Wednesday, January 25th, 2017 | medadmin

Capturing the Inherent Visual Authenticity of Solid Oral Medications

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Four years ago we faced a serious problem. Our team of computer vision scientists was developing a medication adherence monitoring system that could identify tablets and capsules using only an image taken with an iPhone. We quickly learned that due to manufacturing variation there are often several visual “variants” of each medication in circulation – substantially increasing the complexity of this task. However, the recognition that this visual variation was systematic and could be statistically captured through a straightforward sampling process would lead to the development of MedSnap’s highly scalable system for precision product authentication.

Systematic variation can be modeled and used for authentication

Early on we recognized that if you’ve seen one pill, you’ve seen one pill. At the lot or batch level, individual instances can have slight variations in texture or imprint. However, using images of 100 pills from a lot we create composite statistical models which generalize across the lot, and in most cases across that entire production line. Variation between lots from the same line, albeit rare, are accommodated through more frequent lot sampling.

Using the iPhone camera our effective resolution at the surface of the tablet or capsule is 415 pixels per square millimeter. With our Snap Surface background we can measure size and shape to within 0.1mm and differentiate over 250,000 shades of color. Therefore our ability to measure size, color, imprint and texture are well within the tolerances of the production equipment making the product.

The net result is we capture the small unique visual characteristics of a product that make it distinctively authentic. Often we can differentiate authentic products made at different facilities – and attribute them to their site of origin when necessary.

Sampling visual output as a part of lot QA

Dissolution and other tests are performed at the end of the manufacturing process. Visual assessment using our VR testing app can be easily added to this workflow – it takes less than a minute. Any failures represent a statistically significant visual change in the product. QA staff can then decide whether to add this new variant to the set of statistical models which define authentic for that medication, or reject the batch. In this way the definition of authentic is described by a set of models which can be continuously updated and expanded across an entire network of production facilities, keeping pace with changes in tooling or excipients.

Counterfeiters are surprisingly precise but not accurate

Like any manufacturer, in order to make a margin counterfeiters must scale their operations to produce product in sufficient quantities to meet demand and with visual quality high enough to fool a non-expert on inspection. We also sample counterfeit products and compare their visual relatedness. Surprisingly, some counterfeit products show visual consistency across and within samples rivaling that of authentic products. Visual clustering therefore can provide a “fingerprint” of these operations, quantify the product they have produced, and provide important intelligence for investigators.

It can be intimidating to recognize the industrial production capacity that many counterfeiters possess. However, given that two authentic production facilities cannot easily make pills that look exactly the same due to slight differences in equipment, tooling, and excipients, it would be extremely difficult for someone outside your company using different materials and equipment to produce a perfect visual counterfeit. To date we have not found an example.

Setbacks can help you take a big leap forward

The systematic variation in the production process for solid oral medications was at first a big problem for our team, but tackling it led to insights which have allowed for the creation of tools that utilize this variation to authenticate the physical product. With this unique, novel approach there is no need to modify the product to capture its inherent authenticity.

Tuesday, January 10th, 2017 | medadmin

Shazam for Pill Authentication

Back in 2000, audio engineer Avery Wang invented the technology inside Shazam, an app that turns your smartphone into an expert in “Name That Tune”. Far from a frivolous app to alleviate the frustration of having a song’s name on the tip of your tongue, Shazam has revolutionized the way music is promotedwritten, and consumed. Similarly, advances in computer vision along with the speed, capacity, and camera quality of smartphones now make it possible to definitively authenticate pills simply by Snapping a picture – without product modification. Now any consumer, pharmacist, clinician, investigator or QA engineer  – anywhere – can precisely validate the authenticity of solid oral products. How will this change supply chain security and its contribution to the value of pharmaceutical products?

A Secure Supply Chain Becomes a Consumer Marketing Advantage – Especially in Developing Markets

Developing markets are particularly challenging – yet they represent huge growth opportunities. Consumers in markets with a high prevalence of counterfeits are well aware of the problem and can be hesitant to spend hard earned money on brand or generic medications they see as risky. Consumer authentication of the physical product is a huge marketing opportunity and potential differentiator.

Authenticating Returned Goods

A counterfeiter’s backdoor to easy profitability at your organization’s expense is to return fake product for a refund. Given about 2% of all product is returned, there is significant profit to be made – especially with popular brands. Until now there hasn’t been a scalable or practical way to authenticate returned physical product. Combining physical product assessment with the capture of track and trace barcode data could provide additional insights.

