Health Advances team members are actively engaged in thought leadership across the healthcare spectrum. We speak at conferences, participate in panels, and contribute to specialized journals on a wide range of topics, including commercialization strategies, emerging technologies, the changing delivery and reimbursement landscape, and implications of healthcare reform. Our white papers provide detailed perspectives and insights regarding issues of interest to healthcare executives.

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05.23: MedTech Strategist

The Growth of Interventional Spine and What it Means for Traditional Spine Surgery

By Masha Dumanis and David Dopfel, PhD

The interventional pain specialist’s practice is expanding, driven by new training programs, technological advances, growing clinical evidence, and the benefits of a minimally invasive approach. With treatment expanding and the space between interventionalists and surgeons shrinking, opportunities are present for both physicians and OEMs.

Read here.

03.23: White Paper

Healthcare Listing Locations in Asia Pacific

By Eric Woo, Melisa Junata, and Gary Cheng

Where should healthcare companies list in Asia Pacific? What are the characteristics of healthcare listings on stock exchanges in Hong Kong, Shanghai, Shenzhen, Japan and Korea? Explore key insights and trends from the 5-year listing history in this whitepaper.
Read here.

02.23: E-Book

Coming of Age: Women’s Health Maturing in the Digital Era

Women’s Digital Health Team

In many ways, 2022 was a milestone year for Women’s Digital Health. While digital health venture funding overall faced strong headwinds this past year, funding for women’s health startups represented a larger percentage of the pie than ever before – 13.26%. Women’s Digital Health (often referred to as “FemTech” – though we disfavor the word, for many reasons including marginalizing and diminishing the value of the space) features digital health solutions designed to support women’s health. Spurred in part by rapid uptake of telehealth and digital solutions during COVID-19, these products have gained considerable traction and are expected to reach a valuation of $100 billion by 2030. Such success was also achieved in the face of women’s health privacy concerns and legal questions following the landmark Dobbs ruling from the U.S. Supreme Court, which stripped women of the federal protection to abortion rights.
Read here.

02.23: White Paper

High Points and Stumbling Blocks in Cell and Gene Therapy: Exiting 2022, Entering 2023

By Alicia Shields, PhD, Emmanuel Toroitich, PhD, Chris Biondi, Ned Wydysh, PhD, Vivek Mittal, PhD

During the pandemic, public attention on healthcare innovation helped promote a tsunami of investment into the biotech sector. In 2022, however, macroeconomic conditions have created significant investment headwinds for the industry, and CGT companies have not been spared. Companies have laid off employees, pivoted pipeline priorities, and redistributed resources in an attempt to remove organizational redundancies, create operational efficiencies, and reduce expenses.
Read here.

12.22: MedTech-Strategist

Where Does MedTech End and Digital Begin?

Joe Ives, Susan Posner, and Jeff Abraham

The growing pervasiveness of digital tools within medical devices is creating new opportunities to improve care delivery and the benefits are becoming more well-documented. How industry stakeholders should categorize products that leverage this symbiosis, and the implications of categorization, remains a question.

12.22: White Paper

The Chinese Pharmaceutical Market: Size, R&D, Regulations, Market Access and Innovations

Yajie Li, Vice President Technical, Parexel Regulatory and Access Consulting; Gary Cheng, Vice President, Health Advances; Eric Woo, Senior Analyst, Health Advances; Chao Wang, Scientific Data Strategy Leader, Parexel

As China has become the world’s second-largest economy and the largest developing country, its economy and market have assumed a prominent position in the Asia-Pacific region. The pharmaceutical industry is an important part of China’s national economy, with continuous strong demand, need, and capability for innovation. The industry continues to experience high levels of growth. With China’s increasing emphasis on the pharmaceutical industry, and the gradual improvement of healthcare policies, momentum supporting the development of China’s pharmaceutical market continues to accelerate.
Read here.

03.22: White Paper

An Overview of China’s Market Approval Policy and Medical Insurance Payment System for Rare Disease Drugs

According to the World Health Organization, there are around 5,000 – 8,000 rare diseases that have been recognized across the world. In China, rare diseases are recognized in the National Rare Diseases List. In May 2018, the National Health Commission of China published the List of Rare Diseases (First List), covering 121 indications that affect up to three million patients to provide a reference for the rare disease drug review. Since 2021, the compilation of the second list of rare diseases is also in progress under the guidance of the National Health Commission.
Read in English.
Read in Chinese.

