Outcome-based Pricing Initiatives in the Healthcare Industry

By Joe Miles – Global Vice President, Life Sciences (SAP Industries) and Bob Steller – Industry Principle, Life Sciences (Vistex)

A distorted reimbursement model has driven healthcare costs ever higher, and elevated healthcare spend to the top budget item for many governments across the globe. But several major industry players have begun to experiment with outcome-based pricing models as an innovative approach to align reimbursements more closely with positive outcomes, while simultaneously bringing greater stability and predictability to pricing in the life science industry.

Download this eBook to evaluate the current state of reimbursement models, the adjustments that need to be considered, and methods for reform while offering practical alternatives for both outcome-based pricing and payment methods for all stakeholders in the value chain.

Download the eBook

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5 Guidelines for Writing a Useful Clinical Monitoring Report

Taking Your Report from Good to Great

By Brandy Chittester, Chief of Clinical Operations

A well-written monitoring report is an essential part of documenting clinical trial oversight. In addition to being required by ISO and ICH guidelines, it also tells the story of the clinical trial to the FDA, demonstrating site performance and sponsor oversight during an FDA inspection.

Unfortunately, this important task often doesn’t get the attention it deserves. Between scheduling visits, traveling and conducting the visits, it can fall down on a monitor’s priority list.

Whether you’re a monitor out in the trenches or a sponsor overseeing a study at a high level, here are a few important guidelines you and your staff should follow to ensure your clinical monitoring reports are accurate and complete.

1. Do Your Homework Before the Site Visit

To ensure all the information will be available to write the report, you should be thoroughly prepared for the site visit. Before you arrive on site, you should be able to answer the following questions:

  • What data should be source-verified?
  • How many queries are outstanding?
  • Will the regulatory documents should be reviewed and what updates are needed?
  • What data and action items still are outstanding?

A monitor’s time on site is often limited. Taking the time to look into these issues ahead of time will help you prioritize tasks and make the most of the time you have.

In addition to site-specific preparation, you must also be sure to understand the visit report template and the purpose of each question, since these templates can vary from one sponsor to the next. Likewise, you should always consult the monitoring plan for the study to be sure to complete activities during the visit as required by the sponsor.

2. Take Good Notes During the Visit

To make sure you don’t miss an important step, you should keep the monitoring report template open throughout the visit, making note of activities as they are completed.

We can’t overstate the importance of taking good notes. So many things that happen during a monitoring visit seem obvious at the time (like a follow-up item to correct a source worksheet or to re-review select data points), but in many cases, those items are forgotten soon after you leave a site.

Some suggested methods for keeping notes might be for you to mark off sections of the report as tasks are completed or use highlighting or another font color to show what requires assistance from the site. Although monitors always want to cross off every item on the list during a site visit, there almost always will be items that require follow-up later. No matter how you choose to do this, you need make note of what items require your attention after the visit to ensure nothing slips through the cracks.

Each monitor will find his or her own way of taking notes, but filling in the report during the visit is a good way to keep important issues top of mind.

3. Write the Report as Soon as Possible

The report should be written as soon as possible after the visit. The best-case scenario is to write the report before preparing for and going on the next visit, but this is not always possible or practical. The next best practice would be to write one report before writing the next. When a report sits incomplete for a few weeks and other visits have taken place in the meantime, the likelihood that the report will be accurate and complete is low, even with the most thorough notes.

4. Check Reports Carefully

A great monitoring report should be clear, concise and grammatically correct. Sloppy oversights, such as grammar mistakes and carrying over information from a previous report, can diminish confidence in your work. Copying and pasting information from a previous report may seem like a shortcut, but it leaves too much room for error. You should start fresh and check your work carefully when you’re finished.

5. Be Sure the Report Only Includes Essential Information

A good clinical monitoring report should be a summary of items you reviewed during the visit—no more, no less.

Too much narrative or detailed descriptions of what was in compliance can make finding what was out of compliance more difficult. You also should avoid documenting details that are already on record elsewhere. For example, if an adverse event has been submitted to the sponsor, there is no reason to include detailed information about the event again in the monitoring report.

Bonus: Take the Report from Good to GREAT

In general, monitors do an acceptable job documenting in their reports the issues noted during site visits. However, a monitor’s job doesn’t end with simply documenting issues; he or she also needs to document the efforts made to bring the site into compliance. Additionally, a monitor should document any discussions or actions taking place to prevent issues from reoccurring. Adding such details to monitoring reports illustrates the ongoing efforts by the sponsor and site to work together to address issues in real time and ensure the study stays compliant.

