Moving for your career

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Each time you move into a new business environment, you GROW.

You are who you are because of the companies where you worked. If your career had taken a different pathway, you would own a different set of skills and capabilities.

If you have worked for Stryker, you know one way.  

If you have worked for Stryker, K2M, Smith+Nephew, Kyphon and Arthrex, you know five ways. 

Your stack of skills is a result of three influences:

who you have worked with,

what culture you have worked in,

and the location where you worked. 

Let’s look at each influence.

People – We all learn from the people who we work with mostly by osmosis. We pick up new skills and new decision-making processes. We are deeply influenced by management, our peers and mentors at each company.

Culture – We all learn about values and how things are best accomplished within a specific culture. The culture at Smith+Nephew is completely different than the culture at NuVasive. Even Zimmer and Biomet have different cultures in the same city.

Location – We all learn from the city culture where we work. Arthrex in Florida is completely different from Arthrex in Germany. Same for Smith+Nephew, Mansfield versus Austin. People in different cities work differently and make decisions differently largely based on the culture of the surrounding city.

 
Take Home Message
To GROW your career, I believe that you should make a move regularly.  How often? My rule of thumb is that when you start to feel comfortable, it should trigger the “time to move“.  On average, this is usually every 3-5 years. 
Each move will throw you in a new ecosystem in which you will discover new skills, a better perspective, and more confidence. We humans only learn when we are surprised. When we are not surprised, everything fits into our existing thought patterns.  So in order to get smarter, we need the shock of surprise.  
Mindless work habits at your current company, like creating a presentation, designing an implant, training a salesperson, getting approval to start a project, are all different at your new company.
You will be surprised. 
 
Force yourself to move every 3-5 years and enjoy the journey. 

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How Startup Funding Works, a Simple Illustration

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Startup founders often ask me about how to best fund their new venture. There is no single answer.
Every company is different.
Every technology is different.
Every period in time is different.
Every management team is different.
 

For these reasons, and more, there are many ways to fund a startup.
However, for illustration purposes, let’s walk through a hypothetical startup funding.  Let me share Anna Vital’s infographic and blog article.  She provides a good basic example of funding a startup – A Hypothetical Startup.
 

First, let’s figure out why we are talking about funding as something you need to do. This is not a given. The opposite of funding is “bootstrapping,” the process of funding a startup through your own savings. There are a few companies that bootstrapped for a while until taking investment, like MailChimp and AirBnB.
If you know the basics of how funding works, skip to the end. In this article I am giving the easiest to understand explanation of the process. Let’s start with the basics.
Every time you get funding, you give up a piece of your company. The more funding you get, the more company you give up. That ‘piece of company’ is ‘equity.’ Everyone you give it to becomes a co-owner of your company.

Splitting the Pie
The basic idea behind equity is the splitting of a pie. When you start something, your pie is really small. You have a 100% of a really small, bite-size pie. When you take outside investment and your company grows, your pie becomes bigger. Your slice of the bigger pie will be bigger than your initial bite-size pie.
When Google went public, Larry and Sergey had about 15% of the pie, each. But that 15% was a small slice of a really big pie.

Funding Stages
Let’s look at how a hypothetical startup would get funding.
Idea stage
At first, it is just you. You are pretty brilliant, and out of the many ideas you have had, you finally decide that this is the one. You start working on it. The moment you started working, you started creating value. That value will translate into equity later, but since you own 100% of it now, and you are the only person in your still unregistered company, you are not even thinking about equity yet.
Co-Founder Stage
 As you start to transform your idea into a physical prototype you realize that it is taking you longer (it almost always does.) You know you could really use another person’s skills. So you look for a co-founder. You find someone who is both enthusiastic and smart. You work together for a couple of days on your idea, and you see that she is adding a lot of value. So you offer them to become a co-founder. But you can’t pay her any money (and if you could, she would become an employee, not a co-founder), so you offer equity in exchange for work (sweat equity.) But how much should you give? 20% – too little? 40%? After all it is YOUR idea that even made this startup happen. But then you realize that your startup is worth practically nothing at this point, and your co-founder is taking a huge risk on it. You also realize that since she will do half of the work, she should get the same as you – 50%. Otherwise, she might be less motivated than you. A true partnership is based on respect. Respect is based on fairness. Anything less than fairness will fall apart eventually. And you want this thing to last. So you give your co-founder 50%.
Soon you realize that the two of you have been eating Ramen noodles three times a day. You need funding. You would prefer to go straight to a VC, but so far you don’t think you have enough of a working product to show, so you start looking at other options.
The Family and Friends Round: You think of putting an ad in the newspaper saying, “Startup investment opportunity.” But your lawyer friend tells you that would violate securities laws. Now you are a “private company,” and asking for money from “the public,” that is people you don’t know would be a “public solicitation,” which is illegal for private companies. So who can you take money from?

