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Guardant Exposed to Cybersecurity Threat from Phishing Scheme

Pixabay Guardant Exposed to Cybersecurity Threat from Phishing Scheme

Liquid Biopsy specialist, Guardant Health faced a cybersecurity attack about two months ago, according to an SEC filing for the firm’s initial public offering. The Redwood City, CA-based company said that private information from about 1,100 individuals was compromised.

“In July 2018, we experienced a security incident involving a phishing attack, and an unauthorized user obtained access to an email account of one of our employees,” the company said, according to the filing. “We have engaged an independent cybersecurity firm to conduct an investigation of the incident, and while the forensic investigation is still ongoing, it appears that the incident resulted in the unauthorized access of information, including PHI, over a five-day period, relating to approximately 1,100 individuals. The information accessed primarily includes patients’ names, contact information, birth dates, medical diagnosis codes, and, in a very limited number of cases, Social Security numbers.”

Guardant recently announced it was seeking to raise about $100 million through an IPO. But the company could raise more depending on the price and number of share it intends to sell. Historically, the firm, which was founded in 2012 and has done very well with raising funding.

In May of last year, Guardant pulled in about $360 million led by a subsidiary of SoftBank, with participation from Sequoia Capital, Khosla Ventures, Lightspeed Venture Partners, OrbiMed, 8VC, accounts managed by T. Rowe Price, and Temasek. The company brought in about $190 million in a series D round in January of 2016.

An Epic Approach Toward Liquid Biopsy

Courtesy of Epic Sciences An Epic Approach Toward Liquid Biopsy

The liquid biopsy space continues to attract investors and bring in financings that are typically above the average amount medtech firms are able to raise. Epic Sciences is the latest liquid biopsy company to obtain funding and has raised about $52 million in a series E round.

The San Diego, CA-based company said the financing was led by Blue Ox Healthcare Partners, with participation by Deerfield Management and Varian. Existing investors, including Altos Capital Partners, Genomic Health Inc., Domain Associates, VI Ventures, Alexandria Venture Investments, and Sabby Management, also participated in the financing.

“What we’ve been able to do with this financing is bring thought-leading investors from around the world who have really understood Epic’s long-term vision and invest in that global potential," Murali Prahalad, Ph.D., president and CEO of Epic Sciences, told MD+DI.

Epic’s tests are developed with the company’s technology platform called No Cell Left Behind, which uses computer vision and machine learning algorithms to identify rare cancer cells in the blood and characterize immune response simultaneously.

The proceeds from the financing will be used to advance the firm’s portfolio.

“We clearly want to accelerate clinical trials for proprietary tests in earlier phases of development in our pipeline,” Prahalad said. “We think there are some huge blockbuster products at earlier stages and this will help us really turbo charge those clinical trials and accelerate them."

He added that the other use of the funding would be to obtain the regulatory approvals on the platform depending on the specific use case.

“As we see international opportunities emerge and also as we advance conversations for companion diagnostic development, we’ll obviously take the platform through whatever is the appropriate regulatory approval for the intended use case,” Prahalad said.

With more than 20 publications, 65 pharma partners, and 45 academic collaborators, Epic said it has demonstrated how its insights can aid in the characterization of therapeutic response and the early detection of drug resistance. The company also plans to use big data analytics to integrate test results with electronic medical records, establishing patterns of cancer cell evolution, drug selection, and clinical outcomes.

Prahalad noted that Epic has arguably had a machine learning component with its test for years now.

“The Epic Platform itself… was the earliest utilizer of computer vision and machine learning,” he said. “What we would do was take that patient blood sample and look at all of the cells present. We would essentially get millions of cells at a time on a series of proprietary glass slides and then use a combination of immunofluorescent stains and then computer vision and biology to reveal itself. We would then use analytics to essentially understand what was a rare event i.e., a circulating tumor cell vs. what was an essentially normal immune cell present in that sample.”

Earlier this year, the Oncotype DX AR-V7 Nucleus Detect test was launched as the world’s first predictive blood test that extends life by indicating when a patient with castration resistant metastatic prostate cancer needs to switch from targeted therapy to chemotherapy. Developed by Epic Sciences, the Oncotype DX AR-V7 Nucleus Detect test is offered exclusively by Genomic Health and is commercially available in the US.