Writing effective monitoring reports requires an in-depth knowledge of the job, the study protocol, the site, their practices, the sponsor’s procedures, the monitoring plan, the report template and, of course, the regulations.

As a leading medical device CRO, IMARC Research has extensive experience in writing monitoring reports. Before you write your next monitoring report, download this resource for more tips and a checklist you can follow to ensure your clinical monitoring reports are as complete, accurate and useful as possible.

Get the Whitepaper


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Design for Manufacturing Breakthroughs

Producing Innovative Micro Medical Devices

By Lindsay Mann, Director of Sales & Marketing

How to Overcome Roadblocks When Producing a Micro Medical Breakthrough

When trying to produce an innovative micro medical design, you may come to a roadblock. What can you do to move forward and get the project back on track? First, determine the source of the problem. Is your supplier having problems? Is there an issue with your design? Some common warning signs your supplier may be failing are:

  • Failing validation
  • Not achieving lot-to-lot consistency
  • Told your design is “impossible”
  • Asked to make numerous design compromises
  • Lack of communication
  • Same issues cropping up
  • Time between communication is getting longer and longer
  • Feeling you know more than your vendor
  • Lead times between samples getting longer – showing disinterest


If your supplier is failing, it’s time to ask the tough questions. Is it truly feasible for your supplier get your product back on track, or will you spend months or years without making progress? Even though you’ve invested time and money with your current supplier, sometimes the best strategy to get your product to market faster is to find a new supplier who is better equipped to address your product’s specific needs and challenges. While it seems like a major expense to change suppliers, it will likely save you money in the long run if your product gets to market faster and efficiently.

Sometimes the molder simply doesn’t have the specialized medical micro molding equipment needed to produce a particular design. Sometimes they don’t have experience or expertise in working with a certain material or challenging design. Other times, a supplier may excel at low volume or on-demand production but cannot efficiently ramp up production.

What does it cost to not do it right the first time? We worked with one of our customers to calculate what it actually cost their company to have their project rescued from a failing supplier. This OEM had developed a concept for a bioabsorbable fixation device that generated excitement and positive comments from reviewing surgeons. Although the company worked with a reputable molder, after five years of labor, the molder had limited success and could not produce the part represented in its drawing with sufficient quality.

After the five years, the OEM decided to cut its losses and start fresh with a different molder. When the OEM tallied its losses, the results were staggering.

Factoring in an estimated one-year delayed market entry, the loss of potential product sales, the time unnecessarily spent in process development, and the cost of restarting their project with a new molder, the sum came to about $1.5 million.


Are you requesting “no flash”? Requiring extremely tight or challenging tolerances? Assigning a challenging gate location? If so, you may be causing your supplier to chase their tail to solve the problem – or you may be incurring a huge increase to budget and lead time. Is it worth it? Sometimes simple drawing concessions can help.

Inadequate material choice frequently leads to manufacturing issues. There are polymers that demonstrate high compressibility, poor fill properties, poor long term dimensional stability. Tight tolerances like +/- .001″ may be difficult to achieve with these materials. Your design and drawing will dictate what materials can be used.

If you’re tackling design roadblocks, talk to your supplier. They should be able to guide you on better material choice or simple design concessions that will help meet the goals of your part’s functionality.

How can you determine what’s completely unrealistic vs. pushing boundaries?

Engage early. Get a clear understanding of whether your design can translate to injection molding by engaging your molder as soon as possible – and if it can’t, understand why not.

Push the boundaries. Go to industry experts to understand what elements of your design realistically possible and what boundaries can be pushed. When requesting quotes for a micromolding project, ask molders to show similar examples of parts they have created that are similar to your design.

Go with the “true positive.” A molder that is open with concerns and can present options for manufacturing success should be more comforting than a molder with zero concerns or interest in drawing optimization.

Don’t make assumptions. Bring your grand ideas to your molding partner and discuss your wishlist for your design(s). If you allow the molder to evaluate what is possible and realistic as a long-term molding solution, they can listen to your expectations and provide substantive feedback.

How can you efficiently work with a molder to produce your breakthrough idea?

Consult early. Consult your molder early in the development process and, if possible, be open to some flexibility in material, dimensions, and timing in order to increase speed to market.

Come prepared. Know what you need for your part with a high level of understanding about the product’s requirements. Express areas of the design you feel are challenging and/or have concerns about to your molder. You understand the limits of your design and the edges of success and failure. This information allows the supplier to assess how they can help from the most productive angle.

Be mindful. Extremely difficult geometries typically require some kind of unconventional approach to the project in order to be successful. Having an understanding of the technology, experience, and knowledge required to create these complex geometries in plastic will help you save you time in your supplier qualification process.