Accredited investors – People who either have $1 Million in the bank or make $200,000 annually. They are the “sophisticated investors” – that is people who the government thinks are smart enough to decide whether to invest in an ultra-risky company, like yours. What if you don’t know anyone with $1 Million? You are in luck, because there is an exception – friends and family.
Family and Friends – Even if your family and friends are not as rich as an investor,  you can still accept their cash. That is what you decide to do, since your co-founder has a rich uncle. You give him 5% of the company in exchange for $15,000 cash. Now you can afford room and ramen for another 6 months while building your prototype.

Registering the Company
To give uncle the 5%, you registered the company, either through an online service like LegalZoom ($400), or through a lawyer friend (0$-$2,000). You issued some common stock, gave 5% to uncle and set aside 20% for your future employees – that is the ‘option pool.’ (You did this because #1 Future investors will want an option pool, #2 That stock is safe from you and your co-founders doing anything with it.)
The Angel Round
With uncle’s cash in pocket and 6 months before it runs out, you realize that you need to start looking for your next funding source right now. If you run out of money, your startup dies. So you look at the options:

Incubators, accelerators, and “excubators” – these places often provide cash, working space, and advisors. The cash is tight – about $25,000 (for 5 to 10% of the company.) Some advisors are better than cash, like Paul Graham at Y Combinator.
Angels – in 2013 (Q1) the average angel round was $600,000 (from the HALO report). That’s the good news. The bad news is that angels were giving that money to companies that they valued at $2.5 million. So, now you have to ask if you are worth $2.5 million. How do you know? Make your best case.  Let’s say it is still early days for you, and your working prototype is not that far along. You find an angel who looks at what you have and thinks that it is worth $1 million. He agrees to invest $200,000.

Now let’s count what percentage of the company you will give to the angel. Not 20%. We have to add the ‘pre-money valuation’ (how much the company is worth before new money comes in) and the investment
$1,000,000 + $200,000 = $1,200,000  post-money valuation
(Think of it like this, first you take the money, then you give the shares. If you gave the shares before you added the angel’s investment, you would be dividing what was there before the angel joined. )
Now divide the investment by the post-money valuation $200,000/$1,200,000=1/6= 16.7%
The angel gets 16.7% of the company, or 1/6

How Funding Works – Cutting the Pie
What about you, your co-founder and uncle? How much do you have left? All of your stakes will be diluted by 1/6. (See the infographic.)
Is dilution bad? No, because your pie is getting bigger with each investment. But, yes, dilution is bad, because you are losing control of your company. So what should you do? Take investment only when it is necessary. Only take money from people you respect. (There are other ways, like buying shares back from employees or the public, but that is further down the road.)

Venture Capital Round
Finally, you have built your first version and you have traction with users. You approach VCs. How much can VCs give you?   They invest north of $500,000. Let’s say the VC values what you have now at $4 million. Again, that is your pre-money valuation. He says he wants to invest $2 Million. The math is the same as in the angel round. The VC gets 33.3% of your company. Now it’s his company, too, though.
Your first VC round is your series A. Now you can go on to have series B, C – at some point either of the three things will happen to you. Either you will run out of funding and no one will want to invest, so you die. Or, you get enough funding to build something a bigger company wants to buy, and they acquire you. Or, you do so well that, after many rounds of funding, you decide to go public.

