US commands Majority Of Medical Device Startup Deals, with Israel and UK as Runner-Ups

Since 2012, the US has received 80% of global deals to medical device startups. California alone takes more deals than any non-US country.

 Source: CB Insights

The United States is the center of startup investing for many industries and the medical device industry is no exception. 

Source: CB Insights

Globally, Israel ranks a distant second to the US in medical device deals and funding. Recent investments in Israel include V-Wave‘s $28M Series B from a trio of Israel-based investors including BioStar Ventures, Pontifax, and TriVentures, as well as InSightec‘s $22M Series D from investors including the Israel-based Elbit Medical Technologies.

V-Wave is developing an atrial shunt intended to reduce left atrial pressure and heart attack frequency. InSightec is developing focused ultrasound and MRI technology with neurosurgical, gynecological, and oncological applications.

Within the US, California is the center, which is not surprising, and Massachusetts takes second place.

Deals by country

Accounting for 80% of deals to medical device companies, the United States has dominated investment into the industry over the past four years. Israel and the UK rank second, each with a 4% share of global medical device deals. Germany, Canada, and France grab third with a 2% share each.

One of the most active medical device investors, High-Tech Gruenderfonds, made two deals into Germany-based startups in 2016; SeNostic, which develops diagnostic technology for neurodegenerative diseases, and Abviris, a developer of screening tools for HPV-induced oral cancer.

The remaining 7% of medical device deals is spread widely among 24 countries including Switzerland, India, and the Netherlands, none capturing much more than 1% of the global total.

Funding by country

Total equity dollars in the sector are also heavily concentrated, with the US taking an 82% share of equity funding to private companies in the space. Since 2012, Israel has been leading the pack outside of the US with a 6% share of total funding dollars.

In third, Switzerland, the UK, France, and Germany account for 2% each. The remaining difference is split between a number of countries, none making up more than 1%. 

Deal share within US

As in the tech sector, California also commands a large share of domestic investment into medical device companies. The state has dominated US-based deals to medical device startups, with a 31% share of all US deals since 2012 and 38% in 2016 year-to-date. When compared to the rest of the world, California is participating in more deals to medical device companies than the top 5 non-US countries combined. Two such deals include the $120M Series G in Proteus Digital Health and $93M Series F in Halt Medical.

Massachusetts has consistently ranked second, averaging a 10% share of US based deals into private medical device companies. Minnesota, Pennsylvania, and Texas have battled it out for third over the years, with Pennsylvania taking the bronze in 2016 year-to-date with a 6% share of deals.

Featured image credit: Getty Images/ baytunc

How to Build a Startup as a Non-Tech Founder

Source : Founder Institute

Remark CB : To build a company is more a kind of an art then science.  Like with a good recipient it depends on the right ingredients in perfect balance.

Startups and innovative technology have become so synonymous with one another, that many people now think that you can’t create one without the other. And while it is necessary to have an understanding of the technology that you’re building, you actually don’t need to be a developer or engineer or computer scientist to launch an impactful company.

If you’re an aspiring entrepreneur who wants to launch a tech startup but doesn’t have much tech experience, this blog post will give you the wisdom you need to build your dream company, featuring insights from Weiting Liu, the founder and CEO of Codementor.

Can Anyone with Any Level of Technical Proficiency Start a Company Today?

Believe it or not, you don’t have to have ANY tech experience to launch a tech company. Remember, if your goal is to build an app, your mission isn’t to learn how to build an app; rather, your mission is to learn how to get things done.

Regardless of how talented you are, you are going to find yourself - at least several, if not many times - not being able to do something to run your company. Even if you’re an experienced technical founder, your financial, marketing, or managerial skills may be lacking, which means you’ll have to adapt to the needs of your growing company and compensate.

Bottom line: not being able to code is no excuse to not build a company, as coding is only one of many tasks.

How Do You Build a Company Without Tech Experience?

Because of the proliferation of various tech-based markets, it’s getting easier and easier for someone to create a tech product without a degree in engineering or computer science. For example, there are numerous platforms that enable users to build apps without any coding experience, which is a great way for budding founders to build a minimum viable product (MVP).

At the very least, non-tech founders now have the resources that allow them to at least build a mockup of their offering to attract the interest of those with the expertise to build a more finalized product.

Your MVP is Up and Running. What Next? 