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Global Excellence in Delivery Device Testing


There is a need for a fully-informed laboratory in combination device validation services. The ideal is a laboratory that understands both the pharmaceutical and medical device requirements; from extractables and leachables, through bioavailability, to dose accuracy and ease of use. A good pre-clinical partner/test facility, such as Medical Engineering Technologies Ltd. (MET, www.met.uk.com) can provide regulatory guidance and Design Validation Testing (DVT) to help assist in getting a product to the marketplace.

The process of generating performance and safety data should be planned to ensure efficient project management and to help reduce costs.

Design Validation Planning

The pre-requisites to developing a design validation programme are:

  • Competitor submissions review
  • Design inputs / targeted product performance
  • European and/or FDA Guidance review
  • Risk analysis
  • ISO /EN /ASTM/ ICH/ pharmacopeia standards review
  • (If this is a first foray into combination devices) A gap analysis of the Quality Managements System (QMS) and production processes and qualifications in place.

A review of existing product standards and Guidance, along with detailed risk analysis, is essential to defining test programmes. This approach ensures that all the necessary testing has been carried out, and can also reduce any unnecessary testing. Additionally, the key performance requirements must be identified in a product review; this includes design inputs and a literature review. To assist you in saving time and money, MET has developed standard study plans for a large range of devices.

These reviews and risk analyses can then be used to develop the test programme and design test protocols.

Developing a Protocol

The testing regimes in a DVT could include:

  • Assessment of hazards identified in the risk analysis
  • Bioavailability studies
  • Biocompatibility studies
  • Drug / container interaction analysis
  • Extractables and leachables studies, toxicological risk analysis
  • Human factors studies
  • Performance and dose accuracy assessments
  • Reference Listed Drug (RLD) comparison
  • Standard / FDA Guidance compliance testing

Gantt charts and a more descriptive plan, provided by your partner laboratory, keep you informed. These plans can include test cost, time requirements, sample numbers, and an indication of whether a test is essential (or just helpful).

MET testing plans shown below use a transdermal patch as an example and give an idea of the types of testing, sample sizes and time requirements that would need to be considered. These tables are not comprehensive.

Transdermal biocompatibility and chemical safety:

Transdermal  performance tests:

Transdermal distribution testing:

Design Validation Testing (DVT)

All planned tests will require agreed test protocols. These are developed by your test facility, with your approval.

The testing stage might be preceded by a Gauge Repeatability and Reliability (GR&R) study, to provide evidence that the test protocol is robust and that there can be confidence in the DVT results.

The use of a laboratory with ISO/IEC 17025 accreditation will ensure that there is a good, fully audited, QMS and that equipment is qualified and calibrated, whilst processes are subjected to internal audits. It is entirely possible that not all the tests will be specifically accredited. As long as these are carried out to an agreed protocol under the ISO/IEC 17025 QMS, there can be confidence in the results.


Test reports can be succinct or extensive. For regulatory submissions, a Certificate of Analysis will be too brief whilst as 100 page report will not be helpful.

The report should include at least:

  • The test protocol (this can be an appendix)
  • The rationale for analyses included and excluded
  • Any deviations from test protocol
  • Details of equipment and technicians
  • Details of the product/s tested (batches, dates, description, etc…)
  • Test results
  • Summary


When developing a combination device, a pharmaceutical company must decide whether to carry out testing in-house or externally. There is no compulsion for independent testing, as long as a company’s own laboratory is fully equipped, has all the control systems in place, and will act without bias.

The advantages of using an experienced, well informed external laboratory are:

  • Clear independence
  • No capital costs
  • Efficiency of project management, testing and reporting
  • Good advice from a knowledgeable source.

Things to look for when selecting a laboratory are:

  • A good QMS and good quality control
  • Informed and helpful staff
  • Rapid, accurate responses to queries
  • Openness of access
  • A comprehensive range of services, in order to reduce multiple sourcing and adding several companies to your supplier list.

Medical Engineering Technologies (MET) has staff that have developed plans for many projects and a wide variety of devices. These have been successfully implemented within an ISO/IEC 17025 QMS, helping clients achieve a smooth entry into the market (www.met.uk.com).

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The Promises (and Problems) of Real World Data

By David Kronfeld, Head of Real World Data Innovation, Medidata Solutions

Medtech is just starting to access the rich well of real-world data (RWD), which offers some incredible opportunities to build more successful and useful devices. RWD technology can be employed to improve patient recruitment, efficiently deploy a sales team, identify unmet needs in regions, and to tell a value story.

