Are FDA Cleared Medical-Grade Devices Safe?

Disclaimer: This blog is independently written and published by me. The opinions expressed herein are my own personal opinions and do not represent my employer's view in any way.

Today I will be sharing some of the surprising things I learned about the regulation of Medical-Grade Devices in the US. Most people believe that when they are implanted with a medical device or other device that could negatively impact their health that those devices have undergone appropriate testing to demonstrate that they are safe and effective before they came on the market and doctors started using them. But for most moderate and high-risk devices, that may not be the case.

In the US, a ‘medical-grade’ health device is different than devices like personal fitness trackers because these devices must be cleared or approved by the Food and Drug Administration (FDA) and are Health Insurance Portability and Accountability Act (HIPAA) protected. Originally congress intended that almost all new devices go through a process called pre-market approval (PMA). A PMA Is similar to a new drug application, in that a manufacturer must test it first in humans, compile all this data and then present it to FDA scientists who will approve the device if in fact it is safe and effective. But the medical device industry pushed back on the cost of changing their products every year arguing that they need more flexibility to innovate. To address the feedback, congress established the 510(k) process.  

Today’s process stems from the Medical Device Amendments added to the Food, Drug and Cosmetic Act in 1976, establishing the three regulatory classes for medical devices we have today. Because there were devices already on the market prior to 1976, all devices were considered either pre-amendment medical devices, or entirely new concept medical devices.

FDA Clearance vs. Approved

Since 1976, all manufacturers who seek to market medical devices in the United States must go through one of two pathways via the FDA —the section 510(k) process, where a device is “cleared” for distribution, or the Premarket Approval (PMA) process, where a device is “approved” by the FDA.  

Today, the majority of low to moderate risk medical devices (class one and class two) go through the FDA 510(k) Clearance process which is required to market a device in the US. FDA-Clearance through a 510(k) does not require clinical validation studies. They get around this requirement by stating that the device is “substantially equivalent” to a pre-existing device that was already proven safe and reliable. Only quality measures (complying to CFR regulations for medical devices) are required but the manufacturer is only subject to inspection after FDA-clearance. That means, it’s on the honor system (!).

If you’re wondering if you read that right, I’m going to restate this information one more time. For the 510(k) pathway, all the manufacturer needs to demonstrate is that their device is "substantially equivalent" to another device that’s already on the market. Let’s discuss this phrase “FDA Clearance” for a moment. For Class II and Class I, the FDA doesn’t give “approval,” it just gives clearance. The FDA has simply allowed the manufacturer to market their product in the US. Ninety-Eight percent of devices today are regulated under this 510(k) framework giving “Clearance” with only 2% going through pre-market approval (PMA) because it is so much easier and less costly to get to market.

DE NOVO PATHWAY

There is one more pathway for low to moderate risk medical devices, called “De Novo” where there is no substantially equivalent device. De Novos are designed truly for new and novel, low and moderate risk devices. An advantage to the manufacturer is that they don’t have to prove that they are substantially equivalent and that they have more of a blank slate for marketing in terms of how they label their product. You do have to be able to substantiate your marketing claims. The De Novo is not a common submission type. The total number of De Novos that have come through the FDA since it was created a dozen years ago is under 200 while there have been 40,000+ 510(k)s.

Apple has stated that it has received a “de novo” classification for the EKG feature. That means that, although it’s still in Class II in terms of risk and hasn’t gone through as much testing as an “approved” device, it’s unlike anything else on the market. It is the first direct-to-consumer EKG wearable. (A year prior the FDA approved the AliveCor KardiaBand, a watch accessory that essentially does the same thing, but that wasn’t direct-to-consumer). The two FDA-approved Apple apps monitor for atrial fibrillation, a common heart rhythm irregularity that can lead to stroke. They can also detect unusually slow or unusually fast heart rates and record the data for a medical professional.

One of the disadvantages of a successful De Novo, is that it will likely lead to a predicate device, making it easier for competitors to enter the market. Essentially they would bring their device into the market as a 510(k) using the De Novo as a predicate. The labeling of the De Novo will determine how difficult it will be for a competitor to successfully use this strategy.