Once you’ve built your working MVP, your next step is to show it to as many users as possible and get their feedback. If you consistently get feedback on a specific feature or set of features, make the necessary changes to the best of your ability.

During this process, it’s important to keep these two points in mind:

1. Ensure that you’ve built your MVP with the flexibility to make changes as you get feedback from users.
2. Continuously learn how your product works with each iteration so additions and fixes can be made more quickly.

Do You Need a Technical Co-founder Early On?

If you can make changes to your project based on user feedback on at least a weekly schedule, recruiting a technical co-founder at this stage is not necessary. Especially since your product is basically the company itself, doing as much work by yourself will save you time and money.

While it may be tempting to outsource your code to a freelancer, this isn’t recommended, as the iteration cycle is far too long to make any meaningful progress on your product.

Project Management Skills are a Must-Have

As a non-tech founder, it’s important to develop a variety of other skills to compensate for a lack of technical expertise, including basic product management principles. Also, as part of your role, you should take the time to learn at least a little bit of the primary language of your product for a variety of reasons. If you don’t know how to speak to developers, if you don’t know how to set deadlines, if you don’t know what a product development sprint is, you’re going to be lost in the lingo of the people working for you.

Learning a little bit of code can go a long way. For example, if your developer gives you an estimate of how long it will take to build a feature or fix a bug, just having some basic coding skills can help you gauge if that estimate is correct, and will enable you to better articulate the needs of the product to the developers.

Learn How to Communicate with Developers

You can’t write good requirements if you don’t have some understanding of the technology of your product. All modern technology systems consist of a front end and a back end, so it’s essential to understand how these work as they pertain to your product. For those of you not familiar with these terms, the front end is what a user sees on a website, software, or app, while the back end exists on the servers, and features the database, the application layers, etc. that process the data and presents information to the front end.

Many novice founders write requirements by only describing the front end while neglecting the back end, relying on their partners or employees or outsourcers to figure out the back end. This is dangerous, and will greatly increase the risk of delays and miscommunications. Remember, don’t underestimate the power of learning a bit of code.

Also, when communicating with developers, it’s important to keep your scope as limited as possible and to focus on the primary function of your product. If your product’s core function is weak, no amount of flashy features are going to make your product stronger.

Inhouse or Outsource?

As mentioned earlier, try to build everything yourself for as long as possible, or at least keep it inhouse for as long as possible. Especially during the formative stages of building your product, you should directly oversee the core experience of your product, as you are the one getting the initial customer feedback.

However, if for whatever reason you choose to outsource your user experience, you should only do so if the freelancer can have meetings with you on a daily basis and produce product iterations on AT LEAST a weekly basis. Basically, if you’re going to outsource your product to a freelancer, only do it if you can treat them like an inhouse developer.

Additional product features, on the other hand, can definitely be outsourced as need be, as features that are not relevant to the core user experience should only serve to enhance the product, and can thus be handled with more leniency.

Should You Hire a Project Manager Early in the Process?

While this is not exactly common practice among startups (yet), hiring a project manager early on during the formative stages of a startup can yield some surprising benefits. Even without the burden of learning how to code, writing requirements for a product’s front end and back end, holding regular meetings with developers, planning product iteration deadlines are difficult tasks, even for non-tech founders. Hiring someone who specializes in this kind of role can be a potential shortcut for early stage non-tech founders.

How Should You Pick Your Technology?

If you are setting out to build a tech-based product, start by first basing it on a technology that has a large online community that is currently active to ensure that your offering will appeal to a wide audience. Also, be sure to pick a technology that is prevalent and relevant, as this will increase your chances of finding a co-founder that is up to speed and won’t need to go through an extended learning curve. Or, if you already have a co-founder in mind, build your product on the technology that they are most familiar with already.

Final Thoughts 

Starting a company is hard. It’s stressful and unpredictable and daunting. However, learning how to code is actually one of the easier aspects of launching a tech startup, even if it’s just a little bit. Technology is constantly changing, so it’s important to constantly keep abreast of current trends and to learn emerging methodologies. If you can keep up with the pace of technology, then you will be better equipped to keep up with the demands of your company.

