The Food & Drug Administration and the Centers for Medicare and Medicaid Services signed a Memorandum of Understanding June 23 intended to promote data-sharing between the two agencies. Announcement of the MOU came from Center for Devices & Radiological Health director Dr. Jeffrey Shuren at a June 24 public workshop on device innovation. The MOU, Shuren said, “will allow for the first time routine and timely sharing of information and expertise between our two agencies to strengthen our ability to achieve our respective missions.
If, just for fun, you read the Bureau of Labor Statistics’ Occupational Outlook Handbook, you will notice there is a bell curve of earnings for most jobs. Sales is no different. The top 5 percent to 10 percent in a given field often earn almost twice as much as the median income. Within each company, a similar distribution is often evident among the earnings of salespeople, especially when compensation structures are heavily commission-based.
Here are a few observations from my years of sales recruiting on what to do if you want to be in the upper echelon of earnings:
Arne Carlson, the former governor of Minnesota, recently contributed an opinion column to the Minneapolis Star-Tribune, voicing concerns about increased Food & Drug Administration regulation of the medical device industry stifling innovation. The column came as Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, prepared to visit the state — one of the country’s biggest medical device hubs — for a town hall meeting to discuss CDRH’s 2010 Strategic Imperatives and hear feedback from industry officials.
2009 was not a banner year for sales achievement in most industries. Economic conditions certainly played a role. Staying motivated through such a tough economy is probably one of the chief issues salespeople and sales leaders faced last year. Some salespeople steeled themselves by “refusing to participate” in the recession and found ways to exceed their quotas and grow their business. Many individuals and companies did not.
Waltham-based contract research organization Parexel International Corp. (NSDQ:PRXL) hired two former regulatory scientists for its Parexel Consulting division.
The company added Dr. Toby Silverman, who oversaw aspects of the Food & Drug Administration’s Center for Biologics Evaluation and Research, and Keith Watson, a former employee of the U.K.’s Medicines and Healthcare products Regulatory Agency, where he was a liaison to several European biotechnology safety organizations.*
We were meeting with a client — more specifically, with the president, marketing communications director and consulting executive. We were vying to come up with a name for a new surgical product and had been at it for about an hour. We wondered how the name might change when line extensions came into play down the road. And so of course the talk naturally turned to shaving.
“What we’re talking about here is not unlike how shaving companies name their products,” the consultant said.
Restructuring costs cut deeply into second-quarter profits at Parexel International Corp. (NSDQ:PRXL) during the three months ended Dec. 31, with severance and related expenses costing the clinical research organization $14.3 million during the quarter.
The Waltham, Mass.-based clinical research organization recorded net income of $3.5 million, or 6 cents per share, on $284.7 million in revenues during its fiscal second period. That compares with a $5.2 million profit, or 9 cents per share, and $275.8 million in revenues during the year-ago quarter. In addition to severance payments, the bottom line was affected negatively by a client default, lease penalties associated with facility closings and a $6.1 investment impairment charge.
Contract research lab Parexel International Corp. (NASQ:PRXL) boosted its forecast for the three months ended Dec. 31, 2009, and for calendar 2010, reversing downbeat predictions made in October.
The Boston-based contract research organization is now saying it expects to report net earnings of between $3.5 million and $4.6 million on revenues of up to $285 million during the second quarter. It also issued its initial forecast for calendar 2010, predicting profits of between $35 million and about $40.5 million on between $1.115 billion and $1.145 billion in revenues for the 12-month period.
When pitching to potential life sciences technology investors, entrepreneurs know that they need to demonstrate a clear path to reimbursement. Angels, VCs and strategic partners don’t want to commit resources to develop something that won’t get adequately paid for in a reasonable timeframe. That makes perfectly good sense. Indeed, I’d argue that the need to assess a technology’s likely reimbursement status begins even earlier than the investment pitch.
Bruce Lehman’s been in the advertising game since the late 1970s, but the principal at Lehman Millet, a Boston-based marketing and communications agency, has been focused on the medical device and diagnostics industry solely since the 1990s, making it a powerful player in the industry despite its relatively small size.
Today, Lehman Millet‘s client mix includes biotechnology, biomaterials and specialty pharmaceutical firms, along with its core medical device customers. MassDevice: spoke with Lehman, 59, about an ever-present question: “How, exactly, do you market a medical device?”