The path to successful product development for medical device companies is rife with roadblocks. The recession has only added to the pressures of mounting regulatory requirements, particularly those from FDA. And then there is the skyrocketing number of product recalls, which reached unprecedented 845 recalls in 2008—up 43% from just a year earlier.

No one is immune. Start-ups and multi-billion-dollar companies alike have been hit with injunctions, faced product recalls, or found themselves operating under an FDA consent decree.
Device manufacturers are attempting to navigate the convoluted path of regulatory compliance while facing unprecedented pressures for growth. Many of these companies recognize the need to reevaluate their current processes and implement a development approach that meets the requirements for both design control and a fast flow of successful new products. Yet more than half of the firms interviewed in a recent study conducted by our firm, Kalypso, admitted they were falling short of their new product development (NPD) success goals.
Striking a Balance
The majority of product recalls occur because manufacturers aren't properly validating their processes and products, Melvin Szymanski, FDA senior recall coordinator, told The Silver Sheet medical device quality control newsletter (February 2009). At the same time, many companies implementing NPD processes that comply with regulations have overcompensated. As a result, manufacturers are faced with overly bureaucratic systems that delay delivery and cause them to come up short on goals for time-to-market, return on R&D investment, new product revenue, and schedule predictability.
Despite the frustrations of many medical device providers, it is possible to achieve speed-to-market while avoiding an excessive compliance burden. Several innovative companies have gone beyond common industry practices and are applying the lessons learned from past failures. These firms are now implementing next-generation techniques and tools to make step-function improvements in product development effectiveness while complying with increasingly stringent regulations.
Here are 10 innovation and NPD best practices from device industry leaders that have achieved a successful balance between compliance and time-to-market.
Use Separate but Aligned Systems. They allow flexibility where appropriate. NPD processes are typically structured according to one of two approaches. One is a single-process structure encompassing both business and design control work flows. The other offers two separate but aligned systems.
A single-process design has the advantage of one system for both business and quality system needs. However, this approach increases opportunities for noncompliance because process bureaucracy can grow as layers of procedural detail are added to cover each work flow scenario—regardless of whether or not the tasks are governed by design controls. This hinders project teams that need flexibility to adapt business processes to specific project needs.
Separating business-oriented processes from rigidly enforced design control procedures is the alternative. This approach enables project teams to use judgment and experience in adapting the process guidance to specific project needs without jeopardizing design control compliance. While an important part of the overall process, deliverables such as business plans, go-to-market strategies, and sales plans do not go through the same level of scrutiny as design control deliverables. These deliverables include the design and development plan, requirements traceability matrix, risk management plan, and design validation report.
Companies that have adopted separate but aligned systems have discovered additional opportunities to streamline by decreasing the total number of development deliverables and reducing the number of deliverables that need to be circulated for sign-off. One leading medical device company went so far as to not require any signatures on its business deliverables, since going back to each executive to collect a signature provided no added value and only delayed the process. Instead, governance committee approval at each phase gate ensures that the deliverables are complete and provide the information necessary to make the phase gate go/no-go business decision.
Meet with FDA Early. Companies can save time and avoid delays by meeting with FDA early to receive feedback on regulatory plans well before starting full-scale development. FDA representatives are often glad to provide candid feedback, and they can save a company countless hours of pursuing the wrong path.
However, it's best to avoid presenting FDA with open-ended questions. Instead, approach the government officials with a preconceived solution along the lines of “here is what we are planning to do.” If there are flaws with a planned approach, FDA will point them out, leaving time to adjust. This approach avoids problems further downstream when corrections will cost significant amounts of time and money.
Move Validation Activity Upstream in the Design Cycle. Firms should invest in rapid prototyping capabilities and start testing as soon as production-equivalent test units can be made. There is some risk that a subsequent design change could trigger repeat testing and drive up development costs, negatively impact resource utilization, and even delay product introduction. However, the early validation offsets this risk, especially for Class I devices. The key is to manage the risk.
The 20% Test
Test Only Those Subsystem Design Elements That Are New. One company that had recently made time-to-market gains through a design reuse initiative was also able to improve its test efficiency. The firm realized how much time and money it was wasting by testing complete product systems when only certain subsystem design elements had changed. By testing only those subsystems that were new, the manufacturer not only saved time and resources but also eased a significant test-reporting burden.
As one of the company's executive explained, “If the design is 20% new and 80% design reuse, we now test 20%, not 100%.” This approach is facilitated by utilizing a new modular platform architecture and software automation tools that simplify archival and retrieval of past test reports.
Be Mindful of Regulatory Submission. It may sound obvious, but simply keeping regulatory submission in mind at each stage of the design cycle boosts efficiency and a company's regulatory filing success rate. Early stage reports should be written to support—and build toward—the final regulatory submission. This concept needs to be reinforced in all deliverable templates and training materials.
Structure Executive Governance Teams and Decision-Making Processes for Clarity. The top-performing medical device companies are making improvements and achieving transparency around the “who, what, when, and how” of the decision-making process. To fully leverage the formal phase-gate process with an appropriately staffed executive governance team, firms should align gate decisions with portfolio objectives, establish clear leadership, and leave implementation-level decisions to empowered project teams.