Publications Archive
01.22: E-Book

Five Ways to Attract Early-Stage Investors

Biotech companies are a significant driver of innovation in drug development today, with a pipeline growing sharply in recent years. This growth provides hope for patients across many therapeutic indications. It also provides an avenue for future investment by financial institutions, industry partners, and investors. For the last two years, the financial market has supported biotechs with record-shattering funding.
Read here.

10.21: MedTech Strategist

Pediatric Device Showcase: Novonate's Lifebubble

By Andrew Millar, Shoumyo Majumdar, PhD, and Susan Posner

Novonate is a commercial-stage company dedicated to designing products that solve problems in neonatal care. The company is currently commercializing its first product, the LifeBubble, a novel device for the securement of umbilical cord catheters. Health Advances interviewed the co-founder and CEO of Novonate, Eric Chehab, PhD, to discuss the company’s progress to date and advice for pediatric device entrepreneurs.
Read here.

09.21: White Paper

Unlocking Potential Cures with CRISPR: Indication Selection And Portfolio Strategy For CRISPR-Based Gene Editing Companies

By Jeff Bessen, Yinzi Liu, Christie Hung, Ned Wydysh, and Vivek Mittal

CRISPR-based gene editing technology is differentiated from other modalities, even traditional gene therapies, unlocking potential cures for a range of indications but also presenting unique developmental challenges. Devising a portfolio strategy for CRISPR-based gene editing therapies requires considering the novel therapeutic potential but also the technical, clinical, and commercial complexities. In this white paper, Health Advances proposes a framework for indication selection and portfolio strategy for CRISPR-based gene editing companies based on a range of factors including unmet need, level of competition, and addressable market size.
Read here.

07.21: White Paper

Japan and China are outpacing Europe as Leading Biopharmaceutical Innovation Hubs

By Jeni Takasumi, Vivek Mittal, and Gary Cheng

The development and commercialization of novel biopharmaceutical products in recent years has continued to offer more safe and efficacious treatment options for patients across therapeutic areas. While a good proportion of the world’s transformative drug development and early commercial resources for novel therapies are focused in the United States, the level of drug innovation in the rest of the world has begun to shift. In the past decade, Japan and China have invested in regulatory reform and established policies to increase drug innovation within their respective countries.
Read here.

03.21: Journal of Personalized Medicine

A Quantitative Framework for Measuring Personalized Medicine Integration into US Healthcare Delivery Organizations

by Arushi Agarwal (Health Advances), Daryl Pritchard (Science Policy at Personalized Medicine Coalition), Laura Gullett (Health Advances), Kristen Garner Amanti (Health Advances), Gary Gustavsen (Health Advances).

Personalized medicine (PM) approaches have revolutionized healthcare delivery by offering new insights that enable healthcare providers to select the optimal treatment approach for their patients. However, despite the consensus that these approaches have significant value, implementation across the US is highly variable. In order to address barriers to widespread PM adoption, a comprehensive and methodical approach to assessing the current level of PM integration within a given organization and the broader healthcare system is needed. A quantitative framework encompassing a multifactorial approach to assessing PM adoption has been developed and used to generate a rating of PM integration in 153 organizations across the US. The results suggest significant heterogeneity in adoption levels but also some consistent themes in what defines a high-performing organization, including the sophistication of data collected, data sharing practices, and the level of internal funding committed to supporting PM initiatives. A longitudinal approach to data collection will be valuable to track continued progress and adapt to new challenges and barriers to PM adoption as they arise.

12.20: White Paper

Transforming the Regulatory Landscape for Digital Health Technologies in Drug Development

Julia A. Gaebler, PhD, Chelsea Pan, PhD, and John Latimer, in collaboration with Biogen Inc.

As tools that harness data to develop solutions for health applications, digital health technologies (DHTs) hold tremendous promise to transform the lives of patients and the management of diseases. This paper summarizes the value of DHTs in drug development and highlights the inherent challenges of the current regulatory paradigm in the US and Europe.
Read here.

09.20: The MedTech Strategist

Pediatric Device Showcase: Eclipse Regenesis

Andrew Millar, Juliana Perl, and Susan Posner

Eclipse Regenesis is developing a pediatric device for the restorative treatment of short bowel syndrome. In March 2020, the team was selected as the winner of the UCSF-Stanford Pediatric Device Consortium Accelerator competition. Health Advances interviewed two of the company founders to discuss the development of their mechanical solution and advice for pediatric entrepreneurs. Note, this content first appeared on The MedTech Strategist Community Blog.
Read the blog post here.

