Bridging of Technologies: Union of Pharmaceutical and Medical Device Industries Brings Opportunities
Pharmaceutical and medical device companies are finding innovative means to deliver multifunctional healthcare products through converging technologies.
On the Front Lines | Medical Device Advancements
If there is such a thing as a positive outcome of war, it is the advancement of medicine and medical devices. Historically, we have learned much in the areas of surgery, trauma, orthopedics, and wound management as a result of wars. That trend continues as the wars in the Persian Gulf, Afghanistan, and Iraq bring advancements in orthopedics, trauma transport and surgery, wound management, prosthetics and surgical instrumentation.
Blind Faith | Artificial Corneas Bring Hope to Millions with Vision Impairments
Blindness is perhaps the most debilitating of handicaps, affecting more than 10 million people worldwide. Corneal transplants can help some patients, but donor corneas are in short supply, forcing many patients to wait more than 20 years. Last year, several independent research groups released exciting new polymers that will allow patients to regain their eyesight after years of frustration and waiting.
Detecting MRSA | Newly Developed Rapid Diagnostics Help Stop the Spread of Disease
BD Diagnostics’ GeneOhm StaphSR, a rapid blood test for detecting methicillin-resistant Staphylococcus aureus (MRSA), is the latest diagnostic assay designed to detect the often deadly pathogen. Several other companies have assays and test kits to detect MRSA, but from nasal passages or skin sites, not blood cultures. Rapid diagnostics are expected to gain additional momentum due to heightened attention on bioterrorism, food safety, and hospital-acquired infections.
A Closer Look | Study of Laser Eye Surgery's Psychological Effects Could Impact the Industry
The proliferation of medical laser technology is bringing new scrutiny, particularly in eye surgery. Patients are reporting complications involving chronic eye dryness, visual distortions, and chronic pain. In some cases, post-surgery depression has led to suicide.
Bionic Eyes | Retinal Implants, Still in their Infancy, Provide a New Vision of the Future
Virtual Autopsy | CT Scans Can Overcome Cost and Culture Hurdles for Forensic Science
Imagine on an episode of CSI where instead of a human body being sliced up with a scalpel and saw, the cadaver is wheeled into a machine that produces a three-dimensional image of its interior for the medical personnel to view. While the scene might not offer quite the visual drama, the scenario is neither science fiction nor the fantasy of some television script writer. In fact, it is the idea behind the virtual autopsy.
Multi-Billion-Dollar Opportunity | Disc Replacements Will Soon Surpass Fusions as Surgical Soution
For years, patients’ only option to relieve chronic, debilitating lower back pain was spinal fusion. However, in the past 10 years, orthopedic manufacturers have introduced a broad range of artificial disc replacements that promise to eliminate pain and restore motion. Even so, opportunities are there for innovative companies to apply new materials and technologies to an expanding market.
Think Negative | Wound Therapy Could Save Billions in Healthcare Costs
Treating the more than 2.8 million patients with chronic wounds costs billions of dollars per year, just in the United States, posing a continual challenge in medicine. One approach, negative pressure wound therapy, presents the medical device industry with an opportunity to meet that challenge.
Keys to Offshore Outsourcing | Medical Device Makers Starting to Look for Overseas Partners
Like companies across many industries, medical device manufacturers are increasingly turning to international partnerships to find ways to exploit the efficiencies that outsourcing offers. These companies are finding that successful and efficient outsourcing allows them to allocate internal resources to projects more strategically and prioritize tasks in their product pipelines.
Clothing + Sensors = Opportunity | Device Makers Should Look to Alliances for Next-Generation Personal Monitors
With consumers getting ever more involved with their own health, a new market is emerging in the patient monitoring industry. Not content to sit in a doctor’s office awaiting test results—or having to return weeks later to hear the outcome—people want immediate results with little inconvenience. Innovative biomedical companies are developing sensors so minute that they can be sewn into clothing wearable patient monitoring, if you will.
The Skinny on Stem Cells | Successful Human Cloning Stirs Hope and Controversy
When scientists at a small private company successfully cloned human embryonic stem cells, hopes rose for cures to such diseases as Alzheimer’s, Parkinson’s, and Muscular Dystrophy, and for repairing spinal cord injuries. It also amplified ethical, moral and religious arguments against cloning. Yet, there are currently millions of people who could benefit from either direct implantation of autologous stem cells or from the spin-off discoveries of stem cell research. Therefore, I say let’s move forward.
Give the Dog a Shot | Vaccination Changes Bring New Opportunities for Drug Makers and Veterinarians
Until recently, veterinarians and owners commonly administered vaccines to all companion dogs annually for several infectious diseases. In 2005, however, the American Animal Hospital Association’s Canine Vaccine Task Force agreed on a new vaccine protocol based on scientific evidence suggesting that annual vaccinations are unnecessary. What would the financial impact be on veterinarians and vaccine manufacturers? An examination of patent literature since 2006 offers some insight into how pharmaceutical companies have shifted their focus.
