIne world.

Q&A are interesting!

Carl Lincoln There seems to have been a new surge in activity on this discussion. Since I have had quite a range of responses I am now looking at putting together a number of articles based on my discussions. The first should be ready to go by Mid-Feb... keep your eyes peeled!

Our company, Sphinx Medical is a relative 'new kid' on the block. We manufacture, sell and distribute the Flowsecure Artificial Urinary and Anal Sphincters (AUS and AAS) from our manufacturing site in Scotland. We have distributors across the world and our footprint is growing weekly. Due to the unique nature and growing market for such products, funding has not been too difficult to find. I would be happy to assist if you require further information for your article.

If it is a start-up, the future is unknown. How can you rate them?

Juan José Janer Dear Marina,
Congratulations for your product and services.

Hi to all,
In Italy there is a strange landscape about starts up and investments.
We are trying to get funded as we have a patented device for spinal surgery, our strategy was to target specific investors, grants etc. but now we are experiencing a "take what we can get' approach!!
Check our services and product www.espres3d.com (here you will not find information about our patented device but just about what we are ready to sell)

Edward Bukstel I am working with a company that has a patented non-invasive diabetes monitor that has successfully completed clinical trials at a world class health and research organization.

David de Mena Hi Eduard:

I think your technology is very interesting and It will be the future in diabetes. Primum, my company, has a lot if experiences connecting medical devices with mobile element. If you came to the MWC, I will be very honoured to meet you in our stand (CS60#18) to talk about possibles Sinergias.

Carl Lincoln Hi everyone. After a few technical issues with the new website I'm pleased to announce that the first in the now 3 part series of articles is live: http://bit.ly/1eIrnCf
I look forward to your comments.

Edward Bukstel I would rephrase the question, including what innovative new Medical Devices have FDA approval or have passed reputable clinical trials protocols and have shown the potential for outcomes that benefit the healthcare consumer, providers, and manufacturers. I have 67 companies on my watch, maybe 3 will make it. Thank you for the thread, a few interesting comments and companies.. A few with hype.

Carl Lincoln Thanks for your comment Edward, I guess what you're saying is you can't really decide who is a good start-up unless there's a realistic chance of the product getting to market?

Corey Dowdle Carl,

As your article evolves, you might want to look at the people who create these medical start-ups. I work for a company that does hydrophilic and drug-eluting coatings on a lot of start-up's devices, and everyone I work with seems to be from a larger medical device company. These people(usually Sr. employees) then leave, and create their own company for various reasons - it would be interesting look at the specific reasons behind their departure.

Carl Lincoln Hello all. The 2nd article in the series is now live http://bit.ly/1nfN0UV. This one covers in-house vs outsourcing for device design. I look forward to your comments...

Edward Bukstel Carl, Corey, great point..... It is really hard to what the motives are for certain founders. You can tell if people are ready to go through a brick wall for an idea or innovation or they just want bank. There are too many people with great sounding backgrounds in the Medical Device industry and others that want to cash out instead of innovate. The Medical Device industry as it stands today will not exist in 5 years.

Carl Lincoln Corey, Edward. You're right, I think that would make very interesting reading. I'll start a discussion and let's see what happens...

Greg Smith Absolutely right Edward - there is a whole host of "entrepreneurs" who come from companies that have, by most reasonable measures, failed, but they very cleverly manage to get an unjustifiably good reputation in the industry and persuade the next set of financiers that they are successful. They aren't interested in setting up a business, they want a bolus of money to spend for the next few years before exiting and starting again. This would be fine if it was the launch-pad for a successful product or business, but often it's not and only acts to feather their nests for the nest few years.

Carl Lincoln Edward (and anyone else who is interested) as promised I started the discussion a while ago and it's been pretty well received. Search: Why did you start your medical device company? in this group.

Edward Bukstel Carl... It's been a busy couple of months. This group has been an excellent resource for information on Medical Device companies and I have checked it as a sounding board for 2 companies that I currently work with. These companies are in the Diabetes Glucose Monitoring market with game changing technology that makes Google Lens look sick. (pun intended) I have found people in this group to reflect all flavors of the market ... from big Medical Device companies with little innovation to start-ups that will change the world of healthcare delivery over the next 5 years. I thank this group and all comments pro and con for the thoughtful comments that will ultimately help the lives of people worldwide.

Carl Lincoln It's great that these discussions can help in real life and everyone's willingness to participate just goes to show what a great community there is out there.

If you happen to be looking for any services relating to the development of those devices e.g. R&D, design, manufacture etc. I would love to chat.