LITTLE TO NO TESTING IN HUMANS

Human testing of devices is often not a requirement of FDA 510(k) Clearance. I’ve personally talked to several device manufacturers that have told me that didn’t do any human testing or that there human testing was essentially equivalent to 3 human test subjects doing jumping jacks for 3 minutes. Often these companies don’t have the funding to do large scale testing or the access to patients. Getting through FDA clearance alone can take about 18 months and cost about $200,000 and if you’re a startup, this might eat up all your funding. And if the product has a new software update with a new version, it will needs to go through the clearance process again, which entails more cost and time. Hospitals won’t consider testing devices that aren’t FDA cleared. So the natural first step for devices is to become FDA cleared and then seek out relationships to do both human and ROI testing. Finding human test subjects especially in the US is difficult and that’s why many of these companies do their human testing offshore. Some hospitals have a venture arm and may invest in device companies that they believe in and work with them to do the testing. Sometimes government funding can be used to support testing.

Over time, what happens is that one medical device is approved on the bases of being substantially equivalent to a previous medical device that was approved because it was substantially equivalent to an earlier medical device and continues on for generations of devices. The original device might be seven or twenty layers up the chain (often referred to as a “daisy chain”). If a predicate device is recalled from the market because they have safety issues - say its potentially dangerous - a device manufacturer can still use it as a predicate device and get a new device cleared using the “substantially equivalent” clause. The FDA’s stance is not to judge what the prior device is.

Even the most stringent pathway to get a device FDA approved (PMA) but even that is less rigorous than the process for drugs. Most drugs have to have two clinical trials and large numbers of patients. With devices its only one study with small participant pools. Approval process for the riskiest process is not that strict. There are plenty of untested devices on the market. Despite very little data, devices are still approved even with open-ended questions remaining unanswered.

LOOKING AT A REAL Example

The Patient Status Engine (PSE) is a FDA cleared Class II medical device effective April 2018. It uses wireless body-worn sensors to automatically collect and analyze six vital signs in real-time including heart rate, respiration rate, temperature, oxygen saturation, blood pressure and coma (or pain) score. It then streams this data via a patient gateway to a central server and delivers it to the nurses’ station or remotely to clinicians.

510(k) Number: K172329

Device Name: Patient Status Engine

Indications for Use (Describe): […]

Type of use: Prescription Use

Legally Marketed Predicate Device: K152139 - Vital Connect Platform/VitalPatch/HealthPatch MD by Vital Connect Inc.

Device Description: [.]

Clinical Performance Data: There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device.  These types of devices, including the predicate devices, have been on the market for many years with proven safety and efficacy for the use of the device.  The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

Statement of Substantial Equivalence: It has been shown through the documents provided in this 510(k) submission that the minor differences between the Patient Status Engine and the predicate devices Vital Connect Platform/Healthpatch MD/VitalPatch do not raise any new questions regarding its safety and performance. The Patient Status Engine has the same intended use and the same or similar indications for use and technological characteristics as the previously cleared predicate device, Vital Connect Platform/Healthpatch MD/VitalPatch. The Patient Status Engine as designed and manufactured, is determined to be substantially equivalent to the predicate device.

THE PSE DAISY CHAIN

I looked up PSE’s predicate devices to and followed the chain to its dozens of predicate devices before it became impossible to continue. It’s like trying to track down all 256 of your 6th-level great grandparents. I also made note of which ones stated they had submitting results of testing in humans.

510(k) Number: K172329 Isansys Patient Status Engine (2018) Predicate Device:

  • K152139 - Vital Connect Platform/ VitalPatch/ HealthPatch MD by Vital Connect Inc. (2015) Indications for Use: The Vital Connect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological data in home and healthcare settings. Animal and Clinical Testing: Prior clinical testing was performed to support the clearance of the predicate device and is still relevant to the proposed device. The safety and effectiveness of the device associated with the product changes are demonstrated through performance testing. Thus, animal and clinical studies were not deemed necessary. Predicate Device: 1

    • K141167 Vital Connect Platform (2014) An IRB-approved "Long-term Field Study for Home Use" was conducted by Vital Connect with the VitalConnect Platform from September 2013 to March 2014, to assess the long-term use of the VitalConnect Platform in a home setting. The assessment includes the usability of the VitalConnect Platform in a home setting, including interaction with the module, patch, and relay. In addition, the assessment includes the long-term wearability of a series of patches on the same participants. Results indicate successful use of the VitalConnect Platform over a 50-day home use study on 76 participants. (A note here is that this study was performed by VitalConnect, and not a 3rd party, thus bias is a risk). Predicate Device: 1