Monitoring Visual Integrity Across a Global Production Network

CMOs are increasingly a part of production and the manufacturing process has been miniaturized to the extent it can now take place almost anywhere. But different facilities, operators, equipment, and excipients can produce output with significant variation in appearance. Deviation in visual appearance of a product can increase the potential for recalls as well as make it easier for counterfeiters to pass imitations as authentic. Undocumented variation also makes it more difficult to determine the source of diverted product. Authentication of each batch prior to release ensures the product is visually within statistical bounds of visual authenticity. If slight visual variation is desired, then new appearance models can be seamlessly added to increase the scope of the definition of authentic. One application of this is to create slight visual variation between lots to track parallel trade between markets. In this way the definition of authentic can keep pace with an increasingly complex manufacturing network.

Crisis Intervention, Management and Brand Protection

 It’s your worst nightmare. The legitimate supply chain has been breached and a counterfeit causes newsworthy harm to patients. Where to start and how to respond? Rapid deployment of an easy to use smartphone app that allows patients, pharmacists, public health, and law enforcement officials to quickly authenticate your medications projects a strong message of corporate responsibility and preparedness, and allows your compliance, regulatory, and crisis/brand management teams to stay ahead of potentially damaging media coverage. In addition, the extent of the breach and visual characteristics of the dangerous counterfeit can be quickly captured and shared with public health and law enforcement.

Patient Adherence and Logistical Data Converge

In addition to verifying integrity at the end of the supply chain, authentication can be incorporated into branded patient adherence monitoring tools, and accomplish two goals in one – knowledge that the patient received an authentic, unadulterated medication, and observing how they consume them. Along with location and timing information, the value of the data reaches beyond supply chain to marketing and clinical colleagues.

“I can authenticate those pills in one Snap, Jim.”

 New highly scalable authentication technology will broaden interest in product security as a marketing opportunity in emerging markets, increase the ability of QA to track visual variation in product across manufacturing sites, shut down easy routes for counterfeiter profit, and provide new data sets for use by our clinical and marketing colleagues.

Thursday, August 18th, 2016 | medadmin

Value based drug pricing: Supply chain security’s opportunity to shine

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The pricing of prescription drugs has become a recent focus of the media and politicians. Value based and reference pricing models have become increasingly common topics for discussion among policy makers and pharmaceutical industry experts. This new approach to pricing is an excellent opportunity for supply chain security teams to claim their contribution to overall product value – if they can track their success all the way to the patient.

Security is an inherent assumption for value calculations

Value based pricing strategies share one assumption: the drug is delivered intact and unadulterated to the patient without substitution by an inert or potentially harmful counterfeit. This critical assumption allows supply chain security and brand protection teams to add their work to the value statement of their company’s drug portfolio. If the supply chain is compromised, no value is created for the payer or patient and a negative value (patient harm) may result.

Security provides a hefty return on investment

The positive return on investment of popular drugs has recently been emphasized by prominent pharma executives, including Pfizer’s Ian Read underscoring Lipitor’s $4 to $1 return on investment to U.S. healthcare payers.

But what happens if a drug’s supply chain is compromised? The value created erodes at a multiple to the price of the drug. That is, the return on investment works in reverse. For example, for two drugs with a theoretical $4 to $1 return on investment, if Drug A has a counterfeit prevalence of 2% within the supply chain, and Drug B has a 3% prevalence, then Drug A has a 4% advantage in value based pricing (1% increase in counterfeits reduces value by 4%) – plus the cost of any harm caused by the additional counterfeits. Major purchasing decisions are decided by much smaller differences.

Solution: Robust, scalable, consumer-friendly product authentication

To accurately measure how often the supply chain succeeds we must authenticate at the endpoint – dispensation or patient consumption. While track and trace technologies work well at the lot level for transfers of product within the traditional distribution network, they require costly specialized hardware, do not authenticate the actual product, and are not scalable to hundreds of thousands or millions of users.

A scalable, consumer friendly approach delivering robust, product focused authentication can provide the foundation for quantifying the value of a secure supply chain.

As you might have guessed, my company provides such a system. MedSnap uses patented computer vision and the scalability of the iPhone platform to authenticate the physical product – without any product or packaging modification. In addition, counterfeits detected can be “fingerprinted” providing insights for internal and external investigations and valuable data for prosecution.

In summary, investments in supply chain security and brand protection pay dividends in a value based pricing world. But new tools and measurement capabilities are required to quantify these benefits and transform security from a cost center to a core part of the value proposition.

Monday, October 26th, 2015 | medadmin Friday, March 6th, 2015 | medadmin

Pillistics

64F73420-A375-4289-AFE4-097320C83C83What is Pillistics?

