Event Rewind – Regulatory 101

Posted by BioOhio on Jan. 30, 2015

Contributor-CGibsonBioOhio welcomes a new contributor to micrOHscope! Chad Gibson, Project Engineer with R&Q, has years of experience in the medical and in vitro diagnostic device industry. He and the team from R&Q are partnering with BioOhio to produce the Regulatory 101 Series. Thanks again to our event sponsor, Schulman Associates IRB, guest speaker Mark Bode of Joey Medical, and our hosts, the City of Mason.

Post-2015-1-30-Reg101We had a great turnout at the first Regulatory 101 event in Mason last week. As the name implies, we covered the basics of medical device regulation, but we designed the series to benefit both new and seasoned medical device professionals. We walked through the complete medical device life-cycle, from feasibility to post-market surveillance. We also touched on current trends like cyber-security, usability engineering, and medical device apps.

Mark Bode, CEO of Joey Medical joined us during lunch to speak about his experience being an entrepreneur going through the regulatory system, and delivered valuable lessons learned to the audience.

We set out to make the Regulatory 101 series both convenient and an excellent value. Because of BioOhio’s connections, we were able to offer the 4+ hour session for $50 ($100 for non-members), including a lunch. Where else can you get training on medical device regulations for that price, and with less than a day out of the office?

“I really enjoyed the session and felt all information presented had a very practical application to our business.” said Michelle Adamski, Quality Assurance and Regulatory Affairs Manager, Products, NAMSA. “I love that there is a resource in Ohio without having to travel great distances! I look forward to attending the other sessions planned for this year.”

If you missed this one, don’t worry. Regulatory 101 will be hosted in three other Ohio cities this year: Cleveland in April, Columbus in July, and Dayton in November. Dates and registration details will be announced soon. We’ll still cover all of the basics, but will present a different spotlight topic at each session.

Regulatory-Quality-400We believe events like this are critical to Ohio’s success. Regulatory and quality gatherings in our own state are one way we can get a leg up on medical device hubs like Boston, Minnesota, and Southern California. Practical knowledge of quality and regulatory topics helps start-ups and small companies become both compliant and efficient, and large companies build and maintain internal expertise.

With the combination of the BioOhio regulatory forum, the Regulatory 101 series, and MedCon, Ohio is building a strong medical device quality and regulatory foundation that benefits all of us!

Schulman-Associates-IRB-400    Joey-Medical     City of Mason

The Ohio State University holds landmark conference in India

Posted by BioOhio on Jan. 30, 2015

OSU India AIIMS logoOhio-State-University-WideThe Ohio State University recently held a remarkable event in Mumbai, India, with pre-conference events in Delhi and Kolkata, called H3C – “Health Care, Commerce, Career” that sought to establish global partnerships and understanding in health, research, business and much more.

BioOhio was proud to help promote this event, and we would like to share a post-event update from Conference Chair Prof. Chandan K. Sen and the organizers of H3C. The event featured 120 speakers from around the globe, over 300 attendees, key players from Ohio and numerous dignitaries from around India.

“On behalf of the organizers of the H3C at The Ohio State University (OSU) and at the All India Institute of Medical Sciences (AIIMS), I thank you for contributing to the success of H3C. The pre-conferences were instrumental in forging new wound care partnerships with Kolkata. The Peerless hospital in Kolkata is now committed to developing a chronic wound care facility. This opens up new opportunities for business for our visiting industry leaders. On the research front, this partnership will make room for collaborative proposal writing targeting shared Indo-US funding mechanisms offered by both governments.

Post-OSU-India-2-webAt Delhi, I was fortunate to inaugurate the country’s first National Facility for Regenerative Medicine under the framework of AIIMS, the country’s premier institution for health care and research. The new GMP Stem Cell Facility in Delhi plans over a dozen funded clinical trials on cell-based therapies. Our experts from the OSU Center for Regenerative Medicine and Cell Based Therapies (CRMCBT) see remarkable collaborative opportunities in the clinical front.