Successful companies appoint a governance team leader who holds team members accountable, actively drives the team to make the tough calls, and ensures that implementation-level decisions are made by the empowered project teams who are closest to the day-to-day work. The governance team leader also is responsible for using pre-established gate objectives and decision-making criteria to ensure that gate decisions align with portfolio objectives.
Staff Project Teams with a Regulatory Affairs Representative. It is critical for companies to staff core project teams with a knowledgeable regulatory affairs representative. On successful project teams, the regulatory representative not only advises team members on how to comply with design controls but also helps the project team make the delicate and all-too-common trade-offs needed to meet higher-level business objectives.
The primary role for regulatory representatives is to keep implementation-level decisions consistent with corporate-wide quality and regulatory strategies. At the same time, projects can get into trouble when their regulatory representatives take on an enforcer role and are viewed as “process policemen” who only speak up when there is a process “violation.” To succeed, these representatives need to go beyond pointing out problems and instead take an active role in guiding the team toward solutions.
A Behavioral Change
Establish Project Team Roles to Achieve Both Compliance and Project Success. Teams must be structured so that they achieve regulatory compliance and overall project success. This means aligning implementation-level decisions with quality and regulatory strategies, anticipating issues, and planning appropriate contingencies during the early planning stages. This approach is a behavioral change for many firms, and it requires a mindset transformation that is best achieved when reinforced from the highest levels in the organization.
The regulatory representative plays an important role here. Successful project teams willingly consult this representative as someone who knows how to interpret regulations and has the experience to figure out what FDA really wants.
Leverage the Regulatory Representative to Create a Strategy Early in a Project's Planning Stages. Leading companies that have realized the benefits of early regulatory involvement in project planning reap the benefits through fewer project redirects, more accurate budgets, and improved schedule predictability. Regulatory representatives can anticipate issues and help their project teams create a strategy early on.
Some companies assign a dedicated regulatory representative while the project is still in the concept phase and, in some cases, as early as idea approval. Even at this early stage, enough information is known about the product concept that this representative can begin to formulate a robust regulatory strategy in parallel with market confirmation and project planning tasks.
In formulating a regulatory strategy, the regulatory team member looks at the proposed product's intended use, desired objectives, “must-have” claims, and known label requirements. Plans for clinical studies are formulated, including study objectives, the number of studies, duration, timing, and cost. Included are determinations about FDA classification, international regulatory requirements, predicate devices, approval requirements, alternate submission approaches, submission risks, contingency plans, and timing. The regulatory team member also looks at the regulatory plan's impact on production, product cost, competitive positioning, and the overall project schedule and budget. Many companies have also added reimbursement strategy as a regulatory affairs responsibility.
Ease Challenges through Automation. Software tools can aid business processes and speed up development. They can also improve team collaboration and remove much of the administrative burden associated with regulatory compliance. These tools include product and portfolio management (PPM), requirements management, electronic document management, and idea management software.
An important, but costly, aspect to the implementation and use of software solutions is that these systems must meet Quality Systems Regulation (QSR) requirements. QSR requirements state that if “computers or automated data processing systems are used as part of production or the quality system, the [device] manufacturer shall validate computer software for its intended use according to an established protocol.” (See 21 CFR §820.70(i)).
Medical device companies installing enterprise software should always use vendors that provide a validation protocol for the software program's baseline implementation state. Companies that use these suppliers save approximately 50% of the typical time and cost of system validation, research shows. For example, some systems come “out of the box” with validated work flows for corrective and preventive action.
The advantage of software tools can be significant when applied at the right time with a well- thought-out, strategic implementation plan. The old adage rings true that automating poor processes just amplifies problems and that broken processes should be fixed first. Additionally, companies shouldn't underestimate the importance of executive-level and cross-functional “buy-in.” Firms can avoid problems by taking a more strategic approach to system selection and implementation, first by gaining agreement on the business imperatives.
Improve Process Definition, Work flow
Improving product development effectiveness in the face of regulatory scrutiny is a challenge for many of today's medical device companies. However, firms can smooth the road to getting a product to market by deploying the methodology detailed above. As is noted, these methods include improvements in process definition and work flow structure, innovation governance and decision-making, project teams and team structure, and software systems and tools. The benefits of taking these actions include the following:
•Meeting and exceeding development effectiveness goals.
•Achieving time-to-market goals.
•Hitting planned product launch dates.
•Eliminating unnecessary process bureaucracy.
•Accelerating product development process maturity.
These advantages already are being realized today by medical device companies that have achieved an effective balance of product development processes maturity and regulatory compliance. These top-performing businesses are demonstrating how it is possible to overcome the many challenges the industry faces today to deliver safe, effective, and commercially successful products.
Noel Sobelman is a partner at Kalypso (Beachwood, OH), an innovation consulting firm serving the medical device industry. He heads the firm's development and new product introduction practice and has more than 19 years of consulting and industry experience. Sobelman can be reached at [email protected].

© 2009 Canon Communications LLC