Archives for September 2019

IP Portfolio Development: How to Protect your IP

14 min reading time

IP Portfolio Development: How to Protect your IP
Presented by Greg Grissett, Managing Director, Offit Kurman
at the 10x Medical Device Conference – San Diego 2019

Greg Grissett: I’m Greg Grissett. I’m with the Offit Kurman law firm.

I chair the IP practice at the firm. My expertise is in medical devices. It comprises about 70% to 80% of my practice. A lot of it is patent counseling, patent strategy, just helping companies navigate patent issues in a lot of different contexts. We’re going to talk about two of those contexts today.

So part one, just to give everybody an overview of IP and a little bit of a deep dive into patents, what they are, and what they protect specifically.

Part two, is your revenue model protected by your patent strategy? Maybe it’s not question you’d think about from a patent standpoint, but it’s one I like to ask clients.

Part three, what is your risk position with respect to competitor patents? We’re talking about protecting our revenue model, but also mitigating and minimizing risk. And businesses want to know this. Certainly, investors want to know this. Two important issues that you wrestle with as we go through with this.

Part 1: Overview of IP

IP classically is really four different rights.

We got:

  • Trademarks: This is a source of goods or services. This is really your brands. It’s your brand protection; it’s a word, a logo, or what have you.
  • Copyrights: I put here creative works, but the legal definition is a work of authorship fixed in a tangible medium of expression. That sounds very fancy, but it’s art, songs, words, software, software code, user interfaces, your websites, your marketing materials, the things that you express to the world. Either in software form or other mechanisms.
  • Trade secrets: Valuable secrets, their value is derived by their not being generally known and you actually taking steps to keep them secret. That’s an important piece. It’s generally the definition that holds across the country but, more or less, it’s got to be valuable because it’s not known and you want to protect it. If you distribute information publicly through social media outlets, you’re not maintaining that as a secret. If you have a manufacturing plant and you’re not limiting access to important parts or not requiring a non-disclosure agreement before your visitors see your manufacturing plant, that’s not taking reasonable steps to protect your secrets, so trade secrets.
  • Patents: I put products, processes, devices. This is really the protecting structure and function of what inventors are developing. It could be, of course, pharma products, compositions, medical devices. It ranges to the diagnostic space, to implants and what have you. 20 years from filing is how long patent’s last.

Patents

So let’s dig a little bit more into patents.

Really important concept to understand for patents – they’re exclusionary rights.

When you get granted a US patent, it gives the owner the right to prevent others from doing all these things in the United States – important here – “as claimed in the patent.”

I like to use the one-acre example. Let’s say I have one acre in Chester County, Pennsylvania, which is where I came from. I have the right to charge you for coming onto my one acre. Same thing, what a patent does.

What a patent doesn’t give me is the right to go into Joe Hage’s one acre in San Diego, all right. So owning a patent doesn’t necessarily give you the right to infringe on other people’s patents. Important distinction, we’ll explore that a little bit more in a bit.

Then again, important here, the right, the patent, is given in exchange for information. Who here has the pleasure of reading patents and patent documents? Okay. So they’re long, they’re dense, and some of them could be vaguely written. But part of the disclosure is the result of having to tell the world about your invention – how to make it, how to use it, and how it might work in a certain setting.

U.S. Patent Claims

The most important thing you’ve ever read in a patent are the claims at the end. It’s the numbered sentences. This is an example of one at the end of the patent.

The name of the game is the claim. If there’s anything else you read, please read the claims at the end of the patents. That is where the rights are. That defines the scope of the rights.

Important here is valid claims. That’s an important concept. Valid claims are novel and nonobvious over the prior art.

Joe mentioned a good point – what is prior art? Really, it means everything that has come before the time that you filed for your patent. Typically, publications, prior US patents, US patent applications, journal articles, articles that perhaps professors write and publish, that’s all prior art.

Could it be disseminating your product on a Kickstarter campaign? Well, yes, one type of prior art is prior sales. So, if you sell your invention before you file for a patent, you’re foregoing those patent rights. Not such an issue in the medical device context when you have an implantable because you have to go through some more market approval, but it’s important to know.

You can offer your product for sale and that will start the time period.

But the key thing here in the patent is the claim. They define the scope of the rights. This will be important later.

So, in the medical device context, my position and outlook is your patents should cover. And what I mean there, when you hear something or somebody say patents cover, what they really mean is claim different aspects of the value chain in your particular setting.

The other thing that we should think about as we go through this talk is, medical device companies should utilize the US patents system to address competitive threats. I put here “continuation applications” because it’s one area that I see other companies miss the boat sometimes and some companies do it right. We’ll talk about continuation applications a bit more.

Part 2: Is your revenue model protected?

Why am I asking about your revenue model? Well, inventors invent things. They invent technology, and they may develop a new market.

We’ve learned today that, sometimes, you have a problem you solve and you have to create a market around it. The business you’re developing there isn’t direct tied totally to technology. It’s tied to you being able to invoice a company for something and them to pay you on that invoice.

So, when I’m speaking of “are we protecting our revenue model?” your patent strategy should account for what you’re going to generate in terms of revenue in exchange for what you’re invoicing your customers for. An important concept that we’ll dig into more.

Patents in the Medical Device Value Chain

So this is just a generalized version of a value chain. You may have:

  • vendors,
  • assembly,
  • product designer, our medical device company, let’s just call it Med. Co.,
  • surgical use.

This is more in the implantable space, but the value chain you can apply the principles to other contexts.

Let’s say, in this situation, patents are owned and cover the product here as it’s delivered to the hospital system or to the physician. This is a pretty classic scenario. This is, at a minimum, what a company should be doing in the medical device system.

In this example, what you’re shipping to the hospital, you’re going to send the invoice for and what you’re going to get money for, is that which we’re claiming. And the red box in this and the subsequent slides, these are my clients. We want to cover this particular area.

Now, can your customer buy from a third party? Well, practically, not without permission from Med. Co. Now are there other factors in play in the business setting? Of course, but this is just one part of it.

Let’s change the value chain a little bit. We talked earlier today about some ancillary services.

