Carol Ryerson Appointed To Critical Board Member Position For Industry-Leading In Vitro Diagnostics Trade Association

FOR IMMEDIATE RELEASE: Lisa Olson, 952-224-2259, lolson@rcri-inc.com
On November 13, 2017, Association of Medical Diagnostics Manufacturers (AMDM) announced the appointment of Carol Ryerson, Ph.D. to their Board of Directors. Dr. Ryerson will serve a three-year term leveraging her 30+ years of experience in the medical device industry.

Carol Ryerson is one of RCRI’s Senior Principal Advisors in Regulatory Affairs and specializes in regulatory and clinical strategies for IVDs and medical devices. As a member of the AMDM Board of Directors, Dr. Ryerson will be responsible for ensuring the mission of AMDM is accomplished by setting policy, overseeing programming, and developing relationships within the medical device and regulatory communities.

Ryerson said, “I am pleased to join the Board of AMDM who have tremendous depth in the medical diagnostics industry. One of the main benefits this organization offers to members is a connection with FDA staff from the Office of In Vitro Diagnostics and Radiological Health who participate in all of the AMDM organized conferences.”

About Association of Medical Diagnostics Manufacturers
AMDM serves as a nonprofit trade organization to advance in vitro diagnostic development through educational programs, technical information exchnges and interactions with regulatory agencies. From the AMDM articles of incorporation, they state their purpose as: “It is the purpose of this organization to raise the standards of excellence, now prevailing, to even higher levels. To attain this goal, we propose the exchange of technical information among members of the industry and mutual assistance in the formulation of, and compliance with, regulatory legislation standards and protocols.”


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RCRI News April 2017


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RCRI Announces Health Economics/Reimbursement Senior Principal Advisor, Thomas Hughes

Tom HughesWe’re pleased to announce that Thomas Hughes, JD has joined RCRI in the role of Health Economics and Reimbursement Sr. Principal Advisor. Hughes is senior level executive and attorney with nearly 20 years of experience in the medical technology industry and 7 years practicing healthcare law with a major Minneapolis law firm representing physicians, hospitals, and other providers. In his years in the medical technology and legal arenas, Hughes helped advise and provide leadership for start-up and national companies by using a keen eye for strategic planning blended with the unique expertise in developing and executing reimbursement strategies and payer relations initiatives with payers, provider groups, government agencies, and other key decision makers.

In his position, Hughes will be expanding RCRI’s strategic consulting and operational services as well as maintaining relationships. “I see RCRI as a strong, preferred partner to medical technology companies,” stated Hughes. “RCRI provides deep expertise to create customized, innovative partnerships that, in addition to providing end-point services, also truly engage medical technology companies to identify and implement their strategic and business growth needs. These services will be well received by growing medical technology organizations.”

“Health economics and reimbursement is one of the most critical emerging issues in the device space today. Tom’s expertise and problem solving approach in this area will be of tremendous help to our clients in creating novel and effective strategies. We are extremely impressed with his accomplishments and his leadership qualities and are thrilled to appoint him to this position.” stated Lisa Olson, the company’s President.

Hughes holds a BA in Political Science from the University of Minnesota and a JD from the William Mitchell College of Law and is a member in good standing with the Minnesota State Bar Association. He continues active engagement as a member of the Executive Council Member of Health Law Committee and the FDA Regulatory Committee. He is also active in both the Medical Industry Leadership Institute at the University of Minnesota’s Carlson School of Management and the Neurostimulation Device Alliance.

RCRI Announces Senior Principal Advisor, Regulatory Affairs and Quality Systems, Kim Tokach

Kim Tokach has joined RCRI in the role of Principal Advisor, Regulatory Affairs and Quality Systems. With over 20 years in the medical device industry, Tokach has proven leadership in the development and implementation of global regulatory strategies, process, and staff. She has led many successful interactions and negotiations with the FDA on IDE, PMA and 510(k) submissions and she directed over 90 regulatory submissions for OUS clearance.

