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The following argument is made by Dr Frederick Matsen, Professor in the Department of Orthopaedics at the University of Washington; a shoulder reconstructive surgery and shoulder arthritis specialist.
How effective is the U.S. Food and Drug Administration (FDA) in assuring safety and effectiveness of shoulder arthroplasty implants? (shoulder arthritis blog)
New joint replacement systems and implants are cleared for clinical use by the Food and Drug Administration (FDA) by what is known as the 510(k) mechanism.
510(k) clearance does not require testing of safety and efficacy in clinical trials (see Shoulder Arthroplasty Device Clearance: An Ancestral Network Analysis). Instead 510(k) clearance requires evidence of “substantial equivalence” to a predicate device, i.e. one that has previously been cleared by the FDA. 
Companies use the 510(k) premarket notification pathway for expedient approval of arthroplasty. With the passage of the 21st Century Cures Act, a piece of legislation reducing the rigor and amount of clinical testing required before device clearance, the 510(k) pathway has became further streamlined.
The number of shoulder implants approved by the 510(k) process is rising exponentially (see Is there evidence that the outcomes of primary anatomic and reverse shoulder arthroplasty are getting better?)No fewer than twenty-nine new shoulder devices having received 510(k) premarket FDA approval over the 12-month period from 2020 – 2021.
Unfortunately, devices cleared through the 510(k) process are 11.5 times more likely to be recalled than devices approved via the more stringent Premarket Approval (PMA) process (see Analysis of FDA-Approved Orthopaedic Devices and Their Recalls). PMA approval is based on a determination by FDA that there is sufficient valid scientific evidence based on formal clinical trials to assure that the device is safe and effective.
Recalls of devices cleared by the 510(k) process typically occur years after the introduction of the device to clinical practice and after hundreds or thousands have been implanted into patients. Consider, for example, the ASR Acetabular & Resurfacing System which was recalled 6 years after being introduced into the market, after 90,000 had been implanted, and after 30% had been revised (see Out of joint: The story of the ASR).

Similarly, for three elbow implants, the lag between introduction to the market and recall ranged from 4 to 16 years, even though there were earlier reports of failure in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) data base (see Timely recognition of total elbow and radial head arthroplasty adverse events: an analysis of reports to the US Food and Drug Administration and Analysis of 4063 complications of shoulder arthroplasty reported to the US Food and Drug Administration from 2012 to 2016)
The authors of Shoulder Arthroplasty Device Clearance: An Ancestral Network Analysis sought to evaluate the FDA clearance of shoulder arthroplasty components by examining the interconnected ancestral network of shoulder arthroplasty devices and determining equivalency ties to devices that were subsequently recalled by the FDA because of design-related issues of relevance to patient safety.
They reviewed the FDA 510(k) database to identify all legally marketed shoulder arthroplasty devices from 5/28/1976 to 7/1/2021. Direct predicate information obtained via clearance summary documents associated with each device was used to generate an ancestral genealogy network for all shoulder arthroplasty devices cleared between 7/1/2020 and 7/1/2021. FDA design recalls were analyzed, and the number of descendent devices was calculated for each recalled device.
Their evaluation of all 476 shoulder devices cleared since 1976 identified between 0 and 313 descendent devices for each.
Of the 476 FDA cleared shoulder arthroplasty devices, 130 (27.3%) were linked to at least one predicate device that was subsequently recalled for issues with device design. Furthermore among 29 of the most-recently cleared devices (7/1/2020 – 7/1/2021), 16 (55.2%) were linked to predicate devices that have subsequently been withdrawn from the market due to design related failures. During this time interval no devices were cleared by the more vigorous PMA pathway.
80 of the devices (16.8%) cleared by the 510(k) pathway have since been recalled, of which 10 recalls were directly related to implant design issues (5 shoulder implant systems, 4 humeral components, and 1 glenoid component.) Of the ten devices recalled for device design, the most influential by number of ancestral descendants was K052906 (Zimmer Trabecular Metal Reverse Shoulder System) that had served as an ancestral predicate for 110 descendent devices.
One of the devices, (K080642 – Biomet Comprehensive Reverse Shoulder) was cleared by the FDA in 2008 and recalled in August 2017 due to higher than anticipated rates of implant breakage. K080642 – Biomet Comprehensive Reverse Shoulder served as an ancestral predicate for 67 descendant devices as shown in the figure below which indicates all descendants (Key: Red = recalled, yellow = direct predicate was recalled, green = not recalled and does not have a direct predicate that was recalled).
In 2011, the Institute of Medicine held a workshop that recommended replacement of the 510(k)-clearance process and implement in its place a regulatory premarket and postmarket regulatory framework to provide “a reasonable assurance of safety and effectiveness throughout the device life cycle.” In Congress, legislation to amend the 510(k)- approval process – the Safety of Untested and New Devices Act of 2012 – was introduced but failed to receive a vote on the floor.
Questions regarding the effectiveness of the FDA clearance process for orthopaedic devices have surfaced in the lay press. In 2018 the New York Times published, Can Your Hip Replacement Kill You?This article tells the story of how orthopaedic implants can get ‘cleared’ by the FDA for use in patients without rigorous studies of their safety or effectiveness. The author states that the public “assumes that the Food and Drug Administration requires rigorous testing of medical devices before they are approved, the same as the lengthy approval process it requires for new drugs. In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.”
Orthopaedic surgeons should read the related book from cover to cover:

