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Medical Devices
As the medical device industry becomes increasingly complex, you can trust us to be knowledgeable of the latest trends, regulations, and emerging issues impacting you.

Medical Devices

Medical Device Solutions
At Plante Moran, we know what keeps you up at night. Our medical device experts can help you with:

Cost Reduction

Cost reduction can be challenging as you attempt to create a cost structure from developing new products with demonstrated patient outcomes through product manufacturing and delivery. It’s important to look past the initial hard cost of the product and view the cost of the healthcare value chain as a whole. We will identify these costs and leverage such tools as activity based consulting with our expertise in:

  • Operations and manufacturing strategies
  • Product lifecycle management
  • Global tax reduction
  • Revenue Generation and Enhanced Profitability

    As internal and external forces begin to impact your product life cycle from concept to launch, we will provide a supported go-to market process.

  • Commercialization process
  • PMO services and new product development
  • Regulatory and clinical pathway strategies
  • Global distribution and launch strategies
  • Sales effectiveness strategy and implementation
  • Compliance Requirements

    Dealing with current FDA and other regulatory body requirements alone can be a challenge for any business. How do you get ahead of and prepare for FDA requirements? Our regulatory expertise will help you become more proactive and less reactive to all compliance requirements. Our team will help you understand what is required, work with the FDA, and minimize your time on submissions. Services include:

  • Remediation / Project Development Management
  • Validation/Verification
  • Quality System Compliance
  • Audit preparedness and On-site audit support
  • Market Consolidation

    As the market continues to consolidate, you are faced with several business challenges. You face the need to integrate quickly, while trying to minimize your disruptions or any loss of customers. Your consolidated product portfolio must be clearly mapped out with an eye on your future product pipeline. As merger and acquisitions, angel-funding and new technologies continue to grab headlines, we understand your goal of optimizing your value-add proposition to your shareholders and stakeholders. We will partner with you to navigate these complicated and exciting times through:

  • Post-merger integration
  • Transaction advisory services
  • Due diligence and valuation modeling
  • Resource and capacity optimization
  • Multigenerational product roadmaps
  • Supply Chain

    Supply chain issues can bring your business to a grinding halt. We will provide knowledge over the entire continuum, helping you understand processes and costs based on lead time and activities. We will identify idle cash that can be redirected to R&D or other areas, thus increasing the effectiveness of your product delivery cycle. We will guide your supply chain with fundamental program and project management support in:

  • Product and process transfer
  • Field inventory management
  • Supplier managed inventory process
  • Manufacturing and distribution site selection
  • Transfer pricing
  • Evidence-based Strategies

    To operate effectively in a changing environment you need an evidence-based strategy to help you address the provider needs of today. Our medical device specialists will provide you with the pillars of success in the new healthcare reform environment. Assisting you with robust evidenced-based strategies, including product and procedure-specific health economic models, demonstrated patient outcomes, and reimbursement plans.

  • Demonstrated patient outcomes
  • Procedure development and cost model
  • Medicare and Medicaid reimbursement strategy
  • Our medical device consultants have worked with clients just like you who are striving to achieve increased profitability and market share growth in a price pressured, complex, heavily regulated environment. To reach your goals, it’s necessary to be knowledgeable about the latest trends, future projections, regulations, and emerging issues that impact your business.


    Your success comes first
    Our track record for client success is the result of partnering with our clients and leveraging our technical and industry expertise regarding top-of-mind issues facing our clients today.

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    We have the real-word provider and supplier side experience.

    Focus:
    • Up-to-date on industry trends, legislations, and regulations
    • Provide specific project management services across all project needs. Including:
    • Product transfers
    • Strategy development and implementation
    • Mergers and acquisitions
    • New product launch and revitalization of mature product lines

    Experience:
    • Our consultants average over 20 years of experience
    • Several former medical device executives

    Customized Engagements:
    • Practical, customized solutions that clients can readily implement
    • Firsthand knowledge of medical device industry issues
    • Best practices to implement solutions and achieve results

    Collaborative Culture:
    • Individualized project teams to meet your exact needs
    • Partner with colleagues in other practice areas including:

    Contact Us

    Phillip Brown

    877-622-2257, x33640

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