Add Your Event for Free

Turning Clinical Ideas into Market Opportunities with Howard Levin

It wasn’t until I transcribed Dr. Howard Levin‘s presentation at MDTX did I realize how much his past 15 years he packed into 25 minutes.

It was fantastic for anyone who ever works in bringing a medical device concept to market.

For credentials, Howard’s company Coridea issued 120 US patents, raised $100 million, and returned more than 1.4 billion to investors.

Have I got your attention? Then, by all means, watch the video below, and download the slides and transcript.

Click here for the slides and transcript. »

Why 2018 will be the Year You Embrace Continuous Connectivity

Nersi Nazari, 10x for Design and Manufacturing keynote speaker and CEO of VitalConnect, bet the fate of his company on the widespread adoption of continuous patient monitoring.

Sounds like a reasonable bet to me.

In his 40-minute keynote at 10x for Design and Manufacturing, Nersi said patients and consumers are accepting the technology and clinical evidence supports its efficacy. After all, the continuous monitoring of vital signs is not new. In critical care, life depends on it.

So how to make continuous monitoring portable, inexpensive, and effective?

Mr. Nazari answers that question and many more in this enlightening talk. Watch below and click through for the slides and transcript.

Click here for the slides and transcript. »

How To Become a True Medical Device Quality Professional

I was talking to Jon Speer from Greenlight Guru about how to become a true quality professional.

He shared, “I have a choice and the choice is purely up to me. I can choose to be status quo and be a checkboxer or I can elevate my game and focus on becoming a true quality professional.” Here’s a short video of our conversation.

Jon is giving a two-hour workshop, “How to Implement a Risk-based QMS to Comply with 13485 Leveraging ISO 14971,” April 3rd, 2018 at the Meadowlands. You can get the brochure on our homepage.

Click for the transcript. »

Medical Devices in China

“I can’t tell you how many companies said we just didn’t bother protecting in China because they don’t care. They’ll copy anyway,” said Landon Lack at this year’s 10x Medical Device Conference.

“You have to protect your IP in China. If you don’t protect your IP and China no one’s going to want to partner with you.”

You can catch his entire presentation here:

How to Sell Medical Devices in Japan

“If you have a novel technology, come! If you have a me-too product, stay home, said Kirk Zeller, who facilitates launches in Japan and other international markets, at his 10x Medical Device Conference talk in May.

Kirk briefly touched upon subjects that usually make for an hour-long presentation. Click to hear about the Japanese regulatory climate, changes in procedures to commercialize, and what you should know about doing business with distributors in Japan.

Click here for the transcript. »

How the Medical Intelligence Cloud will Revolutionize Healthcare

“If you’re developing a device and it doesn’t integrate some kind of intelligence, you are contributing to the problem,” began Spyro Mousses, PhD, Co-founder and President of Systems Imagination, at his 10x Medical Device Conference talk in May.

Dr. Mousses explained we need to transform your data into something useful, which is less likely if it doesn’t feed into an expert system or cognitive computing / machine learning system. It’s so impractical to consider data from each system independently that we don’t even collect it.

But “the little taste we’ve gotten from using genomic data to position cancer drugs, to using integrated image analysis, to look at cardiology, has taught us there is a massive amount of intelligence to individualize treatments.”

This will revolutionize healthcare. Watch the video and get the slides below.

PDF Click here for a copy of the slides.

And click here to see our April 2018 agenda!

Disruptive Medical Device Marketing

I recognize few Medical Devices Group readers have a Siemens-sized budget, but if you are in medical device marketing or compete in Siemens categories, you won’t want to miss this presentation from Francisco Miguel Trigueiros, Managing Director of Global Product Marketing at Siemens Healthineers.

PDF Click here for a copy of the slides.

And click here to see our April 2018 agenda!

The Dexcom Labeling Change That Really Helped Diabetics

Gary Cohen, Sr. Director Software Center of Excellence at Dexcom, gave us a glimpse how Dexcom won the labeling change that allows them to claim “The Dexcom G5 is FDA-cleared and lets you monitor without pricking your finger.”

PDF Click here for a copy of the slides.

How to Raise the Funds You Seek for Your Medical Device Company

Rick Baron, Dave Sheppard, Teresa Gonzalo, and Enzo Villani led our panel at our fifth annual 10x Medical Device Conference.

Among the topics they discussed:

What kind of capital should I raise?
• Talk to angels, friends, and family; after that stage get an advisor who will guide you. Another: Go to VCs when you are pre-revenue and seriously consider debt once you’re post revenue so you don’t dilute your ownership.

Is there such a thing as “bad money?”
• Yes. That’s when you end up with a partner you can’t tolerate. Find money that wants to work with you and that understands what it takes to succeed in medical devices. Better still if they are connected in the industry and can make introductions for you.

How do investors determine how risky an investment is?
• They evaluate the management, engineering and regulatory expertise, size of market and financials, the strength of your IP, your freedom to operate, and reimbursement.

Rick added: Whenever you’re raising capital ask yourself, “How much do I need? Why do I need it? How will I pay it back?” And, “The day you get the check is the day you start the next round.”

Medical Device Funding and Resources to Jump Start Your Company

Dr. Chris Sasiela gave you a gift at this year’s 10x Medical Device Conference: A list of resources from the National Institute of Health (NIH) and their Small Business and Innovative Research (SBIR) program you may have overlooked.

NIH resources are extensive and include:

• Up to $225,000 for your feasibility study and up to $5 million for companies creating FDA-regulated technologies
• $100 million in grants each year for small business research from the NHLBI (National Heart, Lungs, and Blood Institute)
• $800 million across all the divisions of the NIH annually
• Advisors specializing in regulatory, small business, business development, investments, entrepreneurship, and many types of scientific advisors
• A clinical specimen and data repository where you can leverage their clinical studies to validate your diagnostic
• A video library including one clip about how to write an effective grant
• Innovations created in academic labs that you might be able to incorporate into your company
• Innovation conferences where they put you in front of a room of investors plus partnering with other forums

Click for the slides. »