Let’s say Med. Co. device company says, “You know what, I want a little bit more robust protection. Let’s extend our patent coverage into surgical methods, or use of the implant, or use of the product.”

And also, maybe there’s an app or software as a service that we’re offering to the hospital system as an adjunct to the implant and the instruments that we want to sell. We may not be getting revenue for this, but it may help close the deal.

Now what if you had patent protection for that ancillary service as well as surgical use? Now, remember, we’re having claims that, of course, still have to be new and non-obvious over the prior art, But, now, you’re in a position where you’re covering different parts of your value chain in a bit more robust way.

Is this going to cause money to fall from the sky by itself? No. Will it change how a hospital system or your competitors approach the market? I think so. It typically does.

This is a message, really, to the competitors that to really match the value proposition, I’ve got to then design around this ancillary service patent; I’ve got to design around the surgical use patent; I’ve got to design around a product the designer had created. That’s a pretty significant task to do. You’re just making life difficult for competitors.

Now let’s go one step further and let’s go backwards into the supply chain. Maybe we can cover some method of assembly in putting the patent together. Maybe we can even go further and down to component vendors.

Now, in this situation, three to five years down the road where you’re offering, you’re generating your revenue, you’re engaging with hospital systems and physicians or what have you, but you’re also protecting your supply chain.

So just think about what type of negotiating position your company may have in this environment. Will it be thing be-all end-all? No, you still have to have good products. You still have to have good clinical outcome. You still have to execute. You still have to have good distribution plans.

But is there anybody in the room that wouldn’t like to have a little bit more leverage when you go to the negotiating table with customers or suppliers? Having source protection this far back in the supply chain can give you some comfort. It will make your supply chain professionals probably rest a little bit more easy at night.

Another thing I’ll ask here, could your component vendor sell their product to a third party if you cover their technology? Not without permission.

So, in this context you can see how patents can be used a little bit further back in the supply chain just to help with your business.

Using the Patent System to React to the Market: Continuations

Okay, switching gears to continuations.

How can we use the patent system to address competitive threats and just the dynamics of the marketplace? You introduce a product, somebody’s going to copy you or copy the essentials of what you’re doing or copy a competing product. How do we address that?

Well, in the US, thankfully, you can file this first application, and before it actually matures into a US patent, you can file what we call a continuation. And that’s if you file January 1, 2018. Two years later, while this is still pending, you can file another continuation.

This strategy can be used for as long as there is patent term available. Large medical device companies do it. I think smart companies that have the resources and the ability to invest in IP in a robust way do this. And we’ll go through some examples of why this is important.

All right, you file patent application A, January 1, 2015. The application issues as a patent, January 2, 2018. Your patent covers your product, great. Maybe you even have some patents back in the supply chain or use patents, but you elect not to file a continuation to save money. And we’re talking 4-6000 dollars to file a continuation application.

Two years later, this one happened, introduces a competing product that copies almost all of your essential features. Not quite everything, but just enough to get a similar clinical outcome at a price that’s competitive. The competing product somehow avoids the patent claims.

Well, there’s two conversations you’ve got to have. One is, what do we do? And, then, how did we miss it?

Sometimes you can’t anticipate what your competitors will do and how they modify or change your product. Sometimes, technology changes and shifts the underlying groundwork you’ve been working with. Well, in this case, from a patent standpoint, I can’t really do much to help. You’ve got patents that don’t cover anything.

Let’s fast forward a bit. Same scenario – you file continuations, you’ve got a patent that covers your product, but now you’ve got some continuations pending. Competitor comes, copies the essential features of what it is issued. What do you do?

Well, now my client can come to me and say, “Look, we’ve got a competitor that’s entered the market, what can we do?” I go check, I look at our continuation, I draft patent claims. Now that competitor has patent infringement risk that they didn’t have before.

So continuations are business tools to use to help you protect what you’re investing in.

Protect as much of the value chain as you can, and make use of continuations to react to the market. That’s what you need to learn from part two.

Part 3: Avoiding IP Infringement.

This is about risk mitigation and reducing the expense of dealing with patent infringement risk.

Often, I get a question like this – You develop a product and you’re close to market. You haven’t done a patent search. You don’t know what’s out there. What do you do?

Freedom to Operate (FTO) study

We’re talking about freedom to operate studies here – what they are and when you should do them.

Importantly, this is a search and analysis of patents to determine the risk of patent infringement for marketing a product or service in the US.

Important here that FTO and patent infringement is about the commercial product. It has nothing to do in essence with your own patents. It’s all about what you’re selling in the US.

Why do you do this? Well, you want to know if you infringe a third party’s patents. Some of this is just practical information. That’s the business reason you would do a FTO.

There’s a legal reason. If you get sued for patent infringement and you’re found to infringe and you can’t prove the patents are invalid, the judge can say, “You know what, you wilfully infringed that patent. We’re going to triple damages.” Well, your freedom to operate opinion can be introduced as evidence to minimize that by a third.

So that’s the legal reason we would have a freedom to operate opinion. That is reducing damages awarded that could be significant.

Then again, investors want freedom to operate. Investors don’t want to buy a lawsuit. Freedom to operate gives you an idea of how to assess that.

This chart is available, I won’t go through it, but the idea here is, you only have risk of patent infringement when you infringe a patent that is actually valid.

So the freedom to operate study is about investigating those two things – infringement and validity – separately.

Now, phase one of the FTO. Let’s say the patent claim has a device comprising a brown widget, a gray gizmo, an actuator, and a controller.

You come to me with product A – it has a brown widget, a gray gizmo, a first actuator. And you’re like, “Look, we added a second actuator – I don’t want to infringe the patent – and a controller.”

Well, actually you do. Product A infringes Claim 1 because product A has everything that Claim 1 requires. I’m talking about product A. I’m not looking at your patent applications that cover product A. I’m looking at what you’re going to make and sell.

Well, let’s think about what we could to change it. We’re doing a design-around analysis here. What can we change? The engineer comes back and says, “You know what? Our gizmo doesn’t need to be gray, it can be black,” so you change it.

Right now, product B doesn’t infringe. I don’t have literal patent infringement there, and I’ve avoided that patent risk. You wouldn’t know that if you hadn’t done the FTO study. You wouldn’t know that unless you had your counsel look at this issue in some detail.