Why Companies Go Public?
There are two basic reasons. Technically an IPO is just another way to raise money, but this time from millions of regular people. Through an IPO a company can sell stocks on the stock market and anyone can buy them. Since anyone can buy you can likely sell a lot of stock right away rather than go to individual investors and ask them to invest. So it sounds like an easier way to get money.
There is another reason to IPO. All those people who have invested in your company so far, including you, are holding the so-called ‘restricted stock’ – basically this is stock that you can’t simply go and sell for cash. Why? Because this is stock of a company that has not been so-to-say “verified by the government,” which is what the IPO process does. Unless the government sees your IPO paperwork, you might as well be selling snake oil, for all people know. So, the government thinks it is not safe to let regular people to invest in such companies. (Of course, that automatically precludes the poor from making high-return investments. But that is another story.) The people who have invested so far want to finally convert or sell their restricted stock and get cash or unrestricted stock, which is almost as good as cash. This is a liquidity event – when what you have becomes easily convertible into cash.
There is another group of people that really want you to IPO. The investment bankers, like Goldman Sachs and Morgan Stanley, to name the most famous ones. They will give you a call and ask to be your lead underwriter – the bank that prepares your IPO paperwork and calls up wealthy clients to sell them your stock.  Why are the bankers so eager? Because they get 7% of all the money you raise in the IPO. In this infographic your startup raised $235,000,000 in the IPO – 7% of that is about $16.5 million (for two or three weeks of work for a team of 12 bankers). As you see, it is a win-win for all.

Being an Early Employee at a Startup
Last but not least, some of your “sweat equity” investors were the early employees who took stock in exchange for working at low salaries and living with the risk that your startup might fold. At the IPO it is their cash-out day.
 
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An Orthopedics Startup is quietly dominating Dynamic Imaging

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Trice Medical is a truly disruptive orthopedic startup with great potential.
read press release 
Trice is one of my favorite orthopedic startups. In the crowded world of “me-too” orthopedic technologies, Trice has carved out a niche with differentiated technology and is quietly changing orthopedics forever.  I believe that MRIs will rarely be used for joint diagnoses in the future thanks to Trice.
Back in 2016, I listed Trice Medical as a Hot Startup to Watch, then I interviewed the CEO, Jeff O’Donnell, in 2017.

I predict that Trice will lead the world in the new category – Dynamic Imaging in Orthopedics. The other guys are doing static imaging. Trice’s technology enables the physician to “move” the joint while imaging in the doctor’s office.  Trice’s technology is better, cheaper, more accurate. Physicians want it. Hospitals want it. And when given an option, patients prefer it.
 

2017 > Intra-Articular 
Trice Medical originally created a visual system called mi-eye that allows any orthopod to perform a diagnostic arthroscopy exam and diagnose any pathology in the intra-articular space. The current version is called mi-eye 2.  This is a new movement driven by orthopedists. Social media is covered with physicians demonstrating how easy it is to diagnose joint issues by looking inside the joint in the convenience of an office environment.  In the convenience of an exam room, they diagnose joint issues and discuss treatment options with the patient within 10 minutes.

 
 
2018 >  Intra-Articular + Extra-Articular
Trice Medical has just announced the combination of visual imaging + ultrasound imaging with the addition of the mi-ultra technology.  This combination is called the Dynamic Imaging Platform. Mi-ultra enables the physician to diagnosis intra-articular and extra-articular joint issues in real-time in the office. The ultrasound wand is lightweight, connects to the same imaging tablet and help the physician diagnose joint injuries non-invasively. Mi-ultra can also guide the physician during injections.

 

For more information, you can contact Trice Medical at:
[email protected]
 610.989.8080

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The Future of Orthopedic Surgery (according to the UK)

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The Future of Orthopaedic Surgery (British Orthopaedic Assoc)
As the 21st century comes of age and the global burden of disease shifts increasingly towards musculoskeletal conditions, orthopaedic surgeons will be called upon to rise to the challenge.
 