J&J Takes Break from Divestitures and Hops on M&A Trail

Pixabay J&J Takes Break from Divestitures and Hops on M&A Trail

Apparently two things happen in September: Football season comes back in full swing, and medtech acquisitions begin to pick up. For the third time this week, a new medtech deal has been announced from a larger player in the game.

This time out, Johnson & Johnson, through a subsidiary, is acquiring Emerging Implant Technologies Gmbh (EIT), a privately held manufacturer of 3D-printed titanium interbody implants for spinal fusion surgery, for an undisclosed sum.

This acquisition allows DePuy Synthes, the orthopedics business of Johnson & Johnson, to enhance its interbody implant portfolio that includes expandable interbody devices, titanium integrated PEEK technology and now 3D-printed cellular titanium, for both minimally invasive and open spinal surgery.

The EIT technology complements DePuy Synthes’ investment in the interbody implant segment in spine, including the recent introductions of the CONCORDE LIFT Expandable Interbody Device, and in the U.S., the PROTI 360° Family of Titanium-Integrated Interbody Implants, designed to treat patients with degenerative disc disease.

“Our goal is to offer a complete portfolio of interbody solutions that provides surgeons with even more options for the treatment of their patients,” Aldo Denti, Company Group Chairman of DePuy Synthes, said in a statement.

M&A hasn’t been a staple of Johnson & Johnson’s strategy this year. The company has mostly been focused on shedding businesses. Most recently, Johnson & Johnson received a $2.7 billion offer for its sterilization unit from Fortive and has sold its LifeScan diabetes unit to Platinum Equity for $2.1 billion.

M&A activity in medtech has been very busy this week. On Monday, London-based BTG said it would acquire Novate Medical for about $20 million in cash with the potential for an additional $130 million in milestones.

On Tuesday, Stryker said it made a proposal to acquire Invuity for $190 million.

And late last week, Boston Scientific, which has been very busy with M&A this year, acquired Augmenix for a $500 million cash payment upfront and up to $100 million in sales-based milestone payments.

Modernizing the Medtech Supply Chain

Modernizing the Medtech Supply Chain
Image courtesy of GS1

Medical devices move from manufacturer to healthcare practitioner through a complex supply chain that is in serious need of total, end-to-end modernization to improve efficiency, accuracy, patient safety, and cost savings. Data exchange between trading partners is often fraught with discrepancies that can trigger costly delays, transactional errors, inventory problems, and traceability gaps—all to the detriment of the entire system and most importantly to patients—while also thwarting efforts to contain costs. Increasing adoption of global standards for the data that connects products and transactions between parties is essential to collaborative advancement.

When identification standards are not widely used across an industry, trading partners often use non-standard and proprietary identifiers. This practice can result in multiple identifiers for the same product (e.g., buyer’s part number, supplier’s catalog number, vendor’s item number, etc.) or party/location (e.g., DUNS Number, buyer account number, etc.). Although this was historically the approach in U.S. healthcare, regulatory and industry efforts leveraging GS1 Standards provide the opportunity for organizations to streamline and standardize product identification with the GS1 Global Trade Item Number (GTIN) and party/location with the GS1 Global Location Number (GLN).

Implementing standards that facilitate better communication and data sharing between trading partners will vastly improve transactional accuracies throughout the entire supply chain, from purchase order to payment (order-to-cash), all the way to and including rebate and chargeback claims.

Clarity in Order-to-Cash Transactions

GTINs and GLNs provide a single, globally unique, standards-based device and location identifier, respectively, that many trading partners use to identify a product or party/location in all supply chain transactions and communications. Using these common identifiers helps improve efficiency and drive process improvement efforts, including their use in electronic data interchange (EDI) to help enhance transaction accuracy and more fully support traceability from manufacturer to patient/end user. To assist healthcare companies’ adoption of these standards, the GS1 Healthcare US EDI Implementation Workgroup, consisting of device manufacturers, distributors, and providers, developed guidance for the implementation of GTIN and GLN in EDI order-to-cash transactions from purchase order to payment in U.S. healthcare.

