Let’s look at a story that illustrates the power of innovative and collaborative medical device product development consulting.

In a rapidly changing healthcare landscape, a prominent hospital faced some big challenges. They needed to improve patient care while reducing operational costs to compete. They turned to their primary medical device OEM for better ideas. The already overtaxed OEM faced resource challenges and gaps of their own. This led the OEM to engage with product development engineering consultants. They needed to find new ways to solve their customer’s problems and fast.

By contracting outside product developers, the medical device OEM worked quickly to meet new market demands. The OEM ushered in a new age of efficient and patient-centric healthcare products and services. They not only elevated the quality of care for patients but optimized resource allocation for the hospital. This resulted in significant cost savings. Quality, outsourced product development engineering can transform not only the healthcare industry but any industry.

What Does a Medical Device Consultant Do?

A medical device engineering consultant helps companies bring new devices to market with speed and quality. Their work involves a combination of skilled expertise, project management, regulatory compliance, and industry knowledge. Here’s an overview of what they do.

1. Market Research and Competitive Analysis

They assess user needs, market trends, and the competition, helping clients make informed decisions.

2. Product Design and Development

Conceptualization: They help create and vet product ideas and map out a clear development plan.

Design and Prototyping: Consultants oversee the product’s design and prototyping, ensuring it meets user needs, quality standards, manufacturability, and cost constraints.

Iterative Development: They guide the iterative design and development process, making necessary adjustments as the project progresses.

3. Regulatory Compliance & Quality Assurance

Consultants help ensure that the medical device complies with regulations set by the FDA or equivalent authorities. They establish quality management systems and ensure the device adheres to ISO 13485 or other relevant quality standards.

4. Risk Management

Consultants assess potential risks associated with the product and develop risk mitigation strategies.

5. Project Management

Consultants create detailed project plans, budgets, and timelines. They manage project resources, including teams, materials, and budgets.

6. Clinical Trials

Consultants assist in designing and managing clinical trials for testing the device’s safety and efficacy. They help prepare regulatory submissions for approval.

7. Supplier and Manufacturing Support

Consultants help select and qualify suppliers for components and manufacturing. They work to ensure efficient and compliant manufacturing processes.

Medical Device Product Development Process and Approach

Working with Medical Product Design and Development Consultants

Healthcare product development consultants collaborate closely with clients to understand their needs and objectives. They help clients develop innovative and safe healthcare products that meet the needs of patients and healthcare providers.

When to Hire a Medical Device Product Development Consultant

Product development consultants bring value within several situations:

Early-Stage Product Conceptualization:

When you have an innovative healthcare product idea but lack the in-house expertise to translate it into a viable concept. When you need help with initial concept development, market research, and feasibility assessments.

Regulatory Guidance:

When you are navigating complex regulatory requirements, such as FDA approval, CE marking, or other international regulations. When you have a need for a regulatory strategy to ensure compliance and streamline the approval process.

Quality and Risk Management:

When the company is struggling with implementing robust quality management systems or risk management procedures. When they need help with hazard analysis, risk assessment, and mitigating strategies.

Clinical Trial Planning and Management:

When the company is preparing to conduct clinical trials and needs support in study design, site selection, and patient recruitment. When there are challenges in data collection, analysis, and reporting.

Design and Development Challenges:

When the project faces design, engineering, or prototyping issues, and it’s essential to get it back on track. When product iterations aren’t meeting user needs or regulatory requirements, and design improvements are necessary.

Market Viability Assessment:

When a company is unsure about the market potential or competitive landscape for their healthcare product. When they need help with market analysis, positioning, and defining a successful market entry strategy.

Late-Stage Troubleshooting:

When a project is in the late stages of development, but issues, such as quality problems, cost overruns, or regulatory obstacles, are hindering progress.

Indications you need a product development consultant

Indicators that you might need a medical device consultant include:

  • Regulatory roadblocks or uncertainties.
  • Frequent design or development setbacks.
  • A lack of in-house expertise in specific areas.
  • Budget or timeline challenges that require expert project management.
  • Clinical trials that are not progressing as planned.
  • An unclear market strategy or product positioning.
  • Quality issues affecting product safety or performance.