Incidentally, maybe this black gizmo is patentable in and of itself. So, you’ve done a design-around of the competitor’s patents, and you’ve identified subject matter that can increase your patent asset. Maybe changing from gray to black is not that special, but it’s worth at least looking at it.

The other thing to keep in mind here is, this design-around you may patent – if you do get a patent for it – is also preventing third parties from adopting that design around. So you are staking out claims to the design arounds you’re doing when you’re avoiding patents.

Patent litigation

Just a big summary – why FTOs are important is really at the bottom here.

25 million dollars at stake. Patent infringement through trial costs you two and half million dollars. That’s both sides. That’s a lot to stomach when you’re applying if ever you want to go after somebody, but you also have to know the defendant has the same pressure that you will. And this is a tool you can use.

These are recent statistics from 2017.

Conduct FTO Study at the Right Time

When do you do a FTO study? This is a hard question, I’ll be honest.

It should be after something that’s very basic and conceptual, but it should before you’re about to order millions of dollars’ worth of components to assemble products, or you have a large capital outlay, or somewhere near your submitting your products for clinical trial, because you want to know.

If I get a product approved that still infringes a patent, that doesn’t necessarily help your risk position. So you want to do that some time ahead.

Usually, I’ll tell people, if you don’t have solid models and you don’t a bill of material, a real bill of material, then a freedom to operate is a little premature. You need to be that commercially detailed because you want to have some sense that this is what you’re going to make and sell.

The other part is, what are substantial product changes? It can be different for different companies. But if there’s a significant product change, your risk position could change, and you want to assess that.

The important thing is to build this into your pipeline, build this into the way that you’re innovating your products, so that you’re addressing these points from time to time.

Summary

Patentability, obtaining patents – this is about protecting your revenue model, and part one is an assessment of prior art and the publications.

Freedom to operate is about avoiding patents, focused solely on what you will sell and receive money for.

Q&A

Joe Hage: What do you do if somebody just doesn’t play by the rules?

You put a patent but, perhaps, – just because they’re so easily maligned – China sees it and they knock off. What’s your real recourse here?

Greg Grissett: Well, you’ve got to have the tools in place to have recourse, number one.

Even if you’re worried about actors in China, typically they still have to import into the US. And under US patent law, if you can prove infringement, you can stop goods at a port. That is pretty significant.

No business manager, whether they’re in China or in the US, wants to deal with their goods being held up at Long Beach.

Man: Really great talk, thanks for that.

I just have a question about patenting up the food chain, so components and assembly methods and that sort of thing.

I definitely agree with it, but how practically enforceable are those patents? I can see your finished medical device or your molecule, but I can’t necessarily see how you got there, unless I happen to be in your factory.

Greg Grissett: So there are some generalizations here, but I’ll give you maybe an example about a spinal implant that’s made of three special polymer blends and you blend them together and you put them together in an interesting way.
I have, probably, patent protection for the implant, regardless of what it’s made of. But maybe I can still seek patent protection for these specific polymer blends as a composition.

Now how do you detect and enforcement? That’s a challenge for every industry. Often, we get information that trickles up from the sales people and the sales group and just generally information that comes around.

If you get your hands on a sample, you can test it. Part of my job when we’re drafting these patent claims is to make sure we can assess a device. If I have an implant right here or I have a sample of a polymer blend, that we can send it to a lab and that report will validate that it infringes the claim.

So some of that is just being crafty and thoughtful when you’re drafting your patents.

Joe Hage: Greg, I want to thank you again for being a sponsor because, as I’ve shared, there are some folks here in the audience who otherwise might not have been here had it not been for your support.

So thank you very much, Greg Grissett.

(audience clapping)

How to Outsmart Your Competitors with Claims Data and Analytics

15 min reading time

How to Outsmart Your Competitors with Claims Data and Analytics
Presented by Emily Mortimer and Anja Maciagiewicz, LexisNexis
at the 10x Medical Device Conference – San Diego 2019

Anja Maciagiewicz: I’m Anja Maciagiewicz. I’m a Vertical Solutions consultant working with MarketView. That’s all of our claims base products, and we’ll go into that a little bit in our presentation today.

Emily Mortimer: I’m Emily Mortimer. I’m the Director of Product Delivery and Analytics.
I also focus on all of our medical claims base solutions, having responsibility over the team that works on building those products and supporting our customers as they use the data solutions that we offer.

LexisNexis is really much more commonly known for being a really large legal database. There are a lot of spaces in which LexisNexis has a very large footprint, and healthcare is a more recent venue for them. So we wanted to just focus our presentation today on how LexisNexis makes a difference in healthcare.

Agenda

Specifically, we’ll talk about:

So the main focus we want to talk to you about today is all of our solutions oriented around reimbursement information.

The important thing here is to note that, in addition to a lot of the more commonly known medical claims oriented solutions that let you focus on provider volumes, understand where patients are being seen, things of that nature, what we’re also offering is a suite of solutions oriented to understanding payment.

So, that includes knowing things like what the variation of payment is across payers or across regions of the country. You can get at a lot of important information that helps you to market your products and helps you to understand the space in which you play and what providers are seeing when they go to use your products and eventually get reimbursed for that use.

Overview of LexisNexis

Anja Maciagiewicz: We work with insurance; with health care. We work with different government agencies. And we collect data. That is our bread-and-butter.

We collect data on everyone. Everyone in this room has what we call a Lex ID, and we get information from insurance records, bankruptcy records.

But drilling down into healthcare specifically, we are able to work with the top payers and health systems, the top 10 retail pharmacies, the top 20 life science companies, and we work with different federal and state agencies.

MarketView for Healthcare links to many LexisNexis vast datasets

So what is MarketView? That’s our claims-based products.

Within the med device space specifically, we have a “three-legged stool.” We have three different products that really help companies like med device companies, pharmaceutical companies, target and find the right people to talk to:

  1. Our volumetrics can tell you what a doctor does, what patients they see, and how many patients they see.
  2. Our referral networks can tell you where do these patients go, which doctors have a relationship with each other, and where do those patients go and get treated.
  3. Lastly is the remit data. So how much does a claim cost? How much did a payer pay out to a physician or facility for a certain procedure?

