Tim Mohn
Tim Mohn is an industry principal in Sparta Systems’ product management group. In this role, Tim is responsible for helping both Sparta and Sparta’s clients track and understand changes in the regulatory environment and trends in the life sciences industry. He previously served as worldwide quality systems manager at Ortho-Clinical Diagnostics, a division of Johnson & Johnson. At OCD, Tim championed eMDR and SAP integration activities, owned the CAPA process and supported multiple FDA inspections at OCD's locations. Prior to J&J, he worked at Pfizer Consumer Healthcare and Wyeth Pharmaceuticals. Tim holds a B.S. in Biology and a Masters in Manufacturing Management from Penn State.
There's nothing you can do about looming changes to the 510(k) program. But you can take the time to make sure your internal processes are up to snuff.
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.
07/05/2010 - 09:00
ASTM F2502 is a standard for testing Bioabsorbable Plates and Screws for Internal Fixation Implants.
These types of plates and screws are resorbed into the body once implanted to unstable bone or tissue connected to bone. The advantage over a metallic fixation device is that a bioabsorbable device does not need to be removed. The challenge to medical device manufacturers of bioabsorbable devices is to ensure full healing takes place before the bioabsorbable device is fully deteriorated.
There are four Annexes describing the testing procedures to follow in this specification.
Lisa McCallister
Recently, my daughter and I drove by a BMW dealership.
"What does BMW stand for?" she asked.
"Bayerische Motoren Werke," I told her (or something close to that). "It's German."
"If I worked for them, I would make a sign that said 'Love Your Ride.'" She fanned her hand in front of her, visualizing it.
"That's very good. Maybe someday you'll be in marketing. That's the kind of thing they do in marketing."
"No!" She bounced upright in her seat. "I want to sell stuff!"
"Why?" I asked, bemused at her reaction.
"Because it's fun," she said.
Edward Berger
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.
Reimbursement Row
Jennifer A. Nichols
Well, they must be wearing sweaters in Cupertino because I just purchased an iPhone. I'm the one who went public in my last blog about taking a stand against the Apple brand. When asked what changed, I was finding it hard to explain, especially since I didn't even need a new phone. So to understand how I finally became an Apple convert, I went online for the answer.
Monitor your baby with wireless pajamas; Medgadget's review of Lenovo's new all-in-one touchscreen PC; vital signs monitor interfaces directly with EHR's; NovoDose mobile app helps docs determine insulin needs.
Monitor your baby with wireless pajamas: McLean, Va.-based Exmovere claims to have developed baby clothing, called Exmobaby, that can monitor a child's heart rate, "emotional state," and level of activity, and relay that information wirelessly to a computer or cell phone. Paranoid parents will be able to keep a virtual eye on their kids 24/7, and maybe worries about SIDS and infant sleep apnea can be diminished. An initial production of 1,000 units will be made available in 2011 to select customers.
Hong Kong's hospitals to purchase new medical equipment
Recent investigations found that many of the more sophisticated medical devices that are generally available in more developed countries are outdated or lacking in Hong Kong's public hospitals. Responding in part to these investigations, the Hong Kong government is allotting over $50 million to the Health Authority for medical equipment.
Tinker Ready
Kennedy passes the healthcare reform baton to Dodd
Sen. Ted Kennedy, ill and unable to attend the ongoing Senate health reform battles, appeared in a campaign video this week for his old friend, Sen. Chris Dodd (D-Conn.). Kennedy basically said Dodd is going to be key in the push for health reform that has been, according to Kennedy "the cause of my life." (Aside from running for president, perhaps?):
"Today more than ever, we have a real opportunity to bring health care reform to Connecticut and all across America. And I believe that, with Chris Dodd's leadership, our families will finally have accessible, affordable health care."
Tinker Ready
David Spenciner
Dollars and Spence
Blogs
Hong Kong's hospitals to purchase new medical equipment
Recent investigations found that many of the more sophisticated medical devices that are generally available in more developed countries are outdated or lacking in Hong Kong's public hospitals. Responding in part to these investigations, the Hong Kong government is allotting over $50 million to the Health Authority for medical equipment.
Sales is seen as personality-dependent. What attributes truly make the difference between top-performing reps and everyone else?
Recently, my daughter and I drove by a BMW dealership.
"What does BMW stand for?" she asked.
"Bayerische Motoren Werke," I told her (or something close to that). "It's German."
"If I worked for them, I would make a sign that said 'Love Your Ride.'" She fanned her hand in front of her, visualizing it.
"That's very good. Maybe someday you'll be in marketing. That's the kind of thing they do in marketing."
"No!" She bounced upright in her seat. "I want to sell stuff!"
"Why?" I asked, bemused at her reaction.
"Because it's fun," she said.
Monitor your baby with wireless pajamas; Medgadget's review of Lenovo's new all-in-one touchscreen PC; vital signs monitor interfaces directly with EHR's; NovoDose mobile app helps docs determine insulin needs.
Monitor your baby with wireless pajamas: McLean, Va.-based Exmovere claims to have developed baby clothing, called Exmobaby, that can monitor a child's heart rate, "emotional state," and level of activity, and relay that information wirelessly to a computer or cell phone. Paranoid parents will be able to keep a virtual eye on their kids 24/7, and maybe worries about SIDS and infant sleep apnea can be diminished. An initial production of 1,000 units will be made available in 2011 to select customers.
Career seekers in the medical device industry should leverage their LinkedIn profiles to land a job in medical device sales.
Having a professional LinkedIn profile is a must if you are seeking a job in medical device sales. You can simultaneously promote your current business and open yourself to new opportunities.
If you want to be found by an enterprising recruiter who may have a great job opportunity for you, you need to make yourself easy to be found. Here are a few ways to do it:
Social media offer the most flexible, rapid and transformative communications venue to communicate a medical device company's approach to accountable care and other issues.
By John Smith
Synthetic cornea offers performance on par with cadaver cornea after two years; pocket-sized CPR-assistance device with Analog Devices' iMEMS; engineering polymer surfaces to promote stem cell growth; DNA-based artificial nose senses organic vapors.
Synthetic cornea offers performance on par with cadaver cornea after two years: A small (n=10) Phase 1 study published in Science Translational Medicine last week showed that synthetic corneas performed as well as cadaver harvested corneas over a 24-month followup. The paper's authors wrote, "The biosynthetic implants remained stably integrated and avascular for 24 months after surgery, without the need for long-term use of the steroid immunosuppression that is required for traditional allotransplantation.
It must be cold in Cupertino, because I finally broke down and bought an iPhone. Here's why, and how medical device makers can use Apple's example in their own marketing efforts.
Well, they must be wearing sweaters in Cupertino because I just purchased an iPhone. I'm the one who went public in my last blog about taking a stand against the Apple brand. When asked what changed, I was finding it hard to explain, especially since I didn't even need a new phone. So to understand how I finally became an Apple convert, I went online for the answer.
