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{Medical device capabilities.}A higher return on experience.

plantemoran.com

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We Listen. We Understand. We Deliver Results.As the medical device industry becomes increasingly complex, you can trust our medical device consulting team to be knowledgeable of the latest trends, regulations, and emerging issues impacting you and the marketplace. Leveraging our expertise, we can help you turn a good idea into an approved product ready for market, improve your cost position, implement your global supply chain strategy, and assist your regulatory compliance efforts. We invest in your success to help you thrive.

Our client success is the result of our ability to partner with our clients and leverage our technical and industry expertise in the following areas:

Strategic initiatives

Post-merger integration

Project & program management

Quality and regulatory compliance

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Key Trends Facing The Medical Device Industry

Cost Reduction/ Reimbursement/ Margin Erosion

• Supply chain/manufacturing optimization

• Distribution management

Quality & Regulatory Compliance• Regulatory pathway• Quality Management System

assessment and optimization• FDA remediation

Speed to Market• Commercialization process• Resource availability• Regulatory and clinical pathway

strategies• Product Commercialization pace• Rapid and flawless launches

Market Share Growth• Sales channel strategies• Clinically differentiated products• Product portfolio management• Product pipeline• Acquisition strategies/PMI• Alliance partnerships

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Strategic Initiatives Global Operations Strategic planning and implementation involve coordination of significant supply chain strategy initiatives throughout the product lifecycle management process. Development and deployment of lowest cost, highest quality medical device product platforms require a balanced approach, from mature product lines, to the new product introduction process, with fundamental program and project management support in:

• Product and process transfer• Validation and verification through internal centers and/or

direct-to-site development• Supplier managed inventory processes with a focus on

order-to-cash management• Acquired portfolio products/manufacturing and distribution

site selection• Internal and external product and process transfer• Global tax reduction and transfer pricing

At Plante Moran, we have the technical expertise and resources from within the industry to address the unique requirements of the

medical device supply chain market. Clients rely on us to provide pragmatic solutions within a collaborative environment and a no-surprises. approach

• Engaged by the surgical division of a Fortune 500 medical device Original Equipment Manufacturer (OEM) to program manage the internal/external sourcing for a key manufacturing facility and its four distinct product portfolios internationally and domestically

• Worked with the client to develop the overall plan and plan communication; sourced and transferred the product lines globally with significant cost savings (>30% COGS reduction); preserved quality metrics and regulatory compliance (no inspectional observations and continuity of CE mark usage); improved customer service fill rates (> 99% unit); and wound down facility to real property sale.

CLIENT EXAMPLE

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Program/Project Management

Optimized Capacity Utilization

Manufacturing Development

Supplier Managed Inventory Process

New Product Introduction

Operations Strategy

Implementation

Facility Rationalization

Order-to-Cash Management

Integration of Acquired Portfolio

Products/Companies

Location Analysis and Site Selection

Internal and External Manufacturing and

Assembly

Product Lifecycle Management

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The processes and activities initiated after an acquisition or a merger, in an effort to combine two companies into one, need to be successfully managed to provide enhanced value to shareholders, employees, and customers. Typical integration goals include:

• Achieve cost and revenue synergies• Grow sales and market share• Align business processes• Establish a unified corporate culture• Leverage synergies

Plante Moran systematically breaks down the PMI process into four distinct steps: organize, plan, implement, and monitor. Through this

approach, we provide a framework to balance the resource demands between the day-to-day operations and PMI activities through an integration roadmap. To achieve success, we have found that a robust Project Management Office (PMO) structure provides the direction and control to achieve internal and external customer focus. The result is an aligned organization optimized to realize acquisition synergies and objectives.

Integration Activities

• Engaged by multi-billion dollar medical device company for PMI assistance shortly after a strategic acquisition.

• Provided resources and methodology for successfully integrating the acquired company in less than six months.

• Integration activities included: sales alignment and optimization, product rationalization, and operations and regulatory systems integration.

• New company kept its customer focus and achieved its financial and operational goals.

CLIENT EXAMPLE

Additional resource:

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Developing and launching the right products, on time and on budget, while avoiding pitfalls, such as project scope creep, lack of design for manufacturability, and/or undefined clinical claims, are keys to securing a leading market position. To help achieve these goals, a strong PMO is required. A strong PMO includes the following:

• A structured approach• Standardized methodology and tools • Direction and control • The planning and execution of new product development

activities while minimizing business risks and product launch delays.