The process of implementing industry-accepted standards requires collaboration at each preparation and implementation step. Best practices recommended by the workgroup begin with establishing agreement between parties on the flow of transactions and alignment of hierarchies to be identified for products—from all available units of sale to applicable systems—and for customers, vendors,and accounts including billing inventory and delivery locations. System and trading partner capabilities must then be validated as business transactions and defined to assess readiness to transact. Guidance for each step of the process for establishing the use of GLNs and GTINs in EDI transactions is further provided in the workgroup’s report, “Guidance for Implementing GLNs and GTINs in Order-to-Cash Transactions.

Pricing Accuracy

Healthcare companies are also heavily focused on improving the rebate and chargeback claims process. These efforts are aimed at lowering costs through process efficiency, increasing pricing accuracy and integrity for providers, and reducing the potentially millions of dollars of “at risk” disputed rebate and chargeback claims.

Provider organizations can be quite complex with various business entities, names, facilities, locations, and departments. A pricing contract specifies what the specific discounted price should be for a provider organization or for a certain portion of an integrated provider organization. In administering pricing contracts, a distributor implements the manufacturer’s pricing terms with the distributor’s customers and then submits a claim to the manufacturer to reimburse the difference between the distributor’s normal price and the discounted price charged to the customer per the contract. This reimbursement is referred to as a rebate or chargeback. In order for the claim to be paid, it is essential that the distributor correctly identify the customer so that the manufacturer can match the customer to one of its contracts. This is not as simple as it sounds.

Contract administration involves numerous business processes across many trading partners. Pricing discrepancies in the healthcare supply chain increase operating costs for all trading partners, including providers, group purchasing organizations (GPOs), manufacturers, and distributors. Nonetheless, solving contract pricing issues is extremely challenging, due in large part to the complexity of contract administration in healthcare. Thousands of distinct processes, nonstandard facility definitions, and data formats exist.

Reducing Discrepancies

A joint Health Industry Distributors Association (HIDA)/GS1 US Price Accuracy Initiative (PAI) Workgroup conducted a Proof of Concept in which medical device manufacturers, healthcare distributors, and GPOs evaluated the use of GLNs in rebate and chargeback claim processes. The analysis was performed within the context of claim discrepancies that were due to customer non-alignment, which is a core issue for the majority of discrepant claims. With millions of dollars at issue and significant resources used to reconcile and resolve them, the critical question for the workgroup was whether GLNs as currently implemented across the industry can help reduce those discrepancies.

Five healthcare industry stakeholders, including two medical device manufacturers, two medical/surgical distributors, and one GPO participated in the Proof of Concept. During the analysis, inclusion of customer GLNs eliminated 31% of the discrepancies right off the top. Beyond that, it facilitated reconciliation and resolution of another 35% of the discrepant claims. Combined, inclusion of customer GLNs would have been able to reduce discrepancies in the test sample by 66%.

This test demonstrated that including customer GLNs in rebate and chargeback claims reduces the number of discrepancies caused by customer mismatch and facilitates reconciliation and resolution of those discrepancies. In addition, it produced a simple methodology that manufacturers and distributors can use with minimal effort to examine the same question in the context of their own rebate and chargeback processes.

Detailed recommendations are provided in the Price Accuracy Initiative document, “Proof of Concept: Using GLNs to Reduce Rebate & Chargeback Claim Discrepancies.”

Conclusion

Achieving meaningful transformation for healthcare efficiency and cost savings can’t happen without better communication and data compatibility throughout the supply chain. Using standard identifiers for medical devices, parties and locations, and standardized transactional documentation to support traceability and cost efficiencies will harmonize many of the key business processes required for better communication so that these changes can occur. Implementing GLNs and GTINs for devices will enable significant improvements. It is a collaborative and transformational effort that is mapped out in detail in the two guidance documents recently published by GS1 US, with additional resources available to assist.

Who Is the Inventor? The Art of Determining Conception of an Idea

Pixabay Who Is the Inventor? The Art of Determining Conception of an Idea

In the world of academia and research, scientists spend countless hours thinking, researching, experimenting, and finally, drafting manuscripts before sending them off to journal editors and reviewers. In the course of preparing each article, they may include as co-authors the names of other graduate and undergraduate students, thesis advisors, collaborators, and/or other individuals who gave them valuable feedback along the way.