Orthopaedic surgery is on a path towards less invasive and more precise operations, with a greater proportion of outpatient and overnight procedures1 . This trajectory is likely to continue and will be further facilitated by new technologies, making surgery more selective and the orthopaedic surgeon an increasingly proactive specialist in the management of injuries and conditions.
As the saying goes: “Predictions are difficult, especially about the future.” It would be remiss to presume too much about how orthopaedic surgery will look tomorrow, but there are a few key trends that are becoming apparent. This is occurring against a backdrop of increasing demand for orthopaedic services worldwide and the rising threat of antibiotic resistance2,3,4. Clinical expertise and experience will be needed to inform appropriate responses.
Technology is reshaping the world and, with it, orthopaedic surgery. Whilst many recent advances have occurred inside the operating theatre, much of what is set to change will take place outside of the hospital, beyond the clinic room, in the time before and after surgery.
Measuring quality: Tomorrow’s questions
As new tools and techniques enter orthopaedic practice, accurate and comparable approaches to assess quality of care and outcomes will be paramount. The future success of orthopaedic surgery will be assessed using digitally enhanced Patient-Reported Outcome Measures (PROMs). By applying Item Response Theory and Computer Adaptive Testing (CAT), which shapes remaining survey questions based on those already answered, patients can be asked more relevant questions whilst giving fewer responses.
CAT can make patients’ survey responses more efficient, of higher quality and more easily comparable. Cambridge University’s open-source adaptive testing platform Concerto (concertoplatform.com) and the Patient-Reported Outcomes Measurement Information System (PROMIS) (www.healthmeasures. net) are leading exponents of this approach, with the latter comprising the world’s largest item bank of CAT measures currently being translated, implemented and validated across the word. PROMIS surveys measure generic, commonly relevant outcomes such as pain and physical function that can be used and correlated across and within different patient populations. Increasingly, orthopaedic patients have more than one condition and combining generic scores with disease or procedure-specific measures provides opportunities for more comprehensive assessments with relevance across different groups5 . PROMIS CAT surveys can also avoid the ceiling effects seen with other musculoskeletal function scores6 .
Beyond surveys: Smartphones and sensors
As existing models of measuring pre-intervention function, treatment progress and outcomes are being refined, smartphones, wearables and sensors are adding new layers of objective, real-world data, informing a deeper and more nuanced understanding of musculoskeletal treatments and results. Specialised sensors able to provide continuous, real-time information will increasingly enhance decision-making before, during and after surgery.
Smartphones are rapidly becoming ubiquitous across the world and, with their in-built recording of steps and activity, offer a convenient and scalable means of measuring the physical activity of both individuals and large populations7 . Automatically collected patient-specific data will reveal new insights into recovery patterns and enhance pre- and post-intervention planning. Research using smartphone data in orthopaedics is in its infancy, yet its use has been demonstrated in predicting outcomes including Parkinson’s-related gait progression and recovery from shoulder injuries8,9. Improved tools to estimate recovery progress against activity-related baselines and procedure-specific points of reference may also aid conversations with patients about treatment goals and expectations.
Remote support and day-case surgery
Improved capabilities for accurate remote monitoring and self-care will further enable day-case surgery. Retrospective activity data with clear baselines and tools to estimate outcomes will help to identify patients appropriate for outpatient procedures. Patients will be able to take more active roles in their treatment and improved capabilities for remote support can help to ensure that the potential savings of shorter hospital stays are not offset by increased follow-up appointments or readmissions10.
