Track 1

:: Session 111

The Changing World of Medical Device Standards

Charles Sidebottom, Medtronic

Abstract - For years, the industry wanted regulators to use standards as a part of their regulatory scheme, and now they do. The ever-growing importance of “voluntary consensus standards” in regulation around the world has significantly altered the way these standards are being developed and used. We want the standards development process to be agile and efficient, yet the documents being produced are being viewed with the same intense scrutiny as the regulations they support.

Level: Basic

Session 112

ISO 13485 Certification: Coming of Age?

Art Ward PhD, President AJW Technology Consultants

What are the benefits of ISO 13485 certification for medical device firms? Do some firms have a different conclusion? This ISO certification is finally coming of age. The requirements for this certification continue to increase world wide. Find out why.

level: Basic to Intermediate

Sessions 113 & 114

CAPA Challenges Gateway Qualification or the Path of Least Resistance

Art Ward PhD, President AJW Technology Consultants

Abstract – The CAPA process looks at Risk, Impact and Resources as well as Safety. Such a process should involve a team that also considers urgency and impact. What should I measure to verify or validate corrective action and show no adverse effect before implementation? How can I track measurements over time to confirm effectiveness? These are essential questions in the CAPA process. Learn the answers to these questions and how to implement them.

Level: Basic

Track 2

Session 121

Recalls: A Case Study

Tim Phillips and Kristy Zuroski, FDA

Abstract – A recall is the removal or correction of a marketed product that the FDA considers to be in violation of the laws it administers and against which the agency would initiate legal action (e.g., seizure). 21 CFR 7 sets forth procedures for FDA to monitor and assess the adequacy of a recall. It also provides guidance for manufacturers and distributors to follow. Recalling firms must develop a recall strategy that addresses a number of factors. This presentation will cover some of the key factors that need to be considered when a recall situation arises.

Level: Basic

Session 122

FDA 101

Janis Armendariz, Lt. Commander US Public Health FDA

Abstract – Medical device companies are faced with a myriad of challenges including the need to understand and comply with FDA regulatory requirements. This presentation will cover the basic aspects of establishment registration, Medical Device Listing, Pre-market Notifications (a.k.a. 510(k)'s) and Premarket Approvals (PMA's), Quality System Regulation (a.k.a. Good Manufacturing Practices), and Medical Device Reporting.

Level: Basic

Session 123

FDA Panel

Tim Phillips, Janis Armendariz and Kristy Zuroski

Session 124

Lean and Experience Management in Healthcare

Dave Harreld

Abstract - This session is intended for Clinicians, Administrators, and Continuous Improvement Teams in Healthcare. “Lean” began in the manufacturing industry in the early 1980’s. It has since proven to be a much sought after and successful tool in Healthcare. Coupled with “experience management”, Lean has reduced costs, eliminated waste, and increased patient satisfaction by increasing the doctor/patient portion of the encounter in the healthcare processes. Attendees will take away quick and easy to apply methods to address lean and experience management in any aspect of healthcare. This session is being presented by a Lean expert who led a delegation to Japan.

Level: Basic

Track 3

Session 131

Auditing in a Regulated Environment: Process Validation and CAPA

Dennis Arter - (The Audit Guy) Consultant and world renown trainer

Abstract - The four rules for conducting any audit – Learn the four rules and understand the special considerations for internal and supplier auditing in the medical device community. Not to be missed for Dennis is a great speaker who travels world wide.

Level: Basic

Session 132

Design Control

Dr. Andre Routh, BSI Consultant, 3M

Abstract – This presentation will compare and contrast the FDA process with ISO 13485:1996 design control process, and will demonstrate the close correspondence between them and the European harmonized standard for medical device systems. The previous version of this standard contained a section (Section 4.4) titled Design Controls, whose intent was very similar to that of the FDA in 21 CFR 820.30. The FDA document on design controls (FDA 21 CFR 820.30) combined with the Global Harmonization Task Force, produced guidance for Device Manufacturers.

