MDCI, an Aptiv Solutions company is hosting a seminar November, 9, 2011 that tackles two subject areas that are important for life science and device companies. The complimentary, no-fee seminar is scheduled to take place the afternoon of Wednesday, November 9, 2011 at the Boston Marriott Cambridge Hotel in Boston Massachusetts, and it will offer two different tracks designed to appeal to a wide range of industry professionals.

The first track, “Adaptive Clinical Trials 101″ kicks off at 2:00 pm with a presentation entitled “Seeking Agency Advice for Initiating Adaptive Trials,” presented by Aptiv Solutions Global Director Jenny Vestal. This is followed by Vlad Dragalin’s “Implementing Adaptive Clinical Trials: Challenges and Solutions” presentation at 3:00 pm, which calls on the Aptiv Solutions Senior Vice President’s extensive experience in this field. The final presentation under the “Adaptive Clinical Trials 101″ track will be made by Aptiv Solutions Senior Vice President Mary Riggs at 4:00 pm, and it tackles “Executing Adaptive Trials.”

The second seminar track, “Conducting Medical Device Trials” begins at 3 pm as Dr. Michael Feldstein, Ph.D. of MDCI presents “Medical Device: A Statistician’s Perspective.” At 4:00 pm the second track concludes with “Planning and Implementing Medical Device Clinical Trials: Challenges and Solutions,” offered by Dr. Phil Lavin, Ph.D., Executive Vice President at Aptiv Solutions.

At the end of the seminar, MDCI and Aptiv Solutions will provide all participants a networking reception, beginning at 5:00 pm, which will include an hour of getting to know other industry professionals a little bit better while enjoying delicious snacks and drinks.

Seminar registration is offered online at the following link: http://www.aptivsolutions.com/library/seminars/.

The company will also provide information on its full range of regulatory affairs consulting and CRO services in the conference exhibit area. More than 200 regulatory affairs and clinical operations professionals from leading medical device and IVD companies are expected to attend these conferences.

Aptiv Solutions medical device experts have been selected to speak as follows:

“Panel Discussion: Assurance Case Reports and Their Impact on 510(k) Submissions”, Cynthia Nolte, Ph.D., RAC, Senior Regulatory Consultant and Mark Sheehan, RAC, Regulatory Associate, MDCI, an Aptiv Solutions company; September 12th , 10:50am

“Lessons Learned: Evolving But Still Constant Requirements to Gain PMA Approval”, Philip T. Lavin, Ph.D., Executive Vice President, Medical Devices and Strategic Planning at Aptiv Solutions; September 12th, 1:30pm

“Panel Discussion: Evaluating Recent FDA Approvals”, Philip T. Lavin, Ph.D., Executive Vice President, Medical Devices and Strategic Planning at Aptiv Solutions; September 13th, 9:20am

“Panel Discussion: Best Practices in Avoiding Delays by Conquering Logistical Challenges When Conducting Diagnostic Clinical Studies”, Susan M. Rockwell, Associate Director, Clinical Development, MDCI, an Aptiv Solutions company; September 13th, 10:50am

“Q1 conferences provide excellent content and an ideal environment for sharing information and solutions focused on the unique requirements of medical device, in vitro diagnostic, and biotechnology innovators”, says Bill Morton, Senior Vice President at MDCI, an Aptiv Solutions company. “We are pleased to support and participate in both of these very relevant programs.”

About Aptiv Solutions
Aptiv Solutions is a global biopharmaceutical and medical device development services company focused on recognizing, understanding and enabling clients to capitalize on rapid and fundamental changes facing companies developing products in the pharmaceutical, biotech and medical device market. The company offers clients an extensive portfolio of innovative services including adaptive clinical trial design and execution, medical device consulting and trial execution, early phase product strategy, regulatory services, pharmacovigilance, clinical staffing and the operational support of a global clinical research organization. Aptiv Solutions has over 750 professionals in North America, Europe, the Middle East, Japan, and Australia, and operates out of 23 offices in 17 countries. Visit the Aptiv Solutions website at www.aptivsolutions.com.

About MDCI, an Aptiv Solutions company
Founded in 1980, MDCI is a full-service regulatory consulting firm and contract research organization (CRO) that helps emerging and established firms commercialize novel and innovative medical devices, in vitro diagnostics, and combination products. Clients trust MDCI to deliver customized strategic guidance and creative “hands-on” solutions to address their unique regulatory, clinical trial, and quality assurance challenges at every stage of the product lifecycle. MDCI has helped hundreds of clients conduct successful clinical trials, achieve regulatory clearance and approval, and maintain compliance for products in the U.S. and internationally. MDCI was recently acquired by Aptiv Solutions to provide a broader range of medical device services to its clients. MDCI has offices in Massachusetts and California. Additional information is available at www.mdci.com.