“I am excited to join a consulting organization that is in the forefront of helping clients address their most significant and urgent challenges,” Tokach commented. “I have known of RCRI for a long time and the time was finally right to for me to join this impressive team. It’s exciting to be with an organization with such depth of experience in the biomedical industry.”

Previously, Tokach led the regulatory team at Fortune 500 medical device company where she had direct oversight and responsibility for integration and remediation activities, global strategies, FDA, QSIT, and ISO audits, labeling processes, and multi-site UDI compliance. She has worked with teams at medical device and OEM companies during the initial phase of product design through commercialization.

“Kim’s accomplishments in the industry are extremely impressive and her leadership qualities are outstanding. The RCRI team is thrilled to have her join the company.” commented Lisa Olson, President at RCRI.

Tokach’s medical product experiences emphasize urology, oncology, spinal, implantable biologics and radiology. Her education was at San Diego City College and St. Catherine’s University in Minnesota.

For additional information, contact Kim at ktokach@rcri-inc.com or Lisa Olson, RCRI President, at lolson@rcri-inc.com.

 

RCRI Welcomes Senior Principal Advisor, Clinical Sciences, Mary Kay Sobcinski

Mary Kay Sobcinski, RN, MHA, has joined RCRI in the role of Senior Principal Advisor, Clinical Sciences. In her 20 years of experience in the medical device industry, Sobcinski has worked for both sponsor and contract research organizations – giving her a unique perspective on the goals and necessities to successfully bring new medical devices, diagnostics and combination products to market.

Sobcinski said, “I am very happy to join the extraordinary consulting experts at RCRI who have tremendous depth of industry knowledge and to add my expertise to partner with medical device innovators.”

Sobcinski’s expertise spans the strategic design and development of innovative and successful clinical trials for medical products including global IDE and IND trial approvals. She also has extensive international regulatory experience involving multiple negotiations with FDA, Health Canada, Notified Bodies, and the Therapeutic Goods Administration (Australia).

“I am so pleased to have an expert of Mary Kay’s caliber joining the RCRI team. Her background in both the CRO and manufacturing settings provides her with a distinct advantage in crafting effective clinical strategies to address the most challenging problems medical device manufacturers face today.” commented Lisa Olson, RCRI President.

Sobcinski’s medical product industry experiences emphasize cardiovascular, neuromodulation, spinal, gastrointestinal, and infectious diseases indications. She combines her extensive medical product experience with healthcare administration and nursing backgrounds to bring a unique approach to corporate, clinical and regulatory strategic planning, marketing, project management and problem solving.

She obtained a Bachelor of Science degree in Nursing from Loyola University Chicago and a Master’s degree in Healthcare Administration from the University of Minnesota.

Contact Mary Kay at mksobcinski@rcri-inc.com

 

RCRI Announces Senior Principal Advisor, Regulatory Affairs, Carol Ryerson

Carol Ryerson, Ph.D. has joined RCRI in the role of Senior Principal Advisor, Regulatory Affairs. Ryerson specializes in regulatory strategy, clinical affairs, and research and development for the IVD and medical device industry.

CarolRyerson

In her 30 years of experience in the medical device industry, Ryerson has developed domestic and international regulatory strategies, drafted submissions, and negotiated their approval by FDA and other regulatory agencies. Leveraging her years of R&D and product development experience, Carol has worked with teams at IVD and medical device companies during initial phases of product design to provide regulatory support and guidance, clinical study design, and/or labeling/advertising and promotion reviews. Carol has supported product registrations for clinical chemistry systems and reagents, coagulation systems and reagents, infectious disease IVDs, imaging devices in mammography, oncology, and general radiology.

Based in Boston, Massachusetts, Carol holds a Bachelor’s degree in Chemistry from the College of the Holy Cross, and a Ph. D. in Biochemistry from the Massachusetts Institute of Technology.