Level: Basic

Session 133

Auditing and the Discovery Process - How to reduce your risk

Marilyn Pehl, Consultant

Abstract - It seems that every other day we read or see in the media about some medical device company having to recall a particular product. This announcement is more often than not followed by a blizzard of solicitations for people to join a class action suit. At this time that you will find your audit program and associated reports being scrutinized as part of the discovery process. If your audit program isn't designed to reduce the risks of providing evidence of product or product deficiencies, you find that the words that were once used to identify areas for improvement can and will be used against your organization. This presentation will help you design an audit program that drives the appropriate corrective/preventive actions while reducing the liabilities.

Level: Basic

Session 134

Understanding Capability Indices

Louis Asher, 3M

Abstract - Capability Indices are used by a variety of companies. They provide “The Voice of the Process” as compared to “The Voice of the Customer”. This session will provide a good and humorous explanation of Cp, Cpk, Pp and Ppk. Many companies use Capability Indices (i.e. CP, CPK, PP, PPK) but a lot of their employees are confused by them. This brief session will allow one to pictorial view and understand these concepts. The Minitab software will then be used to calculate them. Attend this session and you will be able to intelligently use these terms.

Level: Intermediate

Track 4

Session 141

Reduce Risk through the Design Inputs Phase

F. David Rothkopf, President MEDIcept, Inc.

Abstract – Each company is responsible for reducing risks and putting appropriate controls and monitoring methods in place. Continuous vigilance of potential product hazards is required throughout the product lifecycle to achieve the product safety. To reduce risk efficiently, companies must apply risk management techniques early. During the Design Input phase and on through the Verification phase, the design should be challenged for potential risks and human factor errors. Only by minimizing or eliminating hazards and efficiently developing contingency plans can risk be mitigated. Methods of post-release monitoring of case report forms and complaints must be fed back into the system to ensure a continuous loop of increase risk knowledge.

Level: Basic to intermediate

Session 142

Enterprise Risk Management

Angelo Scangas, Consultant Enterprise Risk Management

Abstract - Even the most conservative organizations face an array of risks: financial, operational, compliance, security and other forms. For business leaders, this means continued pressure on time, resources and business performance, with more and more attention focused on risk. Yet the greatest risk organizations face may be the risk of lost opportunity. Companies must see risk challenges as opportunities to add value and gain a competitive advantage. By actively managing risk, companies weave risk management into the fabric of the business: Identifying, measuring, controlling and monitoring all types of risk on an ongoing basis.

Level: Basic to intermediate

Session 143

Risk Assessment for Medical Device Business

Russ Ziebel

Abstract – This session will cover how ISO 14971 can be used as the framework for risk assessment performance that can also cover business risk. How risk assessment can be performed systematically to manage the medical device product and business making decisions. This session makes the connection of managing risk to the patient, but also the customer and market segment that the organization has chosen. How judgments of the producer are related to safety, in order to determine suitability in the market place.

Level: Basic

Session 144

Integrating Circuits into a Disposable Microfluidic Biosensor Cartridges; Challenges in Manufacturing, Quality, and Regulatory Hurdles

Mark Tondra, Chief Manager, Diagnostic Biosensors, LLC

Abstract – DB is developing a platform for designing and manufacturing biosensors that combine high performance with the ultra-low cost, portability, and ease-of-use of a disposable consumer item. Specific microchip tools include magnetic nanobeads for biochemical capture and labeling; plastic microfluidic cartridges; and integrated circuit chips for detection and manipulation of the beads. This work falls into a broader category of development called “Lab-on-a-Chip”. This talk will begin with a general overview of magnetic sensors and nanobeads; and the application of these in bioanalytical systems. Then, some descriptions of specific development in progress towards low cost biosensor system using new technology. Needless to say, the story is not yet finished!

Level: Advanced