Looking at the broad level of the medical claims database we have, we have over 1.6 billion claims that we get annually. That equates to over a million practitioners that we have data about, over 400,000 organizations. And we’re able to update our data as frequently as daily, so we can give you near real-time information.

Claims Adjudication Cycle Overview

Emily Mortimer: I’m sure there are plenty in the audience who know a lot more about this process than I do, but we find that when we’re speaking with anyone about our solutions, it’s important to start with a few basics about medical claims, claims processing, and adjudication.

There are a lot of steps to the process. Most importantly, you start with the actual visit to the physician’s office and the adjudication cycle really summarizes how physicians go about getting paid for the services that have been rendered.

After the visit, typically, coding has entered. These days in the EMR system that’s a lot more real-time and helpful, but you often have coding review, things like that that happen in large facilities, like hospital systems will have nosologists who take a lot of responsibility for this work.

There will generally be verification and review of the claims done prior to submission. And at this point, a claim submitted to the company for payment is considered an 837 claim form. This is really just getting out the differences between the submitted and, eventually, the paid or remitted claim that you’ll be seeing.

Unfortunately, there is often a denial/change process that you will go through as a provider. So it might be that some elements on the claim just simply don’t line up and need to be resubmitted. If the patient’s gender is marked as male but some procedure like a mammography was done, you’re likely going to be asked more questions about that.

So, going through that process, potentially resubmitting the form, the insurance company finalizing and signing off on the validation, and payment being issued from that insurance company, at this point a new form is created and that’s really where we’re getting the insights for our Provider Reimbursement Insight solutions.

Another key part of what we do at LexisNexis has to do with the ways in which we acquire the data. So because we have this adjudication system, a lot of third-party companies exist – clearinghouses, switches, they’re typically called in the market – to help facilitate this process for providers so that you are not putting out a lot of your money from a provider perspective in this process. And it is through those clearinghouses and switches that much of the data we are going to talk about today is acquired.

Lastly, I just wanted to highlight a couple of key things.

MarketView medical claims data 101: Anatomy of a submitted claim

Understanding what is present on a submitted claim is pretty important to the backbone of what solutions we can provide and, of course, also understanding what’s not present.

So a lot of the interesting things we’ve talked about around capturing data for medical devices or clinical notes from an EMR system, things of that nature are not going to be present on a medical claim because, in this case, it’s really dependent on what a provider needs to identify in order to be paid.

So pretty limited but you do access information about your ICD-10 diagnosis and procedure codes, CPT procedures if that’s relevant, a specific drug code or HCPCS code – in those cases you’ll have information about patient demographics to help to further differentiate your population if that’s of interest – and then information about payers, practitioners, and locations of care.

MarketView medical claims data 101: Remittance advice

On the remittance claim, which happens after the process of adjudication, you have access to a subset of those pieces of information in addition to additional information.

So you are still seeing what would be considered procedure line information, so CPT codes, because that’s really what you were getting paid out for. You’re not seeing diagnosis information. And now you also have access to the payer information that was provided. That includes the payer or insurance company. It also will include the amount that was covered for the claim.

MarketView Provider Reimbursement Insights

Anja Maciagiewicz: What kind of information do you get if you were to get our remitted product?

So high level we’re telling you the payer, if you paid out the claim, the average amount that was reimbursed and who got paid, whether it’s the facility or the physician. And this dataset, this product, has over 2,500 payers and over 550 million unique claims that make up all of this information we can pull for you.

Provider Reimbursement Insights use cases

So why would this be valuable for a company, specifically a medical device company?

The most common use case is actually being able to figure out the return on investment. So if you had a piece of equipment you’re looking to rent or buy in an office, looking at how much you get remitted or how much you get paid every time you submit a claim can help you figure out how many times do you have to submit that claim to start seeing a return on your investment, when do you start making a profit.

We can also help with competitor pricing, so being able to create pricing models to stay competitive, monitor and respond to market changes, and providers can figure out how to get the maximum reimbursement. They can do this by using the modifiers or place of service on a claim form.

Lastly, it can help with contract negotiations. So, being able to look at what different payers and facilities are paid and figuring out how to use that for your pricing and contracting strategies.

Emily Mortimer: For anyone who has previously or goes on to work with us, one thing that you will learn is that we really like to tell the story of what our data can help you do, but we find that it’s most impactful if we can really demonstrate it by showing you the numbers themselves.

We pulled together, in support of some of those use cases Anja mentioned, actual samples of the data solution that you would see in order to help really clarify what you can see.

So, in this case, we are looking at the remitted claims solution data points. Specifically, for an oxygen concentrator code. And in this case, it is a product that is generally supplied through HME or DME companies to the patient in their home.

It’s a known product in the market. This isn’t something where I would necessarily go in anticipating significant differences in how things are paid because it’s been around for quite some time.

But you can see here that, when we look at this across payers, you do see variation. Specifically, I would call your attention to the median payment amount where we’ve done the work to control for outliers on the both high and low ends. And you can see we are still seeing, even between United Health and Aetna where you have two private payers, a jump of $7 in terms of the median remitted payment likely back to the HME supplier.

On a single case that might not seem that significant, but you can imagine how that scales up and has a pretty significant impact on what’s being reimbursed.

Again, you can see a number of other data points here that Anja mentioned. I’ll just call out for clarity. So we do report out things like the modifiers so you can ensure you’re holding consistent for how the product is used – whether it’s rental of a piece of equipment versus purchase of equipment, in which case, obviously, the price would be significantly different – to really give you the insight into how those various factors impact reimbursement.

Moving forward, we wanted to talk a little bit more at a high-level. So, in this case, we’re looking at the ways in which the median payment varies in its very broad regions.

So this is across the entire state of California. And we’re looking at the same product here, looking at not just where does the median shift but what is the range of payment accepted across these different payers.

So let’s go straight forward to Medicare where you can see there’s almost no range. Medicare, we all know. They’ve defined their payment plan and, in this case, they stick to it. Good to see they’re consistent but not really a surprise.