But there is a problem with medical device companies’ expectations of RWD. Data aren’t magic—they are a digital representation of what actually happens in a real care setting—and there is no such thing as complete data.

Although many organizations are working to improve how data are collected, processed, and managed, significant challenges of applying RWD remain. While we wait for technology to catch up, here are some tips on how to think about RWD:

Problem #1: Data sources are fragmented

Similar to clinical trials, CROs and sponsors face a variety of data sources from which to pull for medical device trials. Electronic medical records (EMRs), claims data, and registries are commonly used sources of healthcare- and patient-related data for medtech. Each of these may or may not be useful, depending on the business case we are trying to solve, and each has its limitations.

  • Electronic medical records
    EMRs are messy. EMR data lives in silos—many, many silos—and as of yet, there are no universal standards that allow users to map different datasets together, nor are there any scaled data-sharing initiatives. Efforts are underway to improve the problem, but not at the pace device makers want.
  • Claims data
    Claims data are extremely powerful. These databases are used to drive improvements in population health and address issues related to cost, quality, and outcomes. They include information at the patient encounter level regarding diagnoses, treatments, and billed and paid amounts. They complement EHRs and combine to offer a broad view of patient interactions. The data comes de-identified for HIPAA compliance, but retains the ‘chain of custody’ and can be used to find patients through their unique provider identifiers. Although this type of data is also not perfect, it can be valuable depending on the use—especially for commercial applications.
  • Registries
    Registries typically focus on patients who share a common reason for needing care, allowing physicians to see what treatments are available and how patients with different characteristics respond to certain therapy. They can yield great insights. However, registries are retrospective in nature and are only as good as the information that goes in, which leads us to our second problem.

Problem #2: Data are not as accurate or complete as you might expect

The most frustrating idea about data is that it doesn’t yet offer us the ability to connect insights to individual patients. This can be wildly unsatisfying, especially when it comes to patient recruitment. Often, the best data can do is tell us how hard recruitment will be.

EMR systems are simply digital versions of old-style patient records where doctors would manually write notes and file them away. Although they contain a lot of information, they are not designed to report insights for individual patients, nor across patient populations. Further, the data are only as good as the information provided by the physician. Data recording is a required task for billing and reimbursement, yet if a physician doesn’t use all the checkboxes and pull-down menus properly, the results are less valuable.

Healthcare providers tend to prefer free text fields because they match how caregivers have historically recorded care. Those fields often contain accurate, higher value information. Natural language processing will be able to create insights from that treasure trove (but isn’t quite there yet), and extra care and security has to be applied considering that this field often includes protected health information.

Problem #3: Patient records are fragmented

Individual patients often have multiple records, which further complicates an already fractured system. People often think that if they’ve seen the same doctor for years, all their data are together. But that might not be true. For instance, the records might be different if they’ve visited the emergency room or been referred to a specialist.

Claims data can often be highly accurate and reflect a continuum of care, but only for the time a patient was under that coverage. A single patient might change insurance, and change care providers several times in their lives. Each will have a record of every system they’ve ever touched, resulting in a wide medical data footprint. In a use case, we ask, how much of that data footprint is needed to yield insights?

How data are getting better

When sponsors ask, “How complete is the data?” often the answer is, “It is as complete as it can be.” This may or may not be complete enough for an FDA submission. The inherent challenges of data need to be respected, but companies should also not be deterred from pursuing a RWD strategy.

Technology companies are getting better at linking datasets to create unified footprints. For example, in April, Datavant acquired UPK (Universal Patent Key). UPK provides HIPAA-compliant de-identification services for healthcare data, while Datavant provides services to safely link their data to improve medical research and patient care. The acquisition could help streamline both services. Along a similar vein, HealthVerity has tokenized technology that provides HIPAA-compliant methods to link records. Over time, these technologies will help.

Other companies are looking to unify data on the level of single EHR. Pharmacy cooperatives, such as altScripts, have rich data from their EMR systems. However, we should understand that these systems also have gaps. For example, physician ordering, and internal or external labs during a hospital stay might not be part of the EMR or EHR—they have their own systems. So, a complete medical record needs to be one step above the level of an EMR and accept a variety of data types.

Such health-system level companies are worth watching. These organizations include Guardian Research Network (GRN) and Syapse, both of which focus on oncology patients. They are looking at how to marry inpatient activity, outpatient activity, medical records, and other clinical systems within the healthcare setting to create a holistic view of the patient journey.

