5 Questions from the Booth: NAMSA
By MPO Staff | 11.20.17
A medical research organization provides product testing, clinical trial, and regulatory related services.
MPO: What technology or service are you emphasizing at Medica this year?
Rachid Zerouali: NAMSA will be meeting with attendees to discuss our one-of-a-kind MRO Approach—a unique strategic process that offers guidance and tactical support for the full device development continuum for product testing, clinical trial management, and regulatory consulting initiatives.
This proven methodology—whereby medical device development activities run concurrently—provides significant time and cost efficiencies to global manufacturers. For example, preclinical testing and regulatory strategy initiatives often occur in tandem, while related clinical trials are executed throughout the duration of a development program.
NAMSA will have testing, clinical, and regulatory experts on hand for complimentary 1-hour consultations to discuss services offered by our team of 1,000 experts throughout 13 locations in Asia, Europe, and North America. We will also highlight information on our soon-to-be-opened ISO 10993-18 medical device testing lab in Obernburg, Germany (Spring 2018), which will offer exhaustive extraction, FTIR, GC-MS, LC-MS, and ICP-MS services.
MPO: What’s the most common challenge customers inquire about and how do you address it?
Zerouali: Globally, medical devices are increasingly being utilized in outcomes-based environments and this requires a well thought-out, all-encompassing medical device development strategy from laboratory testing, regulatory/reimbursement, clinical communications, and commercialization.
Many of NAMSA’s private start-up clients come to us because they do not have the resources necessary to observe development situations in a comprehensive manner, while large companies often have too many siloes to effectively use their resources appropriately. NAMSA, along with our partners, possesses the resources necessary to cohesively develop the required strategies medical device organizations need to differentiate, win market share, and create long-term product success.
Put simply, the alignment of device requirements and involving necessary stakeholders unlocks the value of NAMSA’s service offerings.
MPO: If you could give one piece of advice to companies seeking a manufacturing partner before they make a decision, what would it be?
Zerouali: One of the most important factors for successful product development and market introduction is to own your own quality management system, especially with the industry’s increased focus on risk-based approaches.
Global medical device manufacturers realize several benefits by having control over a proprietary system, including streamlined SOPs that lead to better supplier control, improved monitoring oversight, increased organizational efficiencies, and significant cost reductions due to fewer failed manufactured parts.
MPO: What are the forces driving medical device manufacturers to seek your technology/services over doing it in-house?
Zerouali: There are several driving forces that are requiring manufacturers to outsource all—or portions of—their product development efforts. These include the industry’s ever-changing regulatory environment (e.g., MDR, IVDR, ISO) that is outpacing a manufacturer’s ability to make or keep legacy products in compliance. In addition, the increased requirements surrounding clinical trial data also make it challenging for manufacturers to keep up with obligations with existing internal resources.
It is important for manufacturers to select a product development partner that has extensive experience with the medical device industry’s changing regulatory and clinical standards, and has a proven track record of providing plans that accommodate a range of commercial and geographic strategies that lead to success.
MPO: In what ways is your company able to aid in getting a product (project) to market faster?
Zerouali: Through the utilization of NAMSA’s MRO Approach, global manufacturers are able to realize significant time and cost savings on their way to market. NAMSA, by managing each development program as a whole—and not just divided segments or requirements (i.e., preclinical, clinical, testing, and regulatory)—is able to create efficiencies by running multiple project initiatives concurrently. In fact, a recent example of this approach delivered French biosurgical firm, Biom’Up, 23 months in time savings and $17M in cost savings throughout the duration of their IDE/PMA program in the United States.