The AIIMS Director has invited us to partner in such trials. Stem Cell Rx is a hospital in Mumbai that has delivered stem cell based therapies to over 2000 patients. They continue to provide stem cell based therapies to an estimated 500 patients per year. The head of Stem Cell Rx has invited our investigators to partner and learn from their experience. This cohort provides extraordinary value to our investigators.

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Neuros Medical enrolls first patients in clinical study for post-amputation pain

Posted by BioOhio on Jan. 28, 2015

Neuros-Medical-LogoNeuros Medical announced today that it has enrolled the first patients in its pivotal clinical trial to evaluate the Altius System, patented high frequency nerve block technology for the management of intractable limb pain of amputees.

The study will consist of up to 130 patients at 15 institutions to evaluate the safety and efficacy of technology. When completed, the results will support a PreMarket Approval Application to FDA in order to market the device. The study builds off their long-term pilot study which reported significant pain reduction, up to 30 months. In addition, more than half of the responders discontinued their pain medication use during the study.

“The Neuros High Frequency Nerve Block has the opportunity to be a paradigm shift in treating chronic pain, especially post-amputation pain, due to its on-demand blocking effect, versus traditional stimulation,” said Dr. Leonardo Kapural, the study’s principal investigator, from the Carolinas Pain Institute in Winston-Salem, North Carolina.

Dr. Nagy Mekhail, Director of the Evidence Based Pain Medicine Research, Department of Pain Management at Cleveland Clinic added, “We are honored to be one of the initial implanting sites and part of this important study to investigate the Altius technology for patients with post-amputation pain.”

“We are excited to have our first implants underway as we execute our pivotal study, with our wave of sites commencing recruitment and enrollment,” stated Jon J. Snyder, President and CEO of Neuros Medical.

Download the original release here (pdf), and learn more about Neuros Medical on their website and in our own news page.

Repeal of the medical device tax is a big deal for innovation and jobs

Posted by BioOhio on Jan. 28, 2015

Ohio-Advocacy-DC-150According to reports released today by the Advanced Medical Technology Association (AdvaMed) and the Medical Device Manufacturers Association (MDMA), repeal of the ACA’s medical device tax would benefit innovators and employers across the country.

MDMA conducted a survey of medical technology innovators to assess how repeal of the medical device tax would impact their operations. The survey included over 100 responses from senior executives at some of the United States’ most innovative and entrepreneurial medical device companies.

  • 72% of companies slowed or halted job creation in the United States to pay the medical device tax
  • 85% of respondents said that if the device tax was repealed, they would hire new employees in the U.S.
  • 80% of respondents noted that they would increase R&D investments in the cures and therapies of tomorrow
  • When asked how much they would increase their R&D budget, the average increase was 14%

AdvaMed’s survey details the negative and costly impact of the medical device tax, reflecting the tough choices companies are making to address it including reducing jobs, R&D and other financial investments. Here are just a few of their findings:

  • Employment reductions of approximately 18,500 industry workers
  • Forgone hiring of 20,500 additional employees over the next five years
  • 46% said they would consider further employment reductions if the tax is not repealed
  • 71% said they would reinstate forgone hiring if the tax were repealed
  • 53% said they had reduced R&D as a result of the tax
  • Many respondents would consider further or first-time reductions in R&D if the tax stays in effect, but would reinstate projects or make new investments in R&D if the tax were repealed

Both the House and Senate recently introduced bipartisan pieces of legislation to repeal the medical device tax in the 114th Congress.

Read the full releases from AdvaMed here, and MDMA here.

BioOhio is the Ohio affiliate for global bioscience associations AdvaMed, BIO, MDMA and PhRMA.

AdvaMed 350AdvaMed advocates on a global basis for the highest ethical standards, timely patient access to safe and effective products, and economic policies that reward value creation.

 

MDMA-250The Medical Device Manufacturers Association (MDMA) is a national trade association based in Washington, DC providing educational and advocacy assistance to innovative and entrepreneurial medical technology companies.

BioOhio BioBulletin, January 2015

Posted by BioOhio on Jan. 23, 2015

BioBulletin-HR2

Welcome to the January 2015 BioBulletin! This edition marks the one year anniversary of this monthly e-publication.

