June 24-25, 2009 — Rosemont, Illinois
Nerac Analyst Marco Bafan will be presenting "Keys to Offshoring/Outsourcing."
In a multi-billion dollar contract manufacturing market, industry reports estimate 15% annual growth rate for outsourced manufacturing in medical devices until 2010. Offshoring and near-shoring are increasingly becoming preferred business strategies for many companies due to cost savings factors. Until recently, however, medical device makers have not taken full advantage of offshore outsourcing. Regulatory issues have always presented a major stumbling block, and companies are not always confident that offshore workers would possess the skills to become good partners. That view is changing as these nations’ workers continue to develop skills and gain the certifications necessary to meet regulatory requirements.
With outsourcing/offshoring becoming a common practice across various industries, orthopaedic companies need to pay more attention and be more aware of potential risks and obstacles far in advance to avoid costly mistakes. Among the many factors orthopaedic companies should consider, a calculated cost analysis and a thorough productive labor force evaluation are particularly essential for choosing the right offshoring/outsourcing partner. With many OEMs already practicing outsourcing/offshoring, certain valuable experiences have arisen that orthopaedic companies may follow and utilize to gain better outcomes.
Some of these guidelines and recommendations will be discussed and explored in the following sections:
- Key steps in effective outsourcing-cost structure, accountability, regulations, resource optimization
- Supplier evaluation-outsourcing strategy, business profile and capabilities
- Implementation of the outsourcing/offshoring selection process- what work will be outsourced and how to find the right fit
- Anticipation of potential conflicts - how to define expectations and products, how to map out the process
To learn more about the presentation, please click here.
Nerac Analyst Deb Schenberger, Ph.D., will present “Clinical Literature Reviews and Regulatory Changes in Europe.”
With a rapidly approaching March 2010 deadline to comply with the European Union (EU) revised Medical Device Directive, many medical device manufacturers are faced with an enormous amount of work to complete in a short period of time. At stake is maintaining or increasing share in the growing $86 billion market that accounts for a significant percentage of most U.S. medical device companies’ profits. With nearly 8,000 devices on the EU market, it is possible that a backlog of applications could bottleneck approvals, with serious implications for sales and profits. Companies need to analyze product data now to make certain that they have initiated the required procedures to prevent disruptions to sales pipelines.
Directive 93/42/EEC of the European Parliament and of the Council, which still relies upon "Guidelines on Medical Devices―Evaluation of Clinical Data: A Guide for Manufacturers and Notified Bodies," MedDev 2.7.1, requires manufacturers of any medical device sold in the EU, even those currently bearing CE Markings, to show proof of safety and efficacy before it can be sold in any of the 27 EU member nations.
Changes to Medical Device Directive
Among the most important changes is the definition of what clinical data can be used to demonstrate safety and performance. Clinical trial testing is one option, though it requires a lengthy, expensive process. An alternative is a clinical literature review of published data for similar devices. However, new guidelines tighten equivalence rules, requiring reviewers to establish an exact comparison. To meet the new requirements, medical device manufacturers are encouraged to employ outside parties to conduct independent evaluations and ensure compliance with the new rules. Conducting the literature review is the first step to discovering whether an exact comparison can be made and supported or whether the company needs to engage in a clinical trial.
Why Clinical Literature Reviews
Clinical literature reviews constitute effective alternatives to time-consuming and costly clinical trials that entail recruiting expert investigators and vetting them for conflicts of interests, recruiting large numbers of volunteers, and investing long periods of time to record and evaluate the results. In some cases, it is infeasible to recruit enough volunteers to test a new medical device, making clinical trials impossible without including the results of a meta-analysis of the clinical literature. So even with the new rules, literature reviews present a more efficient path to approval.
A clinical literature review entails gathering and examining clinical data to assess risk, benefit, and performance of devices similar to the product under review. Only clinical data, which the European Commission guidelines define as information relevant to the various aspects of the clinical safety and performance of the device, can demonstrate that the device conforms to regulatory requirements.
To learn more about the presentation, please click here.
