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Ischemic stroke market will likely experience limited impact despite second wave

The ongoing Covid-19 pandemic has heavily impacted markets across the medical devices industry. However, the stroke market has been showing some stability and will likely experience a slight uptick in the near future as a result of Covid-19. A recent study published by the American Academy of Neurology (AAN) highlighted significantly high rates of severe strokes and a higher risk of death among Covid-19 patients of all ages, also reporting younger patients experiencing strokes as their first symptom.

Several leading manufacturers in the neurovascular space have noted stable sales in their ischemic stroke portfolios. GlobalData expects that while the market has experienced some negative impact on growth compared to the previous year, the urgent nature of stroke care will limit the impact to a decrease of approximately 5%.

Growth in the thrombectomy market is expected to return to pre-Covid-19 levels in 2021. Other markets within the neuro space have experienced a significantly greater impact, where procedures to treat neuromodulation and aneurysm experienced declines of up to 50% during the peak of the first Covid-19 wave, while the number of stroke treatment procedures have experienced declines of less than 10%.

The recent AAN study of stroke among Covid-19 patients, in addition to the rising number of stroke cases, highlights the importance of stroke care now more than ever, pushing manufacturers to continue releasing innovative treatment devices. Cerenovus, the neurovascular subsidiary of Johnson & Johnson, recently announced the release of three new devices for clot removal, including its third-generation stent retriever. GlobalData expects that advances in stroke care will be imperative in minimising post-stroke complications, and the stroke market will experience minimal impact in the expected second wave.

For more insight and data, visit GlobalData's Medical Intelligence Centre

05/23/2024 04:06:06

Providing Quality Chemical Characterization So You Can Improve Quality of Life

How Safe Is My Device?

Accurate extractables analysis of medical devices, coupled with toxicological risk assessment, can save time, money, and minimize risk when bringing your product to market. However, recent changes in ISO 10993-18:2020 have made conducting a chemical risk assessment even more challenging than ever before.

When Do I Need a Chemical Risk Assessment?

According to ISO 10993-1:2018, chemical risk assessment is the first step in performing a biocompatibility assessment.
As part of FDA submissions such as Investigational Device Exemption (IDE), 510(K) Premarket Notification, Premarket Approval (PMA).
The EU MDR has similar requirements for chemical risk assessment.
To evaluate a new material of composition or contact material as being chemically equivalent to an “old” material.
As a guideline for internal Quality Control.

What If My Device Is a Short-Term Implant?

If the chemical composition of the device (both the raw materials as well as any manufacturing residues) are unknown or have not been previously characterized, an extractables assessment is typically necessary to determine the composition. Unless the device manufacturer has previous experience characterizing the material/manufacturing process by extractables, sufficient information on the device composition (including impurities, manufacturing residues, etc.) is generally not available for this to be a pure paper exercise.

Note that from an analytical perspective, given the short-term nature of the device, the analytical evaluation threshold (AET) employed will be less stringent than for a long-term implant. This means that when evaluating extractables data from techniques like GC-MS, and LC-MS, the number of peaks which must be identified and submitted for toxicological risk assessment is significantly lower than for a permanent implant--translating to generally lower cost and faster turnarounds.

What If My Device Is Made of Biomedical Grade Materials?

It is true that the use of USP Class VI, ISO 5832, or FDA Master File Materials can reduce the risk of potentially toxic extractables. However, such designations are usually associated with the raw material, which may be transformed or change in composition during the process of converting to the final finished form.

Therefore, the use of a “biomedical” grade material is generally not sufficient justification to avoid chemical characterization or extractable testing. Additionally, if your device is a long-term implant, ISO 10993-18:2020 requires exhaustive extraction.

What If My Device Has Metallic Components?

For a metallic device, the question of chemical composition may seem straightforward: is it simply the alloy the device is machined or otherwise manufactured from? Unfortunately, considering only the base alloy does not take into account the processing aids which are used in the manufacture of the device and which may be left behind as residues on the surface of the part.

These residues may include polishing compounds, lubricants, machine oils, cleaning agents, or adhesive residue from tape used to 'mask off' regions of the device. Inorganic residues (particulates, ions, elemental impurities, etc.) that may be released should also be considered separately from the base material. An additional factor to consider is if the component has highly porous regions (e.g. to facilitate osseointegration) which may make the device more difficult to clean and in which manufacturing residues may linger. Finally, if your metallic device is a long-term implant, exhaustive extraction is required.

What If My Device Is a Short-Term Implant?

What If My Device Is Made of Biomedical Grade Materials?

What If My Device Has Metallic Components?