Machine Learning and Artificial Intelligence: Making sense of more information
Arguably, the uptake of robotic surgery may not have been as rapid as expected, yet its transformative potential is clear. Robotic surgery and Artificial Intelligence, as with any powerful force, must be handled with respect. As costs fall and evidence builds, robotic assisted approaches will become increasingly common across the orthopaedic subspecialties. Rather than replacing clinical skills, however, these new technologies will assist and enhance decision-making intraoperatively, as they will do too in the planning and recovery stages. In time, computer-assistance is likely to also enable new techniques and procedures11.
Currently recognised as the best-in-class approach within AI, Machine Learning techniques combine computer science and mathematics to improve predictive accuracy and translate large datasets into useful insights12. Long before autonomously operating robots become credible competitors, AI systems will revolutionise orthopaedics by working in partnership with surgeons, applying their superior capacity of drawing conclusions from large datasets, to enable surgeons to do more, better. Recent successful examples include algorithms helping to organise operation lists, prioritise workflow and predict in-hospital mortality, unplanned readmissions and prolonged length of stay13,14. Indeed, an appealing vision of the future is one where emerging technologies increasingly shoulder administrative duties, meaning healthcare becomes safer and more efficient, whilst surgeons are freed up to spend more time on clinical work.
New tools of the trade
Biologic treatments comprise a wide field of techniques, including stem cell therapies and platelet-rich plasma injections, which aim to encourage regeneration and repair. Whilst the current evidence for these techniques is variable, biologic approaches hold great potential and will likely play a role in the future evolution of the orthopaedic surgeon as injected therapies 3D imaging, navigation and printing will enable surgeons to be increasingly precise and personalised. Implants themselves will become increasingly ‘smart’ with person specific design, dynamic materials and incorporated sensors providing further data and direct feedback on progress and performance. Smart implants will be able to highlight the need for further review and may even be self-protective by automatically responding to changes in the local environment17.
Virtual and augmented reality will enhance pre-operative planning, training and procedural precision, further supporting safer surgery18. Telemedicine tools are enabling surgeons to share expertise in real-time during cases, adding a new dimension of collaboration to surgical practice, which may evolve further as surgeons become increasingly able to virtually ‘scrub in’ and join cases remotely19.
Coming together
As orthopaedic practice is changing, so too is the fabric of the profession, increasingly matching the diversity of its patients. The current and widely acclaimed online campaign #ILookLikeASurgeon is challenging the white, male surgeon stereotype and helping to redefine ideas about who surgeons are20.
The ability to share ideas and experience is a core promise of a more interconnected and informed world. As highlighted by The Lancet Commission on Global Surgery, five billion people are currently unable to benefit from surgical care and, whilst many new technologies are vying for a place in the orthopaedic toolkit, perhaps the most significant achievements of tomorrow will lie in replicating current successes and increasing access to high quality surgery.21 To echo the author William Gibson: “The future is already here –just not evenly distributed”22.  Communities of orthopaedic surgeons are forming to discuss and define the changing landscape.  To find out more and join these conversations, see the links below to Stefano Bini’s Digital Orthopaedic Conference in San Francisco; the upcoming Digital Orthopaedics meeting at The Royal Society of Medicine and, for more general discourse on the impact of AI in medicine, AIMed Europe.