Comment: As orthopaedic surgeons, we are frequently presented with new implants that have just arrived on the marketplace, most of which have been ‘cleared’ by the 510(k) process because they are stated to be ‘substantially equivalent’ to a previously marketed device. However, these new devices cannot be ‘completely equivalent’ to implants that are currently available (otherwise they could not be patented and successfully marketed). The gap between ‘substantial’ and ‘complete’ equivalency allows for unexpected results and unanticipated complications as well as new technical challenges and learning curves in using the new system. Thus, when considering a new device, we need to ask “in what ways is the new thing different than what is currently in common use?” and “what are the potential adverse outcomes that might result from these differences” (see Assessing the Value to the Patient of New Technologies in Anatomic Total Shoulder Arthroplasty).
Finally, it seems that we should push for a better definition of “substantial equivalency’. Different bearing surfaces, different articular surface shapes, different materials, different fixation systems, and different degrees of modularity do not seem to be ‘substantially equivalent’. Patient safety would seem to be served by a closer examination of systems that are not, in fact, substantially equivalent.
See this related post on device failure and FDA clearance.
You can support cutting edge shoulder research that is leading to better care for patients with shoulder problems, click on this link.

Follow on twitter: https://twitter.com/shoulderarthFollow on facebook: click on this linkFollow on facebook: https://www.facebook.com/frederick.matsenFollow on LinkedIn: https://www.linkedin.com/in/rick-matsen-88b1a8133/Here are some videos that are of shoulder interestShoulder arthritis – what you need to know (see this link).How to x-ray the shoulder (see this link).The ream and run procedure (see this link).The total shoulder arthroplasty (see this link).The cuff tear arthropathy arthroplasty (see this link).The reverse total shoulder arthroplasty (see this link).The smooth and move procedure for irreparable rotator cuff tears (see this link).Shoulder rehabilitation exercises (see this link).

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4 Things Older Companies Can Learn From Startups (Entrepreneur)
Big Ortho does some things exceptionally well.
Small Ortho does some things exceptionally well.
Big Ortho can learn 4 things from the Small Ortho playbook.