13 digital health crowdfunding projects in 2016

Connected CPAP, breathalyzers, mental health apps and more

Source : mobihealthnews.com

Shae, which bills itself as “Siri for Your Health,” has raised $71,23 by 268 backers, far outpacing its $25,000 goal. It still has 16 days left. The app uses interactive voice and text conversation to communicate a personalized health plan via smartphone, tablet, desktop, smartwatch or any connected device. It can integrate with wearable fitness trackers or wellness apps.

One Drop Premium is a glucose meter with companion app. This one has almost a week left to reach its $50,000 goal and is currently at $38,031 from 179 backers. The offering consists of a lancing tool, drop meter, test strips and vegan leather carry case. The meter connects via Bluetooth to an iOS or Android application. Users sign up for a membership that offers 24/7 access to certified coaches and unlimited testing strips delivered each month.

Remora Tracking. This campaign is for a standalone tracking device to put on people, belongings or pets. Remora has 143 backers who have thus far pledged $22,276 of a $100,000 goal, with 32 days to go. It uses a built-in cellular signal that connects to a database using Google Maps. It started as a way for athletes to track themselves, but expanded to include just about anything. The device also has an impact sensor, which sends a notification to whomever may be tracking you. Users can put up “geo-fences” that alert the supervisor when those wearing Remora happen to move out of a preset area, like a preschool doorway, a yard, or anywhere else.

Airmony is a battery-powered hoseless CPAP machine designed with portability in mind. Five backers have contributed $3,447 to its $180,000 goal, with 18 days left. The idea came to CEO Jaume Palou after he had to cancel a trip due to an inability to carry and plug in his CPAP machine everywhere he went. Airmony doesn’t need to be plugged in, fits into hand luggage, and is purportedly user-friendly enough that it can be used by children. It continuously records physiological sleep parameters, providing data that can be stored on a smartphone or tablet, or sent to the doctor online.

WearSmith, a Bluetooth-enabled breathalyzer, is made by CoAsia Microelectronics in Taiwan. It has raised $2,929, from 32 backers, with a month to go to meet the $35,000 goal. The alcohol breath tester is a standalone device with a smartphone application that will analyze how long it takes the user to recover, counting down until they are sober enough to drive. The app will notify the user by linking to the tester via Bluetooth, or it can be used by itself, with the result shown on the OLED display. It’s designed to be slipped into a pocket or bag before a drinking occasion, and it only weighs 19 grams. 

nestCare
This suite of devices has raised $2,545 of its $50,000 goal, from eight backers, with 2 months left. The Bluetooth-enabled devices measure key vitals – a blood pressure cuff, smart scale, pulse oximeter and wearable activity tracker and medications reminder, come with an app for smartphones and tablets that aims to be a personal wellness coach and communication hub.

Mevo 
This fitness and health app for iOS and Android has 18 backers pledging $2,085 so far of a $20,000 goal, with 23 days to go. The voice-controlled app is aiming to replace several others. Tell it what you ate, what you plan to do for a workout, how many reps you do, etc. It will feature automated coaching based on goals and data you provide, quizzes and competitions, a library of recipes, meal plans, exercises.

Phyzit is a cloud-based solution for tracking the metrics surrounding transitional care management. The Kickstarter fund has raised $775 by seven backers, with a goal of $50,000. 35 days to go. Aimed at patients, hospital systems, family practice providers, internal medicine providers and cardiologist, the intuitive dashboard to track patients and help clinical staff stay on top of transitional care management deadlines or tasks.

Fit2U is an app to bring instructors of popular fitness programs and dance classes to the app user, wherever they are. It caters to the “non-gym-going individual” or those who are simply too busy. Eight backers have raised a total of $805 of the $25,520 goal, with 27 days to go. The app will connect users with an instructor in a variety of exercises or dance classes.

Alc Accounting 
This Kickstarter project bills itself as “An accountant in your pocket” – if the accountant only tracked alcohol. The mobile app has raised $625 from three backers, with 57 days to make its $10,000 goal. Alc Accounting is designed to keep track of drinking habits, whether its your blood alcohol content, calories consumed, or when and where you drank. The user selects the type of alcohol, then the specific brand or cocktail name from over 1,000 listed, the size and then scrolls through graphs, charts and maps to log everything about their drinking. The main reason the app needs funding is to cover the expenses of drafting “necessary legal documents for an app of this sort,” which includes privacy policies, terms of use and disclaimers.

