Life Sciences & Medical Devices

Our Expertise
Innovative solutions for groundbreaking organizations

In a time of intense disruption, organizations across the life sciences and medical device industries must balance a wide range of costly dynamics. Funding, product commercialization, research and development, regulatory compliance, and process scaling and optimization are all capital-intensive activities. On top of that, organizations need to keep pace with the new health economy while pivoting to value-based payment models and changing patient and customer needs.

Whether you’re expanding globally, optimizing tax incentives, executing an acquisition transaction, or looking to improve your current operations, we have a deep and diverse bench of tax, audit, and consulting experts to help. Our team provides proactive insights and pragmatic ideas to increase your bottom line and deliver better patient outcomes.

We serve bioscience, medical device, pharmaceutical, and life sciences clients of all sizes and structure from prerevenue startups to public companies with billons in annual revenue, as well as nonprofit research and incubator organizations. When it comes to critical issues, we don’t take shortcuts — we take action.

Stay competitive — achieve growth and thrive in a changing environment

Does your organization have the financial and operational resources necessary to keep pace with unsustainable healthcare costs, innovation, and new competitors? Developing your organizational strengths and agility will likely require transforming your business model.

Reach out today to find out how we can help you with:

Project launch management
Do you want to keep your product launch on target while minimizing business risks and delays? Our experts will collaborate with you to develop a customized PMO strategy that includes a cross-functional team and PMO management. We’ll help you avoid common pitfalls, such as project scope creep, lack of design for manufacturability, and undefined clinical claims.
Quality & regulatory compliance

We’ll help you understand compliance requirements and minimize time spent on submissions. We provide the specific expertise to support your goals, from remediation, project development management, and validation and verification to quality system compliance, audit preparedness and on-site audit support, and post-market assistance.

Supply chain & operations management
We help you improve control over your supply chain. Challenges can bring any organization to a grinding halt. We offer data-driven insights over the entire product life cycle management process, helping you gain greater visibility into — and management of — your supply chain. We’ll provide the support you need, from operations strategy implementation, field inventory and reverse logistics, and facility rationalization to location analysis and site selection, manufacturing development, business process optimization, and regulatory remediation. Furthermore, if you’re looking for product and process transfer assistance, we can help you expand domestically or internationally.
Cybersecurity
How will your product respond to emerging cybersecurity threats? Our experts will keep you vigilant and on top of emerging threats to help you assess risk, isolate vulnerable areas of your organization, and mitigate the impact of and exposure to attacks.
Technology consulting
Are you keeping pace with emerging technologies? With a future-focused lens, we’ll help you develop or improve your strategies in relation to artificial intelligence, blockchain, SaMD, among others. We also assist with technology optimization, software selection and implementation, and help you integrate data analytics and establish critical KPIs.
Merger & acquisitions
Are you looking to sell, expand, or integrate a recent acquisition? We’ll help you realize the full value of a deal. Our team has industry-specific expertise in buy- and sell-side due diligence, valuation, acquisition integration, divestitures, and carve-outs.
Tax

Are you optimizing your tax position? From state and local tax matters, to international regulations, to tax credits and incentives, our expertise touches every area of taxation. We’ll help you maximize your tax position so you’re not leaving money on the table. We have expertise with specialty tax compliance and credit optimization, including manufacturing deductions such as research and development (R&D), Section 382, Section 199, and transaction tax support.

Audit

Our audit professionals have a wide range of transaction experience and have the capabilities to assist you through your most challenging accounting solutions. We provide comprehensive audit and assurance services, including financial, internal control, and government contract and grant services in support of public offerings, private placements, and SEC reporting.


Strategies that work, no matter what's next


Smart medical device companies are launching cost transformation strategies



Client Experience
Specialized expertise for a specialized industry

Our experts — many of whom come to us from organizations just like yours — dedicate their careers to the life sciences industry. Each team member averages over 25 years of experience across manufacturing, supply chain, healthcare — including clinical, cost management, M&A, transformation, strategy, tax, audit, and more. Our experts translate “30,000-foot” concepts, directions, and strategies into implementable solutions that produce measurable results. And when you hire Plante Moran, you don’t get just one person or one team. You receive the support of our entire firm to help you grow, improve profitability, and implement transformational change in a rapidly evolving global healthcare environment.

Furthermore, we’ll take the time to understand your organization — your operations, your challenges, and your goals for the future. From there, we tailor our services and our team to meet your needs. Whether you’re on the path to bring a new product to market, integrate an acquired organization, or improve your current operations, we provide the depth of expertise, proactive ideas, and a hands-on approach you need to achieve your goals.

What makes working with us different? According to Jeff Jenkins, a practice leader, it’s our service model. “We’re not just strategy-focused, nor do we have a limited scope of services. We holistically evaluate your entire organization to best position you for success. We’re on the ground, working side by side with you to execute and implement actionable solutions.”

Our clients say

During the past 15 years, I have called on Plante Moran to provide my organizations with guidance and assistance. On each occasion, their consultants have worked successfully with my team and delivered outstanding results. From setting strategy and our roadmaps for the future to training and facilitation or assisting with customers facing initiatives to assessing, planning and implementing operational tactics that have resulted in significant cost savings and quality improvement…PM has delivered! Not only have they delivered bottom-line results, but they’ve partnered with us to change our culture and make our performance improvement sustainable. The breadth of knowledge and capability they bring to my organization is invaluable. They have and will continue to be a key partner that I count on to deliver results.

Brian K. Hutchison
Chief Executive Officer, RTI Surgical