Such is the way of the research community, but not so when it comes to inventorship on patent applications. To most scientists, inventorship is rooted in collaboration, collective research, and, in some cases, seeming fairness. In fields such as biotechnology and medical devices, where ideas and projects are often the product of extensive research and collaboration across various disciplines, inventorship choices can be intricate, sensitive, and complex. However, the determination of proper inventorship is actually a complicated question of critical legal nature, with vast implications.[1]

So important is the nature of inventorship that its origins are vested in the US Constitution itself.[2] Despite the significance of the role of the inventor in a patent application, the law provides little guidance on who legally constitutes an inventor.

Basically, an inventor is the individual who invented the subject matter of the invention.[3] The rights bestowed upon inventors and owners of a patent to “exclude others from making, using, offering for sale, or selling [their] invention” hinge particularly on the claims listed within a patent.[4]

However, inventorship does not necessarily vest with those who contributed to the entirety or any part of the application, but only with those who contributed to the claims which are ultimately designated. Once the claims have been drafted, determining inventorship comes down to a question of “conception.”[5]

The inventor(s) are generally the individual(s) who actually conceived of the original idea,[6] as opposed to those who performed the experiments validating it. In particular, it is the “idea of a result to be accomplished,” not the “means of accomplishing” a result, that creates conception that rises to inventorship.[7]

Ultimately, if an individual conceived of an invention, he or she is the inventor, unless the invention is merely the result of others’ ideas. “It is the … formation in the mind of the inventor of a definite and permanent idea of the complete and operative invention as it is thereafter to be applied in practice that constitutes … conception within the meaning of the patent laws.”[8] In other words, the conception of the invention is the mental recognition of the problem and the solution. Importantly, the courts have held that the conception itself is not complete until the “idea is so clearly defined in the inventor’s mind that only ordinary skill would be necessary to reduce the invention to practice.”[9]

Who should then be named as an inventor on a patent application when many shared ideas are involved, such as in academic and research collaborations? For example, when two or more “inventors” are working together, these inventors must have each contributed to the conception of the invention.[10] They do not need to contribute to the subject matter of every single claim in a patent, but they each must have conceived of at least one idea in at least one claim, and not necessarily the same claim.[11] They do not even need to physically work together or at the same time or even make the same type or amount of contribution.

However, such joint inventorship does require “at least some quantum of collaboration or connection.”[12] That is to say, there must be some “joint behavior” such that the two or more inventors work together, in some way, even if not physically.[13]

This notion of joint inventorship is particularly important with collaborations between inventors and industry. Often, an inventor will seek input from an industrial partner who will contribute a minor idea which is included in the patent application. Although the inventor conceived of the main idea, the partner may now have established a right to be named a joint inventor, giving rise to rights in the invention to the industrial inventor as well. It is because of this complex relationship that joint inventorship itself has been called “one of the murkiest concepts in the muddy metaphysics of patent law.”[14]

Ultimately, a patent that does not correctly name inventors may be held to be invalid. If inventorship is incorrectly listed on a patent application or granted patent, there are mechanisms to correct the issue.[15] However, “if the patentee does not claim relief under the statute and a party asserting invalidity proves incorrect inventorship,”[16] a court may hold the patent invalid.

As such, determination of proper inventorship is key to the holding of the rights associated with any patent. The inventorship itself hinges on a determination of who contributed to the conception of at least one claim of the patent. The bar for inventorship is not necessarily very high, as even the conception that rests behind a single dependent claim rises to the level of sufficiency for inventorship.

That being said, while numerous individuals may contribute to the ultimate development of a medical device or diagnostic tool, inventorship itself requires the inclusion of those who conceived of the original idea, but not necessarily those who helped perform the critical steps and tests to put the idea into practice. Inclusion of inventors who do not deserve such a title could ostensibly extend patent rights to individuals who have not earned such interest. Furthermore, erroneous inventorship could invalidate a patent. Inventorship determination need not be a scary exercise, but must be done with careful thought.

 

[1] See e.g., Perseptive Biosystems Inc. v. Pharmacia Biotech Inc., 225 F.3d 1315, (Fed. Cir. 2000).

[2] See U.S. Constitution Art. I §8

[3] See 35 U.S.C. §100(f) (emphasis added).

[4] 35 U.S.C. §154(a)(1).

[5] See e.g., Fiers v. Revel, 984 F.2d 1164, 1168 (Fed. Cir. 1993).