MDCI Welcomes Frederick Tobia as Director of Regulatory and Clinical Services

In this new role, Tobia will oversee daily operations of medical device regulatory and CRO services

Medical Device Consultants, Inc. (MDCI), a leading regulatory consulting firm and CRO for the medical device industry, announced today that Mr. Frederick (Fred) Tobia has joined the company as director of regulatory and clinical services. He will oversee the daily operations of the company’s clinical and regulatory services groups, reporting to Vicki Anastasi, vice president of regulatory services and business development.

Fred brings over twenty years of experience in the medical device and CRO industry and has held increasingly senior executive roles in regulatory, quality and clinical affairs at Alliant Medical Technologies, Inc. (formerly UroMed), CareStat Inc., and Seacoast Technologies. For the past six years he was vice president, regulatory and clinical affairs at NMT Medical Inc. He has successfully gained clearance and approval of PMAs, 510(k)s, IDEs, INDs, NDAs, BLAs, and international Design Dossiers with and without clinical data.

“I am excited to welcome Fred to MDCI”, said Anastasi. “His impressive track record of integrating worldwide regulatory, clinical and quality programs, along with a proven ability to manage the device development process from pre-clinical through post-market activities will serve our clients well.”

Fred holds a bachelor of science in biology from Providence College and a certificate in public health from Harvard School of Public Health. He has published numerous articles in peer-reviewed journals and is a recognized speaker and advisor with medical device industry trade and professional organizations, including FDA task forces.

July 18, 2011

MDCI Welcomes Brian Edwards, Senior Regulatory Staff Consultant

Medical Device Consultants, Inc. (MDCI), a leading regulatory consulting firm and CRO for the medical device industry, announced today that Mr. Brian Edwards has joined the company’s regulatory services group as a senior regulatory staff consultant. He will be based in Minneapolis, MN.

Mr. Edwards brings over twenty years of experience in the regulation of medical devices, design and analysis of device trials, biostatistics, quality systems, and US and OUS regulatory submissions. His work spans a broad range of therapeutic areas including work with spinal, audiological, cardiovascular, cardiology, muscle and nerve stimulation, and software/communication devices. During his previous positions as director of regulatory affairs at Zimmer Spine, Inc., Otologics, LLC, and Stereotaxis, Inc., as well as a senior level position with Medtronic, Inc. he managed regulatory clearances and approvals for Class II and Class III devices in the United States, European Union, Canada, Latin America and Asia. In addition, he is experienced in the implementation and auditing of FDA and ISO compliant quality systems.

“I am pleased to welcome Brian to our team, said Vicki Anastasi, vice president of regulatory services and business development. He brings proven regulatory expertise in key therapeutic areas, including cardiovascular, orthopedics and medical device software. Based in Minneapolis, he will amplify MDCI’s presence in the important Twin Cities medical device cluster.”

Brian holds a B.S. in chemical engineering, and an M.S. in biomedical engineering, both from the University of Minnesota. He also earned an M.S. in biostatistics from the University of California, Los Angeles. Brian is a member of the Regulatory Affairs Professionals Society (RAPS).

February 1, 2011

MDCI to Present at the SAS Global Forum

The company will present two useful techniques to allow SAS programmers to simplify and automate common statistical data activities using Excel and PowerPoint
Mr. Laiju Zhang, MDCI’s senior manager of biostatistics and SAS programming will present at the SAS Global Forum in Las Vegas, Nevada, April 5 and 6, 2011. On April 5 he will present, “Writing SAS® Programs with SAS and Microsoft Excel: Generate Batch SAS Programs Based on SAP Specifications”. This paper describes a SAS macro system that will generate SAS programs based on data set information and analysis decisions stored in Microsoft Excel. The presentation is aimed to SAS programmers who work in the strictly regulated pharmaceutical or medical device industries. Using this approach, programmers can automatically generate at least 90% of the standard tables, listings, and graphs for a particular study, and automatically set up debugging facilities as specified.
On April 6, Mr. Zhang will present, “SAS® Flirts with Java: PowerPoint Creation” and describe a process for creating PowerPoint slideshows using SAS and Java. He will first discuss how to create objects from the SAS data step by using the recent addition of javaObject to SAS®9 and then how to use this object created within the SAS session to communicate with Java package apache poi hslf, thus creating PowerPoint slides shows. Users will also have the ability to builds a SAS macro to automatically generate all SAS and Java files for use in as PowerPoint slides.
For more information or to register for the SAS Global Forum, visit http://support.sas.com/events/sasglobalforum/2011/
For more information on SAS Programming Services visit http://www.aptivsolutions.com/medical-devices/services/clinical-trial/sas-programming-services/

December 22, 2010

MDCI to Co-Sponsor Medical Device Clinical Trials Forum

December 22, 2010 – MDCI is pleased to announce that it will co-sponsor the Medical Device Clinical Trials Forum, to be held in conjunction with the 2011 Partnerships in Clinical Trials, March 31, 2011 at the Phoenix Convention Center, in Phoenix, Arizona.
The Medical Device Clinical Trials Forum is the only event designed specifically for medical device clinical trials professionals to improve clinical strategy development and deliver high quality clinical trial monitoring, data management and project management to speed product introduction.
For more information or to register, visit http://www.iirusa.com/medicaldevice/homepage.xml

December 21, 2010

MDCI is pleased to sponsor the free InHealth Webcast, “Agency, Industry, and the 510(k) Process”

For medical device manufacturers doing business in the United States, the primary route to market has historically been provided by FDA’s premarket notification (510(k)) product review process. But in recent years, the effectiveness of the 510(k) process has come under increasing scrutiny from many quarters–including consumer groups, healthcare professionals, and payers, as well as employees of both device companies and FDA.

