Medical Device Product Development Consulting Services & Expertise | TCGen

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 medical device 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.

Our Medical Device Product Development Consulting Services 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 medical device product development 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 important 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



  • 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

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 from other consultants.”

 Dan Keller

HP Executive

“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

Want to Learn More?

Our blog covers a wide spectrum of topics related to medical device product development consulting. Here are some other free resources to help you.

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.

To start consulting as a product manager, you must have broad product management experience and at least one specialized niche (and valuable). Consultants are rewarded for being specialists, not generalists. Once you have something to say, publish it and highlight your unique value through channels like social media, blogs, and content creation. Sales and marketing of your services are crucial; they attract clients and establish your reputation and expertise in the field. If no one knows about you, how can they find you? Begin by offering your services on freelance sites like LinkedIn or Toptal to enable you to build up a client list.

The short answer is yes, and it can be a great career move. To shift from product management to consulting, identify your niche and showcase your expertise through a portfolio of great products you have developed. Sales and marketing are key; create a personal brand and authority through an online presence (podcasts, webinars, groups), securing a domain name for your consultancy to enhance credibility. You will also have to set your consulting fee rate. Setting rates involves researching industry standards, evaluating your experience level, and understanding the value you deliver to clients. Initially, you might adjust rates to gain traction.  

A product consultant offers part-time, expert guidance on product strategy, digital transformation, development, and market fit, tailoring advice through research and competitive analysis. They usually do not work as a full-time employee. They craft product proposals and ensure strategies align with market demands for successful product launches. The consultant’s engagement is time-limited, with their success hinging on performance on the product program and the tangible outcomes as they deliver. As the project concludes, typically just after product launch, they facilitate a smooth transition, focusing on achieving the product’s potential.

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.

Medical Device Product Development Consulting Rates

Medical device product development consultants come from various backgrounds and services, from individuals to established product developers. The following summary table of medical device product development consulting rates provides broad guidelines.

Hourly Rates for Entry Level Medical Device Product Development Consultants

Individuals with medical device product development consultant experience coming to work as employees in your company would typically strive to meet or beat their current salaries. For individual contributors with five years of experience at startups or relatively small companies that lack sophisticated products, those resources would be paid at an hourly rate of $20/hr – $35/hr as employees (, and consulting fees of $40 – $70 (to $100) per hour if hired as consultants. The rule of thumb is that consulting rates are approximately 2x an employee’s hourly rate. Small businesses and their business owners might want to try a product-oriented business consultant to evaluate the merits of a new product or service idea with a quick study. 

ProductSchool and Pragmatic Marketing offer Medical Device Product Development Consultant Certifications, but these don’t do much more than establish a general competence in the field. They may not reflect real-life performance levels, although they are of value.

Also, at this skill level, you can find product owners who call themselves product managers. In some companies, the only difference is the title. However, in most cases, the focus of the product owner is on one release rather than the entire roadmap. Product Owners tend to serve an individual function, while product managers often lead product strategy and supervise a product team.

Hourly Consulting Rates for Experienced Medical Device Product Development and Medical Device Product Development Consultants

On the other hand, at technological firms that prioritize cutting-edge skills and technical knowledge, consulting wages can be much higher. Often, the roles blur between medical device product development consultant and product development since, at this level, these positions have many responsibilities in common. 

Medical Device Product Development to Consulting

It may be tempting to think about career paths in consulting. Still, a product manager with the correct soft skills can be an excellent consultant and help the business improve in many facets, including innovation, design, execution, delivery, and support.  Aside from engineering and operations, it is one of the best roles to launch into consulting.

Due to specialization and job scope (these professionals are involved with marketing and development decisions), the rates are considerably higher. In this case, the national average salary is $49/hr as a full-time employee (ZipRecruiter) and would be ~ $ $100 per hour as a contractor. The employee’s annual salary would be about $100K in this example. Their experience can bring a range of consulting services to help meet your needs.  

LinkedIn can be a source of low-cost medical device product development consulting resources, and it even has job placements where you can see typical qualifications. Often, recruiters and job seekers distinguish between independent consultants and consulting firms with several employees. Consultant salary levels can be higher at consulting firms due to the higher overhead for these companies.

For example, smaller boutique shops may have team members to help with product design and other skill sets. However, on the coasts, where demand is very high, experienced consultants charge between $200 and $400 per hour in niche areas such as AI, SaaS, and Security products. This translates to a daily rate of $1,600 to $3,200 per day. Although you might find consultants at a lower rate, the market rate in Silicon Valley, San Francisco, or New York is about $2,400 a day or a monthly retainer of $50,000.

Deeply Experienced Medical Device Product Development & Medical Device Product Development Experts and Firms

At the top end are product developers who are, in essence, Chief Product Officers (internal roles) or senior partners at strategy consulting firms (BCG, McKinsey, Bain) or are senior management consultants at firms recognized as leaders in medical device product development such as TCGen, R&D Consulting, and the 280 Group. Typically, these organizations bring more than one resource to the job, ensuring you have diverse skills and are an exact match for your industry. Often, these individuals will have C Level of experience (CPO, CMO, CTO).

While a little out of the scope of medical device product development/product management, there may be assignments that focus on the skills of a marketing consultant, such as price optimization or product promotion.

These firms also typically have proprietary tools and models included in the consulting engagement, and they run their project management, so they need little guidance and demand a higher rate. Sometimes, these engagements will identify the needs of business development to understand market characteristics and competition better.  

The range for resources like this is $250/Hr to $1000/Hr as independent consultants and top-flight strategy firms could earn double this rate; Partners may charge $2000/Hr.  Often, these consultants price out projects at a fixed fee, allowing them some flexibility while giving the client a fixed budget. Because these firms are so experienced, they know how much an engagement will cost.