Find out more:
AIMed Europe Shoreditch Town Hall, 11-13th Sep 2018 aimed.events/aimed-europe Digital Orthopaedics: Measuring quality in orthopaedic healthcare The Royal Society of Medicine, Monday 17th Sep 2018 tinyurl.com/rsmortho Digital Orthopaedics Conference San Francisco InterContinental San Francisco, Jan 5-6th 2019 www.docsf.health Axel Sylvan trained in surgery before co-founding the London-based orthopaedic start-up myrecovery.ai with fellow surgical trainee and patient Tom Harte. Aiming to improve patient experience and clinical insight, www. myrecovery.ai enables surgeons to create tailor-made treatment companion Apps and, with a growing team of software engineers and PhDs, is developing the next generation of AI-enabled digital tools for musculoskeletal care.

References
1. Crawford DC, Chuan SL, Sprague S, Bhandari M. Clinical and Cost Implications of Inpatient Versus Outpatient Orthopedic Surgeries: A Systematic Review of the Published Literature. Orthop Rev (Pavia) 2015 Dec 28; 7(4): 6177. Published online 2015 Dec 30. doi: 10.4081/or.2015.6177.
2. Briggs AM et al. Reducing the global burden of musculoskeletal conditions. Bulletin of the World Health Organization 2018; 96:366-368.
3. Briggs AM, Chan M, Slater H. Models of Care for musculoskeletal health: Moving towards meaningful implementation and evaluation across conditions and care settings. Best Pract Res Clin Rheumatol. 2016 06; 30(3):359–74.
4. Arias CA, Murray BE Antibiotic-Resistant Bugs in the 21st Century — A Clinical Super-Challenge. N Engl J Med 2009; 360:439-443.
5. Barnett K et al. Epidemiology of multimorbidity and implications for health care, research, and medical education: a cross-sectional study Lancet 2012; 380:37-43.
6. Hung M, Ami S, Higgins T, Saltzman C, Kubiak E. Computerized Adaptive Testing Using the PROMIS Physical Function Item Bank Reduces Test Burden With Less Ceiling Effects Compared With the Short Musculoskeletal Function Assessment in Orthopaedic Trauma Patients. Journal of Orthopaedic Trauma: August 2014 – Volume 28 – Issue 8 – p 439–443.
7. Anthes, E. Mental health: there’s an app for that. Nature 532, 20–23 (2016).
8. Healthcare Information and Management Systems Society http://www.himss.org/library/artificial-intelligence-prosdevelop-tools-identify-patterns-and-predict-outcomes (Accessed: 06/07/2018).
9. Zhan A., Mohan S., Tarolli C. et.al. Using smartphones and machine learning to quantify Parkinson’s disease severity. JAMA Neurol. (not yet in press).
10. Edwards PK, Levine M, Cullinan K, Newbern G, Barnes L. Avoiding Readmissions—Support Systems Required After Discharge to Continue Rapid Recovery? The Journal of Arthroplasty (2014), doi.org/10.1016/j.arth.2014.12.029.
11. Zheng G and Nolte LP. Computer-Assisted Orthopedic Surgery: Current State and Future Perspective. Front. Surg. 2005 2:66. doi: 10.3389/fsurg.2015.00066.
12. Dhar V. Data science and prediction. Communications of the ACM. 2013; 56: 64–73.
13. Rajkomar A., Oren E., et.al. Scalable and accurate deep learning with electronic health records. Digital Medicine 1(18).
14. Bini SA. Artificial Intelligence, Machine Learning, Deep Learning, and Cognitive Computing: what do these terms mean and how will they impact health care? The Journal of Arthroplasty (2018), doi: 10.1016/j.arth.2018.02.067.
15. LaPrade RF, Dragoo JL, Koh J, IR Murray, Geeslin AG, Chu CR. AAOS Research Symposium Updates and Consensus: Biologic Treatment of Orthopaedic Injuries. J Am Acad Orthop Surg 2016; 0:1-17.
16. Isabel Andia, Mikel Sánchez & Nicola Maffulli (2011) Platelet rich plasma therapies for sports muscle injuries: any evidence behind clinical practice? Expert Opinion on Biological Therapy, 11:4, 509-518.
17. Javad Parvizi, Valentin Antoci, Noreen J Hickok & Irving M Shapiro (2007) Selfprotective smart orthopedic implants, Expert Review of Medical Devices, 4:1, 55-64, DOI: 10.1586/17434440.4.1.55.
18. Pessaux, P., Diana, M., Soler, L. et al. Langenbecks Arch Surg (2015) 400: 381. https://doi.org/10.1007/s00423-014- 1256-9.
19. Bhattacharya S, Rawat D. Comparative study of remote surgery techniques. Global Humanitarian Technology Conference (GHTC) 2015 doi:10.1109/GHTC.2015.7344004.
20. Logghe H, Jones C, McCoubrey A, Fitzgerald A. #ILookLikeASurgeon: embracing diversity to improve patient outcomes. BMJ 2017; 359:j4653.
21. Ng-Kamstra JS, Greenberg SLM, Abdullah F, et al. Global Surgery 2030: a roadmap for high income country actors. BMJ Global Health 2016;1:e000011. doi:10.1136/bmj
 

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5 themes in MedTech right now

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5 themes in MedTech right now
1) M&A is still hot
2) Digital health
3) The Bleeding Edge
4) Fears loom over pending EU rules
5) Industry-FDA friendliness

Read more detail below

5 themes from The MedTech Conference (MedTechDive)
Thousands of executives and dozens of regulators descended on Philadelphia this past week for three days to talk innovation, regulation, business challenges and opportunities at The MedTech Conference.
Here are our key takeaways from MedTech Dive reporters on the ground at the Philadelphia Convention Center:
M&A is still hot
A packed room gathered at the conference to hear senior Boston Scientific, Smith & Nephew officials and others talk about how they look at potential companies to snap up.
“It begins with a relationship that is not unlike dating,” said Scott Schaffner, senior vice president of global marketing in sports medicine at Smith & Nephew.

Is there a perfect IDN commercial model solution to strive for? ZS’s Bret Caldwell discusses why medtech companies need to adopt a more agile approach.