The Importance of Article Selection for Meeting the MedDev 2.7.1 Rev 3 Requirements
This article focuses on the selection of appropriate articles for a successful clinical literature evaluation.
Nerac Intellectual Property Analyst Scott Lloyd Published in MX Magazine
In the January/February 2008 issue, Scott Lloyd writes about how medical device companies considering take-overs can set valuations for intellectual property. Click here to read the article.
Ron Sills chairs the combination products track at MDM West 2008. He also presented the session:"Combining Market Intelligence with Technology: Critical Considerations for Entering the Profitable Space of Combination Products"
Nerac Analyst Ron Sills participated in the Medical Design and Manufacturing (MD&M) West conference and trade show, January 28-31, 2008 at the Anaheim Convention Center, Anaheim, CA.
Wednesday, January 30, Nerac Analyst Ron Sills chaired track #304: “Combination Products: Strategic Partnering and Licensing.”
Mr. Sills’ presentation titled: “Combining Market Intelligence with Technology: Critical Considerations for Entering the Profitable Space of Combination Products” conveyed valuable insight on FDA class codes and time-to-market issues, product trends and promising opportunities.
Scott Lloyd speaks at MDM West 2008 Conference & Expo
Scott Lloyd participated in the Medical Design and Manufacturing (MD&M) West conference and trade show, January 28-31, 2008 at the Anaheim Convention Center, Anaheim, CA.
Mr. Lloyd presented: “Growth Through Valuation and Acquisition of Intellectual Property in the Medical Device Industry, ” taking a closer look at recent Medical Device industry transactions to illustrate this concept.
Deb Schenberger presents at 3rd Annual Frontiers in Biomedical Devices Conference, June 2008
3rd Annual Frontiers in Biomedical Devices Conference
June 18-20, 2008
Irvine, CA
Deb Schenberger presented “Electrical Stimulation of Spinal Fusion”
Growth Through Valuation and Acquisition of Intellectual Property in the Medical Device Industry
Accelerated Growth in Wound Care
The Power of Meta-Analysis | How Smart Companies Are Using A Statistical Methodology to Drive Breakthroughs
Nerac white paper examines how companies can use systematic, quantitative reviews to gain market share and promote innovative new products.
Clinical Literature Reviews | Changes in EU Medical Device Directive Require Immediate Steps
Nerac white paper urges medical device manufacturers to take immediate steps to deal with changes that could affect their access to the EU market.
Fusion Trends & Opportunities | Medical Devices and Communications
This Nerac analyst report discusses the future of remote patient monitoring and its potential in the medical device industry.
Obtaining CE Mark Certification using Clinical Literature Reviews
The European Market for Medical Devices is estimated at over $86 billion, with expected annual growth of at least 5% over the next several years. In order for medical devices to be approved for sale in the European Union member countries they must be certified with a CE mark, which indicates conformity to the Medical Device Directive 93/42/EEC and other applicable industry standards.
A new revision of the directive, MedDev 2.7.1 Rev 3, “Clinical Evaluation: A Guide for Manufacturers and Notified Bodies” was released in December 2009, and supplements the original requirements by offering specific requirements and guidelines for medical device manufacturers to demonstrate the safety and efficacy of devices through a review and analysis of clinical performance data.
It is imperative for medical device manufacturers to achieve and maintain compliance with this guideline as part of the CE Mark certification process. At stake is maintaining or increasing share in the growing $86 billion European market that accounts for a significant percentage of most U.S. medical device manufacturers profits.
This white paper examines the use of clinical literature data as an acceptable and practical alternative to clinical trials, not only for new product introductions, but also for previously CE-marked devices which have been on the market for several years.
Ablynx Competitive Intelligence Overview
This example of a Nerac Research and Advisory "Special Project" Services request is an overview of competitive intelligence on Ablynx NV, a biopharmaceutical company based in Belgium. It includes information to provide a first-pass evaluation of Ablynx as a possible business partner or acquisition target.
Market Overview: Orthopedic Implant Players and Products
This overview of the orthopedic implant coating technology market is an example of a Nerac Expert Research Request report.
Market Assessment: Orthopedic Implants
This assessment of the orthopedic implant market is an example of a Nerac Research and Advisory Services request report.
Ablynx Competitive Intelligence Assessment
This report is an example of a Nerac Research and Advisory "Special Project" Services request. The report consists of a detailed compilation of competitive intelligence on Ablynx NV, a biopharmaceutical company based in Belgium. It includes a broad range of information, with Nerac analysis, that may be used to evaluate Ablynx as a possible drug development partner. It is designed to provide the framework for eventual due diligence.