[6] See e.g., Board of Education ex rel. Board of Trustees of Florida State Univ. v. American Bioscience Inc., 333 F.3d 1330, 1340, (Fed. Cir. 2003).

[7] Id.

[8] Townsend v. Smith, 36 F.2d 292, 293 (Cust. & Pat. App. 1929).

[9] See e.g., Burroughs Wellcome Co. v. Barr Laboratories, Inc., 40 F.3d 1223, 1228 (Fed. Cir. 1994).

[10] Ethicon, Inc. v. U.S. Surgical Corp., 135 F.3d 1456, 1460 (Fed. Cir. 1998).

[11] See e.g., Trovan, Ltd. v. Sokymat SA, Irori, 299 F.3d 1292 (Fed. Cir. 2002); See also 35 U.S.C. §116.

[12] Kimberly-Clark Corp. v. Procter & Gamble Distribg. Co., Inc., 973 F.2d 911, 917 (Fed. Cir. 1992).

[13] Id. at 916-917. (citing Monsanto Co. v. Kamp, 269 F. Supp. 818 (D.D.C. 1967)).

[14] Mueller Brass Co. v. Reading Industries, Inc., 487 F.2d 1395 (3d Cir. 1973).

[15] See 35 U.S. Code §256.

[16] Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir. 1998).

Viveve Sets Its Sights on SUI Indication Target

Pixabay Viveve Sets Its Sights on SUI Indication Target

Viveve Medical has its eyes set on getting approval for a device to treat stress urinary incontinence (SUI). The Englewood, CO-based company has submitted an IDE application into FDA to get authorization to begin the LIBERATE-U.S. clinical trial.

LIBERATE is intended to be a randomized, double-blinded, and sham-controlled trial with enrollment of about 240 subjects at up to 25 study sites in the US. Subjects will be randomized in a 2:1 ratio for active and sham treatments. The trial will evaluate the safety and efficacy of the company’s proprietary, cryogen-cooled monopolar radiofrequency (CMRF) technology.

Viveve said the proposed primary efficacy endpoint is the mean change from baseline in the standardized one-hour Pad Weight Test, an FDA recommended endpoint in SUI clinical research. The study design also proposes to include evaluation of a three-day voiding diary, as well as multiple patient reported outcomes and safety follow-up throughout the study.

In addition, the company said it has initiated LIBERATE-International.

“The IDE submission for approval to conduct the LIBERATE-U.S. trial is an important milestone towards our objective to obtain regulatory clearances for CMRF for the treatment of SUI, a condition that we estimate affects approximately 25 to 30 million women worldwide,” Scott Durbin, CEO and director of Viveve said in a release. “This trial is also another reflection of our commitment to conducting sound scientific research and rigorous clinical trials that support the highest levels of evidence-based medicine to deliver safe and effective treatment of women’s intimate health conditions using our proprietary CMRF technology. Pending authorization to proceed with the LIBERATE-U.S. trial, Viveve will have two ongoing multicenter SUI registration studies underway including our LIBERATE-International trial initiated in Canada in August 2018.”

In an August interview with MD+DI, Durbin said the company would likely go for reimbursement if it was able to gain approval for the SUI indication. Durbin also said during the interview that the company would submit for an IDE application sometime in September.

The submission to FDA comes a little more than a month after the company received a nod from FDA to continue enrollment in a clinical trial to evaluate a technology to improve sexual function in women following vaginal childbirth.

Viveve’s procedure to treat vaginal laxity RF energy deeply into soft tissues – which results in neocollagenesis, or a straightening or tightening of the skin. The company said the technology is applied in a single treatment and in an office setting. The physician delivers the RF around the introitus and the procedure takes about 30 minutes.

No, a Wellness Device Can’t Save Your Life (not Directly, Anyway)

No, a Wellness Device Can’t Save Your Life (not Directly, Anyway)
Image source: StockPhotosLV/Shutterstock

It’s no surprise that a large number of wellness devices are being developed to allow today’s tech-savvy patient-consumers to take charge of their own health. Wellness devices are a great way to empower people by giving them access to data. However, it’s vital to remember that unlike medical devices, they are not required to be proven to be safe or effective. The responsibility and choice to claim a device as either wellness or medical lies completely with the manufacturer. It is extremely important that manufacturers understand the rules. Mistakenly seeking FDA approval for a wellness device might be costly, but not seeking FDA approval for a medical device could be a deadly.