Lastly, we are approaching the point where interested parties will soon move away from “wanting the data” to only wanting the insights it brings. There’s an enormous amount of data out there, and managing and applying data science to it all is an expensive process. When it comes to RWD, every opportunity has a consequence. This is why it is important to first understand the business problem you’re trying to solve. When you’re clear on that, RWD is a tool that can yield innovative advancements for medical product developers.

The post The Promises (and Problems) of Real World Data appeared first on MassDevice.

Putting patients first – e-consent in clinical trials

Medical device developers do not always consider the process of informed consent for clinical trials, since it is often handled at the trial site. But the industry is changing, and digitizing processes such as informed consent can streamline studies to rapidly collect quality data, while reducing costs.

Patient-centric healthcare means patient-centric clinical trials

As the medical technology industry shifts toward patient centricity, novel methodologies and technologies like mobile sensors and cloud software that collects and stores data can save time, reduce costs and increase adherence to regulatory standards. In addition, these technologies can help address challenges in patient recruitment and enrollment.

This is especially true when evaluating precision medicine or therapies for rare diseases. In such cases, there are many hurdles such as shortages of specific patient populations required to complete accurate, timely trials, which is often exacerbated by the increased frequency of trials conducted in tandem. Using e-consent systems during the enrollment process can reduce the cumbersome activities associated with paper-based consent documents, leading to more efficient patient enrollment and quicker study start-ups.

E-consent is an ethical imperative

Patients comprehend the e-consent enrollment process better than paper consent forms, making e-consent a more ethical way to recruit participants. A recent pilot study found that people with a paper version recalled about 58 percent of the material in informed consent documents, while 75 percent recalled information accurately when viewed in an e-consent format.

Moreover, informed consent documents are notoriously difficult to understand. The Center for Information & Study on Clinical Research Participation published a study revealing 35 percent of potential participants dropped from a study because they couldn’t understand the informed consent documents. Due to technical terminology, participants could not understand their rights and responsibilities, and were therefore wary of participating in the study.

In contrast, a digital consent platform that tailors trail information and the way it’s delivered to a patient’s needs enables that patient to participate confidently. E-consent software accomplishes this by using multimedia tools (e.g., participant led videos, characters, virtual trial examples) that track and improve comprehension. Finally, to measure comprehension after completing the e-consent form, participants take a comprehension quiz that reveals whether the testing site staff needs to further clarify risks and benefits of the study.

Saving money and time

A software platform that digitizes the process and eliminates paper consent improves patient understanding and engagement, therefore accelerating and streamlining start-up times. It can also lead to cost and time savings.

Estimating the costs associated with informed consent can be difficult as individual CROs often tally total costs into one sum, estimating that the cost per participant can range from $50 – $1,000. But if stakeholders consider the costs associated with copying paper documents, shipping, storage, archive management, and source data validation, the value of a digital record begins to emerge.

Meeting and exceeding regulatory standards

Information compiled in an e-consent format can be tracked automatically. Participants receive immediate updates, and auditors have access to that data at any point, not just on site. Also, e-consent forms reduce participant errors, such as inputting the wrong date.

According to a Quorum report, from 2011 to 2016, the FDA reported 214 inspectional observations related to the mandate to obtain informed consent, the failure to adequately document informed consent and the failure to maintain documents evidencing informed consent. We estimate that 95 percent of those observations would be eliminated with an e-consent format versus a paper format. These benefits would allow trials to meet and even exceed regulatory standards.

What to consider when looking into digital enrollment process

When transitioning to a digital enrollment process for clinical trials, there are several considerations:

First, for e-consent to be successfully integrated into clinical trials, stakeholders need to ensure that it can be used on commercially available platforms, such as tablets and smartphones.

Second, interactive tools, such as animation or touch screen navigation, provide an active learning experience that engages the patient, improving adherence and completion. Further, look for systems that incorporate tools such as comprehension quizzes following the presentation, which can enhance understanding and allow participants the opportunity to review any confusing sections.

Third, adopting a unified enrollment system ensures consistent consent review across all sites. To help reduce monitoring and site costs, the system should:

  • Include a web dashboard of consent analytics at all sites
  • De-identify consent information for sponsor review
  • Ensure required signatures and manage consent amendments

Finally, the system needs to comply with institutional review boards, quality assurance guidelines and regulatory standards. Such a system should prioritize risk reduction for regulatory audits and, therefore, incorporate tools including real-time enrollment statistics and traceable electronic signatures.


Investing in e-consent is no longer a luxury. Compared to traditional methods, adopting a unified platform that enables e-consent can streamline studies, while saving time and reducing costs. The healthcare market is shifting to ensure products have a patient-centric approach, and that directive must include clinical trials.