Chemical Risk Assessment Workflow

The chemical risk assessment workflow may be viewed as a three-tiered structure composed of:

Click on elements above for more information

Step 1: Made explicit in ISO 10993-18:2020, the critical first step of the chemical risk assessment is information gathering. This involves collecting all available data on the medical device’s materials of construction, additive packages, surface treatments/coatings, etc. In addition to information on the compositional level, the information gathering step also includes collection of the manufacturing processing aids and processing conditions: e.g. machine oils, spin finishes, polishing compounds, sterilization modes, etc.

Essentially, the practitioner should consider anything that may be left behind on the device as a residue and result in subsequent patient exposure. In practice, the information gathering step is often challenging to thoroughly complete due to the use of proprietary mixtures/formulations in the device or its manufacturing process. Such information gathering efforts provide a baseline level of information that may be able to justify whether additional chemical characterization testing (extractables) is necessary. Furthermore, the information provides critical context for guiding analytical method selection, reference/surrogate standards employment, and is an invaluable aid in compound identification.

Step 2: For devices of greater risk or more uncertainty in materials/manufacturing, an extractable study is likely to be required, at minimum. Such extractable studies generally aim to remove either more chemical species than would be expected to leave the device under anticipated clinical conditions (exaggerated extraction), or aim to remove all chemical species that could conceivably be removed from the device (exhaustive extraction). For permanent implant devices, exhaustive extraction is performed.

Compounds identified through these extractions are first considered through a ‘worst case’ lens—e.g. the device suddenly dissolving and all potential extractables are released in a single bolus.

If the results of this extractable study and conservative risk assessment flag compounds at concentrations that present a potential toxicological concern, leachable studies may be necessary to more accurately estimate the actual patient exposure to these species under simulated clinical use conditions.

Step 3: After the extractable testing is complete, identified compounds and their concentrations are submitted for a toxicological risk assessment, generally by ISO 10993-17 (this process should be performed by a certified toxicologist). A key output of this assessment includes margin of safety (MoS) values for each chemical, however the process of evaluating the results should also consider if individual chemicals are “expected” and “unexpected’’ based on the device materials and manufacturing process, as well as evaluating variability between samples or manufacturing lots.

If some chemicals are found to present a potential toxicological risk (i.e. MoS near or less than 1), a targeted leachable study may be necessary in order to evaluate the actual concentration of the compound when the device is subjected to simulated end use conditions. Only compounds flagged as potentially above toxicological threshold need be evaluated in the leachable study.

Why Choose Cambridge Polymer Group for Your Chemical Risk Assessment?

Cambridge Polymer Group scientists recognize that chemical characterization is not a once-size-fits-all approach and does not usually lend itself to turn-key solutions. Every medical device represents a unique combination of materials, manufacturing steps, and end use conditions. Each must be fully considered to provide adequate justification for analytical method selection and crucial context for confidence in extractable identifications.

In addition to leveraging our state-of-the-art lab instrumentation and deep knowledge of polymer science, CPG scientists work closely with you to ensure that your workflow is grounded in the context of your product. CPG's successful track record with medical device extractables and leachables enables us to avoid the typical pitfalls of chemical characterization projects, such as:

non-compliance with most current regulatory guidance
incomplete analytical methods
unclear confidence in identification
unknown extractables
inaccurate measurements of extractable concentrations

If you usually perform extractables and leachables testing in-house but no longer have the resources to meet your testing volume or the new regulatory standard, Cambridge Polymer Group can provide E&L testing on an as-needed basis. If your company is a start-up or small business, working with CPG allows access to the testing and expertise essential to bringing your device to market, without an investment in expensive instruments or new hires.

AET- How Low Do I Go?

The AET answers the critical questions of:

1. How sensitive does the analytical method have to be?

2. Of all the peaks detected in a sample extract, which must be identified and undergo toxicological risk assessment?

The AET is not a single value for a compound—it is calculated (see Annex E of ISO 10993-18:2020) on the basis of a toxicological threshold and depends on the nature of the patient contact, the frequency and duration of the device‘s use, the number of devices that may be simultaneously implanted, and the specific extraction conditions employed in the chemical characterization study (accounting for dilutions etc.).

The AET prevents analysts from getting buried in the weeds; identifying and assessing compounds that could not pose a toxicological risk. It also ensures that the practitioner has confidence in the suitability of the analytical method sensitivity at the outset—mitigating the possibility of finding out months later that potentially hazardous constituents were buried in the baseline noise, requiring costly retests and delays.

Cambridge Polymer Group works closely with our toxicology partner, who prepares a toxicological risk assessment report using CPG’s chemical characterization data.

How Do I Comply with ISO 10993-18:2020?

Given the dramatic changes and changing regulatory landscape, medical device manufacturers are encouraged to review the standards carefully, consult with expert practitioners, and where possible present a detailed experimental protocol to the FDA ahead of time.