Trivia: Did you know this weekend Columbus is hosting the National Hockey League (NHL) All-Star Weekend? Some stats: $12 million expected visitor spending; 140,000 attendees; 8,000 hotel-room nights booked by the NHL; 150 countries in which the game will be televised; 400 members of the media attending; $50 million estimated value of media exposure. Go Blue Jackets!

This edition of features Membership Updates, BioOhio Education Summit & Career Fair, NHLBI Regional Innovation Conference, BioOhio Statehouse Day, Event Updates, Sponsorship Opportunities, Talent & Training Programs, Advocacy Updates, Savings Programs and a wrap up of the News!


Membership

We proudly welcome 9 new members since the December edition of BioBulletin! Thanks for joining ChromocareEarly Stage Partners, HIMSS Innovation CenterKaleidoscope, Kulis Freeze DrySlone Partners, Synergy Health, and two individuals.


Bioscience Talent, Workforce & Education Summit

February 9 in Columbus

Southwest-Ohio-Bio-Consortium-200OASBlueLogoBioOhio, in partnership with Southwest Ohio Bioscience Education Consortium and The Ohio Academy of Science, is hosting the Bioscience Talent, Workforce & Education Summit. The goal of this event is to gather the state’s educators, school administrators, career counselors, workforce professionals and industry representatives to discuss the quality, comprehensiveness, and challenges of bioscience education in Ohio.


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Case Western Reserve Univeristy and Cornell University doctors receive nearly $700,000 to fight prematurity-related blindness and lung disorders | Cleveland.com, January 30, 2015

Neuros Medical enrolls first patients in pivotal study for post-amputation pain | Neuros Medical, January 28, 2015

Ohio State cancer center’s former home might house brain, spine hospital | The Columbus Dispatch, January 28, 2015

Exsurco Medical achieves ISO 13485 registration for Medical Device Design & Manufacture | PR Web, January 27, 2015

Shark Tank’s Mark Cuban to join Cincinnati Children’s in startup pitch competition for medical devices and digital health tech | Cincinnati Business Courier, January 27, 2015

Taylor Strategy Partners’ Nicole Plant appointed to the Create Columbus Commission, adding a millennial voice in branding Ohio’s capital as a destination for young professionals | PR Newswire, January 27, 2015

Sen. Sherrod Brown warns against letting Children’s Health Insurance Program expire, Dayton Children’s Hospital | 91.3 WYSO, January 27, 2015

Nationwide Children’s Hospital researchers use video game tech as a method for measurement of upper extremity movement in muscular dystrophy patients | Muscular Dystrophy News, January 26, 2015

$100M development planned in Madisonville near Medpace | Cincinnati Business Courier, January 26, 2015

EnvisionRx and Gilead Sciences sign exclusive agreement to help in the fight against Hepatitis C | Business Wire, January 26, 2015

Sen. Portman and Sen. Baldwin op-ed: The nation needs the Critical Care Assessment and Improvement Act, ensure ability to respond to public health emergencies | The Hill, January 26, 2015

New powered vascular stapler from Ethicon offers greater precision during thoracic surgery | PR Newswire, January 26, 2015

Big Data pioneer Explorys plans to expand in University Circle, adding 80 employees | Cleveland.com, January 26, 2015

Leading with core values, BioOhio member Slone Partners interview with Elizabeth Hutt, CEO, NuGEN | Slone Partners, January 26, 2015

Exsurco Medical, manufacturer of advanced tissue processing devices, now ISO 13485 registered | Morning Journal, January 24, 2015

Repealing medical device tax has bipartisan appeal, Columbus Dispatch Editorial | The Columbus Dispatch, January 24, 2015

Midmark opens exhibit at Versailles Ohio Museum for 100 Year Anniversary | Midmark Corporation, January 23, 2015

Sparton acquires Real-Time Enterprises, developers of embedded software to operate medical devices and diagnostic equipment | Business Wire, January 22, 2015

Invacare Corporation names Matthew E. Monaghan President and Chief Executive Officer | Business Wire, January 22, 2015

VentureOhio appoints executive director from Columbus’ Hicks Partners, Emily Turner | Columbus Business First, January 22, 2015