Deadline fast approaching for Class II medical device compliance with UDI

September 24, 2016, a date fast approaching, is the deadline for Class II medical devices to be compliant with unique device identifier (UDI) regulations. For compliance, device manufacturers have to submit device identifiers (DI) to FDA for inclusion in the GUDID (Global Unique Device Identifier Database). Device labeling documentation planning is key since once the DI is submitted for a device and entered into the GUDID; further, there are rules for editing during a grace period only and companies may find themselves in situations requiring them to have to obtain a new DI for a device. Keep watching for any FDA updates that may post as this deadline approaches.

More details can be found in Michael Mezher’s informative article posted on RAPS. Pearl Pathways has an experienced team ready to help with your UDI compliance planning and execution, contact us here.

Reflection on the IBJ Life Science Power Breakfast panel discussion

The Indianapolis Business Journal (IBJ) hosted the IBJ Life Science Power Breakfast Series this morning at the Marriott Hotel downtown Indianapolis.  It was a great panel discussion with industry leaders and well represented by many of the regional life sciences companies and service providers, including  (and proud sponsors) Pearl Pathways’ CEO Diana Caldwell and Director, Business Development Chad Pannucci.  In addition to an interesting presentation and panel discussion, we enjoyed conversation and getting better acquainted with some of our life science clients & colleagues from Indiana startups, universities and industry experts hosted at the Pearl Pathways table.  The impact of the Indiana life science industry cannot be overstated.  As mentioned, the output by Indiana life science companies (#medical device, #pharmaceutical, #biotech, #diagnostic etc) represents a $59B per year economic impact and almost $10B in worldwide annual exports where 1 out of every 10 Hoosiers (or ~56,000) work in the life sciences sector.  There is tremendous innovation happening right now at places like Purdue University where current president and former State of Indiana governor Mitch Daniels have done a tremendous job to accelerate innovation by creating a framework to spin up startup companies and pursue licensing opportunities with Purdue based research and intellectual property (IP).  For example, Purdue recently gained national press and media coverage when researchers recently deciphered the structure of the #Zika virus which will help to more quickly identify and develop therapeutics to treat it, while #GE and #Rolls Royce announced significant multi-year and multi-million dollar investments to further their partnership with the university and leverage engineering talent and facility capabilities to develop and built out new technologies related to jet engine research and advanced manufacturing.  Closer to Indianapolis mentioned was the 16 Tech project which will be anchored by the new $250M Indiana Bioscience Research Institute on 60 acres of land situated just northwest of downtown along Indiana Avenue between Indiana University School of Medicine, IUPUI and downtown Indianapolis, not to mention only 20 minutes from the Indianapolis International airport.  16 Tech will be designed as an #innovation hub and a conduit between life sciences research institutions, industry, expertise and facilities to foster and speed development of new products and technologies for medical innovation in Indiana.  Events like the IBJ Life Science Power Breakfast Series are important to showcase the progress we have collectively contributed as a state under the guise of not just as a national, but a global effort to push forward technology and breakthrough medical advances to help patients around the world.

What is your company doing about Cybersecurity for Medical Device?

cybersecurityEarlier this year, FDA released recommendations for medical device manufacturers in managing cybersecurity risks related to safety, efficacy, and integrity of medical devices and patient health. If you haven’t already, take a look at this timely draft guidance from the FDA to learn more. The draft guidance addresses cybersecurity issues throughout the entire product lifecycle of a networked medical device that utilizes software(firmware) and includes the ever important postmarket management. Risk to device functionality or loss of important data due to a cybersecurity risk is a consideration that could result in bad outcomes for patients. Device manufacturers need to take a look at their own risk management programs and assure they have a comprehensive plan established.

Pearl Pathways looks forward to the opportunity to work with you and provide support to your ongoing successful product development activities including risk management program development as part of your overall Quality System. Contact us to set up a discussion.

Image courtesy of thomasdinnocenzi.wordpress.com

Next Wednesday, April 20th… Join in a complimentary webinar on Post Market Compliance from Pearl Pathways partner, Brandwood Biomedical

brandwood logoBrandwood Biomedical is hosting a webinar, Post Market Compliance – keeping those hard won registrations. For the latest news on staying on top of your post market obligations including customer feedback, post market reporting, advertising & labeling compliance join in next Wednesday, April 20th.  Registration here today. Find Brandwood Medical by clicking here.