Carol’s experience enhances RCRI’s knowledge and experience base of IVD product development which includes regulatory strategy, study design and execution, statistical support, data analysis, reporting, and regulatory submissions across a wide range of applications, e.g., coagulation, hematology, cardiac, gastrointestinal, urology, pulmonary, women’s health.

Contact Carol at cryerson@rcri-inc.com

 

RCRI Announces a New President

RCRI has announced the position of President is being transitioned from Mandy Klosterman, JD to Lisa Olson, MBA. Mandy has made many wonderful contributions to RCRI over the years and is now retiring.   We thank her for her dedication and leadership and wish her much happiness.

LisaOlsonRCRIphotoWRCRI was fortunate to pass the scepter to Lisa Olson effective April 27, 2015. Lisa previously held several leadership positions at WuXi AppTec, most recently as Vice President, Marketing and Technical services, working with the business and technical teams to develop new markets and services in the medical device and biopharmaceutical industries. She started her career at the University of Minnesota developing monoclonal antibodies and later joined ViroMed Laboratories for the development of new testing services as well as serving as Study Director for all genotoxicology assays. In her tenure with WuXi AppTec, she oversaw facility operations and laboratory workflow, development of new methods and SOPs, test protocols, and staff training. After WuXi Pharmatech’s acquisition of AppTec Laboratory Services, she led efforts to implement biocompatibility testing programs in China, including the development of testing programs and staff training.

Lisa received her undergraduate degree in Microbiology from the University of Minnesota and her Masters of Business Administration from the University of St. Thomas.  She has co-authored numerous ISO Biocompatibility Standards, served as a Co-Chair of the AAMI/ISO Technical Advisory Group on Cytotoxicity, and sits on working groups related to materials safety for the Association for the Advancement of Medical Instrumentation (AAMI) and the American Society for Testing and Materials (ASTM).

We look forward to Lisa’s business leadership experience from complimentary scientific and FDA-regulated service industries. As noted above, she has held numerous executive positions within which she has been responsible for directing research and business management in accordance with FDA regulatory requirements for the medical device and biopharmaceutical industries.

Should you have an opportunity to visit RCRI’s Minneapolis office, Lisa would appreciate the opportunity to meet you.

Stephan Norsted, PhD
CEO

 

RCRI offers Merge Healthcare EDC as a Certified Developer

“eClinicalOS” from Merge Healthcare is a unified, cloud-based system that offers all of the EDC and study capabilities you need. It’s flexible and scalable so RCRI can configure it precisely to any workflow. Choose the features you need and pay for only what you use. Best of all, your study can be up and running in weeks, not months.
With RCRI utilizing eClincalOS, you have expert advisors and exact practices configuring a solution that leverages years of intelligent design to meet all of your stakeholders’ needs and your project’s evolving demands:

  • Choose what you want: RCRI will help to define your system, selecting only those features and services that fit your needs.  Optional modules allow full customization, flexibility, and cost savings. For example,
    – Electronic patient reported outcomes: Merge eClinicalOS has one of the best and easiest systems available today.
    – Endpoint Adjudication Module: Eliminate expensive paper processing and face-to-face meetings.
  • Pay as you go: Maximize savings as you only pay for the features you use when you use them, with no long-term contracts.
  • Eliminate upfront capital costs: No upfront licensing costs like other systems.
  • One system. One database. One platform. All in one place.: Login to a single, secure URL from anywhere using any browser or mobile device running iOS, and your complete data set is right at your fingertips. Interface allows quick document upload and storage.
  • Learn only one interface: Use one part of eClinicalOS, and you’re ready to master all the rest (Study Start-up tracking, randomization).

Find out more about how RCRI utilizes Merge eClinicalOS as a standalone solution for EDC and Data Management services, as well as its crucial role as a solution for your full-service clinical trial needs. Contact Mike Anderstrom at manderstrom@rcri-inc.com
June 27, 2014

Significant challenges to medical device studies demand strategic thinking from collaborative advisors with deep medical device expertise and full operational services.