Why Choose Cambridge Polymer Group for Your Chemical Risk Assessment?

non-compliance with most current regulatory guidance
incomplete analytical methods
unclear confidence in identification
unknown extractables
inaccurate measurements of extractable concentrations

AET- How Low Do I Go?

The AET answers the critical questions of:

1. How sensitive does the analytical method have to be?

2. Of all the peaks detected in a sample extract, which must be identified and undergo toxicological risk assessment?

Cambridge Polymer Group works closely with our toxicology partner, who prepares a toxicological risk assessment report using CPG’s chemical characterization data.

How Do I Comply with ISO 10993-18:2020?

Please contact us for more information on how we can assist in evaluating your devices to the new ISO 10993-18:2020 standard and workflows.

How CPG Can Work With You

REGULATORY COMPLIANCE

STERILIZATION IMPACT

CLEANING ASSESMENT

EXTRACTABLES & LEACHABLES

RAW MATERIALS TESTING

MATERIAL SELECTION

sales@campoly.com | +1 617 629-4400

05/23/2024 04:06:06

Data

Mental health data: it’s not so private after all

Third-party tracking cookies can be found on a large number of mental health-related web pages, the data from which can be taken and used to inform targeted advertising. So, how much of our personal health data really stays private – and how can we stop it from falling into the wrong hands? Chloe Kent reports.

or years, retailers have been storing data about consumers in order to provide them with targeted offers and advertisements. By tracking the demographic, likes and dislikes of an individual, manufacturers can make sure their products are seen by the audience most likely to make a purchase. If advertising algorithms can work out that you have recently bought a house, for example, you may then start to receive targeted advertising for paints and other DIY tools.

Sometimes, however, targeted advertising can get more personal – and more sinister.

US retailer Target infamously ‘knew’ a teenage girl was pregnant before her own family did, when it sent a batch of coupons to her home address for baby clothes and cots. Her father, enraged that a major retailer might encourage a teenager to have a child of their own, complained to the family’s local store. Days later, he found himself forced to apologise, when he learned that his daughter was indeed expecting a baby.

Target assigned every customer a guest ID number, tied to their credit card, name or email address, and had 25 products that it used to assign each customer a ‘pregnancy prediction’ score. The teenager had bought enough of said products that the company automatically supplied her with vouchers for things her baby would soon need.

Cut to 2020, and companies aren’t just tracking your purchases, but some of the most personal data it can access from your web searches – data concerning mental health.

Analysis from UK information services company Rightly has found that of the 51 most popular web pages related to depression listed on Google UK, 86% contained third-party trackers for marketing purposes. These included the website of popular online counselling service Better Help, and the Priory Group’s webpage on depression.

Why do advertisers want this kind of information?

If a person’s web browser can be linked to online searches about depression, advertisers can target them more strategically. These wouldn’t just be adverts for private counselling providers or wellness apps such as Headspace or Calm, although these do appear with increasing regularity after a few anxiety or depression related Google searches. A person who is struggling with their mental health may feel bad about their appearance, for example, and therefore be targeted by adverts for cosmetics and fashion companies.

This happens because platforms such as Google, Facebook and Amazon allow third-party advertisers to target people who exhibit certain kinds of online behaviour on their domains. If a user visits a few depression-related web pages that track their information, this can then be passed onto third-party advertisers, who will bid to show the type of targeted ad a depressed person may be more likely to click on when they later use Facebook.

Rightly content executive Klara Lee says: “If advertisers understand exactly what you feel and when you feel it then they can target you a lot more accurately, because they can understand when you’re in a vulnerable state of mind.”

“If advertisers understand exactly what you feel and when you feel it then they can target you a lot more accurately.”

This tracking is done through cookies, small files that websites place on visitor’s computers that allow them to obtain personal information about that user. These can be divided into session cookies, which are deleted when you close your web browser, and persistent cookies which stick around even if you switch your device off entirely. Session cookies are commonly used to do things such as store cart data on ecommerce websites and exist on the relatively benign end of the online tracking spectrum.

Persistent cookies can also be fairly harmless, helping websites remember things like your login information or language preference. These are known as first-party persistent cookies, ones that are set by the host itself to make the website easy to use.

Then, there are third-party persistent cookies, also known as tracking cookies. Unlike the first-party kind, these are accessed on websites that didn’t create them, allowing the third-party creator to collect and receive user data every time an individual visits a certain page.

When a website integrates a third-party tracker like this, it is able to receive a certain amount of user information, such as the URL of the website the person is visiting, the browser they use and the device they’re searching on. The data is typically also shared with a unique identifier, stored in a cookie, which can allow third parties to track users across the web and build a profile of them.

Shouldn’t data protection laws stop this from happening?