But you look at something like Blue Cross Blue Shield and you see the variation in payment is really significant. So you’re looking at payment amounts that can be as low as about probably $20 and, even ignoring the outliers for a moment, if you look at that third quartile, we’re talking about payments nearing $100.

So this information alone isn’t going to tell you why you see that variation, but it is an interesting thing as you think about your contract negotiations because you want to understand what’s going to be an acceptable range for those different payers.

Another piece of information that can really impact the payment reimbursement information is setting of care.

So, in this case, we’re looking at a set of codes that are all pretty specific and similar to each other. You might consider them biosimilars. These are for blood products in the IG space, and all of them have use cases that vary in different settings of care.

What’s interesting is, even where two products can be used in the same setting of care for normal purposes that are approved, the payment can vary. So, in this case, you see that for one product. J1561, its median payment in the home setting or HME is only around $8, whereas a competitive product has a medium payment of $13.

Again, these are not hundreds of dollars different but scaling them up makes a pretty significant impact on how they’ve been used.

The office setting, you don’t see quite as big of a jump between two single products. But, from the low end to high end, you similarly see a jump of about $5. It’s really interesting to see that play out.

And the other thing to note here because these are infused products is, these median rates do hold units consistent. So this is not being skewed by the fact that one product might require more units to be infused than another product.

Using that same set of codes again, here we’re looking at the ways in which the payer differs by product.
So you can see that, for a single product, payment variation happens between payers. And you can even see across the payers.

So looking at the fact that – UnitedHealth Group is red for all of these products – the lowest payment for them is a code that is a higher payment for Blue Cross Blue Shield.

So it’s interesting to see that the same pattern doesn’t even hold true – so it’s not that United always pays the most – and it differs by the products.

Summary

So we wanted to make sure we left some time for questions. I think the most important thing here is to think about how this could be used for you guys and your market.

So we talked about being able to use this for an ROI calculator. That’s certainly something that providers can do themselves as they think about capital expenditures.

It can also be a part of a medical device company’s marketing effort to say, “We know that your return on an investment will become clear after X utilization of this product.” I think it’s a powerful way to be able to bring that message to bear in addition to what medical device companies will do to negotiate with payers and be a part of marketing their product more broadly.

Q&A

Joe Hage: I have a question. How does the typical account respond when you come in and say, “I know all this detail about you”?

I know if somebody gave me that level of detail about me before I met them it’d be a little creepy.

(laughter)

Emily Mortimer: Really, in this case, it varies a lot by vertical.

We play with med device companies, with pharma companies, and also a lot in the provider space. When you go to a hospital system and you tell them what you know about them, they mostly just want to tell you you’re wrong. They know everything about themselves.

What we know about them is complete, it is comprehensive, it allows for competitive intelligence. But we said, “There are 19 procedures done with this J code,” and they actually have 20, so they’re going to point that out.

When it comes to speaking with pharmaceutical and med device companies in general, it’s more around having a strategy conversation. So we’re not saying what we know about you as a medical device company or what we know about you as a pharmaceutical company. We’re saying what do we know about the landscape in which your devices and your products play; how can we help you to focus your efforts and energies in the right place, make sure you’re using your resources, and make sure that you’re telling a really good story to all of the providers and the facilities that you’re working with.

Joe Hage: Tell me how you actually help people integrate this data into their processes.

I can imagine one group made the decision to bring you in. It might be the marketing side; it might be the sales side. Getting them in the same room, talking off the same playbook, I imagine that’s challenging. How do you go about it? How successful has it been?

Anja Maciagiewicz: A lot of times it’s the people going out to find the doctors, who are they targeting. But also a lot of the pricing groups. So how do we know what to price this device at or how do we price this drug? How can we compare that to our competitors that might be on the market?

I think people see this product and know it can be helpful, but people are scared to dig into the pricing a little bit. They wonder, “How do you have this information? Are you allowed to share it?” We are, and for our clients who have used it, they definitely have gotten a lot of value out of it.

Emily Mortimer: One other thing I would just say about that is bringing the people together.

Depending on the scope of the engagement, it can vary a lot. So we may or may not need to bring IT resources to bear to really load and process data.

It might be that the data set someone’s interested in is small enough to put into an Excel file and it can be worked by a single analyst and it’s not a really large enterprise-wide solution, but there are certainly engagements we do where we do have an entire implementation team and we want to ensure we’re focused on ways to build up a relationship that’ll be sustainable, that will make utilizing data over time easy and consistent and not too resource-intensive for our customers.

Joe Hage: Thank you.

Sarah Wright: Hi, my name is Sarah Wright.

I really like the collection and treatment code data and I understand you can’t have identifiable patient information, but how deep does that demographic data go? No information about the patient’s name etc, but can you see repeatable data sets? Or can you see when someone presents and needs these treatment codes?

I’m just more interested in how do you put all that together in terms of repeatability and being predictive and proactive.

Anja Maciagiewicz: I’m thinking of some of our additional products that I mentioned in the beginning – some of our volumetrics. We’re able to figure out when a patient may have come in for CPAP but also had COPD.

So we can look at a history. We can see what the patient has had, whether it’s been on the same claim or has it occurred within the past 12 months. We call that a co-occur with our volumetric data.

For the remit data, I’m not sure.

Emily Mortimer: So what Anja’s discussing is really related to the fact that, while all of our data is de-identified, we do have a unique patient identifier attached to the claim.

So we can look at things over time. There are various ways we can put solutions together that look at those different criteria.

From a remitted solution perspective, most of what we are doing right now is not as much patient-cohort related. Part of that is because what we are leveraging here is just the reimbursed claim by itself – the ERA a lot of folks call it – and we do not yet link it back to the submitted claim.

That’s really the next phase of this product, to say, “Now that we have linked to those two claims together, we have all that patient demographic information. We have the diagnosis information on those patients, and we’ll certainly be building robust solutions like that in that product line the future.

Gunter Wessels: Are you able to do some trending across reimbursement by payer and so forth?

Emily Mortimer: Mhm.

Gunter Wessels: How about switching between different modalities like lithotripsy to laser in urology?

Emily Mortimer: I think that it’s going to be a little bit dependent on what the indicators are for the modality switch. For a lot of those things it’ll be based on the modifier, so we would have access to that and could look at it overtime or for a specific provider. But it’s just going to depend on how that’s coded on the claim.