SnapClarity, is a mental health app to reach a community with a suicide crisis. The project has 8 days left to reach a flexible goal of $25,000, $616 so far. The Terrace Wellness Group is working on the app to make therapy convenient and easily accessible to 100 kids in two at-risk Canadian communities, and it is crowdfunding to soft launch this summer. A pre-loaded smartphone will be given to the youth, with the ability to have an online chat with a professional therapist at any time. Healthcare professionals in the community will have access to the Terrace Wellness experts.

Never Be Alone
This is a heart attack app that works with smartphone and wearable heart rate monitor to constantly keep track of heart rate has raised $217 so far with a month left on a $50,000 flexible goal. If Never Be Alone detects an abnormal heart rate, it will initiate a countdown, and will end in a call to emergency services unless canceled by the user, family member or healthcare professional. If a user’s heart suddenly stops beating, Never Be Alone will immediately call 911 and dispatch emergency responders using the phone’s GPS. Medical data, current location and other information is converted from text-to-speech so the app can communicate over the phone on the user’s behalf. At launch, the company wants to include the Apple Watch and heart-sensing Fitbit devices. 

Warrior Distress App for Veterans 
These founders are working on an app to get mental health care to veterans, with the goal of ending the nation’s current rate of 22 veteran suicides per day by getting distressed veterans in touch with a peer counselor via text, email or phone. No one has pledged any money yet for this Kickstarter fund, which has 42 days to go to reach its $14,000 goal.

HealthTech innovations : FDA clearances so far in 2016

Source : MobiHealthNews



Comment :  ++  interesting overview about HealthTech innovations

FDA clearances roundup

Israel-based startup Biogaming received FDA clearance for its YuGo Microsoft Kinect-based physical therapy system. Physiotherapists can use the system to create personalized gamified routines for patients, which patients can then complete at home using an Xbox or a computer connected to a Kinect device. The system tracks patients' movements, automatically creating a record of the therapy. It appears that the company may have gone out of business while awaiting FDA clearance.

Also based in Israel, Labstyle Innovations secured FDA 510(k) clearance for its smartphone-connected glucometer called Dario. The glucometer syncs with a companion app and is small enough to fit in someone’s pocket. Dario consists of a glucose meter, a disposable test strip cartridge, and lancing device. The companion app, available on iOS and Android devices, includes a nutrition guide, logbook, and monitoring system. The app allows users to view all their information as well as insights and patterns in their data.

Switzerland-based Sensimed announced it received a de novo FDA clearance for its connected contact lens, Triggerfish, which helps physicians track the progression of glaucoma in patients. The sensor-embedded contact lens will record continuous ocular dimensional changes for 24 hours. The data is sent from the lens wirelessly to a recorder that users wear around their neck. After the recording period has ended, the data is transferred from the recorder to a physician’s computer via Bluetooth -- meaning the patient needs to return to the physician's office to upload it.

Lowell, Massachusetts-based InfoBionic received FDA 510(k) clearance for its remote patient monitoring system, MoMe Kardia, not to be confused with AliveCor’s recently product portfolio rebrand, which is also now named Kardia. The MoMe Kardia is designed to help detect cardiac arrhythmias in patients by sensing ECG, respiration, and motion. The lightweight monitoring device can be worn as a necklace or belt attachment. A first generation of MoMe Cardia already received FDA clearance, but that version was never commercialized.

Neurometrix got FDA clearance for a new smartphone-controlled version of Quell, its wearable for pain relief. Like its predecessor, the device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids. It's worn around the calf. The new device will let the user directly control the nerve stimulation -- they can turn it on and off and increase or decrease therapy levels, and toggle between two different validated therapy modes, one which feels like a constant vibration and one that feels more like a fast pulse.

Wing, an app-connected spirometer from St. Louis, Missouri based Sparo Labs received an over-the-counter clearance, meaning the company can market it directly to consumers, but Sparo sees provider and pharma channels as important ones too. With Wing, Sparo aims to help people manage asthma and other respiratory conditions, such as COPD and cystic fibrosis, with a pocket-size sensor and corresponding app to track lung function.

