Life Sciences
Managing a Global Online Presence in Medical Device Companies
This week’s webinar, hosted by Lionbridge Life Sciences, brought together global marketing and strategy leaders in medical device and diagnostics companies to learn the results of our recent survey on managing a global online presence in an increasingly interconnected world.
Webinar speakers included Kristina Isakovich, Founder and CEO of Strategic Choices and most recently Chief Marketing and Strategy Officer for Philips Healthcare, and Ray Goforth, Global Digital Strategy Manager for St. Jude Medical. I had the pleasure of moderating the webinar on a topic that weighs heavy on the minds of healthcare marketers working in tightly regulated industries. Continue reading »
Caveat Emptor in Clinical Trial Translations
I was recently summoned to a client’s headquarters for what I was told was a “serious issue.” When I arrived, I was met by two Study Leaders, a Senior Project Manager and the Head of Procurement—a distinguished audience by any measure. Straight away, I was informed that a validated instrument had been translated by our team, and it was grossly inaccurate. Needless to say, I was at a loss as to how this disaster happened, given our ISO certifications, rigorous quality methodologies and SOPs. But then, something clicked in my head and I realized that, although we did quote for this project, it was not awarded to Lionbridge Life Sciences.
Buyer Beware
It turned out that another language translation provider had executed the project. Given that validated instruments were not a regular part of the provider’s discipline, they had failed to perform any sort of Cognitive Debriefing or Pilot Testing. Moreover, it appeared they had used less-than-optimal translators for the project. Continue reading »
Global Clinical Trials: Partnering Paradigms to Meet Global Demands
The three-day Partnerships in Clinical Trials conference in Orlando brought together senior-level clinical decision makers focused on innovation in the clinical trial process. There were presentations given by more than 80 respected pharmaceutical, biotech and medical device industry experts, where attendees heard their take on the future of clinical trials.
I had the opportunity to attend the Patient Centered Clinical Trials summit, which provided insight into the importance of a patient-centric approach to clinical trials. Topics covered included trial design (pediatric case study), recruitment/retention, informed consent, analytics, patient organization partnerships, managed care patient access programs, and patient data collection (ePRO). Continue reading »
The Global Medical Device Market: West to East
On April 10, 2013, I had the honor of moderating my 20th Life Sciences Business Roundtable in Singapore. This Asian trip was my first visit to this beautiful country and provided a great opportunity to meet with peers from the APAC life sciences localization industry.
During my taxi ride to the hotel, I learned from the very talkative Singaporean taxi-driver that this southeast Asian island city-state has four official languages: Chinese Mandarin, Tamil, Malay and English. According to Pacific Bridge Medical, the medical device market in Singapore reached $535 million in 2012, and there is a strong demand for better healthcare. This creates a thriving market for Western medical device companies. US, Germany and Japan today supply more than 85% of the country’s devices. Continue reading »
Partnerships in Clinical Trials: An Opportunity to Engage and Collaborate on the Future Landscape of Clinical Trials
The upcoming Partnerships in Clinical Trials Conference in Orlando is sure to be a great venue to discuss issues surrounding clinical trials. Attendees will have full access to four diverse summits that build the framework for clinical trial success, plus five concurrent tracks that attend to the hottest topics in Clinical Operations, Outsourcing and Data Management.
There is a focus on the future landscape of clinical trials. As noted in this year’s program agenda, the data indicates a need to further refine, retool and rethink clinical trials: Continue reading »
Pharmaceutical News: India’s Supreme Court Continues Low-Cost Generics
The New York Times recently reported in a front-page story that “Production of the generic drugs in India, the world’s biggest provider of cheap medicines, was ensured on Monday in a ruling by the Indian Supreme Court.” This means the populations of developing countries “will continue to have access to low-cost copycat versions of drugs for diseases like HIV and cancer…”
The court ruled that a previous patent for Novartis‘ Gleevec prevented the company from taking out a new patent on the drug. According to the Times article, “the debate over global drug pricing is one of the most contentious issues between developed countries and the developing world.” Because the US allows companies to re-patent a drug by altering its formula or changing its dosage, the country “pays the highest drug prices in the world.” Continue reading »
Global Clinical Trials: India Appoints Two New Committees to Improve Trial Quality
India’s Ministry of Health & Family Welfare recently announced it will create two new committees to oversee clinical trials, guidelines, policy, drug approval and Fixed Dose Combinations (FDCs). These committees will operate independently from other departments.
While the announcement is quite broad in detail, the ministry expects industry comment and collaboration before they begin their work on April 7th. One committee will focus on policy, guidelines and SOPs for drug approval. The second committee will focus specifically on FDCs.
Continue reading »
The State of Global Online Marketing in Medical Device Companies
The global medical device market will achieve $440 billion by 2018, growing at about 4.4% per year, according to a new report from EvaluatePharma and as reported in Fierce Medical Devices. When compared to the prescription drug market projected to grow at an annual rate of 2.5%, it’s clear that global medical device companies anticipate a bright few years ahead. In vitro diagnostics will be the industry’s top segment by 2018, with sales of $54.5 billion, displacing the entrenched segments of cardiac devices and imaging systems.
How are marketers contributing to this robust global growth? With great effort, it seems.
Continue reading »
FDA Takes Steps to Align with GHTF
In June 2012, the United States Food and Drug Administration will pilot a program allowing medical device manufacturers to submit ISO 13485:2003 quality system audits to satisfy the FDA 21 CFR Part 820 inspection requirements for one year.
FDA Issues a guidance on their position on the use of social media
Drug and device makers have asked for regulators to issue rules on the use of social media. Earlier this year, the FDA issued a draft guidance to address how companies should respond to certain requests for information on off-label use of products. Although the draft guidance will not give the device and drug manufacturers a roadmap to navigate social media sites such as Twitter and Facebook, it does provide some direction on how companies should process without getting in trouble with regulators.