Passion drives employee engagement
The ability to adapt to change is a must
Innovation allows you to keep up with the times
Knowing your employees creates a better culture.

read more below…

One of the defining characteristics of startup culture is the energy in the workplace and among the employees. When you talk to the employees at a startup, they tend to believe in the mission of their company, and they want to help it succeed. Because of this shared passion for the goals of the organization, these employees tend to have the passion and drive that are necessary for creating a sustainable sense of engagement.
A Gallup case study with New Century Financial Mortgage showed that engagement is more important than any other workplace perk in driving results. Over a period of six months, account executives at the company who were reportedly disengaged produced 28 percent less than their colleagues who reported feeling engaged at work. New Century then took steps to improve employee engagement at certain branches. The branches who improved engagement grew at a rate six times faster than branches whose engagement stayed the same.
Engagement is one of the things that startups have done a really good job at creating. Long-established companies can see major success if they can replicate the type of engagement that is commonly seen among employees at startups.
The business world is constantly changing, and startups know how to change with it. They have to be scrappy to keep up with competitors who are more established and have more resources.
Because of this, successful startups are good at pivoting as necessary and adjusting course when the situation calls for it. The most recent event that required worldwide businesses to adjust more rapidly than ever before was the Covid-19 pandemic. The companies who were able to successfully pivot to the changing needs of the world were able to keep revenues stable, and sometimes even increase revenue during that time.
AXA PPP Healthcare was one of the companies that adapted quickly when the pandemic swept the world, and their business thrived. As a major insurance provider, the company had to provide value to customers while hospitals were not available. They did this by offering more digital services. This involved a massive communication initiative to inform customers how to use new and altered products and services.
Because AXA PPP Healthcare was able to adapt with the speed and efficiency that you see in startup companies, it thrived throughout the uncertainty of Covid-19. This type of adaptability is essential for successful companies to establish.
There’s a reason so many of the world’s most successful companies are young tech companies. Companies like Facebook, Netflix, Airbnb and Uber are all companies that saw a changing need and built an innovative solution.
Old companies have to be able to also recognize changing opportunities. They must be creative in providing solutions to customers if they don’t want younger, more creative companies to pop up and take their place.
One of the industries that has recently seen innovation is commercial real estate. While this industry has been around for centuries, it’s only in recent decades that innovators have brought tech into the field. Tech has helped reinvent real-estate investing, allowing people in the industry to remain competitive as the world progresses.
Startups have a huge advantage because of their size. It’s easy for top leadership to know everyone at the company when the company is smaller than 100 people. Even though it’s more difficult for employees at larger companies to be well-connected to each other, it’s important to cultivate this feeling of connection and communication.
Employees are more likely to feel fulfilled and engaged when they feel like they have a voice. Top leadership is also more likely to offer valuable direction to the rest of the company when they know what it’s like to be on the front lines of the business.
Even if you have a large company, take steps to ensure employees are well-connected. Provide social opportunities and make sure that communication channels are open to everyone.
Chances are, if your company has been around for a while, you’re doing something right as part of your operations. However, there’s plenty to be learned from young startups and how they’re able to so successfully break into the markets and take off. If you want to keep up with these new companies, it’s important to add an element of freshness to your operations and stay open-minded.

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Volume – Data from Thousands of patients is not enough. Hundreds of Thousands is better. Millions is best. Once we are talking Millions of patients and Millions of surgeries, algorithms can tease out mind-blowing predictions and analytics.
Access – Today, a given device manufacturer cannot access their competitor’s data. For instance, it will be hard for ZB to obtain data from surgeries with Stryker or DePuy, so likely an independent 3rd party company will have the competitive advantage to capture all data.
Regs – You must navigate the hurdles in privacy, HIPPA and regulatory compliance in the US and other markets.  How does a company get a patient to opt-in to “giving away” pre-op and post-op data for the greater good of medicine?  How do you encrypt the data to protect the patient ID, surgeon, hospital? Who “owns” the data?
Technology – How many data capturing devices are needed in the continuum of care, and where are data capture devices located? How do you get the data during the surgical procedure and also from a stroll in the park a week later uploaded into the cloud?

This is not “winner take all”. One company doesn’t need ALL of the data. There will be many data subcategories where smaller software companies can carve out niches and create large SaaS wins.
Let’s review some of the subset data opportunities.