Redwood City, California-based smartphone-connected breast pump startup Naya Health, which makes a device called the Smart Pump, received FDA clearance for its first pump system. The Smart Pump uses a hydraulic system instead of air to collect breastmilk. As a result, the pump is more comfortable and quieter, according to the company.  Some data from the system, including how often a mother pumps, is sent to a companion smartphone app, called Naya Health Tracker. The app also allows users to track pumping sessions, record their child’s feedings, and manage breastmilk inventory by telling users which milk in their fridge needs to be used first. The company is developing an Apple Watch app as well.

Withings, the French connected device maker recently acquired by Nokia Technologies, received FDA 510(k) clearance for Withings Thermo, the company's WiFi-enabled thermometer. The device was first announced in January at CES in Las Vegas. Rather than being inserted in the mouth or armpit, Thermo measures temperature from the temporal artery on the user's forehead. The user simply holds the thermometer next to their head or a child’s head and an array of 16 independent infrared sensors measure the heat being emitted. Readings appear on the side of the device but are also automatically sent to a companion smartphone app, where users can assign them to a particular user and add any other notes.

Sandstone Diagnostics received FDA 510(k) clearance for its Trak system, an app-connected home test for male fertility. Trak's device aims to disrupt the current model for testing male fertility which is viewed by many as awkward and inconvenient. The device received over-the-counter clearance as a Class 2 medical device. The device itself uses a centrifuge to isolate sperm cells in specially designed cartridges. It then sends results to a smartphone app that will tell the user whether their sperm count is low, moderate, or optimal, based on World Health Organization guidelines. The app not only informs the user of their sperm count, but allows them to compare it to population averages based on aggregated data from users and gives personalized feedback on wellness and lifestyle steps that might help improve their numbers.

Sweden-based Qbtech received an FDA 510(k) clearance for an online tool, called QbCheck, that offers clinical decision-making support for diagnosing and treating children with ADHD.According to the company, the normal route for diagnosing ADHD is complicated, involves, administrative costs, and carries risk for bias. Qbtech’s process aims to make ADHD easier to identify, rule out, and monitor.

Reciprocal labs, which runs Propeller Health, received clearance for its Propeller Sensor 2014-Rsensor-enabled inhaler and accompanying software.

Medtronic received FDA clearance for its AVIVO Mobile Patient Management System, which continuously measures, records and periodically transmits data for patients with cardiac illnesses. The system uses a wearable sensor and patient-held transmitter that sends information to the Medtronic server.

Salem, New Hampshire-based AgaMatrix got FDA clearance for its wireless blood glucose monitoring system. The device and companion app, called the Jazz Wireless 2 Blood Glucose Monitoring System, was built upon a previously cleared device and can communicate with either both iOS or Android devices via Bluetooth. After taking a reading, the user gets a result in an average of five seconds, which then syncs to the app and can be shared with family and physicians.

Amsterdam-based QServe Group was cleared for its Dyna-Vision Telemonitoring System. The system uses Dyna-Vision devices that monitor cardiovascular health, then transmit data to the system’s server. From there, the data is sent over WiFi or 3G and can be accessed by telemonitoring software and connected smartphone apps.

LifeWatch Technologies received clearance in January for its ECG Mini Continuous ECG Monitor and Arrythmia Detector. Though not smartphone-connected, the single-lead ECG patch transmits data over a cellular connection to a monitoring center.

LifeWatch also got an updated clearance in January for its Vital Signs Patch (VSP) which was originally cleared in December 2014. The device is a disposable adhesive strip which contains sensors to monitor ECG, heart rate, respiration rate, temperature, saturation, and movement. It also contains a battery which allows the device to collect data continuously for five to seven days. The system also includes a wireless connected blood pressure cuff and an Android app that processes and transmits the data. The app can also monitor the patient and generate alerts in the event of unusual vital signs. According to a summary document, the update allows the patch to interface with a clinical consul tablet and adds a “Patient Posture Sensor” to the device.

Andon Labs, the parent company of iHealth Labs, got FDA clearance in February for the iHealth Track Blood Pressure Monitor, a new smartphone-connected blood pressure cuff. It’s very similar to a previously-cleared version of the device, according to the summary document. “Only their appearance, the memory capacity, electrical power, measure process, average measure function and the MCU are different, and a new software platform has been added,” the document says.

Shanghai-based Biolight Meditech received clearance in January for a wireless connected thermometer. The battery-powered, handheld device can take temperature orally or under the arm and transmits the data via Bluetooth to an iOS or Android app called Temp Sitter.

