Instilling Certainty

Patients live and die by medical device innovations – and so do the companies that make them. While regulations have made dangerous products somewhat rare, focusing on compliance tends to leave medical device companies struggling to innovate as rapidly as they would like.

Uncertainty is not new in the medical device industry, but has some added dimensions today. One long-standing area of uncertainty is the efficacy and safety of products in early development and trials. In both established and emerging markets, there is great uncertainty in the regulatory landscape — whether it is from the FDA's discussion of changing the interpretation of the 510(k) for streamlined product approval or supply chain partners introducing risk through improper control processes.

Any company in an industry that rests on frequent new product introductions has a guarantee of some uncertainty. When the product portfolio is changing constantly, it causes uncertainty in marketing and development – and throughout the operation in manufacturing, distribution, quality, sales, and regulatory affairs. Regulations are also critical factors as they present a much longer cycle to actually gain FDA clearance and sell improved products.

The FDA has made it clear that the final device maker or brand owner is responsible for the compliance of all materials from each of their partners. To continue to innovate, companies must show that their suppliers have adequate quality based on purchasing controls. Unfortunately, right now many companies' new product introduction (NPI) and engineering change (EC) processes are unpredictable.

With all of this guaranteed uncertainty, many companies are looking to reduce the variability of their own processes. Fortunately, the regulatory agencies recognize that need as well.
 

TPLC vs. Traditional
The FDA states that the stages of a product's lifecycle — from concept through development, production, use, and obsolescence — must support and leverage each other. This way the FDA encourages medical device makers to embrace the Total Product Lifecycle (TPLC) approach to streamline approvals and improve access to information, thereby lowering costs and improving quality. Companies must apply information learned in one stage for one product to future products that they develop.

Disciplines: TPLC spans the entire lifecycle of a device and crosses functional boundaries to involve research and engineering, clinical, production, quality, regulatory, and commercial departments. Information from product users, both patients and healthcare providers, must be included in this TPLC view, whether from adverse events and complaints, focus groups, or any other direct input. Just as design for manufacturability is a major thrust at many companies, supply chain, quality, and many other factors can be included during initial product design to ensure products meet the needs of patients, regulators, and profitability goals.

Proactive Quality: A holistic approach to product innovation creates sound design processes that generate quality and regulatory compliance. Designers can only make sound design decisions if given easy access to well managed and clear information, whether that be about past versions, other products, or post-market events. Traditional development leaves the risk of quality and compliance issues for later in the cycle, which often leads to significant challenges when a change needs to be made within paper-based record-keeping and filing systems. TPLC's proactive quality and compliance also generates predictable costs from the outset.

PLM Important Role
Starting and sustaining TPLC requires good information flows and, ideally, a centralized information repository. Information created throughout the product lifecycle should be accessible in a useful, easy to find context for any given product. This is where PLM systems come into play.

The best PLM solutions have easy ways to interface with nearly any source of data, be it internal, suppliers, distributors, or other external sources. Real-time information dashboards deliver information in an intelligent, dynamic method, with links to related components and processes. Conversely, sensitive information is not shared with everyone; data is made available to individuals depending on their role so everyone has the data they need to complete their job without the risk of high-level data leaks.

The following scenarios for holistic NPI and product change assume not only approaching this with a TPLC-oriented process, but also that the process is supported by enterprise PLM software. Both the process and the information capabilities are crucial to achieving TPLC.
 

Quality and Compliance
The overall cycle of new product development may not change dramatically between traditional methods and TPLC; however, streamlining end-to-end process and the benefits that result are significant. Another important difference is how quality and compliance flow from the NPI process, rather than forming completely separate processes that do not benefit one another.

Requirements: In either traditional or holistic approaches, processes begin when customer requirements, research, or new technology generates a market need for a new product. Market needs become marketing claims against which product efficacy will be measured in regulatory review cycles. That means that data to measure efficacy and quality must be defined as early as possible.