      • K132447 VitalConnect Platform (2014) “Clinical study was performed on human subjects.” Here is the 2013 study I found: The sensor measures heart rate, heart rate variability (HRV), respiratory rate, posture, steps, and falls and was evaluated on a total of 25 adult participants who performed breathing exercises, activities of daily living (ADLs), various stretches, stationary cycling, walking/running, and simulated falls. Predicate Devices: 4

        • K110809 CareFusion, Wireless Monitoring System (2011) Predicate Devices: 2

          • Philips Intellivue Patient Monitor. K052961(2005) The names of the devices are the Philips MP2O, MP3O, MP4O, MP5O, MP6O, MP7O, and MP90 IntelliVue Patient Monitors with 802.11 Wireless LAN. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K014159, K021778, K030038, K032858, K040304, K040183 and K040357, K041235, K41741, K042845, K050141, K050762, and K051106

          • Nihon Koden Multiple Patient Monitor. K071058 (2007) The ORG-9700A Multiple Patient Receiver is intended for use by medical professionals with Nihon Kohden telemetry transmitters and central stations to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The device detects patient vital sign alarm conditions and includes an algorithm to detect cardiac arrhythmias. The intended use of the modified device has not changed as a result of the modifications. The device is available for use on all patient populations

        • K121197 Preventice, BodyGuardian (2012) Predicate devices: 1

          • AVIVO Mobile Patient Management System (k083287)

        • K113054 Hidalgo Ltd, Equivalent TMVital Signs Physiological Monitor EQo2

        • K083287 Corventis, Mobile Patient Management System. (2009) The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. Predicate devices: 4

          • CardioNetTM ECG Monitor with Arrhythmia Detection, K072558; DSI, "Arrhythmia Detector and Alarm"

          • LifeShirtTM Real-Time, K043604; DQK, "Programmable Diagnostic Computer"

          • ZOETM Fluid Status Monitor, K042113; DSB, "Impedance Plethysmograph"

          • SenseWear Armband, 510(k) exempt, IKK, "Isokin-etic Testing and Evaluation System"

REPORTING DEVICE PROBLEMS

One might assume that the FDA has the data that they need to crack down on bad devices or to recall a product if needed. Indeed, there is a system for reporting complications but it’s a voluntary system of patient self-reporting. If a physician sees an adverse event, they do not have to report it. Thus much goes under-reported with only about 3% of all adverse events get reported to the FDA. The only bodies that are required to report adverse events are the device companies themselves and they are clearly not incentivized to do so. One study found that the worse the outcome was, the less likely a device manufacturer was to report it to FDA (yikes!). Adverse effects of a new implant are often not known until months or years after it’s on the market. By then, it may have affected hundreds of thousands of people.

SUMMARY

Like drugs, new device innovations are important to making strides in healthcare. But what I want you to take away with is that new devices on the market are often unproven, more so than drugs. Don’t assume that FDA clearance means that a device is safe, it simply means that it is equivalent to a predicate device and so on. Do your own research, be cautious, and use your own judgment. Ask your doctor if he or she understands what FDA clearance means and more importantly, what it doesn’t mean, before trusting their judgment on whether a device is safe for you or your family.

How products define and influence who we are

Disclaimer: This blog is independently written and published by me. The opinions expressed herein are my own personal opinions and do not represent my employer's view in any way.

Take a moment and think about how you might describe yourself to someone you just met.

What did you come up with? 

Our mental construct of who we are, which I will refer to as “the-self” or “self-concept” is often constructed by things like relationships, affiliations, and objects. For example, you may consider yourself… “a wife”, “a daughter” (relationship-based), “a New Yorker”, or a “a female” (affiliation-based), “a skier”, “a homemaker”, “a wine connoisseur”, “a cycler” (object-based).

Are you surprised that objects help define who you are?

Identity is not fixed. We often think our identities are quite fixed but in reality, they are much more malleable than we think, constantly being re-evaluated and re-defined. We are constantly adapting our view of ourselves. 

Products and brands help us construct our social image

We are constantly managing how we come across to others, and we do this through our actions and our choices with little to no conscious involvement. When we choose products, we strategically choose products with desirable personality traits to signal positive aspects of who we are such as our beliefs and aspects of our personalities [2]. The more these products match to who we are and what we believe the more strongly we will attach to the brand and love the product. But we feel uncomfortable when the social reasons for our purchases are too obvious. Someone who buys a BMW to make them feel like they made it, will tell his friends that the reason for the purchase is the many features it offers that he cannot get elsewhere.

As product designers, the implication here is not to avoid status, but to embrace it in a hidden way. We should craft experiences that help elevate someone’s social standing while at the same time hiding this intention entirely. 

