With the unsteady economy and the ever-changing regulatory world that we find ourselves in, strong design controls within the medical device and biotech industries are a necessity. When faced with a multi-million dollar recall, no medical device company wants to wish it had instituted more robust design controls. Therefore, having a solid design control system is a must in the world in which we live.
By instituting QbD within the design control area potential impacts may include a flexible regulatory process which may be applicable, the offering for timely manufacturing process improvements, and a high mitigation of risk.
TOTAL PRODUCT LIFECYCLE: All new medical devices start out in the concept phase. Questions which are asked typically include:
Increasingly, new product launches have become combination products. In order to facilitate any FDA issues, the question needs to be answered in relation to what makes the product different or new to the marketplace: are the indications for use going to be new to clinical applications? There may be older features of the new product that have already undergone an FDA regulatory submission. The onus on the developers is to ensure a safe and effective device design via reasonable controls within the critical performance specifications.
If a new material is to be evaluated, there may be standards from international organizations or from FDA that deal with specific biomaterials or provide a model for the evaluation of a new material.
FDA's policy has historically been to provide medical device companies with the least burdensome path to market for both PMAs and 510(k)s. As medical device designs approach marketing, the specifications of manufacturing become more important during the course of the design project. The total product cycle components overlap and interconnect. Medical devices are "multigenerational." Information is gathered from one part of the life cycle and may be applied to the redesign of a next generation. Many types of medical devices have very short life spans on the market and are replaced by the next version of the device which may offer enhanced functionality, improved user interface, faster response time, etc. Medical device designs are viewed in this industry as a pipeline of innovation and offer room for continual design improvements. The sheer nature of this ever-changing design environment provides a backdrop of a very different regulatory challenge aside from regulating a pharmaceutical with a long patent life and very few, if any, changes to the original formulation.
FDA (QSIT) DESIGN CONTROLS PERSPECTIVE: Why are medical device companies interested in design controls? Simple. Within the FDA QSIT Guide, there are specific references to the purpose and importance of Design Controls. Additionally, objectives, flow chart, and narratives for Investigators are included within the QSIT Guide. Who is ultimately in the middle? Management is. Design Controls are one spoke of the wheel with Management in the center. The other spokes of the Regulatory QSIT wheel are CAPA, P&PC, Material Controls, Equipment/Facility Controls, and Records/Documents/Change Controls.
FDA looks for specific design control responsibilities to address all aspects of the project. Typically, these responsibilities include Marketing and Sales Departments to conduct market research to establish user needs. Engineering is responsible for implementation of design controls and all employees, within multiple levels of the company, are involved in developing new products or modifying existing products.
A Design History File (DHF) is created and maintained for each new development project and describes the design history of the finished device. The DHF demonstrates that the device was developed in accordance with the design plan, requirements, and the established Design Control Standard Operating Procedure. The DHF may be modified to meet the needs of the development project.
In summation, by implementing Quality by Design, understanding the Total Product Lifecycle, and developing medical devices in accordance with the FDA Design Control regulations, a medical device company will be on the road to providing the American people with safe and effective products in this ever-changing technology arena.
Lori Carr has more than 14 years' experience in the medical device industry. As a Medical Device Specialist FDA Investigator in both the Cincinnati and Denver District Offices of FDA, she conducted international and domestic inspections of medical device facilities and trained FDA investigators in conducting medical device inspections. As an FDA regulatory compliance consultant, she performed numerous quality assurance audits for medical device companies. She has created and implemented quality systems and provided guidance on quality, regulatory, and compliance issues throughout the world. Her clients include companies that have received FDA Warning Letters, are under FDA injunction or have had product seized by FDA.
In her capacity as a Medical Device Specialist, she conducted numerous domestic and international inspections to ensure compliance with applicable FDA regulations including routine GMP, Pre-market (PMA), 510(k), and directed inspections from the Center of Devices and Radiological Health (CDRH) while working in both the FDA Denver and Cincinnati District Offices.
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