09.20: Future Medicine

Health economic impact of a biopsy-based cell cycle gene expression assay in localized prostate cancer

Gary Gustavsen, Kelsey Taylor, Doria Cole, Laura Gullet and Nicolas Lewine

Prior studies have established that broader incorporation of active surveillance, guided by additional prognostic tools, may mitigate the growing economic burden of localized prostate cancer in the USA. This study sought to further explore the potential of a particular gene expression-based prognostic tool to address this unmet need. Materials & methods: A deterministic, decision-analytic model was developed to estimate the economic impact of the Prolaris® test on a US commercial health plan. Results & conclusion: When adopted in patients classified by the American Urological Association as low or intermediate risk, the assay was projected to reduce costs by $1894 and $2129 per patient over 3 and 10 years, respectively, largely through the increased use of active surveillance.
Read the article here.
Read an interview with Gary Gustavsen, Partner at Health Advances, about the article.

05.20: :Journal of Vascular Surgery: Venous and Lymphatic Disorders

Correlation of Disease Comorbidity with Prescribed Treatment Among Insured U.S. Lymphedema Patients

Thomas F. O’Donnell, Jr., MD, Jessica Izhakoff (Health Advances), Julia A. Gaebler, PhD (Health Advances), Timothy Niecko, MS, Mark D. Iafrati, MD

The purpose of this study was to define the current forms of treatment in lymphedema patients with breast cancer (BCRL) and venous leg ulcers (PLEDU). Our analysis of a large administrative claims database showed clear differences in treatment between each group, suggesting lymphatic therapy may be undervalued for treatment of chronic venous swelling and prevention and treatment of PLEDU.

03.20: White Paper

Launch Costs—Spend Wisely: First-In-Class and Follow-On Launch Cost Analysis

By Wyatt Gotbetter, Dean Giovanniello, Mike Davitian, Alexandra Young, and Steven Chang

Successful launch planning requires appropriate financial and resource planning. Launching a drug is a high-stakes and high-cost endeavor that requires the coordination and execution of many cost-intensive activities across different functional areas over multiple years, pre- and post-launch. Efficient and effective launch planning is critical to ensure the long-term commercial success of a new product. Health Advances conducted an extensive launch cost analysis based on products launched between 2012-2017.

10.19: MedTech Strategist

How Medical Device Companies Can Play in Big Data and Remote Patient Monitoring

Paula Ness Speers and Greg Chittim

Orthopedics and other device companies are exploring the newly invigorated remote patient monitoring opportunity as a way to adapt to increasingly rigid CMS reimbursement. This gives them an important role in the fast-moving world of healthcare big data, but leaves other key components of that world like aggregation, analytics, and systemic perspectives up for grabs.

09.19: Journal of Vascular Surgery: Venous and Lymphatic Disorders

Lymphedema-Associated Comorbidities and Treatment Gap

Andrew Son, MD, Thomas F. O’Donnell Jr, MD, Jessica Izhakoff, BS (Health Advances), Julia A. Gaebler, PhD (Health Advances), Timothy Niecko, MS,and Mark A. Iafrati, MD

Lymphedema (LE) has been called the forgotten vascular disease, given such scant knowledge about LE-associated comorbidities or causes. Such knowledge of the comorbidities and treatment of LE may assist in diagnostic decisions and health care planning.

05.19: Medtech Strategist

3D Printing’s Future in Orthopedics: The Who, What When, Where, and Why

By Paula Ness Speers, Masha Dumanis, Brandon Wade and Matthew Barnes, Health Advances and Aenor Sawyer, MD

Growing experience with the use of 3D printing in orthopedics, plus declining cost differences between 3DP and traditionally manufactured implants, are enabling device manufacturers to expand the applications of 3DP in the musculoskeletal sector.

01.19: In Vivo

All Razor and No Blades: Is “Big Iron” Back in Vogue?

Mark Speers

There is a wave of capital-intensive medical device companies that are challenging conventional wisdom of the razor-razor blade business model. Health Advances Co-Founder and Managing Director, Mark Speers, captures key insights from panelists representing Varian Medical Systems, INSIGHTEC, RefleXion Medical, and CyberHeart at the 2018 Wilson Sonsini Goodrich & Rosati Medical Device Conference.

01.19: MedTech Strategist

The Challenge of Pediatric Device Development

Bridget Shaia and Andrew Millar

The pediatric patient population has been historically underserved, in part because designing and commercializing a pediatric device presents a host of unique issues. The Boston Children's Hospital Pediatric Device Strategic Partner Challenge was created to help develop novel pediatric device ideas, and Health Advances partnered with one of the winning teams of innovators to discuss their new heart valve device and the difficulties of pediatric device design and development.