We Judge ourselves relative to other people as well as other things

Researchers have found that we judge ourselves relative to standards set by not only relative to standards set by other people (e.g., the thinness of a model), but we also judge ourselves as well as objects we judge ourselves (e.g., how thin am I relative to the the thinness of MacBook Air). By affecting self-evaluation, such standards can shape consumer preferences.

We affiliate ourselves with brands and products that are congruent with our self-image in order to signal positive aspects about who we are. Thus, the product’s social job is to signal these desired traits.

  • Students feel smarter after choosing and using a pen with an MIT logo

  • Women felt sexier after choosing and using a Victoria-Secret bag

  • Owning a short (vs. tall) looking coffee mug lead people to feel shorter and less physically attractive.

We prefer products that match how we see ourselves

Products and brands are perceived as having certain “personality” traits that in turn reflect the traits of their users. When we make our buying decisions we attempt to choose brands and products that match our own self-image.

Here are some examples: A 2014 study found that participants gave more favorable ratings to an online store the closer the image of the store was to their own self-image [9]. Another study found that when women were made aware of the shape of a product, that those who perceived their bodies to be curvy, rated the curved products higher [6].

Marketers have known for a long time that consumers are significantly more interested in purchasing a brand when they identify with the personality of that brand. Thus, a fragrance commercial that is youthful, sexy, and sophisticated would be most attractive in terms of purchase intent to those that view themselves as having those same qualities [11]. 

Consumer Psychology studies have repeatedly shown that a match between the brand image to a consumer’s self-image (often referred to as “self-congruity”) influences consumption behavior-pre-purchase behavior (consumer attitude towards the product, preference for a brand, willingness to purchase the brand, and brand choice) and post-purchase behavior (satisfaction with the brand, brand trust and commitment to the brand and word of-mouth related to the brand). Even when we choose what store to buy our clothing from, we first construct an image in our minds of who the typical consumer is of that store and whether or not that imaginary person is like us. This creates real consumer value, generating sustainable competitive advantage and brand equity [10].

Why do we do like reminders of ourselves so much? In general, we are naturally motivated to behave consistently with our own self-perceptions. To do otherwise would cause dissonance, resulting in discomfort that threatens to invalidate our beliefs about oneself. Basically, we like to reinforce our beliefs and feelings of personal worth because that simply makes us feel good [12].

Products can alter how we feel about ourselves

It turns out that products can impact how we feel about ourselves in powerful ways. A 2016 study found that owning a short (vs. tall) looking coffee mug lead people to feel shorter and less physically attractive.

Other studies found that women felt sexier after choosing and using a Victoria-Secret bag, and that students felt smarter after choosing and using a pen with an MIT logo. Even receiving an object as a gift can impact our emotional state and make us feel worse about ourselves — consider that the next time you accept a hideous sweater at Christmas.

“Our findings suggest that when people acquire an object, not only do these people gain control over it, but ironically they also surrender control to it, allowing its traits to systematically influence the way they see themselves and behave.” — Liad Weiss, Gita Venkataramani

The mere choice of one design of one product over over another as demonstrated by the coffee mugs can influence how we feel about ourselves. When designed well, products have the power to affirm — they can help us be more secure in ourselves and in our values [2].

Psychologists have found that these kinds of affirmations of the self can actually change the trajectory of someone’s life. Here is an example: “Feeling affirmed, a student may perform better on the next classroom test, and performing better, the student may feel more affirmed, in a recursive process that lifts the student’s trajectory and eventually becomes a continual source of self-affirmation” [3].

Another example of how self-affirmations boost our ability to adapt and cope comes from a study on weight loss. Researchers looked to see how their overweight participants responded to health messages like “People who sit less are at lower risk for certain diseases.” It is typical for messages of this sort to evoke negative reactions — it is threatening and makes participants feel bad about themselves. They think things like “what if I sit too much and get a disease!”— and it’s common for them to just give up. Researchers found in this study that self-affirmation can prevent this reaction, because it reminds people that their self-worth has a broad foundation and thus the messages comes across as less threatening. The researchers found that the participants in the self-affirmation condition responded better than control participants to the health messages, becoming more active in the ensuing month after the study [4].

As the creators of products and brands we have the ability to craft affirmations of self that generate well-being and spur confidence to take on new opportunities for our users and I think that’s pretty awesome.