RCRI is the medical device consultancy that works with you, offering you advice and support from our team of experts with complete services for the most complex trials. Our approach examines every detail of your product to uncover opportunities, reduce cost, and improve timelines.

We help you achieve your goals by developing robust evidence in support of market acceptance.
RCRI has:

  • Broad, in-depth knowledge of medical device, IVD, and combination product development in a variety of therapeutic areas.
  • Full breadth of operational services for complex trials.
  • Scientific advisors that will address the most formidable changes in today’s medical device global environment.

More than 500 companies worldwide – from entrepreneurial start-ups to Fortune 100 market leaders – have experienced the value of RCRI’s expert insights and have achieved their product goals. Contact Todd Anderson at tanderson@rcri-inc.com

RCRI Announces David France as Principal Advisor

Regulatory and Clinical Research Institute, Inc. is pleased to announce that David France has joined RCRI in the role of Principal Advisor. Prior to this role, France served as the Director of Clinical Affairs at St. Jude Medical.

France said, “I am very happy to join RCRI’s highly respected team of experts and add my experience and knowledge to help our clients navigate an increasingly complex healthcare landscape.”

In his 28 years of experience in the medical device industry (25 years in clinical studies), France has held leadership roles in clinical affairs, regulatory affairs, and training for both small and large companies. His extensive knowledge in a wide variety of clinical and regulatory settings and geographies includes, but is not limited to, strategic planning (including Class III active implantable devices), protocol development, enrollment strategies, report authorship, FDA advisory panel preparation, extensive site and investigator management, and publication strategy development and support.

Additionally, France has built and managed numerous clinical study teams both in-house and in the field and he has utilized his training expertise to strengthen clinical operations and provide highly technical product education to physician customers, sales teams, and field engineers.

Mr. France holds an undergraduate degree in Biology from Gannon University, and has completed graduate-level science coursework in Bioengineering at Pennsylvania State University.

Contact David at dfrance@rcri-inc.com

RCRI Welcomes Kim Knish as VP of Clinical Research and Health Economics

Regulatory and Clinical Research Institute, Inc. (RCRI) announced that Kimberly Knish has joined RCRI in the role of Vice President of Clinical Research and Health Economics. Prior to this role, Knish served as the Vice President of Worldwide Regulatory Affairs and Clinical Trials at EndoStim, Inc.

“We are very excited to have Kim join RCRI. In addition to her extensive technical expertise, Kim brings strong business acumen and strategic thought-leadership. Her role merges the RCRI Clinical and Health Economic departments for a collaborative approach to address regulators and payer expectations for new and existing products and therapies,” said Mandy Klosterman, RCRI’s President.

Knish said, “I am delighted to be joining RCRI’s team of industry leading experts who are committed to client service and delivering high-quality research results. I look forward to contributing my experience to help our clients navigate an increasingly complex healthcare landscape.”

In her 18 years of experience in the industry, Knish has held leadership roles in clinical affairs, regulatory affairs, quality assurance and health economics. Her prior clinical research experience spans the industry from start-up companies to Fortune 100 medical device companies, including Medtronic and St. Jude Medical. Her experience includes the development and execution of a clinical research program for a multi-physician clinic practice. Her prior regulatory affairs experience includes responsibility for creating and leading a global team responsible for regulatory compliance and product approvals in more than 100 international markets. Ms. Knish holds an undergraduate degree in Biology from the College of St. Benedict, a master’s of science in management from Cardinal Stritch University, and has certifications in clinical research (CCRP) and regulatory affairs (RAC-EU).

Contact Kim at kknish@rcri-inc.com to learn more about RCRI’s clinical and health economics services.