Alex Gerwer: Two quick questions.

One of the things that surprised me was when IMS was acquired, not by you folks, and then brought into IQVIA. Do you interface with drug data from IMS?

Then, the second part, are you folks making any efforts to work with some of the major EMR vendors to get clinical data to correlate with claims data?

Emily Mortimer: We absolutely work to partner with other vendors who have access to drug data.

We do not specifically partner with IQVIA. There are absolutely reasons why their DED data is very strong, but we have great partnerships that can help solve that problem. We don’t have the prescription data in-house ourselves.

In terms of the EMR, there are conversations we continue to engage in around ways EMR data can be helpful and be impactful in our products. It may or may not be related to a volumetric-type solution. Some of what we’re actually looking at are almost other investigations and other analyses. Things like patient clustering, pre-diagnosis for a rare disease state, or something like that where the clinical notes are really informative in the absence of a diagnosis.

But those are all in the nascent stage. I wouldn’t say we have an offering in that space.

Joe Hage: I’d point out that the folks in this room are a microcosm of the folks watching in TV land. So if these questions are an indication, there’s a lot of interest in how to use data to be smarter about going to market.

So Anja and Emily, thank you so much for joining us.

(audience clapping)

ISO 11607 Packaging: Are you prepared for the changes?

14 min reading time

ISO 11607 Packaging: Are you prepared for the changes?
Presented by Jan Gates,
Principal Packaging Engineer, Adept Packaging
at the 10x Medical Device Conference – San Diego 2019

Jan Gates: I’m gonna be talking about ISO 11607-1 and -2. If you are making terminally sterilized medical devices, you should be compliant with this standard. The FDA and the EU and Japan really like this standard.

A little bit about me. I say 35+ years cause I’m not gonna tell you how long I’ve been in the business. I’ve worked on a whole bunch of different aspects of packaging with various types of companies.

I was very glad I got high-speed production with detergents, even though I was allergic to the perfumes. Which is why I had to get into a business that didn’t have any scent to it.

How I ended up in medical devices. I also worked with a lot of different standards, ASTM and ISO BEAM. Fun ones to be working on. That’s what this tag is.

I actually have a group of standards that I try and get other packaging experts around the United States to give me their opinion on so we can vote on them as a U.S. representative for whether we like those standards or not. And we’ve got some new ones coming up that I really enjoy.

These are some of my old products, just so you know. My only claim to fame is inventing microwave popcorn. I was pregnant with my first kid with that one.

Anyway, I’ve worked on some of these other products and then I started getting into in-vitro diagnostics here. Which was quite interesting putting these kits together, and they had to be controlled temperature shipped. My thesis work for my master’s was actually on brick packs with tomato sauce.

Now, the products I work on, I say, if you know what they are, I’m sorry. Cause that usually means you’re sick or have some problems. But I’ve worked on active and non-active devices, making sure the packaging works, some of the programmers that go with them.

Blisters, prefilled syringes, so it’s a wide variety of packaging. This is what a Packaging Engineer can do for you. And I’ll let you read that later.

We do help you save money in the long run. And we try to make sure we do it right the first time, because if you have to go back and change, that’s resubmissions for a lot of different countries you have to worry about.

The Standard Titles

Dash one is actually about design and development. Dash two is talking about equipment and process validations.

They’re actually the first standards that were ever developed for packaging, putting it on the same level as product. Because you do not have a product going out, if you can’t package it right.

This is the history of it. It took about ten years for this to be published. There was a lot of FDA inputs, as well as other people around the world.

I don’t know if you know ISO documents give you an idea that you should be doing something, but they never tell you how to do it, so we developed a standard with AAMI, which is a group that does sterilization stuff in the US, and came up with this TIR 22.

That’s a technical information report on how you can actually comply with that standard. And I was lucky I got to work as a task group leader on that standard. They had taken the TIR and made it into an ISO document. Took ’em a little while to decide to do it, but it’s there.

Unfortunately, this is a little hard to read because they also have it applied to hospitals, and it’s a little bit hard to pull out manufacturing stuff from the hospital. They’re rewriting that and it should be out in another year or two.

Now, at the end of February they just revised the 11607. And they put in human factors and use pieces into it.

They changed critical process parameters. They’ve taken that out because they found too many people were looking at one point in the process instead of the whole thing. So they wanted to make sure that people look at the whole process.

As I said before, if you don’t have acceptable packaging that you’ve validated, qualified, you don’t have a product going out, because it’s gotta survive distribution, warehouse and aging. If you’re sterilizing, you gotta make sure your material doesn’t fall apart too.

So these are new terminologies that were introduced. There is no primary packaging for medical devices any more. It’s all called sterile barrier system, and these terms should be used in all submissions and on your reports.

And I know I usually have to work with the regulatory people and make sure the language is done properly. We do work with terminal sterilized medical devices. We don’t do sterilization validation, but what we do have to do is make sure that the packaging system you have never gets a hole in it until you open it.

So we have to know a lot about the different types of sterilizations and how they affect the materials. Shall statements.

When you are working with ISO documents and they say shall, you must comply with that. Well, there’s over 115 ‘shalls’ in the ISO documents.

There’s a few that you can actually say, “Well that isn’t applicable to my product,” but almost everything else has to have the shalls done with it. I put a few up there. These are ones I found in my role as a consultant, a lot of companies have problems with. I don’t want to read ’em to you all. I do have a few more slides saying what those things are.

Joe Hage: Jan, do you have a favorite ‘shall?’

Jan Gates: A favorite shall. The newest, the hardest one to do? I’m not saying it’s my favorite, but.

Joe Hage: It’s your favorite.

Jan Gates: No, my favorite is actually sampling plan. Statistical sampling.

Because I’m finding most people don’t know how to do that very well. But this one is actually been reinforced with the new standard that’s come out saying that you have to show and document that you can have aseptic presentation, and you have to have documentation that the people actually know how to open your package correctly. So that’s been a fun one to go through.

Test method validations always kills people off. I’ll talk to it a little bit.

So this is my first one, why it says statistics.