What’s the difference?

Medical devices require a much higher standard of design, design control, and testing than is necessary for a wellness device. This is all risk-based: a wellness device can’t be responsible for high-risk, life-saving actions. In fact, they are defined as being at low risk to cause patient harm.

Wellness and Mobile Apps

A number of wellness devices are software programs that run on smartphones and other mobile communication devices. They can also be an accessory or a combination of accessories and software. If these devices are medical devices, then they are called Mobile Medical Apps, otherwise they are simply referred to as mobile apps.

Can a Device be Both a Wellness and Medical Device?

A specific product line is typically one or the other, but a family of devices may include both. For example, a device can measure heartrate for wellness purposes, and the manufacturer could also develop a medical version with a similar architecture for acute care applications. Devices that jump between wellness and medical indications often fall into one of two categories:

  • Wellness-first business model: creating a first-gen device as a low-barrier-of-entry first-step to market for companies seeking to eventually make their way to an FDA approved product. In these cases, the manufacturer (typically) releases a product as a wellness device with a clearly non-medical indication for use (e.g., “supports an active lifestyle,” or “promotes self-health”) before releasing generation-two with a more specific, medical indication for use (e.g., “used to diagnose sleep apnea”).
  • FDA confidence marketing model: A marketing strategy is to create a device for improving wellness that is also FDA approved. In this case, it’s a wellness-indicated device trying to gain confidence from their consumers by getting FDA clearance, despite being technically unnecessary. Their manufacturers are simply choosing to submit to FDA to increase sales and prove they have developed a safe and effective device.

So It’s All about Medical Information?

You’ll note that in neither case is a wellness device indicated to provide medical information or treatment, which is actually the difference between the two terms. Indicating medical performance for non-medical devices is unsafe, and it’s a major risk to a manufacturer’s commercial success and to patient safety to deliver medical information via an uncontrolled, unapproved device.

Then It’s All about Indication for Use?

Indications for Use is arguably the biggest factor in differentiating between wellness and medical devices, but foreseeable use is also a factor. A manufacturer can’t create a defibrillator and then add a disclaimer for non-therapeutic use when customers will obviously use it for that very purpose—it’s too risky to patient health. In one often-cited example, FDA ordered 23andMe to stop selling its Health and Ancestry DNA product because of “potential health consequences that could result from false positive or false negative assessments for high-risk indications.”

Are There Official Examples of What Is and Is Not a Medical Device?

FDA has set mobile apps into three buckets with examples: non-medical devices, maybe medical devices, and definitely medical devices. Mobile apps are not exactly the same thing as wellness devices, but the same general logic seems to apply to both upon review of FDA’s wellness device policy guidance (which also contains examples).

A Modern Case Study

This brings us to an example I want to highlight: the iBeat, which launched this summer. The iBeat monitors your heartrate via a smartwatch and alerts its response center via your smartphone if you are having a cardiac event. In the company’s words: It’s a “Smartwatch that could save your life… [by] continually monitoring your heart rate and blood flow for potential life-threatening emergencies and can send you help.” Personally, I interpret this as posing a risk to a patient’s safety if the mobile app were not to function as intended: for one example, if a user is relying on this device to send help but it malfunctions and doesn’t, that could be a life-threatening problem.

The FDA guidances state that devices that reference a certain condition (in this case, life-threatening cardiac emergencies) without specifically expressing the relationship as “may help to reduce the risk of” or “may help living well with” the disease are not wellness devices. Specifically, cardiac monitors including rate alarms are Class II medical devices, product code 870.2300.

However, this particular device is not approved by FDA. One stand-out quote is a sort of disclaimer: “While the company is pursuing FDA approval … the product is currently a consumer wearable and is not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease.”

In this case study, there is a real possibility that FDA will take action to have iBeat adjust its claims and its disclaimer.

What about Health Information?

Wellness devices often argue their information is not health information, and therefore is not within the bounds of HIPAA. This ups the stakes, because if devices like iBeat are found to be medical devices, their information may also be found to be Health Information.