Outcomes-Based Contracting: A Helping Hand for Cell and Gene Therapies

Amanda Sani, Divya Harjani, Tara Breton, Ned Wydysh, and Vivek Mittal

To anyone watching, the story of rising healthcare costs in the US is not a new one. Prescription drug prices in particular have made headlines in recent years, from outrage over the 56-fold increase of anti-malarial drug daraprim, to controversy over the steady rise in price of EpiPen packs used to quell life-threatening allergic reactions.

Launch Excellence: Once in a Life Cycle Opportunity

Mike Davitian, Haley Fitzpatrick, Grace Perkins, Tara Breton, Remy Denzler, and Dean Giovanniello

Launch planning is critical for the long-term commercial success of a drug product. Health Advances distills launch planning best practices learned from prior experience and illustrates the importance of those best practices with cases studies.

07.18: MedTech Strategist

Beware the Seductions of M&A

Mark Speers, Co-Founder and Managing Director

Co-Founder and Managing Director Mark Speers points out some of the potential missteps that device executives may not consider when caught up in the excitement of the M&A path.

07.18: Journal of Medical Economics

US budget impact of increased payer adoption of the Flexitouch advanced pneumatic compression device in lymphedema patients with advanced chronic venous insufficiency and multiple infections

Adam Cohen, Engagement Manager, Health Advances; Julia A. Gaebler, Partner, Health Advances; Jessica Izhakoff, Consultant, Health Advances; Laura Gullett, Senior Analyst, Health Advances; Timothy Niecko, MS, Niecko Health Economics, LLC and Thomas O’Donnell, MD, Tactile Medical

To assess the budget impact to a US commercial health plan of providing access to the Flexitouch (FLX) advanced pneumatic compression device (Tactile Medical) to lymphedema (LE) patients with either comorbid chronic venous insufficiency (CVI) or frequent infections.

06.18: Journal of Vascular Surgery

Health and Economic Benefits of Advanced Pneumatic Compression Devices in Patients with Phlebolymphedema

Michelle Lerman, Engagement Manager, Health Advances; Julia A. Gaebler, PhD, Partner, Health Advances; Sunday Hoy, Esq, Tactile Medical; Jessica Izhakoff, Senior Analyst, Health Advances; Laura Gullett, Senior Analyst, Health Advances, Timothy Niecko, MS, Niecko Health Economics, LLC; Pinar Karaca-Mandic, PhD, University of Minnesota, Carlson School of Management; Thomas O’Donnell, MD, Tactile Medical; and Stanley G. Rockson, MD Falk Cardiovascular Research Center, Stanford.

Phlebolymphedema (chronic venous insufficiency-related lymphedema) is a common and costly condition. Nevertheless, there is a dearth of evidence comparing phlebolymphedema therapeutic interventions. This study sought to examine the medical resource utilization and phlebolymphedema-related cost associated with Flexitouch (FLX; Tactile Medical, Minneapolis, Minn) advanced pneumatic compression devices (APCDs) relative to conservative therapy (CONS) alone, simple pneumatic compression devices (SPCDs), and other APCDs in a representative U.S. population of phlebolymphedema patients.

02.18: Biosimilar Development

Beyond Pricing: Can Biosimilars Compete On Value?

By Brendan Loftus, Wyatt Gotbetter, and Julia A. Gaebler

In recent years, the growth in U.S. drug spending has become a hot-button issue. Data released in 2017 by the pharmacy benefit manager (PBM) Express Scripts illustrates which drugs account for the increased spending. In 2016, spend on so-called specialty drugs, a class that contains many biologics, grew by over 13 percent, while spend on traditional drugs actually declined by 1 percent. Five of the top 10 earning drug therapies in the U.S. in 2016 were biologics.

Looking Forward: Catalysts for Change in CAR-T

Zach Donnell, Divya Harjani, Amanda Sani, Ned Wydysh, and Vivek Mittal

CAR-T cell therapy is currently one of the most exciting areas of clinical research. To create these living therapies, human T cells are genetically modified to express a CAR (chimeric antigen receptor) that has been programmed to target specific antigens found on the surface of cancer cells.