Pre-op Clinical data – activity, pain, bone quality, ROM, baselines before surgery.
Patient demographics – zip code, sex, age, wt, pain score, activity, occupation, etc.
Surgical procedure data – devices implanted, surgery images in 3D space with references, frame by frame, time of surgery, materials used.
Device usage data – type of device, tissue implanted, manufacturer, cost, date of surgery.
Surgeon performance – compared the data set baselines.
Hospital/ASC performance – device survivorship from time from primary surgery to revision at a given primary Hospital/ASC by a given surgeon.
Post-op Clinical data – ROM, post-op x-rays, steps, activity, pain score, life quality.

Once the winning company has Millions of data across patients, hospitals, surgeons, PTs, the company can slice and dice the data into endless SaaS products. This is gold.
The future buyers of these SaaS products will be insurance companies, national healthcare systems, clinical registries, the FDA, wealthy patients, and even device companies themselves.
Insurance companies will want to know… Which device and which hospital has the best outcomes for the lowest cost?
National healthcare systems will want to know… For a given procedure, which device and which hospital has the lowest complication rates?
The FDA will want to know… What are the real outcomes per device? Per device, what is the adverse events rate and how does it compare with the self-reported rates in the MAUDE database? This will be the first time in history that the FDA has a true feedback loop.
Patients will want to know… Who is the best surgeon for my upcoming procedure? Which hospital has the best outcomes record from my upcoming procedure?
Device companies will want to know… How does my device outcome compare with competitors’? What surgeons (potential KOLs) will have the best clinical outcomes using our new device? What procedures are the best design opportunities for us (ranked by worst outcomes by procedure)?

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Let’s talk about another killer app for orthopedic companies, SPEED. I have already written about Risk and Iteration. Let me share how startups use speed to win, and how your company can use speed to win.
Successful orthopedic startups use SPEED as a strategic weapon against the incumbents. Startups leverage speed to win even though they have few resources.  Speed enabled Danek, NuVasive and Arthrex to come out of nowhere to totally dominate categories in orthopedics within a few years. BTW, the NuVasive mascot is the cheetah. 

No matter how hard an established ortho company tries to create a culture of speed, other factors won’t let it happen, because they are bogged down with existing product lines, inventory, market reputation, and distribution models.  Simply going through the process of determining how a new product or technology will impact their existing businesses will take Big Ortho more time than it takes for the Startup Ortho to do it. 
While the Big Ortho employees are stuck in meetings, startups make more progress each day, each week and each month. They finalize the designs faster. They complete the testing faster. They achieve regulatory clearance faster. They finish the FIM surgeries faster. They even execute sales faster.  

This constant acceleration has a compounding effect (like compound interest with money) that creates uncanny results within a few years. 

When we are talking about speed, the resulting output is innovation and operational speed:  

speed to the product concept faster, 
speed to the final design faster, 
speed to regulatory clearance faster, 
speed to product-on-shelf faster,
speed to commercialization faster
speed to new territories and countries faster.

But it even goes beyond this.  Speed is not just doing business faster. Speed actually becomes a currency for startups.  Speed has the real equivalence of cash, productivity and innovation. 
Here are a few benefits of speed that successful startups enjoy. 
Cash

If your startup can achieve more progress in less time, you get a triple benefit. You burn less cash each month, you reach sales faster and you build valuation faster. An overlooked advantage to speed is that it helps to leverage you cash on hand. If a new product can be launched six months earlier, then the resulting sales come in without the additional burden of six months of payroll and operating expenses.
Innovation
If your startup can generate and execute design concepts rapidly, you can outrun your competition, even if you are starting at the same point in time. Then with the compounding speed of repeated innovation, you can out-innovate everyone. The gap between your innovation, and that of your competitors, will continue to grow. Remember that most products iterate their success based on real customer feedback and usage. No first launch is ever perfect. The key is fast innovation plus fast innovation feedback. 
First Mover
If a new product can be launched 12 months earlier, you can beat the competition to market. You also start to get feedback and can work on the Gen 2 design before the competition has even launched. The sooner you get your product in your surgeons’ hands the sooner you can refine the design. Not to mention that being first to market can have permanent impact.  Only one company can be first. If you are first to market, often you can set the price and service that all followers will be compared to. 
Simplicity
Speed clarifies what is important, what is critical, and what is in the way.  If you want to achieve more progress in less time, you have to simplify your systems, streamline decision making and feedback loops. Speed forces a company to streamline, to round off the rough corners, or anything that creates friction in the business.  Carry fewer ideas, simplify pricing, simplify contracts, simplify communication, simplify the Org structure, simplify hiring, etc. 
Psychological
If you move at super-fast pace, eventually your would be competitors will capitulate and say “Never mind, we cannot keep up with X in this area. Let’s focus in another area.” You win by eliminating potential competition.
At Ellipse Technologies we were chasing S+N in the product development of the remote control limb lengthening nail. I nailed a giant banner to the wall, “Beat S+N”. Using our speed culture, we flew right past them. We froze the design in 6 months, whereas S+N (after 7 years and counting as of this writing) is still thinking about their remote control nail project. I personally believe that our speed culture helped to demoralize S+N product development efforts. 