People ‘hire’ products to do jobs for them

  • These jobs can be functional and/or emotional in nature. Jobs have a desired outcome.
    Functional Jobs: Tasks people seek to accomplish.

  • Personal-Emotional Jobs: The way people want to feel

  • Social-Emotional Jobs: How people want to be perceived by others

“When purchasing an automobile, for example, a woman may want to be able to transport children from one location to another (functional job), but she may also want to feel successful (personal job) and be perceived as attractive by others (social job). A mom throwing a party for her child may want to arrange the party (functional job), but she may also want to feel loved by her child (personal job) and be perceived as a good mom by the other moms (social job).” - Jobs to be Done A Roadmap for Customer-Centered Innovation.

Design your product such that it signals attributes about your customers or how they want to feel. Design your product such that it reaffirms the self and makes your customer better. It’s an amazing privilege to be a PM or designer and get to influence people’s perceptions of themselves in such a positive way.

References: 

  1. Products as Self-Evaluation Standards: When Owned and Unowned Products Have Opposite Effects on Self-Judgment

  2. Liad Weiss, Gita Venkataramani Johar. J Consum Res (2016) 42 (6): 915–930. 2016. Products as Self-Evaluation Standards: When Owned and Unowned Products Have Opposite Effects on Self-Judgment. 

  3. The Psychology of Change: Self-Affirmation and Social Psychological Intervention Geoffrey L. Cohen and David K. Sherman

  4. http://nymag.com/scienceofus/2015/11/why-self-affirmation-works.html

  5. Multiple reference effects in service evaluations: Roles of alternative attractiveness and self-image congruity Chi Kin (Bennett) Yim∗, Kimmy Wa Chan 1, Kineta Hung 2007.

  6. Ghoshal, Product Curvature or Angularity Preferences: A Theory of Self-Concept. 2015

  7. Self-Affirmation through the Choice of Highly Aesthetic Products Author(s): Claudia Townsend and Sanjay Sood Source: Journal of Consumer Research, Vol. 39, No2 (August 2012), pp. 415–428 Published by: Oxford University Press Stable URL: http://www.jstor.org/stable/10.1086/663775

  8. The Compensatory Consumer Behavior Model: How Self-Discrepancies Drive Consumer Behavior. Journal of Consumer Psychology, 2016

  9. Actual and ideal self-congruity affecting consumers’ emotional and behavioral responses toward an online store Wanmo Koo a , Erin Cho, Youn-Kyung Kim c,1 2014

  10. Routledge International Handbook of Consumer Psychology 2016).

  11. http://gandrllc.com/reprints/usingselfconcepttoassessadvertisingeffectiveness.pdf

  12. Lucia Malär, Harley Krohmer, Wayne D. Hoyer, & Bettina Nyffenegger. Emotional Brand Attachment and Brand Personality: The Relative. Importance of the Actual and the Ideal Self 2011

  13. The Sum of Small Things 

  14. Status Is a Four-Letter Word. Self Versus Other Differences and Concealment of Status-Striving. 2014

Why talking to customers may not lead to success

Disclaimer: This blog is independently written and published by me. The opinions expressed herein are my own personal opinions and do not represent my employer's view in any way.

In the age of customer empathy, it might seem outlandish to not take ask for product suggestions from your customers. As a product lead for Research and Development at Capital One, I asked consumers if the design of their credit card mattered to them (the physical material, colors, pattern, weight etc). They almost unanimously said things like “absolutely not”, “it’s the rewards that matter”, “other people would care about that, but not me”. There was a clear consensus from the research: credit cards are utilitarian, an object that simply provides functional value.

But then I came across a research study that made me question what I heard and learned from customers. The researchers found that people would often forgo using a card with more reward benefits in order to use the platinum card in social settings. This provides evidence that in certain contexts there may be values, such as social signaling, that are more important than rewards and that a credit card can be more than a functional object. 

JOBS TO BE DONE

As a follower of “Jobs to be Done” methodology pioneered by Clayton Christensen, I knew that products can offer emotional value to customers beyond a purely functional value. Emotional value can be in the form of making the consumer feel a desirable way (e.g., successful, beautiful, cool, fashionable), or showcasing favorable qualities to others (aka ‘social value’).

Beats headphones is a great example of emotional value. If Beats creators had asked customers what they cared about when choosing headphones, they most certainly would not have said “looking cool”. Rather, they would have talked about technical specs and thought about past experiences with headphones and what they liked and didn’t like.  For decades headphones were made to satisfy a functional utility and brands competed to offer consumers the best technical features such as audio quality or noise cancellation. Beats did something radically different. They focused on building consumer value by making the wearer feel and look cool (an emotional job) even while arguably having inferior audio quality. Ultimately Beats was acquired by Apple for $3 billion.