Orphan Drug Pricing in Europe

Kelly Cockerill, Andrew Funderburk, Sheela Hegde and Julia Gaebler

While orphan drugs offer novel treatments for patients who previously had no options, the high price points they often command have resulted in restricted access by many European Health Technology Assessment (HTA) systems and intense discussions about how to determine their value. Against this backdrop, manufacturers are eager to understand how to value their innovation and collect sufficient evidence to support a price that appropriately reflects the improvement in clinical outcomes versus the standard of care. The white paper indicates that patient prevalence is highly correlated with orphan drug pricing in Europe, highlighting the importance of budget impact to payer decision-making.

Leveraging FDA’S Accelerated Pathways for Market Advantage

Andrew Funderburk, Partner, Sheela Hegde, Partner

Over the past 15 years, the FDA and Congress developed several accelerated pathways to provide incentives for manufacturers to develop innovative new drugs to treat conditions with substantial unmet need. The objective of this white paper is to describe recent trends in the use of the FDA’s accelerated pathways and to examine the market advantage associated with these pathways, particularly in oncology.

03.16: Value in Health Journal

A Multidimensional Analysis of Prostate Surgery Costs in the United States: Robotic-Assisted versus Retropubic Radical Prostatectomy

Mike Davitian, Associate; Holly May, Consultant; and Mark Speers, Partner

Intuitive Surgical’s da Vinci® surgical robot has often been accused of adding unnecessary costs to the healthcare system. The Company enlisted Health Advances to perform a rigorous and comprehensive study of the robot’s long-term economic impact to hospitals, payers and society when deployed to perform radical prostatectomies for prostate cancer patients. The resulting study, “A Multidimensional Analysis of Prostate Surgery Costs in the United States: Robotic-Assisted versus Retropubic Radical Prostatectomy,” was written in collaboration with leading researchers and clinicians at Mount Sinai Hospital in NYC and has been published in the well-respected Value in Health Journal. The study estimates that, when factoring in all the costs of a surgery, the robot usually saves hospitals money. In addition, payers and society benefit from treating fewer downstream complications and less lost days of employment.

08.15: MedTech Strategist

Market Outlook: Simple Infusers: Unlocking the Potential of Insulin in Type 2 Diabetes

Marie Schiller, Arushi Agarwal, and Sheela Hegde

Simple insulin infusers are emerging as an important new tool to help people with type 2 diabetes gain better control of their disease. Although only one simple infuser product has been approved in the US to date, more are on the way and interest among physicians and payors is on the rise—all of which suggests a budding new market opportunity in the years ahead. Also Included: CeQur: Overcoming Barriers with PaQ Simple Insulin Infuser.

Big Bets on Value-Based Care

Bruno Nardone, MHSA, FACHE

Value-Based Care (VBC) initiatives are capturing a lot of attention, and in some cases capturing scarce IT budget allocations, as health industry stakeholders prepare for what some believe is an inevitable shift in the way care will be financed and delivered. For Health Information Technology (HIT) vendors, this shift presents a double-edged sword of both new opportunity and risk.

Type 1 Diabetes Prevention Landscape: A Guide for Navigating Emerging Opportunities

Health Advances

The T1D prevention landscape evaluation validated that numerous efforts to date have resulted in many important advances that will set the stage for future progress. Over 25 observational and intervention studies have been completed or are ongoing across primary and secondary prevention, with the majority of these in secondary prevention.

09.14: American Journal of Managed Care

Economic Study Published for Novel Breast Cancer Test

Gary Gustavsen, Vice President and Patrick Kennedy, Consultant

Health Advances published the results of its system economic analysis of bioTheranostics’ Breast Cancer Index, a second-generation gene expression test that predicts risk of breast cancer recurrence and likelihood of benefit from extended endocrine therapy. The study showed that the test has the ability to lower costs for third-party payers which will be an important consideration as they seek to establish medical policy surrounding the test.

The Rising Importance of Quantifying the Value of Health IT

Bruno Nardone, Vice President and Andrew Matzkin, Manager

Selling health IT (HIT) solutions to hospitals and other healthcare providers has never been easy. HIT companies have always faced long, arduous sales cycles and the very real risk that growth will never extend beyond a few early adopters to the broader market.

03.14: IN VIVO

Established Orphan Disease Markets: Innovators Wanted

Soren Peterson, PhD, Senior Analyst; Michelle Lerman, Senior Analyst; Vivek Mittal, PhD, Partner

As traditional specialty drug markets have become increasingly crowded, large pharmaceutical companies and biotech companies alike have successfully turned previously ignored rare diseases into a robust business model. Are these first-mover products protected from competition by virtue of being in orphan markets? Here, we argue that meaningful product differentiation is required for new drugs to enjoy rapid clinical development and commercial success traditionally associated with orphan markets.