Speed culture comes from the top.  The speed culture is basically a mind-set to move fast and experiment without any wasted motion. The CEO must show that “no one gets shot” if they make a mistake by moving fast. The CEO has to publicly value speed over other tradeoffs such as accuracy or completeness. Remember that the enemy of best is better. When you get to better, just GO!
1) Decide now
Make decisions immediately with the information at hand.  Good decisions can always be made with only 80% of the information and most decisions are reversible. You don’t need to complete 10 tests to figure out if it will work. You don’t need to know the exact pricing to create a plan. You don’t need to interview the candidate to death to hire him/her.   Think like fighter pilots. They use OODA, a  term that stands for Observe, Orient, Decide and Act. They use OODA so they have a higher chance for survival, so should startup companies. 
2) Different goal setting
To inject speed into your company, set simple, company wide goals to make the processes more efficient. 
Think short-term incremental goals that you can touch and feel, not future milestone goals.  The key hack here is to set the time goal, not the output goal.  Instead of asking, “When will the product be on the shelf?” ask, “What can you do with your team in 3 months? in a month? in a week?”
At my first startup, we had an idea for a complex mechanical implant mechanism.  My Design Engineer showed me what he had designed on CAD and proudly told me that we would have a Titanium prototype in 6 weeks (a real implant). I told him I wanted a plastic prototype in my hand tomorrow. The next day we determined that the design wouldn’t work. I was very pleased. The company had just saved 5 weeks and 6 days and $1,000 chasing a bad design.  If needed, we could do this 42 times in a row in 6 weeks. 
3) Hiring without waste
 If you want to hire faster, you need less wasted motion, not more information.  The best feedback about a candidate is fresh feedback. At my last startup we made the decision about the candidate at 5:00pm each day just after the candidate left the building. All interviewees, including the CEO, went into the conference room and at the count of 1, 2, 3 gave a thumbs-up, thumbs-down or something in the middle. This came to be called “the Gladiator meeting” for obvious reasons. There were only three outcomes. 

All thumbs-up, “make the offer” tonight. 
Most thumbs-down, “send the candidate a nice note”.  
In-between thumbs created brief discussion about perceived deficiencies that were resolved in the next couple of days.

These were 15-minute hiring meetings. No wasted motion. 
4) Ready to sprint
Stories of people sleeping under their desks in orthopedic startups are myth (this is silicon valley lore), however, it does happen in short spurts. 
Ortho startups must have the ability to sprint from time to time. These sprints are needed when there is a big problem that is either an imminent major loss of time or a potentially fatal issue to the company. On these sprints most of the organization focuses on a single key problem.  This is commonly called a “all hands on deck”.  These sprints can last for a few days or a few weeks. The big problem can be just about anything – the product has a technical issue, the FDA threw back a submission with tough questions, first ever regulatory audit, lost key supplier, new competitor pops up in your space, an unexpected sales dip, etc.
At my last startup, we were planning on moving to a new building and did not want to waste time to get a new cleanroom approved. So the CEO called for a 4-day sprint. 20 volunteers disassembled the existing cleanroom, reassembled it in the new building, carried out the requisite bug tests for 2 days, then disassembled it and moved it back to the existing facility. Cost was 4 days and a lot of pizza and beer and our cleanroom was pre-approved before we brought it over to the new building.
The point is that you startup must have the culture to sprint when necessary. 
5) Avoiding noise
This may be the biggest one.  Startups with speed cultures remove all of the friction to enable speed. At all cost, they avoid politics, focus groups, usability studies, QA, endless debates, boards of directors, business development deals, budgeting processes, and marketing plans.
6) Skin in the game
In every startup I worked in, all employees had skin in the game. From the CEO to the admin, everyone was awarded stock options or bought into stock through their paychecks. When employees own a piece of the boat they tend to row faster and all row in the same direction.