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Preparing for EU MDR Product Submissions: A Sustainable Approach

By Michelle Boucher, VP of Research for Tech-Clarity

Every medical device company wanting to do business in Europe must comply with the new EU MDR regulation. Yet this is no small feat considering the more stringent requirements. While the new regulation is largely an extension of the existing regulation, it requires far more data. As a result, companies must competently manage data throughout the product lifecycle – and update it as their product changes.

Rather than see this is a challenge, Michelle Boucher, VP of Research for Tech-Clarity, views this as an opportunity. Download the guide she authored to position your company for a long-term advantage.

The guide covers all the essential details you need to understand the data requirements of EU MDR product submissions and how to comply. You’ll find guidance on:

  • Determining your strategy to collect data and prepare submissions.
  • Prepping your product data for the new regulation.
  • Overcoming the obstacles that make data submissions challenging.
  • Taking advantage of the power of Product Lifecycle Management.
  • Five steps to adopting a product-centric approach.

The post Preparing for EU MDR Product Submissions: A Sustainable Approach appeared first on MassDevice.

Join Cognition Corporation in Boston September 20-21 for NAVIGATE2018

By Nick Schofield, Content Creator

Interested in networking with and learning from top voices in life science industries about the latest topics and challenges in product development? Are you looking to learn more about how organizations use Cognition’s products and services to help bolster regulatory compliance from premarket to postmarket environments? Then come to NAVIGATE2018, Cognition’s annual user conference!

NAVIGATE2018 will features talks, panels, and discussions from industry leaders about the latest topics, ideas, and concerns in life science product development. Topics include:

  • Risk management
  • Cybersecurity
  • Computer systems validation
  • Systems engineering

Our featured keynote speaker, Steve McRoberts—Group Head of Quality and Regulatory at LumiraDx— will discuss holistic risk management and its benefits in satisfying all relevant standards and regulations for life science products. Through both this talk and a follow-up Q&A, attendees will discover how they can empower better decision making throughout development and product lifecycle, managing risk data in a well-integrated, company-wide system, and better prioritizing product quality from the start.

Other talks will focus on how organizations leverage Cognition products and services to help bolster and empower their design controls and risk management activities throughout the product lifecycle. Scott Patchett, Lead PLM Development Engineer at Cook Medical, will dive into how Cook utilizes the Cockpit® Platform and other Cognition services in managing process validation and process-associated risks. Ryan Ward, Director of Engineering for Zimmer Biomet, will talk about the intersection of design controls and risk management in remediation activities and how his teams are leveraging Cockpit to bolster their efforts.

Attendees will also be able to participate in panels and roundtable discussions with speakers from life science industries and the Cognition team. Talks from Cognition include:

  • Information sessions on the latest happenings at Cognition
  • Explorations of Cognition’s roadmap through 2025 and beyond
  • Open discussions with Cognition’s Application Engineers about unified risk approaches in practice

NAVIGATE2018 will also provide attendees plenty of occasions for peer networking. From cocktail receptions to an awards banquet, those who attend will have the chance to talk with fellow professionals across life science industries to discuss the latest challenges and opportunities in regulatory, product development, and postmarket environments. Outside of the confines of normal work settings, these chances to network provide a great space in which to share ideas and perspectives around the state of the industry today and moving forward.

Sign up today for NAVIGATE2018 to experience all this user conference has to offer. Attendees can even explore some of the best of what Boston has to offer, all within walking distance of the conference venue. Held at the Marriott Long Wharf Hotel, NAVIGATE2018 offers attendees endless opportunities for learning, networking, exploration, and recreation. All-around, it’s a fantastic experience that industry professionals won’t want to miss. Sign up today!

The post Join Cognition Corporation in Boston September 20-21 for NAVIGATE2018 appeared first on MassDevice.

Bioelectronic Medicine: Targeting Inflammatory Disease with Electricity

Placement of bioelectronic implant on vagus nerve

Clinical Results in RA and Crohn’s, Looking Ahead at MS

By Anthony Arnold, CEO of SetPoint Medical

Inflammation – it’s a term that conjures up two very different scenarios in the body: one that is vital to healing and another that can lead to chronic inflammatory diseases. Inflammation, at its best, is the part of the body’s fight response where it rushes blood, fluid and proteins to an impacted area to create swelling and heat to protect, repair and heal.

In the second scenario, when this carefully regulated system goes awry and inflammation in the body becomes chronic and systemic, it can lead to a growing list of cardiovascular and autoimmune diseases including heart disease, stroke, peripheral vascular disease, rheumatoid arthritis (RA), Crohn’s disease and multiple sclerosis (MS).