Markush Claim and Substructure Research
This is an example of a Research and Advisory Services patent investigation for Markush claims.
Our chemistry analysts are well-versed in researching chemical structures and substructures that exist in the technical and patent literature, including
the Markush claims. Using such search tools as the CAS RegistrySM and MARPAT™ databases in STN™, Nerac analysts are able to research worldwide publications including over 60 international patent authorities for publications that incorporate chemical structures.
Recent Developments in Biomarkers for Type II Diabetes
This report is an example of an expert research request for research into scientific literature and US patents over the last year (2011) on biomarkers for T2D. The report will enable the client to learn about recent prior art that may interfere with his invention.
Post Market Surveillance for Dental Panoramic X-ray
Competitive Intelligence Briefing | Competitor Watch
Nerac's Competitive Intelligence Briefings are designed to help you keep a watchful eye on competitive activities, emerging technologies, key market indicators and trends. Nerac analysts draw upon a wide variety of expert resources to track relevant news, newly published patents and technical journal literature. This information, along with an analyst overview on topics of key interest, is delivered on a timeline customized to your needs.
Technology Scouting Research Report
Technology Scouting is a critical activity in an open innovation paradigm to discover key innovations. It involves searching for, identifying, and evaluating potentially relevant and interesting technologies and/or inventors.
Nerac can provide an independent third-party view into new technology areas and supplement internal resources with critical adjacency/non-core expertise via a specialized analyst review of the data. Customizable and flexible deliverables for both large and small engagements make our service uniquely valuable.
Download our free Technology Scouting Research Report sample on "Thermal Management Technologies" below, and contact us to discuss how this service can benefit you and your Tech Scouting teams!
Brazil Medical Device Market and Reimbursement Overview
This sample report is an example of a market overview of the medical device market and reimbursement situation in Brazil. It examines the public healthcare system, overall insurance usage, and complex surgical procedure rates in the country. Access the free report by clicking the download icon below.
What is Your Intellectual Property Worth?
We invite you to listen to the first of a three-part series of podcasts produced in collaboration with Knowledge@Wharton that examines how companies can determine the value of patent portfolios prior to acquisitions. Nerac intellectual property analyst and registered patent attorney Scott Lloyd and David Hsu, a management professor at the Wharton School of the University of Pennsylvania, discuss the variables involved with valuing intellectual property in general and medical device patents in particular.
For more information about Knowledge@Wharton, visit knowledge.wharton.upenn.edu
Developing and Marketing Your Combination Product
Innovators and Analysts from Nerac, Thomas Medical and Pervasis share insights on the market for combining therapeutics, biologics or medical devices, which is expected to reach over $9.5 billion in revenue by 2009. Bringing a novel combination product to market can be particularly complex for partners who co-exist in opposite worlds of development.
Adding Combination Therapies to Drug Pipelines
This podcast examines how combination therapies are taking on considerable importance as pharmaceutical companies adjust their development pipelines. Featuring author and futurist Jonathan Peck and Nerac Life Sciences Analyst Irene Zajac, the podcast is based on the idea that small molecule blockbuster drugs an endangered species threatened by patent expirations, generic corrosion and biotech drugs. As a result, big pharma is integrating with biotech under one roof, forming what can be called the bio-pharma industry. Along with this industry transition, new modes of therapy are being developed and conceived that are thought to be the future of the drug industry. Of these, combination therapies appear likely to compete with, if not replace, blockbusters as revenue-producing products. Mr. Peck brings 25 years of experience consulting with pharmaceutical and biotech companies. He has authored many articles and books, including Regulating Change: The Regulation of Foods, Drugs, Medical Devices and Cosmetics in the 1990s. Ms. Zajac, who recently co-authored a Nerac white paper titled, “New Perspectives on the Future of Drug Discovery,” has more than 25 years of research experience as a scientist at the NIEHS, Glaxo, and Pfizer. Together, they look at several key areas regarding combination therapies:
- Combinations have the potential to play a central role in the pharmaceutical industry’s future by bringing together two or more medications or devices in combination to treat a single disease or a group of associated disorders.
- Combination therapies are more likely to be developed for disease prevention than for treatment.
- The FDA, through its new Sentinel System, will require new relationships between government and private entities in reporting the adverse events.
- New business models must be created to handle the multiple products necessary to personalize medicine. Diagnostics are certain to be a part of the combinations.
- As the technology behind combination therapeutics matures and business models evolve, the future for this approach to medicine is promising.
- This podcast is no longer available but for more information on the topic, please contact Ms. Zajac directly at izajac@nerac.com.