Holistic NPI environments add new products' requirements and opportunities into a context of the requirements and design intent for the product family, or even in adjacent product families. PLM systems enable effective search for all relevant design and product feedback. It also provides a way to store and leverage requirements data from sales, healthcare providers, and other non design-oriented departments. The PLM repository stores input from clinical trials and products as they are used in the market to build quality and compliance histories, as well as requirements for new versions and products.

NPI Project Launch: One of the key aspects of a project launch in a holistic environment is that the task is considered one of many projects. This ensures that appropriate resources are available and assigned to the project. PLM systems go beyond timelines and resource allocation; they also serve as design history file (DHF) and the device master record (DMR) creation and management environments.

Conceptual, Systems Engineering: Systems engineering aims to effectively design and test product definitions, behavior, and interaction of a device and its components by linking requirements to its functional, logical, and physical assets. In complex devices, this involves not only putting the system through modeling and simulation, early on, but also exploring alternative concepts and configurations. The iterative and collaborative nature of this process is just what TPLC specifies.

Product Development: Multi-disciplinary approaches to integrated or mechatronics engineering to evaluate interactions between mechanical, electrical, electronic, and software elements are increasingly critical for achieving quality and regulatory compliance in complex devices. Development may include aesthetic and ergonomic design for patient and caregiver comfort, as well as device and drug interactions for combination devices. Development also includes testing a unit, sub-system, and fully integrated device for verification and validation of product design outcomes.

Complex products make assessing risk far more challenging for companies. Hazard analysis and failure modes and effects analysis (FMEA) must be built at the early product development requirements stages. A PLM system's information structure and workflow naturally build up the DHF and DMR in each design step. Documentation is an integral output of the process, not a time-consuming post-facto search.

Purchasing Controls: Concurrent with the design engineering process, procurement will be finding and qualifying suppliers for the product. Suppliers should be involved in optimizing the product design based on their knowledge of how their contributions impact product design. A PLM system gathers all of this information, automatically, to ensure full material compliance through traceability for the product down to all its parts, including the sourced ones.

Design Transfer: Ensuring that device design correctly translates to product specifications for manufacturing is always a challenge, but doing so within compliance enforces the need for comprehensive documentation. Design transfer benefits greatly from the use of traditional engineering tools, and a system that encourages and supports collaboration between suppliers, manufacturing engineers, and production teams in the design process. PLM's collaboration tools include production process simulation and 3D-based product manuals.

Regulatory Submissions: Many pieces of information are developed or collected during the product design and development cycle that may also be needed for regulatory submissions and to address inspectional findings. Naturally, the FDA's premarket approval (PMA) and 510(k) processes – or equivalent marketing approvals from other regulators – are major filing points, but there are others including risk evaluations that are based on FMEAs, fault tree analysis, and preliminary hazard analysis. PLM supports these processes with a central repository for the design process that includes product analysis, test results, trial results, and post-market information. Design teams working on new products can leverage this information about current products and build the records for new products during the normal course of their work.

Service Hand-off: While initial design transfer to the service team is similar to the manufacturing hand-off, a major TPLC benefit is that all versions can be stored and signed off in a single system. PLM enables organizations to generate, automatically, technical documentation from all product data in the repository.

Beyond Software: In addition to implementing TPLC supported by a PLM system, other factors must be in place for this approach to succeed. These include:

• Gain support from the entire executive team and the business unit leaders by exploring business benefits.
• Focus on the collective outcome of the initiative to change the culture of the organization and eventually eliminate turf battles and departmental us-vs.-them approaches.

 


Conclusion
Accelerating innovation in an uncertain and stricter regulatory environment will present medical device companies with challenges for the foreseeable future. Embedding a TPLC framework within the product innovation engine minimizes compliance worries, improves quality and safety processes, and enables cross-functional participation. Companies that employ these processes, regardless of the how regulations evolve, will be ready to face compliance-related issues by supporting and deploying a holistic approach to product introduction and changes processes.

Dassault Systèmes Lowell, MA 3ds.com

Cambashi Inc. Boston, MA cambashi.com