The introduction of the general data protection regulation (GDPR) in 2018 was supposed to tighten private companies’ access to personal information about individuals in the EU, but loopholes can allow this sensitive kind of data to be mined regardless.

Lee says: “Although it’s illegal to share mental health data for advertising purposes, Googling ‘what is depression’ or ‘am I depressed’, doesn’t necessarily mean you are ill. It can be legally argued that therefore this doesn’t necessarily count as your mental health data. It’s not as clear cut as something like records from a therapist.”

It’s true that web history doesn’t constitute a medical diagnosis, so advertising companies can legally argue that they’re not strictly trading in health data when they track this kind of information. Regardless of this fact, analysis by Privacy International has found that many websites process personal mental health data like this in a way that is neither transparent or fair, lacking a lawful basis under GDPR on multiple grounds.

“It’s not as clear cut as something like records from a therapist.”

Under Articles 13 and 14 of the GDPR, an individual is entitled to know the purpose for which their personal data will be used and who the recipients have been or will be. Despite this, cookie consent popups are usually opaque to the average web user and lack meaningful explanation for how information about them will be used. This is despite Article 12 of GDPR, which requires this information to be provided in a concise, transparent and easily accessible format.

Article 5(1)(a) of GDPR also requires personal data to be processed lawfully, while Article 6 sets out an extensive list of legal reasons personal data can be processed.

“Given the overlap with ePrivacy laws,” reads the Privacy International report, “the only basis applicable to the sharing of this data with third parties is consent, and in the case that it is special category personal data under Article 9(1) of the GDPR, i.e. personal data revealing data concerning health, this would be explicit consent.

“However, in this research, we found that many mental health websites don’t provide users with a genuine or free choice. This is particularly concerning since visiting health-related websites can reveal very specific information about the user’s health. Such is the case when taking a depression test online.”

It is all well and good putting regulations like GDPR in place, but it can all feel rather meaningless when their implementation is so lacking.

It's not just mental health data that’s up for grabs

As well as webpages visited, this kind of data can also be mined from mobile phone apps. Research from Privacy International, published in September last year, found that several popular menstrual tracking apps share user data with Facebook via the social network’s software development kit (SDK).

The SDK allows software developers to receive analytics on which aspects of their app are most popular with users, as well as allowing them to log in with their Facebook account instead of signing up directly with the app developer. More crucially, however, Facebook may also use SDK data to provide individual users with personalised adverts.

“In the US, it’s estimated that an average person’s personal data is worth $0.10.”

While Facebook is only able to do to with the user’s consent, said consent is usually buried deep in a terms and conditions page that most users are unlikely to read.

“In the US, it’s estimated that an average person’s personal data is worth $0.10,” says Lee. “But a pregnant woman is $1.50.”

It’s Target-gate all over again. Pregnant people drastically change their spending habits in the months before their child is born, so information about whether or not someone has a baby on the way, is immensely valuable to advertisers. If a user doesn’t register their period, it could be a sign that there’s a moneymaking opportunity coming their way as journalist Tania Shadwell found out.

Shadwell wasn’t pregnant – she’d just forgotten to log her most recent period. Seemingly without warning, she suddenly found herself bombarded by mother and baby ads. When she later corrected the app, the ads stopped.

Alongside missed periods and other potential pregnancy indicators, many of these apps record details on mood, general physical health, sexual activity, alcohol and drug consumption, sleep duration and weight.

Can any of this be avoided?

The Trump administration has said that as part of any post-Brexit trade agreement, it wants unrestricted access to the 55 million health records in the UK, which it estimates have a total value of £10bn a year. So, while it’s hard to put a price on this more covert health data market, it’s safe to say that it’s likely to be rather high.

But how do consumers avoid having their personal data catalogued in this way? When there are third-party cookies at seemingly every turn, it can feel almost impossible to prevent tech giants from building an intimate portrait of one’s personal wellbeing – but there are steps people can take.

“There are definitely things that you can do to protect your data from being used against you, although none of them are fool proof,” says Lee. “You could turn off ad tracking in your browser or download an ad blocker. You could use a privacy-focused browser like Mozilla Firefox or Brave.

“There are definitely things that you can do to protect your data from being used against you, although none of them are fool proof.”

“If you don’t really want the hassle of having to switch browsers or anything, you could open a different tab called DuckDuckGo – that’s like a different search engine and it’s really privacy-focused, so if you want to make a few more sensitive searchers then you can use DuckDuckGo, and then just return to Google for regular use.”

Many consumers feel that, on principle, they shouldn’t have to put this much effort into guarding their personal health information like this – third parties simply shouldn’t be tracking it in the first place.

But like it or not, this is the quandary that modern internet users find themselves in. Do nothing, and risk having hugely personal information used against you to sell consumer goods – or fight a losing battle to keep this data private.

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05/23/2024 04:06:06