MDUFA: Medical Device User Fees go up in 2018

I had the opportunity to speak with Terry Sweeney of Philips Healthcare about the upcoming changes in the Medical Device User Agreement. With MDUFA going up in 2018, this information is essential to anyone in the medical device community.

Click for the transcript. »

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How to Save Your Company Money Importing Merchandise

import yardA guest post by Bob Hartwig, Stratos Product Development Project Manager

Import duties and fees getting killing your budget? Don’t let the daunting complexity of import get you down!

Today’s laws regarding importing merchandise into the USA have shifted the legal responsibility to the importer. The importer must declare the classification, value and rate of duty applicable to the merchandise they are trying to bring into the country. But navigating the rules and regulations for importing merchandise into the USA is daunting. The goal, of course, is to meet the rules and regulations and to pay a fair share of duties and fees. But, if you do not know what you are doing, your goods may be stalled in U.S. Customs, and you may pay far more duty and fees than you need to. So, how does one ensure efficient and fair Customs processing?

Read this money-saving post. »

Raising Early Stage Investments

Raising Early Stage Investments was a panel topic at the Medtech Showcase in January.

Among the points that caught my ear:

• Joseph Gulfo: When you raise public money, ask (1) What is the maximum percent of a company the investor can own and (2) What is the investor’s minimum bite size? These help you determine if you’ll get their money.

Points from Klein, Abbaschian, Li. »

Breaking Into the Medical Device Sales Industry

o shutterstock_1148737As leader of the Medical Devices Group, I get asked multiple times per week by medical device sales candidates how they can break in to the medical device sales industry.

I wish I had an easy answer, definitive resource, or job for them. I don’t.

But I do have a collection of insights from members of the Medical Devices Group about this question, starting with mine: I have a list of medical device recruiters available but few, if any, find it worthwhile to recruit for entry-level talent. It’s a simple matter of supply and demand, and the economics of recruiting.

I believe your best bets for a medical device sales job as an entry-level person (or career changer) are:
(a) apply at the biggest firms who may have training programs,
(b) work your network as best as you can (you’re probably already doing that) – remember to contact alumni,
(c) intern or shadow a sales rep for free,
(d) go to trade shows and meetings and ask for complimentary admission,
(e) work solely on commission for companies seeking medical device reps. They have little to lose if you “don’t work out.”
(f) set about getting a business-to-business sales job that demonstrates your selling ability and transition into medical device sales later.

Read on. »

Are You Trying to Maximize Your Company Portfolio Value?

Group member Richard Bayney writes, “Everyone likes a portfolio of prioritized projects but how do you know that this portfolio creates the highest value for your company?

Unfortunately, if you don’t search for the highest value portfolio, you’ll never know how much value you’re leaving on the table. To be sure, if your portfolio choices are sufficiently broad, project prioritization will almost always lead to a sub-optimal or inefficient portfolio where untold value is unintentionally destroyed. On the other hand, if you adopt a different portfolio selection methodology – portfolio optimization – you’ll always be pursuing an optimal or efficient portfolio.”

African Relief Medical Device Program


Kountable™ is a mobile app driven platform that facilitates global trade in developing nations and economies by leveraging social and business connections, effectively turning social capital into financial capital. Using our app to empower entrepreneurs of small & medium enterprises (SMEs), we qualify and fund SMEs and projects that can enhance the economy, quality of life, health and education in these markets.

Learn how you can participate. »

Minimum Medical Device Deal Size

We had a discussion, "Got a $10-million idea? Who cares!" at nearly two years ago.

At the time I asked a panel of VCs, "What about the guy who has the $10 or $20 million idea, where does he go?"

Serial entrepreneur Danny Sachs answered, "Pick another project," and continued, "I mean, you’re going to spend as much time and sweat on a $10 million idea as a $500 million idea."

The comments on that thread are worth revisiting.

Last Month

Fast forward to last month. I asked another panel almost the same question. But they came back with a different answer. You can watch it below.
Dave Vachon, Founder of Novion Technologies: "You're not going to get a VC to fund it but you can actually raise non-dilutive funds," adding, "I don't think NIH (National Institutes of Health) will scoff at a $10MM idea that solves a problem.... You don't always have to go through someone to invest in your company."

Mary Waiss, President/CEO of Precision Image Analysis: "Sometimes it's hard to know how big the market really is.... As people become aware of your solution, there are other applications you may not have even thought about."

Phil Fraser, CEO of Innovative Dental Technologies: "We are in that boat. We raised $325,000. We started with one concept and through relationships with other dentists, other idea generators, partnerships... in 18 months we've developed an additional five products and now the company's valued at $7 to $8 million."

Randy Hamlin, Vice President for Point of Care at Philips: "We don't have a fixed number about size. It's based on puzzle pieces we're putting together for a complete solution. That piece may be a relatively small element but when you add it to the other pieces it represents a huge opportunity," concluding, "I wouldn't hesitate if something is a $5MM opportunity as it stands by itself because it could represent, as a puzzle piece, much bigger."

Your Thoughts

Both viewpoints ($10MM is too small • No it's not) seem valid, based on your role in the industry.

For discussion, what do you think of the quotes above?

What sized idea is too small? Is there a level?

Thomas Weldon Accuitive Medical Ventures on working with VCs

Joe Hage: Hi, it’s Joe. I’m here with Thomas Weldon. He is the Chairman and Managing Director of Accuitive Medical Ventures venture fund and we were talking in the hall at the Innovation in Medtech Conference in Dublin here in April 2016.

And Thomas was sharing with me how he goes about choosing the companies in which he invests. Would you repeat what you told me out in the hall?

Thomas Weldon: Yeah, sure. There are a couple of things. We look for very large market opportunities first. Typically something that would have at least $500 million in addressable market – not just the total market but actually the addressable market.

His requirements »

Klaus Stöckemann Peppermint Venture Partners on Caterna, an app reimbursed in Germany

Joe Hage: Hi, this is Joe, I’m here with Klaus Stöckemann. He is the co-founder of Peppermint Venture Partners and he was telling us today about digital health and, in particular, a company that focuses on lazy eye that’s based out of Germany that’s in your portfolio.

Klaus Stoeckemann: It’s called Caterna Vision, it’s based in Germany and they have developed a stimulation software which is stimulating the lazy eye and that is coming with a game so that a kid sitting in front of the computer, being patched, get trained for their lazy eye.

And because they have shown clinical effectiveness they got that product reimbursed…

Joe: … in Germany?

Why not in the US? »

Your Diagnostic Is Not Patentable

Gavin Bogle, an intellectual property lawyer I met at PEDS2040 surprised me when he said, “At this point, diagnostics are really not patentable.” Watch the five-minute video to understand why he believes this.

Click for the video transcript. »