TaiDoc Technology, a Taiwanese firm, received FDA clearance in March for a Bluetooth-enabled pulse oximeter. The device is part of a large suite of connected devices for telehealth that TaiDoc offers to providers.

2Q Venture Capital Report : Rock Health, CB Insights count $2B, $3.5B respectively for 2016 health funding

Source : RockHealth, KPMG, CBInsights

BB Comments : In a year when everyone expected funding to decline, digital health has been as steady as ever and accounted for a healthy 8% of total venture funding. Beside that the first half of 2016 came out with a record-breaking 151 companies which raised more than $2M.

As we come to the midyear point of digital health funding, two reports from Rock Health and CB Insights / KPMG offer up analysis of how 2016 is coming along.



Rock Health reported just more than $2 billion in total venture funding – on track with the levels of both 2014 and 2015. While funding hasn’t continued to surge upwards as it has in the past, Rock Health analysts Mitchell Mom and Ashlee Adams write digital health funding is "hitting its stride."

Following two record years of digital health funding, they report, 2016 has started with a more moderate pace, with overall funding about $191 million below 2015’s first half record.

"While this number ($2B) didn’t eclipse either of the previous years’ numbers, it’s important to keep context," they write. "In a year when everyone expected funding to decline, digital health has been as steady as ever and accounted for a healthy 8 percent of total venture funding."

CB Insights, which is newer than Rock Health and tracks a much broader range of digital health companies, reported $3.5 billion in funding across 476 deals. Both noted a leveling off of funding in Q2. Both also track the top geographic region for funding as California, followed by New York.

As we’ve written before, it’s important to note that, generally, Rock Health’s process is a bit more conservative than most, as it only includes funding rounds that are more than $2 million, avoids conflating investment dollars with transactional costs associated with M&A, and has a stricter definition of a digital health company than either CB Insights or StartUp Health, whose midyear funding we reported earlier this month.

While the dollars might be leveling off, the sheer number of companies receiving funding at an all-time high, Rock Health reports, with 151 companies raising more than $2 million.

Rock Health reports the average deal size for 2016 at $13.3 million. While the first quarter saw larger rounds (deals averaging at $15.4 million), the leveling off during Q2 brought the overall midyear average down quite a few pegs. The largest deal thus far has been Flatiron Health, in a $175 million round led by Roche.

The top six categories of the year that received 54 percent of all funding were analytics/big data with over $300 million in funding (Flatiron alone accounted for more than half of that with $175 million); wearables and biosensing at $217 million (Jawbone making up $165 million of that); population health and management at $184 million; personal health tools at $132 million; EHR/clinical workflow at $127 million; and digital health devices with $122 million.

Rock Health noted that the consumer space also continues to receive consistent investor attention, with two of the top three digital health "unicorns" -- 23andMe and ZocDoc -- being consumer-focused companies. Rock Health sees consumerazition as an area ripe for "disruption by digital health startups," thanks to the fact that over one-third of adults are now convered under high deductible health plans, a shift in coverage that transfers more of the burden to the consumer. While healthcare consumer engagement still didn’t make the top six, it did experience year-over-year growth of 127 percent.

Two hundred and forty-eight distinct investors funded digital health companies in 2016, according to Rock Health’s definition. Most active venture investors for 2016 have been a mix of new and old, with corporate investors outpacing traditional venture funds in the number of deals. Top venture investors were Khosla Ventures, Jump Capital, Norwest Venture Partners, Pritzer Group, Safeguard Scientifics and Jump Capital. UPMC, Heritage Group, Blue Cross Blue Shield and Merck topped out the corporate most-active list.

As has been the trend for the past two years, Seed and Series A stage deals represent most of the deal volume, and later stage deals account for a little more than a fifth of all deals.

Looking at exits, Rock Health reported 2016 has also been slower in public markets than previous years, with NantHealth's $1.5 billion offering accounting for the only IPO. Overall, IPO performance hasn’t kept pace with funding, with nearly all public companies trading below their initial share price.

Halfway through the year, 87 mergers and acquisition deals have already been closed (slightly below 2015’s midyear mark), with total disclosed dollars eclipsing $10 billion.

As Rock Health analysts say, "Stay tuned to find out if this year will become the new normal or if we’re still waiting for the proverbial shoe to drop."