“Lost time is never found again.” — Benjamin Franklin

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Sharing some thoughts to help you figure out if you are built for a Big Ortho career…. or a Startup Ortho career.
I talk with people every week who are struggling with the Big versus Startup choice. There can be a pull in both directions.
The following thoughts will help you figure out your inclination.

A Big Ortho job is likely to give you financial stability.The probability of the next paycheck is higher.If money is a necessity, then the choice works for you.If salary becomes an addiction, then the choice works against you.
A Startup Ortho job will throw you into an ocean of ambiguity.Where you will have to navigate most of the journey yourself.If ambiguity doesn’t intimidate you, then the choice works for you.If ambiguity weakens you, then the choice works against you.
A Big Ortho job shows you the power of process and systems.Of planning in advance towards an outcome far out.If you wish to aim and shoot, then the choice works for you.If you to shoot and then check if you hit the aim, then the choice works against you.
A Startup Ortho job’s flat hierarchy gives you access to the leadership.You witness them up-close.If the comprehension gap between them and you isn’t wide, then the choice works for you.If it’s wide and you fail to understand most of what they do, then the choice works against you.
A Big Ortho job shows the power of teams.How the microcosm of your work adds up to a collective outcome.If you love to see huge indirect outcome of your work, the choice works for you.If you love to see micro direct outcome of your work, the choice works against you.
A Startup Ortho job tends to fail fast.Feedback loops are short and you get to see the impact of your work quickly.If you tend to reflect on all of your failures, the choice works for you.If you tend to move on quickly from your failures, the choice works against you.
A Big Ortho job requires you to communicate effectively, in order to convince people to deploy resources.If you believe persuasion is just as important as capability, the choice works for you.If you believe your work should speak for itself, the choice works against you.
A Startup Ortho job offer a very small probability of a very big life-changing financial outcome.If taking risks comes naturally to you, the choice may work for you.If taking risks isn’t you, the choice may work against you.
A Big Ortho job more often than not comes with brand recognition.You do not have to explain where you work.If the brand adds to your credentials, the choices works for you.If you are doing it for social validation, the choice works against you.
A Startup Ortho job nurtures you as a generalist.You handle multiple roles at the same time, while learning about them on the job.If you wish to build a generalist profile, the choice works for you.If you wish to specialize, the choice may not work for you.
A Big Ortho job will discuss, debate before taking decisions.The damage of a decision gone bad is far greater. If you love taking decisions by analysis and conversation, the choice works for you.If you love taking decisions by your gut, the choice works against you.
A Startup Ortho job will offer you professional growth that is thrilling.You will be given a mandate far bigger, far earlier than expected.If you prefer given a role and then growing into it, the choice works for you.If you prefer growing into a role, the choice works against you.
A Big Ortho job will train you adequately for your role. It will offer tools, skills, mentoring and feedback, at every step.If you prefer structured learning, the choice works for you.If you prefer learning via trial and error on the job, the choice works against you.
A Startup Ortho job will come with transparent communication.You’ll know how the company is doing, how you are doing, more often than you would wish to know.If transparency appeals to you, the choice works for you.If radical candor is hard to digest, the choice works against you.

Your decision about Big vs Startup career isn’t about the companies, it’s about you.
Where do you see yourself fitting in more? Where do you see yourself growing more?Learning more? Failing better?
send comments to [email protected]