Statistical justification

To do that, we have to make sure we have our risk assessments known.

From that, we can develop the confidence in reliability around defects. Once you get your confidence and reliability set up, which is individualized by company, then we can come up with a way of having a statistical sampling.

A lot of people are trying to use AQL, it’s a AZ one point four by the quality group, American Society for Quality, but it says right in the scope it’s not for individual lots, so you can’t use that, you have to have a different way of doing your statistics.

So I always try and work with the company and get a policy set up so that the engineers don’t have to know all their statistics too, they can just point to that standard and get the sample sizes they need.

We’ve got test method validations. This is a very key thing to know about. They say just because test method is published, that does not mean that it’s validated for your lab.

You have to validate that test method.

A new ASTM test method

There’s a new ASTM test method that we’ve put out on how to validate packaging test methods, so that’s been a help for people so they can actually figure out how to do it.

Test method sensitivity for whole package integrity is very important to do, and some people don’t know how to do that, but it’s a fairly easy one.

You have to have Design and Development Documents too for your packaging. Just like you do with your product, you’re supposed to be doing it with the packaging too. Some companies will put that into their design reviews when they’re doing their product stuff. Other times companies will keep that as a separate type of design review.

Equipment EIOQ. This one has been an interesting thing; the clause talks about requiring it for your equipment.

What I have found is a lot of people will do the installation qualification, and then they mix up a material OQ with the equipment OQ, and then they get a new material in that has to be sealed at different conditions, and it doesn’t work because they have to redo their EIOQ. And then you want to make sure.

Hopefully you know what all that is, EIOQ’s and know Q’s and PQ’s. A lot of people don’t realize there’s production drift with your PQ, which is supposed to be your nominal center point on how you’re producing your stuff.

Well, you’ve got to make sure that that drift is within your OQ, your extreme parameters for your production qualification.

All those qualifications

Joe Hage: Jan, to be safe, I’m confident someone watching this video does not know those acronyms. What do they mean please?

Jan Gates: Okay, a DQ is a design qualification.

You’re required to find out what the extra worse case conditions are that your product will ever be in and test them.

An EIOQ would be equipment installation and qualification. Making sure that it actually works the way that you think it’s gonna work with all of your information pulled in there. And that includes parts for consumable parts, and the electrical work, and everything works right.

And then you have the OQ, which is an operation qualification for how you think your production will actually be set for a high and a low.

And then you have your PQ, which is where your supposed to be operating all the time as a nominal.

Okay, so we get through all that. I’m just giving you little highlights on this.

Here’s your PQ, it says you must have a minimum of three lots for medical devices. And please note it says minimum, that means you can have more. And a lot of people don’t realize that sometimes three isn’t enough, especially if you’re only doing maybe a hundred units a day.

If you’re doing that as a lot, you might want to do more than one or three lots of a hundred units.

There are best practices.

Statistical Equivalents.

One thing that’s fun is statistical equivalents. Sometimes you will find out that your statistically equivalent stuff really practically doesn’t make any sense, which you need to put into your protocols and what you’re working on to show that it’s okay, even if they’re statistically nonequivalent that might mean that it’s still okay practically, and that’s where you might get something that has…

Like I’m doing case compressions, you might have a 25-pound difference, and statistically that’s significant from another one on this 25-pound plus or minus difference, but when you’re looking at the test method and cases themselves, 50 pounds really doesn’t make any difference between cases.

Well, I can just say that’s no practical difference where I’m trying to use logic with my statistics, and a lot of people don’t do that.

Well of course with production qualifications, you should have consecutive lots, and you’re supposed to have all of your production stoppages and material changes and stuff. But sometimes you can’t do material changes.

You should have three lots of material you’re trying to test. I had a case where three lots of a foil pouch would give me ten years’ worth of production.

That wasn’t practical, so I had to come up with a new way of testing the material so that if they changed the master lots somewhere along the line, I could actually see it, and incoming receiving, and decide if we needed to re-qualify.

Stability testing.

Everything has to be stability tested. I know people are doing it with their products, but you have to do it with materials too of the packaging. You’ve got to make sure it’s actually gonna last the same length of time as your product. And believe it or not, that’s difficult for some people to understand.

Luckily, there is a ASTM test method we’ve developed that helps with that. And usually they look at just the sterile barrier system, but you also want to make sure any cartons or cases and other things you might be using, labels, don’t have any problems and fall off, or discolor, or fall apart.

Oh, the other note, what’s nice, once you do qualify a material with aging, you never really have to do it again if you change the design, because the aging is separate from performance, which is a different kind of test.

Anyway, I talked about humidity not being part of the aging considerations. Well, we’re having a lot of problems with people not understanding humidity, and so that’s something we go through, making sure people understand that what you’re really worried about is the actual water vapor density in the air at a particular temperature and humidity. Not, excuse me, at a particular temperature and with a saturation of water in there.

You’re not really looking at relative humidity when you’re doing your tests.

So in that case, like if I’m doing something that’s two to eight degrees, and I bring it into a room that’s 20 degrees, it’s gonna be sweating, okay?

You don’t want to test at an accelerated temperature and aging with something that if you actually took that 20-degree thing and put it in to your eight degree that it would start having problems there too.

So those are things that we work through as a packaging engineer to make sure that we do the tests properly. Because if you don’t you get labels bubbling up or something falling apart that shouldn’t be.

Aging and Performance Tests are two separate things.

Performance test is the vibration and the handling that’s out in the field and what’s happening to it. Where aging is just having the material and seeing if it’s gonna fall apart on you.

The best analogy I could figure out how to do was rubber rot on tires. You know after tires get about five or six years old they start cracking? And it doesn’t really matter if you’ve driven on them or not. Well that’s aging. Your tire has hit its stability, and you shouldn’t be using it anymore.

And be careful, ’cause the US is the only country in the world that I have found that actually allows tires that are over five years old and not been on a car to be sold as new, and they shouldn’t be. That’s why we’re seeing a lot of the tires falling apart out on the road.

This is just to show a performance test that was done with D4169 in ASTM, and it simulates what’s happening out on the road with a truck. And I had fun trying to get a drop test and a compression test on vibration.