Boston Scientific’s business development team has been busy. In 2018, the device manufacturer has struck at least seven acquisition agreements worth more than $1 billion upfront to strengthen its presence in the cardiovascular sector and other fields. Boston Scientific owned a stake in several of the acquired companies before deciding to buy them outright.
“We look at three things — strategic fit, financial fit, execution risk. Those are the three things that have to click.  First and most important is strategic fit — that is where it all begins,” Charlie Attlan, Boston Scientific senior vice president for corporate strategy and business development, told the panel.
During the courtship process, be careful not to give away too much information — in case the deal falls through and in the event that something leaks, advised Martha Shadan, chairwoman at IlluminOss  Medical. Shadan was CEO of Rotation Medical when it was acquired by Smith & Nephew last year.
“Whatever you tell them, is not a secret,” so don’t “give away the secret sauce,” Shadan said.
And know your audience. When pitching to doctors, “go granular,” but business development folks have a short attention span, she said to audience laughter.
Digital health
The incursion of digital health into the medical device space was a theme woven through many panels, with much interest in the FDA’s software precertification program under development.
The effort involving heavyweights such as Apple, Fitbit and Johnson & Johnson is on track to launch another version of its working model before the end of the year and is set to launch a pilot program in 2019, Bakul Patel, associate center director for digital health at FDA, said.
Patel said the agency is also still working through what types of Software as a Medical Device will be able to go through FDA with or without review. Throughout 2019, FDA will continue to work on mechanisms to measure real-world performance data from the pilot participants to benchmark the benefits and risks of SaMD products and work to “quickly correct adverse events related to products cleared through the model.”
Although the idea is to precertify companies, Patel said the bigger vision is for continuous oversight. The goal is for few intrusions into business processes while allowing FDA to know “what’s going on.”
The Bleeding Edge
AdvaMed CEO Scott Whitaker took several questions about the controversial Netflix film The Bleeding Edge. The film takes a harsh view of the medical device industry and the FDA, which it describes as a captive agency.
The device industry chief argued that public perception of the medical device industry is still broadly positive, casting the film as a one-sided sensational attempt to get viewers.
“Unfortunately, The Bleeding Edge to me became more of an entertainment documentary than a fact-based documentary,” Whitaker said to reporters. “What the film didn’t do was talk about all the patients’ lives that have changed for the better.”
When asked if anyone involved with the film was invited to the conference, Whitaker said they had not considered it, pointing instead to invitations to the patient community.
“I would say we have a significant patient pavilion on the exhibit floor,” Whitaker said. “A lot of our companies … and the patient community will be there talking about their products.”
He also said he saw no reasons for changes to the regulatory process in light of recent events or the film until specific ideas are put forward to improve it. As a general rule of thumb, Whitaker argued the medical technology industry has contributed inventions that “have proven overwhelming positive for our society … that suggests to me that the process is working pretty well right now.”
“I didn’t see that film as a way to try to solve any of the issues that they believe exist. It only came across as an attempt to salvage an industry,” Whitaker said. “If there are ways to improve the FDA process, I’m happy to have that conversation. If we can make it better we should. We want every product to be safe.”
In front of hundreds of medtech executives, Whitaker charged the audience to share stories of the industry’s successes in light of the movie.
“When critics unfairly criticize or attack this industry and the good work you are doing, we’re ready to engage, quickly, factually and enthusiastically in the court of public opinion,” Whitaker said in his state of the industry address.
Fears loom over pending EU rules
The new EU medical device and diagnostic rules are a moving target, with many key implementation documents spelling out exactly how they will work late in coming.  Companies expressed frustration at the holdup, with many of the so-called EU implementing acts still not finalized.
“We might have a surprise … The system is not totally settled,” Michel Marboeuf, senior director for corporate and regulatory affairs at Stryker, said.
At the same time, experts said companies should not overreact. Several noted that the rules did not contain drastic changes, just codification of existing rules.
“We are not reinventing the wheel … [instead] putting in clearly written requirements no longer subject to interpretation,” said Ibim Tariah, tech director at BSI Healthcare, a notified body.
One piece to keep a lookout for is FDA’s work with the International Medical Device Regulators Forum.
“I think there has been a very strong component this year of greater interest on international harmonization. I anticipate that this is going to continue to be an ever-growing area of both interest and activity,” said Jeff Shuren, director of FDA’s Center for Devices and Radiological Health.
Industry-FDA friendliness
It’s hard to keep track of all collaborations with the industry going on at the FDA. Pre-Cert, the private payer pilot, improving third-party reviewers for certain 510(k) applications and improving pre-submission communication were among topics getting big airtime at the conference. While the 21st Century Cures Act does compel FDA work closely with industry, it was striking to hear the often friendly tone between regulators and executives.
FDA officials took pains to describe their efforts to listen to feedback in front of an industry audience.
“We’ve also had a big focus on customer service. We train all of our staff on customer service. You can rate us through customer satisfaction surveys built into the signature blocks, in our emails, you can see it on the website,” Shuren said. “We take all that feedback very seriously.”
In the context of private payer program pilot, Shuren said that industry has even been surprised how fast the agency is moving, adding he has heard positive feedback about where the program is headed.
“I think this year there were a lot of discussions about truly more innovative programs that we have been piloting,” he said. “I think if you hear any message, it is ‘hey FDA, you seem to be moving fast in some very novel directions’ and more of the industry side is saying ‘well maybe, are we comfortable or not, you’re really being more innovative.'”
FDA officials also emphasized that they want to hear from industry when developing guidance.

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