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| MEDICAL DEVICE CAPABILITIES1
{Medical device capabilities.}A higher return on experience.
plantemoran.com
PLANTE MORAN | 1
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
| MEDICAL DEVICE CAPABILITIES2
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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| MEDICAL DEVICE CAPABILITIES4
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
| MEDICAL DEVICE CAPABILITIES6
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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| MEDICAL DEVICE CAPABILITIES8
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
PLANTE MORAN | 9
| MEDICAL DEVICE CAPABILITIES10
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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| MEDICAL DEVICE CAPABILITIES12
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
| MEDICAL DEVICE CAPABILITIES14
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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