Many companies continue to miss big opportunities to differentiate through emotional value. Why is that? The benefit of emotional value through design is less concrete and tangible for product managers and designers to articulate. And who’s to say what’s trendy or professional, or know how your customers want to feel without asking them? This is hard work. Furthermore, imagine trying to champion the case for design in front of your stakeholders when your own target consumers argue profusely that the design doesn’t matter to them. So which is it? How do you make the case that design matters when your customers are saying the opposite?

SOCIAL STIGMAS

I tried to understand why what people say and what they do can be different things. One thing in particular that I found interesting is that researchers have found consistently that people actively conceal that they strive for status, even though they found that stays striving is ubiquitous in everyday life. This is just one of those cultural rules we all abide by and don’t even think about. One study found that people negatively stereotype materialistic people and associate problematic personalities to them (like insecure and self-centered). Most of us know these stigmas intuitively and have been conditioned by our culture to avoid these social stigmas. These stigmas have only grown greater, especially among the affluent, now that materialism is more accessible to all (anyone can get their hands-on luxury goods or knock offs).

Credit cards are naturally associated with status. It is tied to your wealth and for many cards you have to be approved. It’s also a symbol of materialism — the ability to buy what you want. Thus, it’s a dangerous territory for trying to avoid social stigmas and conforms with more traditional forms of luxury that millennials are eschewing. Conspicuous status is moving away from platinum credit cards and toward conspicuous experiences (like posting your vacation photos to Instagram). Both demonstrate status, but one is less obvious.

Our brains have many motivations and we are good at managing most of them on autopilot. One of our motivations if to manage our social impressions and with do this even when we don’t realize it. While there is a desire to signal positive qualities about yourself to others, there is also a need to avoid negative social signals, and sometimes these two things overlap and so what we hear from customers isn’t necessarily what they will do.

HOW TO LISTEN TO CUSTOMERS

So what's the formula for success? Should you listen to what customers say or not? The answer is… listen with caution but focus your energy on gathering data about what they do (how they behave) rather than how they hypothesize what they might want. Our decisions are often based on emotion and may not be logical at all. When designing research, carefully design studies to find out how customers want to feel about themselves and whether they view your product as congruent with that feeling. (Need help on this? Contact me!)

The wildly successful Chase Sapphire Reserve card is a great example for a better way to display status for the millennial generation. It allows its customers to display status while giving them a different and much more socially acceptable reason for having the card. Chase Sapphire Reserve members tell their friends about the no brainer rewards and benefits. Talking about these benefits have social capital  —  consumers feel smart and savvy (qualities that are not stigmatized). They can talk about how they used their travel points for their last awesome vacation to Tahiti. Ultimately the card demonstrates high status in a subtler way and avoids the stigmas of the traditional black, gold, and platinum cards that are simply ostentatious. This leads me to my concluding recommendation.

DESIGN TO CONVEY & CONCEAL STATUS

Design your product such that it evokes high status while carefully giving avenues for concealment of the stigma of status.  Display status in a subtle way. If your product is materialistic, ensure there is an additional feature that isn’t stigmatized that the consumer can point to as the reason for having that product. For example, BMW drivers likely won’t tell you necessarily how cool and powerful they feel when driving their car or that their emotions were involved in making the purchase, but they’ll be quick to point on the technical specs that make their car special and socially acceptable.

For more on these topics, I highly recommend reading “Customers Included” by Mark Hurst and “The Sum of Small Things: A Theory of the Aspirational Class” by Elizabeth Currid-Halkett.

16 ways you're botching your resume

Disclaimer: This blog is independently written and published by me. The opinions expressed herein are my own personal opinions and do not represent my employer's view in any way.

Your resume is perhaps the most important document that you will ever write, but so few of us craft it to its full potential. As a hiring manager, I have reviewed thousands of resumes and as a mentor, I have coached students and friends on how to improve their resumes.  To begin with, it’s important to understand the objectives of your resume.