06.13: Personalized Medicine Journal

Combating Complexity: Partnerships in Personalized Medicine

Kristin Pothier, Partner and Gary Gustavsen, Manager

The increasing complexity of the personalized medicine field necessitates an entirely new roadmap to success in the sector. The article provides a resonating agenda to innovators who realize that strong partnerships are absolutely vital to a future in personalized medicine as well as a truthful forecast for companies that do not.

05.13: Age of Personalized Medicine

Balancing the Need for Guidance, Communications, and Education to Support Personalized Medicine Diagnostics

Kristin Pothier, Partner

Kristin Pothier, Partner at Health Advances and contributing writer for the Age of Personalized Medicine, broke down her recent panel at the PMC/BIO Solutions Summit, “Evidentiary Standards and Data Requirements for Payer Coverage”. Kristin explains the frustrations around data requirements for coverage and voices the opinions of her respected panelists on key issues and most importantly, solutions.

04.13: InVivo Magazine

Matchmaking and Integration In The New World of Diagnostics M&Ao

Soren Peterson, PhD, Senior Analyst; Vivek Mittal, PhD, Vice President; Kristin Pothier, Partner

Nontraditional molecular diagnostic buyers, including pharmaceutical companies, life science tool companies, and diversified conglomerates, are driving molecular diagnostics M&A. The needs of these buyers dictate the assets targeted, premium paid and integration strategy pursued.

03.13: Science Translational Medicine

Breaking a Vicious Cycle: Commentary on Tumor-Marker Diagnostics

Gary Gustavsen, Manager

This article explores the root causes of the vicious cycle leading to the pronounced undervaluation of tumor-biomarker tests, and the resulting failure to become standard clinical practice. A roadmap to break the cycle is described, recommending changes in processes across the board to stakeholders nationwide.

12.12: InVivo Magazine

Molecular Diagnostics M&A: Dormant But Not Done

Vivek Mittal, PhD,, Vice President, Soren Peterson, Senior Analyst, and Kristin Pothier, Partner

The current crop of molecular diagnostics acquisitions – especially those made by nontraditional buyers – must mature prior to the commencement of additional M&A activity. Historical data suggest this could occur starting in the 2014-2015 timeframe. Health Advances provides a contrarian view to the negative press surrounding Molecular Diagnostics M&A, and suggests a new window of opportunity could open in the near future.

09.12: InVivo Magazine

Commercialization Alternatives in the New Medtech World

Susan Posner, Vice President and Mark Speers, Partner and Managing Director

Health Advances outlines commercialization options for emerging medtech companies and the potential valuation and exit implications. Susan Posner, Vice President and Mark Speers, Partner and Managing Director, describe challenges that are emerging in the current industry climate that make early sales and commercialization decisions a critical component of a company’s overall strategy. Ultimately the strategy will not only drive sales and revenue but have a direct impact on exit valuations.

11.11: InVivo Magazine

Next Generation Combination Therapy in Oncology

Contributing Authors: Aidan Finley, Consultant; Vivek Mittal, PhD, Manager

Traditional cancer development in the 1970s and 1980s focused on individual druggable targets and combinations were developed empirically post-approval. In the new age of molecular medicine, this incremental empiricism is no longer acceptable to patients, physicians, and payers. Drug developers need to seize upon the FDA's combination therapy guidance to accelerate the development of rational combinations.

02.11: InVivo Magazine

Oral Molecules in an Injectable World: What Developers Need to Do Now

Contributing Authors: Andrew Funderburk, Vice President; Kimberly Howland, Vice President; Kate McLaughlin, Consultant

Therapeutic areas currently dominated by injectable or infused therapeutics are beginning to see competition from oral therapies intent on taking market share because of their perceived delivery advantages. However, the head starts enjoyed by injectables in these markets – and the physician, payer, and patient familiarity they create – translate into higher efficacy and safety hurdles for oral therapies. Oral delivery is not without downsides – including poorer compliance and reimbursement challenges in specialty markets dominated by injectable competitors. Companies willing to face these issues head-on and engage constituents early about the drawbacks and advantages of their new oral agents can fully realize the value of their therapies.