Patient Safety is Number One

It’s important to remember that while simply writing “not to be used a lifesaving device” may be good enough for pool floaties, it is not enough (per FDA’s guidances) to transform a medical device into wellness device. If this disclaimer were enough, a lot more companies would be slapping such a disclaimer on their devices and rushing to market as fast as possible. You might argue that if these devices are being designed and tested properly, they could save more lives at lot faster by being sold as wellness devices; however, if they were really that effective and safe, then it would be simple for their manufacturers to get FDA approval.

Always carefully consider your claims and the type of information your device is collecting before deciding that it’s a wellness device—the stakes are too high, both for companies and for patient-consumers who may mistakenly rely on wellness devices.

Stryker Goes after Another from Most Attractive M&A List

Pixabay Stryker Goes after Another from Most Attractive M&A List

Now it could just be a coincidence, but it seems like Stryker is going after firms that made the list of the Top 25 Most Attractive Medtech Companies on the M&A Radar.

In late August the Kalamazoo, MI-based firm revealed it would acquire K2M, a company that develops minimally invasive spine technologies and techniques, that was featured on the list. This time around Stryker is setting its sights on acquiring Invuity, which was also on the list, in a deal valued at $7.40 a share, or about $190 million.

San Francisco, CA-based Invuity is known for its Intelligent Photonics devices used to evenly light surgical cavities. Placed at the site of surgery, the illuminators provide cool lighting that allows surgeons to see into dark surgical cavities.

The handheld lighting devices are primarily used in breast, orthopedic, and spine procedures, but the company expanded into gynecology in 2016. Additional applications include procedures for general surgery, electrophysiology, spine and orthopedics.

"The combination of Stryker's established leadership in minimal access surgery paired with Invuity’s suite of enabling visualization and surgical devices should facilitate better patient outcomes and operating room efficiencies in women’s health, general surgery, electrophysiology and orthopedics," Scott Flora, Invuity’s Interim CEO said in a release. "It is with this in mind that Invuity's board voted to recommend this transaction to Invuity’s stockholders."

Stryker has been at the center of a few M&A conversations this year. In April, Stryker executives noted the company had cash in hand and was ready for acquisitions.

In June, Stryker was rumored to be interested in Boston Scientific, another company that has been very active on the M&A trail this year. However, Stryker shot down such rumors disclosing on a regulatory form that it was not in discussions with Boston Scientific regarding a potential acquisition.

Take Device Performance to the Next Level

Take Device Performance to the Next Level
Image source: Gustavo Frazao/Shutterstock

When it comes to the world of medical device design, there is always a concern about how different technologies will perform under various environmental conditions. Will your wearable device perform well in high temperatures? Will your latest implantable device withstand the harsh conditions of the human body? Whether it’s high temperatures, high humidity rates, or just a sensitivity to electrical voltages, device makers have to account for a bevy of different environmental conditions when evaluating device performance.

For many device makers, evaluating performance means researching all the requirements needed for the device to perform in any environment—which could take some time. This can often lead to lengthy testing phases where design teams can get overwhelmed with different variables and performance metrics. So how can device makers be more proactive when it comes to predicting and solving issues to help boost product performance?

Perry Parendo has spent the last 30 years developing a series of Design of Experiments (DOE) techniques, a method that runs all the way back to his days working for General Motors Research Labs in 1986. Parendo eventually began to use these DOE techniques to help solve complex problems that would arise during the product and process development phase for international design teams tasked with new product development.

These DOE techniques are what eventually led to the founding of Perry’s Solutions LLC in 2006, when Parendo began helping organizations and companies with critical product development activities. Parendo has spent countless hours consulting with design teams from different organizations to help them maximize product performance to take their product to the next level. He will be speaking on the subject November 1 at MD&M Minneapolis in the session, “Getting Your Product Performance to the Next Level.”

Parendo recently spoke with MD+DI ahead of his MD&M talk to discuss some of the nuances of evaluating and improving product performance. He shares a few tips on how device makers and design teams can predict and stay ahead of issues that can affect device performance in various environmental conditions.

MD+DI: For starters, can you talk about the process of evaluating your product during design characterization? What are some of the things that are important to look for to help boost product performance?

Parendo: The process starts with knowing your requirements and which ones may be challenges. Then, assemble potential input variables that may influence those outcomes. This includes any noise factors or environmental conditions. This can all happen at the beginning of the project. Characterize these items and then “confirm” the next tier requirements are working as expected. If not, then more characterization work is needed to reduce project risk.