The webcast will be held live, December 22 at 2PM Eastern, and will be available on demand for those who cannot attend the live event. For more information visit http://event.on24.com/r.htm?e=273101&s=1&k=1561558D7E27066FABCEDC2EA88F13C2

August 2, 2010

MDCI to present
“Medical Device Complaint Handling:
What the New FDA Wants to See Today (and How to Show Them)”

On August 4, 2010, Judy Andrews, Director of Quality and Compliance Services, will present a 90-minute webinar to discuss the changing FDA compliance environment, which includes greater emphasis on complaint investigation and follow-up. Participants will learn how to how to ensure their complaint handling systems are proactive, effective, and compliant. Following this interactive session, attendees will know:

• The first thing you should do when a possible complaint comes in
• How to determine if a complaint should be investigated
• Strategies to prevent the 7 most common complaint failures
• 9 channels a complaint can come through, and how you should monitor them
• 6 elements to include in every complaint file
• When complaint coincidences become trends, and how they inform investigations
• How to ensure your complaint handling integrates fully into your overall CAPA program
• Documentation that effectively shows investigators you are handling complaints successfully

To register and find additional information, visit http://pages.elsevierbi.net/AC080410LP/.

This inspection of MDCI, a medical device and diagnostics contract research organization (CRO) involved in the conduct of clinical trials and regulatory services, was one of the first of its kind.  According to Michael Marcarelli, Director of the Division of Bioresearch Monitoring, Office of Compliance, Center for Devices and Radiological Health, in a presentation at the 2010 ACRP global conference entitled, “Outsourcing Medical Device Trials – FDA and Industry Perspective,” the FDA has embarked upon an initiative to improve the quality of clinical research through increased scrutiny of vendors that assist medical device companies in the conduct and reporting of FDA regulated clinical research.  This increased scrutiny is taking the form of routine, on-site inspections and data audits of a variety of vendors, including CROs, core labs, and others.

Previously, FDA inspections of medical device CROs were study-specific and, in essence, audits of specific safety and clinical data at CRO facilities.  The new interpretation of “inspection” in the Investigational Device Exemption regulation (21CFR Part 812.145) appears to extend the FDA’s jurisdiction to mandate access to the vendor’s quality system and all clinical study records.  Even though there is typically no transfer of responsibility from the sponsor to the CRO under the medical device regulations as stated in the background section of CDRH’s Bioresearch Monitoring Compliance Program 7348.810, FDA may now enter a CRO, request a listing of all applicable studies at the facility, select specific studies to review, and access all files as previously done in an announced, study-specific manner.

MDCI is pleased that no deficiencies were found during this inspection.  The experience was viewed as educational for all involved.  This initiative is another indication of the changing environment at FDA, as well as CDRH’s intention to raise the bar on clinical trial conduct and to improve the quality of safety and effectiveness data collected in support of new medical device product introductions.

June 2, 2010

Medical Device Consultants, Inc. Completes Successful FDA Inspection

June 2, 2010, North Attleboro, MA – Medical Device Consultants, Inc. (MDCI), a full-service regulatory consulting firm and contract research organization (CRO) serving the medical device and diagnostics industry, underwent a routine surveillance inspection by the FDA, March 3 through March 16, 2010, at its corporate headquarters. MDCI’s Quality System and clinical departmental SOPs were audited. In addition, FDA asked to review the study files for three active clinical trials. The Establishment Inspection Report (EIR) stated there were no significant concerns, no 483 was issued, and no response was required.
Leslie Rose, Director of Clinical Services, commented, “MDCI staff has demonstrated our commitment to adhering to the highest quality standards in the conduct of medical device clinical research. We are obviously pleased with the results of the FDA inspection. We work diligently to maintain high quality standards and are pleased to continue to demonstrate our efforts to sustain and continuously improve the quality of MDCI’s services.”

About MDCI

Founded in 1980, MDCI has helped hundreds of clients conduct successful medical device and IVD clinical trials, achieve regulatory clearance and approval, and maintain compliance for innovative and cutting-edge medical products and technology in the U.S., Europe, Canada, and internationally. By leveraging MDCI’s comprehensive knowledge of FDA and international regulations, clients capture and grow market share, increase productivity, and stay competitive in an increasingly complex global marketplace. MDCI has offices in Massachusetts and California.