Within the last decade, chronic disease numbers have grown rapidly. About half of all adults, an estimated 117 million people, are currently living with one or more chronic health conditions, and one in four adults have two or more chronic health conditions, according to the CDC.

While medical devices have not historically played a role in treating inflammatory diseases, that is changing due to the fast-growing field of bioelectronic medicine.

Bioelectronic medicine builds on traditional neuromodulation and combines advances in bioengineering, immunology and neuroscience with a deeper understanding of disease mechanisms to create a new way to harness the body to fight chronic conditions using electric pulses. What sets bioelectronic medicine apart is the biological impact it has in the body, going beyond the mediation of symptoms to address the underlying disorder by harnessing the body’s own mechanisms to treat disease.

Scientists and researchers at the NIH, DARPA, MIT, Northwell Health’s Feinstein Institute, GSK, SetPoint Medical and other academic institutions believe bioelectronic medicines will have an important role to play in diseases ranging from RA and Crohn’s to Alzheimer’s, asthma, MS and diabetes, leading to more than $1 billion being invested in bioelectronic medicine to date.

California-based SetPoint Medical is first in the clinic with bioelectronic medicine trials in rheumatoid arthritis and Crohn’s disease. SetPoint is targeting chronic inflammatory diseases, stimulating the immune cells in the spleen, gut and elsewhere to drive a coordinated response to regulate inflammation.

SetPoint Medical

SetPoint bioelectronic implant

First Clinical Data: RA and Crohn’s

Rheumatoid Arthritis

  • SetPoint published data demonstrating positive results from a first-in-human trial in rheumatoid arthritis in Proceedings of the National Academy of Sciences (PNAS) (available here).
  • Eleven of 17 patients saw a clinically meaningful drop in their DAS28 (Disease Activity Score).
  • Seven of the ten patients that had failed to respond to multiple biologic agents of differing mechanisms demonstrated robust DAS28 responses.
  • The findings indicate that active electrical stimulation of the vagus nerve inhibits tumor necrosis factor (TNF) production in RA patients and significantly attenuates RA disease severity.
  • SetPoint is following up its proof-of-concept trial with a U.S. pilot trial in RA using its proprietary bioelectronic medicine device.

Crohn’s Disease

  • SetPoint recently completed a bioelectronic medicine study in Crohn’s disease, conducted at five European centers in 18 patients with severe Crohn’s who were not responsive to traditional TNF-targeting drug therapy.
  • We presented positive initial results in Crohn’s disease at the 2016 United European Gastroenterology meeting: six of the eight patients had seen a substantial reduction in their disease activity index scores, and three were in remission from the disease.

As SetPoint looks ahead, several chronic disease areas are emerging as key bioelectronic medicine therapy targets, and our company is exploring a number of these. One of our preclinical programs explores bioelectronic medicine’s potential role as a treatment for MS.


New Target: Multiple Sclerosis

  • In late 2017, SetPoint presented positive data from a study exploring the therapeutic effects of a bioelectronic medicine approach for MS at the European Committee and Americas Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS-ACTRIMS).
  • Data showed that SetPoint’s therapy reduced demyelination and, more importantly, accelerated remyelination, which is a significant challenge in treating MS with currently available drugs/biologics.
  • The study also demonstrated this approach reduced leakage of the blood-spinal cord barrier, which can prevent immune cell infiltration and further reduce disease progression.
  • Current approved treatments for MS target the overactive immune response but do not repair damage to the myelin sheath – a critical aspect.
  • These results show promise for a possible bioelectronic treatment for MS and lay the groundwork for further studies.


Bioelectronic Medicine Device: How it Works

Bioelectronic medicine uses a small implanted device to deliver targeted electrical pulses along existing physiologic pathways, triggering the body’s natural biological responses to create a systemic disease-fighting effect that can last hours or days.

SetPoint developed the first self-contained rechargeable bioelectronic device for placement on the vagus nerve to deliver electrical doses on a preset schedule. This approach requires only one surgical site, potentially making implantation take less time with less risk for patients. Bioelectronic doses are prescribed by the treating clinician using a prescription pad application on a standard iPad and the doses are automatically delivered by the implant.

Bioelectronic medicine has the potential to offer an alternative for physicians and patients with improved quality of life – a solution that could provide fewer side effects, lower cost and better compliance. SetPoint continues its research to bring this important new medical technology to patients.

The need for new treatment options for inflammatory diseases is great and urgent. Many believe this new approach could be life changing for patients living with chronic conditions and a disruption to what we previously believed was possible in treating them.

