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Medical Device Product Development Consulting

TCGen’s Medical Device Product Development Consulting helps you develop better products, faster

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Increase product innovation and reduce time to market, while ensuring compliance

Successful products are a company’s lifeblood, and your medical device product development strategy is essential to success. But even great companies occasionally experience periods where they are late to market, troubled by regulatory compliance, and their design control or quality management systems limit agility. This is where TCGen can help.

When should you hire a medical device product development consultant?

A consultant with experience in medical technology can bring an outside view and expertise to help you bring your product execution to the next level and increase product-market fit. They help you get perspective about how to improve predictability in the face of the FDA. You may need to…

  • Improve medical device product development process and move faster
  • Develop a strategy for technical or scientific research
  • Increase performance of your cross-functional teams
  • Provide expert coaching for your product leadership team
  • Evaluate and set best-in-class benchmarks, metrics, and KPIs
  • Transfer technology from research into product development efficiently

In select cases, you may want a consultant to lead a specific initiative, such as streamlining validation and verification, improving the regulatory submission process, or improving NPI or commercialization. Or to fill an interim role for a short-term urgent initiative. TCGen can advise in these areas and, in some, may refer you to outside partners.

Why Work with TCGen

Trusted Expertise

All of our partners are experienced product leaders with C-level experience in multiple functions. We understand the product development process and how it fits into the bigger picture.

Proven Methodologies

We help people work better and faster. Practitioners of… Agile Project Management, Design Thinking, Product Roadmap. Structured Deliverables. Improve product design. Full Lifecycle.

Industry Knowledge

Our breadth of experience will give us an advantage when working with your team. We’ve worked in a wide range of Med Tech, including Diagnostics, Devices, and Disposables, with products ranging from blood collection to surgical robotics.

What Our Clients are Saying

TCGen has years of experience helping numerous clients build better products, faster.

TCGen was able to come into a complex assignment and teach both the art and science of project leadership. Seek them out.

Todd Tomba

Roche R&D Executive

TCGen has that rare combination of brilliance and pragmatism that truly sets them apart. TCGen is world-class.

Dan Keller

TCGen’s principals combine a logical brilliance with charisma and fire. They are able to quickly see the best path to a solution and they are brilliant at executing.

Matt Belge

Senior Product Designer, Imprivata

Our Medical Device Product Development Consulting Strategy

We listen carefully and tailor our approach to you and are selective about the clients we take on – only work with those where we think we can add tremendous value quickly.

Outcome-Driven Mindset

Focus on outcomes instead of process. We want the least possible process and no less.

Build Your Capability

We help you build your team’s R&D skills rather than take over from you.

Focused Implementation

We change only the things that matter, avoiding organizational disruption from change.

How It Works

When engaging a consultant, it’s essential to know how long it will take and how much it will cost. We will scope this out in advance and provide an up-front fixed-bid pricing.

Generally speaking, we structure our implementation in three phases:

Assess and Recommend

  • Interview stakeholders, review current metrics, and conduct a project history
  • Assemble a working team from your org, including a product owner
  • Provide focused recommendations

Implement

  • Choose 1-3 initiatives with big bang for buck, aligned with your product vision
  • Develop framework, prioritize, and roll out
  • Measure KPIs and share data-driven results

Refine and Iterate

  • Review progress, iterate for incremental improvement
  • Transition to internal team
  • Build roadmap for ongoing improvement

Want to Learn More?

Our blog covers a wide spectrum of topics related to medical device product development consulting. Here are answers to two questions we hear often.

What is a medical device product development consultant?

A medical device product development consultant is an expert in product development, market fit, lifecycle management, and overall product success. They work with organizations to identify product opportunities, define product visions, set product strategies, and devise go-to-market strategies. They often bridge gaps in internal expertise, offering insights into customer needs, competitive analysis, and product innovation. Medical device product development consultants are crucial in accelerating product growth by collaborating closely with development teams and their executives.

Who typically hires a product consultant?

The CEO, CTO, or Head of Product usually hires a product consultant. Less common would be to be hired by the CMO or even Head of HR. They typically work closely with a member of the product management team; they can help define an MVP or prioritize features within an existing product.

Take the Next Step

Ready to transform your product development process? Contact us today to learn how we can help you achieve faster timelines, consistent execution, and increased team productivity.