Take a moment to think about the desired outcomes of your resume:

  • You are moved to the phone screen / interview stage by the resume screener (could be HR, the hiring manager, or the recruiter)

  • Sets the initial impression of you as positive as possible

  • Conveys positive attributes about yourself through its presentation

  • Influences what questions will be asked of you during the interview

After screening hundreds of resumes, here is my advice on common pitfalls to avoid:

1. You’ve written a multi-page professional biography

The purpose of your resume is not to relay your professional biography, it’s to get you to the interview stage. No one will spend 30 minutes deciphering your novel of a resume. A lengthy resume, however, will cause cognitive load, and lead the reader may simply move on to the next resume that’s easier to parse.

Reviewers look at dozens of resumes in one sitting and will only spend a few seconds looking at your resume. They will glance at your resume and look for keywords (hint: these keywords can be found in the job description itself). All they want to know is simply — does it appear that you can do the job? If you haven’t demonstrated that in the first 5 seconds, they move on.

What I recommend is to remove all distracting content and limit your resume to one page. Yes — ONE page. If you’ve reduced enough content about 50% of the page should consist of white space. Yes, that means that HALF the pixels on the page should have absolutely NOTHING on it. 

It is critical that you radically simplify your content so that you don’t overload the reviewer. When the viewer sees large amounts of text, their brain doesn’t know where to focus and they may miss the important information (also my favorite principal of UX design). Here are some examples of well-designed resumes with ample white space:

Example 1

Example 2

Example 3

If you can’t simplify your own resume, you’re not demonstrating that you can do a job that requires prioritization skills. For that reason, I deeply hesitate to interview any Product Manager that has longer than a 2 page resume even if their experience is relevant. 

At minimum, please — PLEASE — do not end your resume using a quarter of a page. Any additional pages should deserve to exist, otherwise reduce and remove the page.

Tips for simplifying your content

About 60–75% of your text should be reserved for your experience section. Consider only adding descriptions for your last 3 jobs. For your current job description, use 5 bullet points or less, drop that to 3 bullets or less for your previous 2 jobs. For jobs prior to that, simply list your title, the company name, and the dates you worked there. Add adequate spacing between each job listed (10pt minimum) and and use slightly larger spacing between your major sections. Your margins should not only exist but be at least an inch on all sides. 

2. Your content doesn’t fit the job description

If you’re applying for a position as an iPhone developer, don’t go into depth about the projects that you did in 8 other languages. Ensure that your resume screams iOS. Your first bullet point should list your iPhone development work. Don’t make the recruiter hunt to find it because they won’t.

Everything on your resume should demonstrate that you can do the job as it is listed in the job description. That may mean spending extra time to tailor your resume to each job description. Other details, like that you’re fluent in C#, are of low importance and should be removed as not to distract.

Look at the job description and for each skill listed, add a bullet on your resume with examples of how you’ve illustrated that skill. Mimic the tone of the job description. If a good culture-fit is highlighted, you might consider adding some of your hobbies to your resume.

3. You’re hiding the key points

What are the top 5 things you want the recruiter and hiring-manager to know about you? Write them down on a separate piece of paper (avoid including generic things like “I’m a hard worker”).  Are you getting these points across in your resume? 

Perhaps you want to showcase that you went to a top engineering school or that you won a prestigious award. In general though, you want to highlight that you are credible in your field: your titles and where you have worked. These are easy ones to just make bold. 

Using bold wisely though — do not bold random words or phrases within a description as it truly looks hideous. Instead, make the important information the first thing you read in that section and eliminate any other content that distracts or doesn’t add significant value.

Test your new resume out by flashing it to a friend for a few seconds and then ask them what information they remember. Did they see any of your top 5 things?

4. You’re simply listing duties

Wherever possible, highlight your accomplishments rather than simply listing your duties — ask yourself how did you succeed in this job? For example, if you’re a social media strategist, don’t just list “ran social media campaigns”, include the key results, “that resulted in 2x sign ups per day” Showing your impact will make you stand out.

5. You’re repeating the same content for each work experience

Your resume should show a progression of skills learned and an increase in responsibility over time. You don’t need to repeat that you ‘write functional specifications’ and ‘run daily scrum’ under each of your past jobs. Each section should present new information. 

6. You have typos and poor formatting

Proofread your resume and then proofread it again and then get someone else to proofread it for you. It is shocking that almost all resumes have spelling errors and inconsistency issues like these: 

  • Ending some sentences with periods and not others.

  • Abbreviating some months and not others. Use ‘February’ and ‘March’ or ‘Feb’ and ‘Mar’ but do not use ‘Feb’ and ‘March’ together.

  • Using short hyphens ‘-’ with long hyphens ‘－’ within the same context, particularly in date ranges. Stick with one type please.