It is important to look beyond the obvious design factors. It is easy to identify 30 or more factors that could impact performance. I am not suggesting to go crazy with it during a test, but limiting ourselves to the easy and obvious 2-3 variables is clearly limiting. Being in an unstable operating zone with one input variable can make the entire design/product unreliable. By taking advantage of hidden replication, we can ensure our sample size is still manageable.

MD+DI: When it comes to evaluating a product’s ability to perform in different environmental conditions, what are some basic barometers for success that you look for?

Parendo: Success depends on understanding the sensitivity of the key design requirements. How much shift in performance is going to be noticed by a user? Any noticeable change is likely going to be considered bad. How can we operate in a stable performing region? How do we know where it is at? Once these answers are determined, the design tradeoffs can be made. It is one thing to create a capable design, but it really takes no more effort to find a level of robust design.

MD+DI: What are some ways that designers can accelerate the evaluation and testing process, and how will that benefit the product in the long run?

Parendo: We need to understand which design parameters may interact together and make sure to test them together. Design of Experiments (DOE) is the only technically and statistically efficient way I know to do that. When I ask people which variables may interact, it is a complex set of possibilities. It is rarely a clear cut answer. However, those same variables are often tested in isolation, which does not allow us to extract the information. We assume, or hope, that the interactions are small, but the truth is some of them are not. We do not know which one it is without performing efficient tests of the combinations. This is considered strategic testing.

MD+DI: What are some tips that you could share with design teams when it comes to selecting the best combination of variables for short-term testing?

Parendo: Testing in isolation is bad because we lose combination effects. However, testing everything together is too complex and inefficient. The best tip is to group our tests with variables that may interact together. As a simple example, in one test, combine mechanical variables together, and in another test combine the electrical variables together. I have heard it called testing within the “energy bands” and is something I consider on every test I set up.

MD+DI: In your experience, how can designers try to be more proactive when it comes to both predicting and addressing issues in a fast and effective manner?

Parendo: It is not easy, but we need to be honest about our designs. Be up front about risks and uncertainty. This does not make you a bad designer. Instead, it makes you realistic. We get surprised at times, and that is okay. Ensure we evaluate our higher-risk items deeper than our lower-risk items. Unfortunately, many designers test everything to a similar level, regardless of the risk involved. We are optimistic that things will work out, and we end up doing inadequate work.

MD+DI: Finally, if you could give one piece of advice to designers when it comes to taking product performance to the next level, what would it be? In essence, what’s a good piece of advice that you’ve picked up over the years that many design teams often overlook?

Parendo: Be humble in design. Testing is intended to help us learn, so a “failure” can be a good thing early on. Use early tests to make a better design, not just prove that you were right. It is a subtle, but very important difference.

Join Parendo November 1 at MD&M Minneapolis in the session, “Getting Your Product Performance to the Next Level." The session is part of the MD&M MInneapolis Technical Solutions track, which Parendo is chairing.

BTG Intensifies Focus on Pulmonary Embolism Through Acquisition

Pixabay BTG Intensifies Focus on Pulmonary Embolism Through Acquisition

BTG is busy on the M&A trail today. The London-based company has acquired Novate Medical, a firm focused on the prevention of pulmonary embolism (PE) in patients at high risk of venous thromboembolic events, for $20 million in cash with an additional $130 million in milestones.

Novate Medical has developed Sentry, a bioconvertible inferior vena cava (IVC) filter, which has recently been granted 510(k) regulatory clearance.

Sentry’s 12-month clinical trial data demonstrated no new symptomatic PE and no evidence of device migration, tilt, fracture, perforation or embolization, complications which have been associated with some other IVC filters. Novate Medical said bioconversion feature eliminates the need for an additional interventional procedure to retrieve the device.

“This bolt-on acquisition further enhances BTG’s strength in the vascular space,” Louise Makin, BTG’s CEO, said in a release. “Novate’s unique IVC filter offers our existing customers a highly complementary product in the management of PE.”

The acquisition follows an FDA advisory panel voting against the approval of BTG's Elevair endobronchial coil system for the treatment of people with severe emphysema. The company said it plans to work with the agency to address the specific concerns the advisory panel raised. The Elevair system is called the PneumRx coils in Europe.