The Reimbursement Landscape for Novel Diagnostics: Current Limitations, Real-World Impact, and Proposed Solutions

Contributing Authors: Kristin Pothier, Partner; Gary Gustavsen, Associate; Kerry Philips, Senior Analyst with support from BIO

Personalized medicine has the potential to revolutionize patient care. The fundamental goal in advancing our healthcare system through personalized medicine is to deliver the right treatment to the right patient at the right time. Novel diagnostics hold great promise as tools that allow physicians to differentiate patient-specific characteristics, design personalized treatment approaches, and ultimately improve patient outcomes. The successful delivery of novel diagnostics is the foundation of personalized medicine in our evolving healthcare system.

11.10: InVivo Magazine

Continuous Glucose Monitoring: A Case Study for Commercializing Products in the Era of Patient-Driven Health Care

Contributing Authors: Marie Schiller, Partner, Sheela Hegde, Vice President, and Brittany Carroll, Associate

While continuous glucose monitoring offers significant value to a broad range of patients, the technology has still not fulfilled its market potential. Many hurdles to adoption still exist including product accuracy issues, ease-of-use hurdles, and insufficient payer coverage. However, for patients who have successfully built CGM into their therapeutic plan, the results have been impressive. So why is a technology that can have such a meaningful impact on some individuals gaining traction so slowly?

09.10: Point-of-Care Journal

Has Point-of-Care Come of Age?

Contributing Authors: Health Advances: Kristin Pothier, Vice President and Sonia Gupta, Former Consultant LipoScience: Mark Kirtland, Vice President of Strategy and Business Development

The prospect of point-of-care (POC) testing, enabling near immediate diagnosis and subsequent treatment, has been alluring to clinicians for years. Science and technological progression, evidence based clinical and economic drivers for POC use, and the current health care system's demand for streamlined options suggest that POC products should be instrumental in today's diagnostic paradigm. Nevertheless, relatively few POC tests have attained commercial success. The article reviews the current barriers to the use of POC, the emerging success factors, and the evolving future of this space.

04.10: Future Medicine Journal

Advocacy in Personalized Medicine: A Developing Strength in a Complex Space

Contributing Authors: Health Advances: Kristin Pothier, Vice President and Michael Dunn, Senior Analyst bioMérieux: Iain Miller, Senior Director, Oncology Strategy and Theranostics Business Unit

Multiple stakeholders play a role in the adoption of personalized medicine, including payers, patients, policy makers, diagnostic manufacturers and providers, and clinicians. These stakeholders span multiple positions, institutions and points of view, and are interested in making sure that each diagnostic launch covers a particular, sometimes contradictory, market need. A growing number of advocacy groups have emerged to unify these stakeholders in this increasingly complex marketplace. This article identifies examples of these advocacy efforts in personalized medicine today. It discusses how far these groups have been able to go, what they are currently pursuing, and how they and others can continue to work to move personalized medicine from concept to reality.

03.10: IVD Technology Magazine

Manufacturing Obstacles in IVD Product Development — Perspectives from Health Advances and KMC Systems Inc. (an Elbit Systems of America company)

Contributing Authors: Health Advances: Donna Hochberg, Ph.D., Manager KMC Systems: Walter Gilde, Business Development Manager

With the IVD market changing rapidly, the pressure to deliver new products to market less expensively and more efficiently is mounting. The changes in the IVD industry are being driven by increased laboratory test volumes and growing pressure to lower turnaround times (TAT) with fewer skilled lab technicians. Any new product launch must be able to address this demanding environment. Such sweeping demands in the industry are accelerating the development of three specific areas of advancement: point-of-care (POC) technologies, automation, and graphical user interfaces. To reduce costs and shorten product development cycles, some OEMs and start-up companies have been turning to contract instrument developers and manufacturers for their guidance and relevant experience to overcome common development challenges. This article will examine these trends, outline common obstacles associated with them, and discuss how working with contract partners can overcome product development challenges by showing examples of instruments that were introduced to the market with the help of a contract partner. Also available is an audio discussion with Donna Hochberg and Walter Gilde.

01.10: Medical Device & Diagnostic Industry Magazine

Medical Devices Deserve More Respect

By Mark Speers, Partner and Managing Director, Susan A. Posner, Vice President, and Jennifer Kim Cutie, MD, Professional Development Manager

Should devices be considered earlier in the treatment paradigm? Devices are often reserved for patients who have already failed multiple drug therapies, but in some cases, devices may ultimately provide better long-term outcomes more cost-effectively than drugs. In order to pursue these opportunities, manufacturers must effectively develop technologies that can surmount traditional therapeutic hurdles, including physician perceptions of drugs and devices and the short-term payer outlook. Health Advances Medtech Practice Group shares their insights on the potential paradigm shift that would move devices to an earlier position in the treatment pathway, potentially expanding the market opportunity for devices and the medtech industry.

