Some Medical Device Companies Leverage Clinical Trials to Supplement FDA Submissions and Enhance Marketing Messages

David Richardson, pharmaceutical commercialization and launch expert
By David Richardson,
Director of Research

The US Food and Drug Administration (FDA) does not require that all medical device manufacturers file clinical findings along with regulatory submissions.  Companies developing medical devices that are similar to other products in the US market can use the pre-market notification 510(k) submission which requires bench and laboratory data, but not full-blown clinical trials. Continue reading


Securing Stable Sponsor-CRO Partnerships: Never Underestimate the Power of Communication

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Contract research organizations (CROs) can offer multiple benefits to sponsors: from helping teams to hone their internal expertise to supplementing in-house staffing and technological capabilities. Some life science teams prefer to leverage CRO partnerships when conducting clinical trials.  Others may reach out to vendor parties to assist in product development well before Phase 1 studies.  Still others may contract with CROs to expedite the manufacturing of active pharmaceutical ingredients (APIs). Continue reading


Health Economics Spending: Prioritizing HEOR Activities at Global Groups

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Research Analyst

Pharmaceutical companies under increasing pressure to provide a full product story to key payers.  As such, heath economics spending is also growing.  Rising stakeholder expectations demand that HEOR groups generate more pharmacoeconomic and outcomes data for each emerging drug or medical device.  To provide these data, global HEOR teams allocate a large percentage of their annual funding to cultivating  information for government and private payers worldwide. Continue reading


The Big Three: How Payers, Patients, and Physicians are Driving the Future of Comparative Effectiveness Research

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

Over the past few months at Cutting Edge Information we have been working on collecting data for a new report on comparative effectiveness research and a common theme throughout the research has been the need for stakeholder engagement that goes beyond the traditional payer-centric model.  Working with patients and physicians — along with pharmacies, regulators, and other stakeholders — is not a new phenomenon for manufacturers.  However, the emphasis on getting this engagement right is growing as companies respond to the changing healthcare marketplace in the US and in Europe. Continue reading


Medical Science Liaison Compensation Survey

Cutting Edge Information is conducting an unsponsored survey of field-based medical specialists (MSLs, RMLs and others listed below) to examine how factors such as therapeutic specialty focus, team size, experience level and performance affect their compensation. Participants will receive unique findings about field-based medical compensation at the project’s conclusion.

Interested specialists can complete the short survey here:
https://cuttingedgeinfo.co1.qualtrics.com/SE/?SID=SV_2bC7DvmqiHlXfiB Continue reading


Medical Device Commercialization: Rightsizing Investments to Match Approval Pathway Complexity

Victoria Cavicchi, pharmaceutical social media researcher
By Victoria Cavicchi,
Research Analyst

Developing and commercializing medical devices can quickly become a costly endeavor.  Overall, medical device commercialization investments increase alongside development duration.  Commercial boards are charged with optimizing investments in device development and product launch. While these boards work to minimize costs, key factors—including device complexity and development time impact total investments.  More complex products, typically those requiring pre-market approval (PMA), often require more funding than those seeking 510(k) clearance. Continue reading


Trouble Engaging HCPs? Medical Science Liaisons Should Try Hospital Meetings

Natalie DeMasi, clinical development and medical affairs researcher
By Natalie DeMasi,
Senior Research Analyst

Medical science liaisons (MSLs) continually strive to engage healthcare providers (HCPs) in scientific discussions.  These interactions not only benefit HCPs, but they also arm the MSL with invaluable clinical insights.  One-on-one discussions between HCPs and MSLs are a hallmark of MSL activities, but it can sometimes be difficult for MSLs to schedule one-one-one meetings — especially with HCPs they’ve never met before.  Because of this, MSLs may want to supplement these discussions with hospital meetings. Continue reading


Supporting Investigator-Initiated Trials: Develop IIT Management Team Numbers In-Line with Centralization Practices

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

Investigator-initiated trials (IITs) are developed and executed under the direction of third-party clinical investigators.  However, life science teams often require ample in-house teams to support these activities from start to finish. Dedicated teams handle tasks such as managing online investigator portals and reviewing IIT submissions. Continue reading


Where the Patients Are: Leveraging Social Media in Clinical Trial Patient Recruitment

Sarah Ray, regulatory affairs and safety researcher
By Sarah Ray,
Senior Research Analyst

When it comes to patient recruitment techniques, digital channels, including social media, represent a valuable, albeit somewhat untapped resource.  Despite the plethora of online patient engagement groups, not all industry groups are establishing an equally strong social media presence.   Certainly, existing guidance restricts the scope of pharmaceutical and other life science teams’ interactions with healthcare consumers.  However, because social media groups may contain patients interested in participating in clinical trials, companies often benefit from reaching out to them, to the extent allowable. Continue reading


Keeping Track of Advisory Board Basics in a Changing Technological Landscape

Jacob Presson, pharmaceutical market access researcher
By Jacob Presson,
Senior Research Analyst

Successful advisory boards depend on many things going right, only some of which are in the sponsor company’s control.  As a result, pharmaceutical companies look to minimize this risk and find the most successful formulas for answering the questions put to the advisory board.  Over time, these practices have led to the development of several rules of thumb to follow when conducting advisory boards. Continue reading