Types of Medical Device Development Consulting

Diagnostic Equipment

Medical device consultants can help design and prototype diagnostic devices, ensuring they meet precise specifications for accuracy and reliability. They also navigate the complex regulatory landscape, assisting with submissions to regulatory agencies.

Digital Technology

Consultants help shape digital product concepts into user-friendly, functional solutions, ensuring the software meets specific needs and technical requirements. Their guidance also includes effective project management to keep development on track and within budget.

Drug Delivery

Consultants can guide clients through the complex regulatory pathways for drug delivery devices, ensuring compliance with stringent safety and quality standards while expediting the development and approval process.


Consultants help optimize electronic product concepts, ensuring they meet technical specifications and performance requirements. They also assist in selecting reliable suppliers and manufacturing partners while managing cost-effectiveness, quality, and production efficiency to bring innovative electronic devices to market successfully.

Surgical Tools

Consultants collaborate with medical device manufacturers to create surgical tools that are ergonomically designed for ease-of-use, precise in their operation, and meet stringent sterilization and quality standards. They also guide clients through regulatory compliance and ensure that the surgical tools are safe, effective, and optimized for medical procedures.

Healthcare Furniture

Consultants collaborate with medical facilities and manufacturers to develop furniture that is durable, ergonomic, and compliant with healthcare standards. They ensure that the furniture design prioritizes patient comfort, staff functionality, and infection control, creating a safe and efficient healthcare environment.

What Qualifications Should You Look for in a Product Development Consultant?

Medical device product development consultants help you expedite the complex process of bringing a medical device from concept to market. They ensure safety, quality, and regulatory compliance every step of the way. Look for these qualities.

Educational Background

Medical device product developers should hold at least a bachelor’s degree in a relevant field like biomedical engineering, mechanical engineering, product design engineering, software engineering, etc. Many have advanced degrees.

Industry Experience

Good consultants bring years of experience in the medical industry, having worked for medical device manufacturers, regulatory agencies, or in R&D. A cross-industry background is advantageous to solve problems in innovative ways.

Regulatory Knowledge

They are well-versed in medical device regulations, such as FDA regulations in the U.S., and may have experience in securing regulatory approvals.

Quality Management Expertise

An understanding of quality management systems, especially ISO 13485, is crucial.

Project Management Skills

Knowledge and experience in project management are important for successful execution.

Communication Skills

Consultants need strong communication and interpersonal skills to work effectively with clients, teams, and regulatory bodies.

Cultural Fit

When the consultant’s work style and values align with your company’s culture and expectations, collaboration, performance, and innovation hits a higher level.

An medical device consultant reviews a design on a whiteboard with a conference room of people.

Get Help with Your Medical Device Development

Whether you’re a promising startup or a global leader in the healthcare industry, DISHER is ready to help. We can fill your talent gaps with experienced, cross-functional, degreed expertise you can trust. Since 2000, DISHER has served the healthcare industry with advanced product development, engineering, and manufacturing tech solutions that have made a positive difference in our world.

To learn more about DISHER, or to partner with us for your next medical device project, get connected with our team. We’ve helped hundreds of clients move forward with product development, engineering, and manufacturing tech support. Here’s what a few of our healthcare partners have to say about working with DISHER.

“I have been truly blown away by the commitment and focus of the DISHER team to deliver on this platform launch for the acute care business. The process technologies you have introduced have established new standards and expectations for future projects which include the standard workstations, AGVs, SCADA, next gen weld cells, and validation strategies to name a few. Be proud of what you have accomplished as a TEAM!”            

“The DISHER engineers have been great team players who have been willing to step in and take on large challenges in our project. They worked on the hardest subsystems of our entire project and designed great, comprehensive subs that will allow us to hit our weight and cost targets—something we could have never done without their expertise!”

“Our partnership with DISHER has helped us create a healthier planet while providing a great financial return on investment.”