Maintaining Attractive Biopharma Returns in the Face of Healthcare Reform

Contributing Authors: Health Advances: Marie Schiller, Sheela Hegde, Kerry Phillips, and Urvesh Shelat Cowen Healthcare Royalty Partners: Greg Brown M.D., Paul Hadden, and Wendy Liu

Healthcare reform is the Obama Administration’s top domestic priority. Although the Administration’s original goal was to have a reform bill passed in October, it now appears that a final vote will not take place before December. The rigorous debates have focused on three key components: access to care, cost of care, and value of care in the US healthcare system.

09.09: Medtech Insight

Value Proposition is Key to New Product Success in a Cost-Conscious Medtech Market

By Susan A. Posner, Jennifer Kim Cutie, MD, and Anna Chen

Management teams are well aware of the need to demonstrate compelling economic data, but can a product still be successful without an economic benefit in the increasingly cost-conscious health care marketplace? Overcoming negative economics requires a combination of positive attributes; many compelling advantages like clinical or safety benefits are well-known, but other key attributes may be overlooked. Recognizing all of these potential advantages is crucial for appropriate planning to compile relevant data and position the product accordingly, thereby optimizing product success. Health Advances Medtech Group shares its thoughts and observations on current products that have overcome negative economics, highlighting the keys to their success and lessons learned for emerging products.

03.09: InVivo Magazine

How to Earn the Economic Payback Diagnostics Companies Deserve

By Gary Gustavsen and Kristin Pothier

For most diagnostics companies, the prospect of premium pricing has been an evasive dream. The health care landscape is peppered with expensive novel drugs priced to underscore their clinical impact on patient care. A similar strategy for pricing novel diagnostics with significant clinical impact makes sense, especially since many of them are driving the decisions to deploy novel drugs in the first place. But logic has only recently translated into reality for most novel diagnostics. The existence of an antiquated CPT code system which bases reimbursement for diagnostics largely upon the cost of their underlying laboratory procedures, rather than on their benefit, made for a slow start. In addition, many diagnostic companies did not fund studies to document their products' ability to affect clinical outcomes. However, strong system economics arguments are becoming more mainstream and payers are beginning to reward companies with reimbursement of their premium priced tests. Rewards are based upon rigorous clinical arguments supporting the diagnostics' benefits to clinical decision-making and compelling economic arguments customized to each major payer. Identifying and documenting these arguments for each product is the key to attaining sustainable premium pricing in diagnostics.

12.08: Start-Up Magazine

Will Simpler Devices Tap the Largest Diabetes Market?

By Marie Schiller, Andrew Funderburk, Sheela Hegde, and Kathryn Strayer-Benton

Historically, technological advances to the insulin pump market have concentrated on slow but steady improvements to the pump's functionality, size and design. What the market hasn't yet experienced are dramatic improvements that would embrace the needs of both type 1 and type 2 diabetes patients while keeping costs low. This may be changing as companies expand their focus on developing simpler, lower cost insulin pumps that will benefit a broad spectrum of diabetes patients and providers. Health Advances Diabetes Practice Group shares its thoughts on the push to move insulin pump therapy into the larger type 2 diabetes population and some of the hurdles that will need to be overcome.

09.08: MDDI Magazine

Taking the High Road: Building the Right Foundation for a Medtech Product Launch

By Mark Speers, Managing Director and Partner, and Susan Posner, Vice President; Health Advances

Many companies launch products onto the medtech market concurrent with their initial FDA approvals in an effort to realize revenue as soon as possible. Delaying a market launch may seem counterintuitive, however having the fortitude to delay revenue may lead to far greater returns. Executives must be careful to differentiate between their regulatory and commercialization strategies. Each device company should carefully consider whether it has amassed the critical clinical and/or economic data necessary to catalyze purchase decisions by physicians and payers before launching. The article describes an analytic approach to optimizing the commercialization plan including launch timing.

01.08: InVivo Magazine

Biomarker Diagnostics: Place Your Bets Wisely

By Kristin Pothier and Donna Hochberg

Biomarker diagnostics are critical to achieving the promise of personalized medicine. Unfortunately, building a successful business around such tests is difficult, given the complexities associated with both their development and commercialization. Many biomarkers present the risks of drug development and only the profitability of devices. Therefore, molecular diagnostic companies need to think carefully before they choose a "go it alone" strategy. It may make far more sense to forge a partnership with another diagnostic company or a drug developer with the goal of sharing costs, risks and profits.