UDI to Bring About “Huge” Changes in Medical Device Identification”

reposted from PMPNews.com, October 28, 2013

Unique Device Identification (UDI) will bring about a “huge global change” in the way medical devices are tracked and identified, Amy Fowler told MD&M Minneapolis conference attendees. Fowler, who serves as a Principal Advisor in Regulatory Affairs at RCRI, presented “UDI Draft Guidance on GUDID and Perspectives on Practical Implementation and Planning for Companies” on Monday, October 28.

MJ Wylie, senior director, healthcare, for GS1 US, later outlined how to employ GS1 standards when instituting UDI, speaking after Fowler in “The Next Steps in UDI Implementation.”

Fowler outlined the final UDI regulation and explained what will be expected of medical device companies over the multiple-year rollout. “Every medical device label must have a UDI, and every medical device package must have a UDI, but there are some exceptions,” she explained. If a company causes a label to be applied to a medical device with the intent to distribute comercially, that company must comply with the rule, she added.

Fowler also explained FDA’s draft guidance for the Global Unique Device Identification Database (GUDID), which was published September 24. She encouraged attendees to review the draft and submit comments to FDA before its 60-day comment period ends. Wylie later explained how companies could use GS1’s Global Data Synchronization Network (GDSN) to publish UDI data to the GUDID.

UDI is essentially “a reference number,” and with it FDA hopes to decrease medical errors and identify the devices associated with adverse events and recalls, Fowler explained. UDI will help users make “quick decisions” and answer questions such as whether a medical device is MRI compatible, she added. “And it will bring more efficiency to the system.”

UDI consists of a mandatory, static device identifier (DI) along with a conditional, variable production identifier (PI); the UDI must appear in plain human readable text and in automatic identification and data capture (AIDC) technology. A new UDI is required with every new version of a medical device and every new package, Fowler added.

Fowler explained that single-use devices (SUDs) packaged together and not intended for individual distribution do not need to carry UDI on their individual packages, just on the master package. And devices within kits bearing UDI have an exception where they will not be required to bear a UDI, she explained after the conference.

“Every company has to go through its product lines to see what exemptions apply,” she said.

Some of the more debated aspects of the UDI draft were changed in the final rule, such as date formatting and direct-part marking, Fowler said. “The standardized date format is now aligned with international standards: YYYY-MM-DD,” she said. “And direct part marking is not required for implants, but it is required for devices intended to be used over and over again and reprocessed.” Directly marked UDI can be identical or different from label UDI, and it can be text or AIDC or both, she explained. “And there are exceptions to direct part marking, if it interferes with safety or effectiveness or is not technically feasible.”

FDA can grant or rescind exceptions, and it will make those decisions available on its Web site. “Any labeler can use that exception, even competitors,” she said.

The rest of the world is following FDA’s UDI efforts closely, Fowler added. A common UDI “very similar to FDA’s UDI” was proposed in March 2013 and is expected to be adopted in 2014, followed by an implementation period, she said. And “Turkey has been a pioneer in requiring UDI,” she said.

Wylie explained how GS1’s Global Trade Item Number (GTIN) could be used for UDI. She then explained how the GDSN, which consists of multiple data pools around the world, is a “probable mechanism to publish UDI to the FDA GUDID,” adding that “the GDSN allows you to publish data once to FDA and to your customers.”

“As a summary UDI is about marking your products and submitting that to FDA,” Wylie added. In other words, medical device companies need to “mark labels with UDI, and submit the multiple required data attributes to the GUDID.”

Attendees interested in learning more were invited to sign up for “GS1 Healthcare US Open Industry Calls” at www.gs1us.org/hcudi and to visit FDA’s UDI Help Desk at www.fda.gov/udi.

UDI implementation deadlines are as follows: September 24, 2014, for Class III devices; Class II/I implants and life-supporting/sustaining September 24, 2015; the rest of Class II September 24, 2016; and finally Class I devices September 24, 2018.

 

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