Anthony Arnold is CEO of SetPoint Medical, a biomedical technology company developing a bioelectronic therapy for inflammatory diseases. Arnold has more than 20 years of medical device industry experience, including key roles at Advanced Bionics/Boston Scientific, Medtronic and Smith+Nephew. For more info: www.setpointmedical.com.

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Navigating the Life Science M&A Savannah

Daniel Wolf

Still recovering from a market correction two years ago, and with a scarcity of attractive targets and ongoing macroeconomic uncertainty, the life sciences dealmaking space is in a state of flux. As big pharmaceutical companies more narrowly tailor their business models and hedge fund activists become more active in the space, M&A lawyers working in it must be ready to deal with the unexpected.

Daniel Wolf, a partner at Kirkland & Ellis — recently named one of the top deal firms in the latest update to the Life Sciences Law Firm Index from Lake Whillans, Above the Law, and MedCity News — has seen it all in his 22 years of practice, from 11-figure deals to private equity transactions to the increasingly common hostile bid, experience he and the Kirkland team bring to bear during a complex period in the space. He recently spoke with us and shared his perspective on life sciences mergers and acquisitions.

Hostile bids used to be comparatively rare in the life sciences M&A arena, but in recent years have become more common. What is driving that change, and how can it be dealt with?

Historically, there’s been a certain amount of reluctance to pursue hostile transactions in the space, particularly when the companies were smaller targets, given the view that there was a significant importance to the people who were developing the drug candidates. With the maturing of the biotech industry, and because a lot of the big pharmas have retooled themselves to be more like biotech companies, they feel they have the infrastructure and in-house skills to develop the compounds better, and, therefore, they’re a little less reluctant to pursue it. Activists have also clearly played a significant role in generating unsolicited activity.

We think about life sciences as a very important subset of our transactional practice, where we bring a broad set of M&A skills to bear on a market segment. If all you are is a life sciences deal person, when that hostile deal presents itself, you probably don’t have the special skills to do that type of transaction. When a client calls us up and says they’re launching a hostile bid for a rival, or says, “We’ve received a hostile bid from a large pharma,” being able to say, “We’ve done those types of transactions,” is invaluable to the client.

What does the market for life sciences M&A look like right now?

Two years ago, the market saw a crazy flourish of deals. Last year was a more measured pace. I think it’s going to continue to be that way until we get more clarity or resolution around the tax policies and whether overseas capital is going to be able to be accessed on attractive terms. Another overhang on the whole industry is the environment for drug pricing. All of those are limitations on deal motivation among the various players in the market, and the smaller number of assets that are left sometimes are relatively overpriced from a true-value perspective. When the number of move-the-needle targets goes down, the ones that are left — even if they aren’t the juiciest steaks — may look better than they are because of that scarcity value. It creates a cycle where no one wants to buy some of them because they end up being overpriced.

Why are there so many fewer targets today than in recent years?

If you look back about five years, there were a few dozen companies in the $5 billion to $10 billion range, which tend to be the type of targets that attract both buyers and activists. That category of company has dwindled to a handful. A significant number of those companies have been bought or fallen in value. Within pharma, the practice of developing compounds from scratch in house has been partially displaced by going out and buying or partnering with smaller independent companies to build the pipeline. Pharma companies are looking to replace drugs going off patent and really have scoured the landscape, buying those companies that fell into that sweet spot because those targets are big enough to make an impression and move the needle, but are not bet-your-company type deals. So, for a big pharma, a $2 billion or $4 billion deal shows you’re doing something and can add a meaningful Phase II-B or III compound, but it doesn’t break the bank if it fails. The carnivores surrounding the savannah have picked off many of the juicy-looking meals, and what you’re left with are often less-attractive zebras.

There has been a concentration of specialization, where each pharma company is choosing its areas of expertise. That means a more concentrated competition for assets with a greater desire to win. Ten years ago, when an oncology asset went up for sale, everyone looked at it, but not one of them viewed it as a must-have. Now, you probably have five or so companies looking at it, but they’re companies that are all-in on oncology — a more concentrated group of buyers who are much more motivated.

The weakness in the IPO market is another factor that’s going to continue to drive M&A activity because you’re getting less fresh targets in the market. There’s a lot more private deal-making going on, a lot more collaborations and collaborations with options to buy. Those are structured transactions that are tougher to do once the company’s public. You’re seeing a lot more of those because a lot of companies that would have gone public 10 years ago when biotech IPOs were the rage are not seeing the same receptivity in the market for a public offering.