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. »

Dr. Joseph Gulfo on FDA Safety and Effectiveness

In his insightful 10x Medical Device Conference talk, Dr. Joseph Gulfo explained the official FDA mandate: To promote the public health by PROMPTLY and EFFICIENTLY reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner… protect[ing] the public health by ensuring… reasonable assurance of the safety and effectiveness of devices intended for human use….

But Gulfo says FDA is no longer content approving safe and effective drugs and devices with pre-approval requirements skyrocketing. We need to use our voices to get FDA back to focusing on safety and effectiveness and letting the market decide the clinical utility and winning products.

Click for the slides. »

ResMed CEO Mick Farrell’s Keynote 2017

This presentation is a must for anyone who wants to understand how dramatically the smart use of big data can impact the entire healthcare system.

With ResMed’s investments in digitization, they are lowering costs for sleep apnea and COPD therapy and increasing patient adherence.

Click for the transcript and slides. »

Legacy Search CEO Paula Rutledge on the State of the Medical Device Market

I asked veteran medical device recruiter Legacy MedSearch CEO Paula Rutledge about the state of hiring in medtech and she said, “It’s great if you are a candidate, not so great if you are a hiring manager.”

As of May 2017, unemployment for SIC codes 3840 and 3841 is less than three percent for ages 25-64 (excludes non-college graduates). Paula says the more experience you have, the more difficult it is to find a great job. So you’ve got to be proactive: Reach out to your network, and invest in a professionally done and keyword-rich resume.

For a list of medical device recruiters, see http://medgroup.biz/MedDevRecruiters.

The European Unitary Patent Package

My friend Stephen Carter from Mewburn Ellis gave a 10-minute talk about the European Unitary Patent Package at the 10x Medical Device Conference in May 2016 – before the Brexit vote.

If you have a European patent, or aspirations to get a European patent or licenses, this is going to impact you.

Stephen explained, in Q1 2017 we should see a “single patent that gives you protection across the whole of the EU. We also expect a single Unified Patent Court with jurisdiction not only over this new European Unitary Patent but also over existing European patents that have already been granted.”

Watch the video for the implications to your business.

Click for the transcript and slides. »

How to Save Costs on Your 510(k) or PMA

Did you know 77% of the cost to develop a 510(k) device is spent in clinical research and regulatory submissions? It’s 80% for PMA devices.

“A lot of that cost is due to how poorly we handle data,” explained Jim Rogers, President of Nextrials, at the 10x Medical Device Conference.

Jim’s solution is “why didn’t we think of this before” simple: Re-purpose electronic health record (EHR) data as the source data for clinical research.

Jim: “FDA wrote a Guidance. It came out September 2013 to give people action items around using electronic source.” If you re-use the data you already have, you’ll:
• Eliminating duplication of data entry.
• Eliminating or reducing transcription errors.
• Remotely accessing your source data.

And Jim anticipates your question: “There’s so many EHR systems, how could we ever begin to integrate with them?” Watch the video for his answer.

Click for the transcript and slides. »

20 Introductions in 60 Minutes (2016)

A new and well-received feature we introduced in May 2016 was giving 20 of our guests three minutes to introduce themselves.

The video and transcript follow.

Click for links to their profiles and the transcript. »

Medical Internet of Things (IBM): Creating and Deploying Connected Medical Devices

It was a treat to feature IBM’s Kimberly Cobb at this year’s 10x Medical Device Conference.

Kim finds manufacturers who say, “We don’t want to be a medical device company any longer, we want to be a services company. We want our services to drive the demand for our devices.”

Are you among them?

Click for the transcript and slides. »