  • Using inconsistent spacing around hyphens. Always use a space before and after a hyphen.

  • Capitalizing Some Words and not others — Like I’m Doing right Now. Pick a sentence Case and use it Consistently.

  • Using sloppy alignment. Ensure your dates line up nicely. It can be tricky to do but gosh darn-it I know you can do it. I use an invisible table in Word.

  • Using different size bullets all over the place. You are screaming that you have no attention to detail.

  • Using too many fonts, silly looking fonts, or inconsistency with font sizing. 

7. You’re using a MS Word Template

If you’re using some template that you found online or on Word, you’re likely not doing yourself any favors. Horizontal line dividers are a common component of these templates and they make the page look outdated and busy. Use white space as a natural divider instead. Watch your fonts — use something respectable and stick to one or two types. Absolutely do not use clipart. Unless you’re a designer, stay away from company logos or contact info icons on your resume. They typically look cheesy and date your resume.

I’ve passed over seemingly qualified applicants simply because their resumes were eye sores. If I’m looking to hire a Product Manager with UX and UI responsibilities, how can I trust someone with an unsightly resume to manage the design of our website?

8. You’re not including your Linkedin information

If a hiring manager is interested in you they will look you up on LinkedIn. So do them a favor and make it easy — add your LinkedIn information directly to your resume. Ensure your LinkedIn photo is a professional headshot, not something odd, creepy, or unprofessional (it happens more than you think), and that you have some great peer recommendations on there. If you have a portfolio or website, link to it.

9. You’re using LinkedIn to apply to jobs

When a recruiter looks at resumes that have been submitted via LinkedIn, they appear as .txt files. This means that the recruiter sees a dump of unformatted text (ruining all the effort you went to in steps 1–8 above). This may be ok for automated keyword matching, but it’s not good for human eyes. It is so difficult to read .txt files generated from candidates applying via LinkedIn that I often don’t bother with them. Besides that, applying through LinkedIn shows that you are mass-applying and aren’t really that interested in my company. Go to the extra effort of applying on the company’s site using a PDF and do include a cover letter.

10. You’re submitting a MS Word doc instead of a PDF

Are you using a Word file for both your resume and cover letter? You’re making a huge mistake. Here’s why: When I open up a word file, I’ll see all the red underlining from spell check and it appears to me like it’s still in draft mode. Simply save your Word file as a PDF. It’s easy, it is critical — there is no excuse.

11. You’re using bad file names

Did you know that recruiters can see what you name your files? So don’t do use names like this: “Johnson_June_2016_forGoogle.pdf” or “MyResumeV4.pdf”. This can appear like you are applying to several places and it also just simply looks unpolished. A recruiter or hiring manager may choose to download your file so stick to something simple like “HenryJohnsohnCV.pdf”. This goes for your cover letter also.

12. Your cover letter is absent

Don’t have a cover letter? Some hiring managers (like me) may take this as demonstrating a lack of enthusiasm. It sends the message that you don’t care much about the role. Cover letters take time but do make a difference. If a hiring manager is on the fence about you, a strong cover letter can tip things in your favor. 

13. You’re including your fraternity affiliation

Unless you know that the hiring manager was in your fraternity, I would suggest leaving off your Kappa Sigma whatever affiliation. It may actually work against you when the hiring manager may imagine colorful fraternity life in their head.

14. You’re using 1st or 3rd person

Avoid using personal pronouns in your resume such as ‘I’, ‘me’, or ‘my’ as it may come across like you’re taking all the credit and not a team player. Don’t jump to referring to yourself in the 3rd person either: “Margot is a Program Manager with 20 years experience..” as it may come across pretentious (Fortune 500 CEOs can get away with that, but you probably can’t). Instead just omit the pronouns and simply write something like: “developed a virtual reality game generating $50,000 in sales.”

15. You’re including your less than stellar GPA

No one is forcing you to put your GPA on your resume. Most hiring managers won’t notice if it’s not there. Only add your GPA if it’s a 3.8 or above. Don’t give someone a reason to think you’re not smart.

16. You’re listing MS Word in your skills section

Iit’s 2020 — knowing MS Word equates to knowing how to tie your shoes. Unless it’s explicitly listed in the job description, remove this as a skill.

Remember that a skill doesn’t have to be a software program. It could be anything — Brainstorming, Leadership, Innovation, Social Media Marketing, Tai Chi, Improv Comedy, Dog Whisperer etc. 

What sets you apart? Write that.