Pillistics is the use of computer vision to evaluate the integrity of a pharmaceutical product in order to assess whether it is authentic or counterfeit, and the collection of aggregate visual surveillance data across products and markets to determine the source of counterfeit production.

How can Pillistics help the pharmaceutical industry and/or my company?

In 2015 smartphone users will exceed 2 Billion worldwide and are estimated to reach 50% of the world population by 2017. Smartphones now incorporate both high quality cameras and high speed Internet connectivity. Pillistics makes use of the scalability of this platform to capture the inherent visual indicators of authenticity from your products – without requiring specialized field equipment, product alteration, or production changes.

How does Pillistics differ from track and trace?

Track and trace is driven by regulatory requirements, focused on packaging, uses industry standard markings, differs by market, and normally requires specialized field equipment in order to differentiate authentic product. In contrast, Pillistics uses inherent characteristics of your production process and the small variations inherent in that process – within or across production facilities – to identify a product as authentic. Although covert changes can also be made to accentuate or increase the difficulty of counterfeiting a particular product.

Pillistics is complimentary to track and trace, as it is product focused and provides qualitative aggregate data that powers investigations into breakdowns in your supply chain.

What can be learned by deploying Pillistics across my product line?

Counterfeiters leave visual “fingerprints”. Profitable counterfeiters achieve a degree of scale in their production, leaving their fingerprints across their “product line”. Pillistics aggregate analysis can identify and cluster these fingerprints providing actionable intelligence to your team.

Do I need to alter production processes to implement Pillistics for my product?

No. Visual capture of the data needed to form a reliable visual model of your product is straightforward and can be completed quickly without any alteration of your production process. We will work to capture both historical data from retained product and prospective data from current lots in circulation.

How can I get started with Pillistics?

MedSnap’s team can work with you to provide historical analysis of counterfeit products already seized. Insights gained can be compared with ongoing investigative efforts to highlight the value of incorporating Pillistics into your anti-counterfeiting efforts.

 

 

Tuesday, August 12th, 2014 | medadmin

Computer vision can tell these pills apart – but can your 75 year old patient?

Often busy clinicians ask us “Why should I take the time to open up the patient’s bottles of pills? Do I really care what the pills they have look like?”

Quick answer: You should.

We know that outpatient medication errors and non-adherence are huge problems within healthcare. They drive preventable readmissions and ER visits.

It’s recently been established that changes in the appearance of generic medications cause patients to be less adherent to their regimen (http://bit.ly/1zDwTTZ).
Continue reading

Tuesday, August 5th, 2014 | medadmin

Treat the patient, not the record — Or, how I learned to stop worrying and love the brown bag of pills

On my ICU rotations as a medical resident, a fundamental teaching point from our professors was to never be fooled by all of the flashing data about your patient on the various bedside LCD screens. Always verify the data. Your primary point of reference should always be the person lying in the bed, not just the data being seductively presented all around them. Continue reading

Thursday, July 10th, 2014 | medadmin Tuesday, April 1st, 2014 | medadmin

MedSnap to Launch Verify Services in Basel, Switzerland, April 7-10, 2014

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Counterfeit drug sales doubled between 2005 and 2010, reaching $75 billion per year globally according to the International Journal of Clinical Practice. Counterfeit medicines are an increasing threat to public health and can erode consumer confidence in pharmaceutical therapy. Using our proprietary computer vision pill recognition technologies, MedSnap has developed MedSnap Verify Services to respond to this growing global crisis. Continue reading

Friday, March 21st, 2014 | medadmin

Creating Better Medication Histories… In a Snap

In a busy clinic there is often inadequate time to devote to detailed patient medication history taking. Patients can easily become confused in managing their many medications, yet determining whether they have possession and a correct understanding of their pill regimen can be time consuming, difficult and prone to error. When medication history errors occur, readmissions and overall costs are increased. A quick, easy, and accurate method for improving the quality of medication histories in clinic and triage environments is needed.

MedSnap ID combines an easy to use computer vision app and a durable vinyl Snap Surface, allowing nurses, doctors and pharmacists to develop a more comprehensive medication history from the actual pills that the patient is taking. By having patients demonstrate what they actually take to their clinician, the common gaps in patient understanding become apparent and can be addressed. Using MedSnap ID, clinicians are able to “Snap” the pills first hand and in seconds receive a full picture of their patient’s medication regimen in a way that is time and cost efficient. MedSnap ID expedites the history taking process and also provides quality information about the patient’s actual behavior which can make a significant difference in outcomes.  MedSnap ID data can be securely integrated into electronic health record systems, further increasing clinician time savings.