Gretchen Bowker speaking at the IMDMC REG 101 workshop on April 21st

imdmcThe Indiana Medical Device Manufacturers Council (IMDMC) is hosting a workshop on April 21st for those new to the medical device industry or for those looking for a regulatory refresher. Pearl Pathways’ own, Gretchen Bowker COO & RAC, FRAPS, will be presenting on, Pathways to Market – 510(K) Requirements at 10:15am. The workshop provides a background in FDA regulations of medical devices.

What: A workshop exploring FDA regulations of medical devices and pathways to market.

When: Thursday, April 21st, 2016, 8:00 AM to 5:00 PM EDT

Where: The Montage – 8580 Allison Pointe Boulevard, Indianapolis, IN 46250

Are you new to the medical device industry? Do you want to learn more about the FDA and the Pathways to Market? Register here today! (Lunch will be provided.)

To learn more about the workshop and register for REG 101 & 102 Workshop, click here. We hope to see you there on April 21st!

What’s your take on Outsourcing Pharma’s phrase “Chindia” for drug substance market?

Check out Melissa Fassbender’s intriguing article on API contract manufacturing trends to “Chindia” and perhaps back West again.  Have we come to understand API outsourcing to China and India as the new normal? 

According to Oursourcing Pharma‘s Fassbender, there are over 1,500 suppliers of API in China and 2,300 in India with an output of $27 billion. Dr. Enrico Polastro was quoted from his recent DCAT session entitles “Pharma fine chemicals outsourcing:  Back to the West?”

Check out the article here.  Need API supplier audits in China or India?  We can help with expert auditors on the ground in both countries.  Contact us to discuss your auditing needs. 

Pearl Pathways’ own Gretchen Bowker speaking at Roche Devices and Diagnostics for a Purdue University Course, April 8th

Gretchen Bowker, Pearl Pathways COO and Co-Founder, is teaching a class to Purdue students on the campus of Roche Diagnostics in Indianapolis on “Ethics, Quality and Human Safety in Clinical Trials: The Role of the IRB in Medical Device Studies”. The lecture will be held at Roche during a two-day event, April 8-9, and will provide current industry perspective on devices and diagnostics. This presentation is an excellent opportunity for Purdue students to learn from industry experts.

Pearl’s Pannucci Honored as ICBI Advisory Council Member

Pearl Pathways’ Director of Business Development, Pannucci one of select group of Indianapolis area life science industry executives to make up the ICBI Advisory Council

INDIANAPOLIS, INDIANA – March 23, 2016 – Pearl Pathways’ Director of Business Development, Chad Pannucci was selected as an Advisory Council Member for the new Indiana Council for Biomedical Innovation (‘ICBI’).  Pearl Pathways’ President and CEO Diana Caldwell, shares “We are so proud that Chad will be representing Pearl to the life science community and sharing his expertise and knowhow with area startups and entrepreneurs.”

The ICBI recognized a select group of life science and industry executives to bring expertise, mentoring, networking and experience to fledgling entrepreneurs and startup companies.  On March 15, 2016, the ICBI held its official grand opening ribbon cutting ceremony at their newly renovated space in Noyes Pavilion at Methodist Hospital on Indianapolis’ near northwest side.

To read the full press release, click here.

Bill passed Senate that would add the Zika virus to FDA’s list for priority review vouchers

Last week, the US Senate added the Zika Virus to the priority review voucher (PRV) program for FDA.  It could be the 22nd tropical disease on the list if the bill passes in the House which seems likely. Zachery Brennan published a comprehensive article on this topic which shares a good history on the program.

While the Senate and Congress seem to be big fans of the PRV program, not all industry experts completely support this program which gives corporations who apply and earn the vouchers the ability to cut the FDA review period from 10 months to 6 months, or, they can sell them for hundreds of millions of dollars on the market.  FDA’s established opposition to the program is reviewed in an article earlier this month on www.raps.org .

Need help navigating which rare, neglected, and tropical diseases are eligible for PRVs?  Contact our staff, we can help.

Pearl Pathways’ Director of Business Development, Chad Pannucci, weighs in on the opioid epidemic after recent life sciences event in downtown Indianapolis

Pearl Pathways’ own, Chad Pannucci, shared his thoughts regarding the ongoing opioid epidemic after a recent life sciences event hosted by BioCrossroads and moderated by AIT Labs CEO, Matthew Neff at D’Amore in downtown Indianapolis. To read Pannucci’s article on LinkedIn, click here.