Plante Moran supports your efforts with years of experience in successfully launching products in the medical device industry. At

Plante Moran, our approach is to work with your organization to develop a tailored PMO construct that includes a cross-functional team and management. We can provide much of the project-management responsibility, thus leveraging your employees’ unique expertise to execute delivering a strong new product pipeline.

Project and Program Management

• Engaged by a client to investigate the business feasibility of a new device innovation.

• Conducted a product portfolio analysis, evaluated the product development process, and conducted a need-gap assessment of the documentation against design controls requirements and desired product claims.

• Conducted Voice of Customer studies by contacting several key opinion leaders and distinguished academic centers to best understand clinical needs and concept viability.

• Developed and provided a differentiated value proposition, along with a clear regulatory roadmap identifying specific clinical outcomes and claims to achieve a successful product launch.

CLIENT EXAMPLE

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When developed internally, delivering a medical device to market is a long and complicated process. The requirements can expand exponentially when acquiring, redesigning, or trying to integrate products from external entities. Medical device OEMs require:

• Responsive and efficient quality management system assessment and implementation support for the new products and facilities being acquired

• Regulatory pathway and quality services across the full spectrum of product design and development to sustaining activities in the supply chain

• Remediation support in the forms of project management, and development and execution of plans.

• Post-market support including practical working solutions based on proven experience in regulatory action impacted facilities.

Plante Moran serves as both an extension of in- house capabilities and/or specialized expertise as needed. We partner with our

clients in a collaborative approach, bringing an average of 20 years of industry experience per consulting associate in regulatory compliance, quality management, manufacturing, supply chain management, clinical, marketing, and R&D to help formulate regulatory strategy and implement tactics to optimize your global compliance.

Quality and Regulatory Compliance

• Engaged by a global medical device OEM to program manage the development and implementation, monitoring, and communication of a quality and regulatory remediation plan in response to a field voluntary product removal and recall. Plante Moran managed and revamped the facility production strategy post- acquisition and pre-integration to avoid remediation and facility shutdown.

• Achieved compliance well ahead of targeted completion. Transfer and closure plans were reversed based on the renewed viability of the facility and eliminated threat of business impact to client.

CLIENT EXAMPLE

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While Plante Moran helps clients with their strategic direction, what differentiates us is our ability to translate “30,000 foot” concepts, directions, and strategies into implementable and impactful actions that produce results. We partner with our clients to implement pragmatic solutions that matter. We do it with and for our clients.

The Plante Moran Medical Device Team is a unique partner with our clients in three distinct ways:

Focus | Our unique focus specifically on the medical device industry gives us the advantage of being up-to-date on industry trends, legislation, and regulations. We also are able to provide specific PMO services for our clients with short-term project needs such as product transfers, M&A target due diligence evaluation, and product launch support.

Experience | The average consulting professional in our practice has over 20 years of experience, with several members of our team having been medical device executives. Our Plante Moran experience goes beyond medical devices, as we can leverage best practices from other industries. We are engaged in our client’s business from the beginning of the project to the end of the project. When you hire us, you get us for the whole project.

Customized Engagements & Collaborative Culture | We specifically serve your defined needs in a collaborative culture. We create specialized project teams to meet your exact needs using the depth and breadth of our related practices.Depending on the needs of a project, we have the ability to partner with colleagues in other practice areas including technology, health care, and due diligence.

The Plante Moran Difference

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Specialty-focused

Mega Consulting FirmsStrategy-focused

Plante Moran Differentiators• Execution and implementation

focused

• Collaborative approach 

• Proven project management methodology

• Change management expertise 

• Pragmatic approach

• Industry expertise

• Focus on exceeding client expectations 

Boutique Consulting Firms

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Plante Moran Overview

By the Numbers• Founded: 1924• Rank: 14th largest in the U.S.• Team: 2,200+• Locations: 23 offices in Illinois, Michigan,

Ohio, China, India, and Mexico• FORTUNE’s list of the “100 Best Companies

to Work For” for 18 consecutive years (highest-ranked accounting firm for seven consecutive years)

Client Benefits• An established partner, focused on

serving you• The benefits of a large firm, while

receiving personalized service• A breadth and depth of talent at

your service• A firm serving clients no matter their

geographic location• We take care of our people so they

can take care of you

90 years of history in 30 seconds or less.

One-Firm FirmOur firm is fundamentally built different than our competitors because of our “one-firm” firm philosophy and structure. You receive the best resources regardless of office location or geography.

Transactions Technology

TalentStrategy & Operations

Financial

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Notes

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