And we’ve been using this particular test method for something like 35 years and refining it and making sure that it follows what’s actually happening out on the field.

How high is up?

This is always fun, trying to figure out what altitude you want to test a non-permeable package to. Because if you can go over the continental divide, and you go over 14,000 feet, guess what’s going to happen to your package?

I had a problem with a bunch of sterile medical devices being shipped to China, and we had ’em on a plane, and they went up to 18,000 feet, and I had only tested to 16,000 feet.

I thought if you’re gonna get up to 18,000 feet the pilot should have an oxygen mask or something, but they didn’t. So that was pretty interesting, that was 25,000 dollars’ worth of product that we were sending there for testing that could not be used.

These are the normal performance tests that are done. There is ASTM and there is ISTA, International Safe Transit Association, but they are not as broad as a consensus standard as the ASTM, and they’re a little more restrictive on what can be done.

This is not being used in medical devices too much right now because there’s one part of the test seems to be overdone and it destroys the packages when it doesn’t really happen in the field, we’ve got to fix it. These test methods are used for environmental conditioning of cases, just to see if they’re gonna fall apart and have problems.

It’s best when someone can develop their own standards for testing. They can take all the different test methods and string ’em together in a way that makes sense for them, but most companies don’t know how to do that at this point in time which is why the other test methods are there.

I was talking about performance testing and aging test, if you are going to work on it, you have to make sure that you don’t get those defects confused. So this was a performance problem because this IFU actually punctured a hole in the pouch when it was doing vibration.

This is a design problem from a performance test. If you were doing aging with it, it would still be a performance problem. If it were an aging problem, you would have a crack going up the foil pouch. And its hard to keep those different types of defects separated, but that’s what packaging engineers work on.

These are just talking about the ‘shalls’ on how to do it.

The biggest thing that I have found too, or one of the big things I should say, is packaging engineer or product development has to test the product after distribution testing and conditioning to make sure the product is still good.

In pharmaceuticals we do it a lot because some of the liquid products, if they get vibrated at the right vibration level, they actually precipitate out the active ingredient and have problems.

Here we can have something break in a medical device that wasn’t set up properly for shipping, and we need to make sure if it’s still functional or not.

I always find it easier to try and have the product testing done separately from the package testing so we don’t overlap each other. As long as we do the same tests.

So you got to know your distribution system. I don’t have time to go into this but I always put the bicycle in because I had problems with that once. This is a general distribution mapping, just to show people what it looks like when you’re shipping things.

Where you’re handling it, where you’re gonna stack it, where you’re gonna put it on a plane. I went and did a detailed analysis for a multiple shipping issue that we had at one point in time. Trying to show how many times when we had round trips going on with a product we were getting different handling plane transits, those things.

My ASTM test I can probably justify up to one or two round trips. Beyond that we’ve got to do other kinds of tests, cause those ASTM and ISTA was not set up for multiple testing.

Update. Here’s update on my opinion, not a lot of changes. These are the reds, are the ones that are big and new. And there is a new labeling requirement that’s gonna take a lot more room for sterile barrier systems.

This was the O2-2, and you can read that. Human factors we have to do a lot of testing on. Doctor Laura Bix at Michigan State is about the only person I know that’s working on that and actually developing numbers that we can use and test to. I want to show this really bad.

Joe Hage: Okay.

Jan Gates: This is design. Do you think the FDA would like the way this product was being used? So this is where I’m just trying to say you’ve got to design…

You’ve got to design your product properly so it can be used properly. This is just to show you some examples of how they think the sterile barriers should be labeled so you can inspect the sterile barrier before use by the customer.

Unfortunately, even though it’s in the standard, these have not been checked. You have to validate it yourself that they’re actually gonna work. And we do have some new challenges, and then off just two slides and then I will be done.

Jan Gates: Well, what I will say is, having had the luxury of a little extra time to review your presentation there’s a lot in there.

Jan Gates: Yes, it’s an awful lot but I wanted to make sure you had some technical information to ask questions to whoever you’re working with.

Joe Hage: The point I would make is that packaging is a lot harder that I thought.

Jan Gates: And I’m only skimming the top for ya.

Joe Hage: So with a half hour skimming the top, and not having enough time for even that, my advice to anyone watching this video is, there’s a lot, and you need a packaging engineer.

Jan Gates: Yeah, well we’re also looking at this third-party distributors are doing really weird things with the packages that we haven’t validated, and they are. And that’s scaring us. And then with the new stuff where they’re actually handling and putting product into UV cabinets for 24 hours a day.

I don’t have UV inhibitors in my packaging materials, and I don’t know if it’s in the product either. Spraying… hydrogen peroxide.

Joe Hage: Jan, you’d be more familiar certainly than I. What percentage of companies that need a packaging engineer have one on staff?

Jan Gates: Big companies tend to have at least one.

Joe Hage: Okay. big companies have one.

Jan Gates: Yeah, smaller companies, well really big companies will have 25, 30, so that you can do a lot of development on packaging materials and get things done before it has to actually be used anywhere.

Smaller companies I’m finding… I know I worked with Dexcom when they were first starting up and helped them with a product and they kept calling me and calling me, and I finally said, “You need a full time packaging engineer.”

So they got a full-time engineer, they now have 12. So there’s a lot more than what most people realize can be done and helped with the packaging engineers, so.

Joe Hage: Well.

Jan Gates: And I think it’s fun because it’s always changing, and it’s always new.

Joe Hage: I’m grateful for this presentation, and that you’re making it available online for later. It sounds to me as though, at a minimum, folks should be getting a consultation from you or the folks at Adept, talk to a packaging engineer sooner rather than later.

Jan Gates: Yeah, the sooner, because we can give you little ideas that will help with shipping, sterilization, what kind of materials to use, then we can disappear for a while until you get everything done and then…

Joe Hage: I recently worked with a manufacturer who had his entire clinical trial pushed back like a month or two because packaging was an afterthought, and the bottle that they had didn’t survive the drop test, and then they had to go, and then they needed another carton, and it was a mess, so if they had only asked Jan first.

Jan Gates: And there’s other ones too but…

Joe Hage: Ladies and gentlemen, Jan Gates. Thank you Jan.

[applause]