Designing New vs. Extending Existing Medical Devices: Examples and Business Cases

The choice between new design and product extension depends on a company's risk tolerance, financial position, and strategic goals. By carefully weighing the pros and cons, analyzing market needs, and considering financial implications, medical device companies can make informed decisions that benefit both their bottom line and patient care.

Many successful medical device firms maintain a balanced portfolio, pursuing groundbreaking innovations while continuously improving their existing product lines. This approach allows them to drive long-term growth while maintaining steady cash flows.

Let's dive deeper into each option with  examples and business considerations.

Read more below.

The focus and discipline of DFX is a powerful tool if used as part of a broader strategic approach to developing product/process differentiation, and a sustainable advantage against competition. Involve Design for X in Strategy. Once your team has determined the focus of your strategy, place the focus of design on developing competitive advantage. 

At Boston Engineering, DFX is a core part of creating values during our product development process. We focus on several key DFX areas that align with our expertise:

• Design for Manufacturability (DFM)
• Design for Assembly (DFA)
• Design for Cost (DFC)
• Design for Testability (DFT)
• Design for Reliability (DFR)
• Design for Serviceability/Maintainability (DFS)
• Design for Usability (DFU)
• Design for Modularity (DFMo)

Learn more about Design for X (DFX) at Boston engineering: Boston Engineering Design for X

The following are illustrative examples of a potential product design decisions a company might make to take strategic advantage of the noted benefits of introducing a new product to market vs. updating an existing product. The cases are presented to evoke thoughts and questions around the potential business case for such decisions, and the reasoning behind each. 

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Case Studies for Designing a New Medical Device Product

• Innovation Example: A neurotechnology company develops a brain-computer interface for paralyzed patients to control robotic limbs.  

• • Reasoning: Addressing a previously unsolvable medical challenge.
  • Business Case: High development costs but potential for premium pricing and market leadership.
    
    
• Market Differentiation Example: An imaging company creates a portable, AI-powered ultrasound device.

• • Reasoning: Standing out in a crowded market of traditional, stationary ultrasound machines.
  • Business Case: Higher initial investment, offset by potential market share gains and new revenue streams.

• Addressing Unmet Needs Example: A diabetes care company invents a non-invasive continuous glucose monitor.

• • Reasoning: Eliminating the need for finger pricks, improving patient compliance.
  • Business Case: Large addressable market with potential for recurring revenue from consumables.
    
    
• Improved Patient Outcomes Example: A surgical device company introduces a minimally invasive tool for heart valve repair.

• • Reasoning: Reducing recovery time and complications compared to open-heart surgery.
  • Business Case: Higher product cost justified by reduced overall healthcare expenses and improved outcomes.
    
    
• Intellectual Property Example: A wound care company develops a novel antimicrobial dressing using nanotechnology.

• • Reasoning: Securing market exclusivity through patents.
  • Business Case: Protected revenue streams and potential licensing opportunities.

Case Studies for Extending the Life of an Existing Design

• Cost-Effective Development Example: An orthopedic implant manufacturer updates its knee replacement system with improved materials.

• • Reasoning: Enhancing product performance without a complete redesign.
  • Business Case: Lower R&D costs and faster return on investment.
    
    
• Faster Time to Market Example: A ventilator company adds a new software feature to its existing product line.

• • Reasoning: Quickly responding to changing clinical needs.
  • Business Case: Maintaining market relevance with minimal regulatory hurdles and development time.

• Established User Base Example: A surgical robot maker introduces advanced instruments compatible with its widely adopted system. 

• • Reasoning: Leveraging existing infrastructure and user familiarity.
  • Business Case: Incremental sales with minimal additional training or marketing costs.

• Proven Track Record Example: A pacemaker manufacturer extends battery life in its current model.

• • Reasoning: Building on a product with known safety and efficacy profiles.
  • Business Case: Reduced liability risks and easier market acceptance.

• Streamlined Manufacturing Example: An infusion pump company updates its user interface while maintaining core mechanics.  

• • Reasoning: Improving usability without overhauling production lines.
  • Business Case: Minimal additional manufacturing costs while refreshing the product offering.
    
    

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Financial Impacts and Business Considerations

All decisions have a both a financial Impact and an effect on the business plans of a company. The following explores the potential of both when the decision is made to develop a new medical device vs. updating and existing one. 

 New Product Design:

• Higher upfront costs: A company might invest $50-100 million in developing a novel surgical robot.
• Longer breakeven timeline: It could take 5-7 years to recoup development costs.
• Higher potential returns: Successful products could capture significant market share and command premium prices.
• Greater risks: There's a chance of regulatory rejection or market failure.

Extending Existing Products:

• Lower development costs: Updating an existing diagnostic device might cost $5-10 million.
• Quicker returns: Breakeven could be achieved in 1-2 years.
• Modest but predictable growth: Incremental improvements typically yield single-digit percentage sales increases.
• Lower risks: Building on proven technology reduces chances of major setbacks.

New eBook Available Now! 

"Leveling Up Existing Products through DFX" 

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Developing successful new products from scratch is challenging enough, but what about improving on existing designs? 

In this eBook, we’ll dive into the real-world experiences of DFX subject matter expert John DePiano, exploring the common areas where existing product owners excel, as well as the key opportunities where targeted DFX support can drive major improvements.

 Understanding the Importance of a DFX approach in medical device design & development

Applying Design for X (DFX) methodologies upfront in medical device  development optimizes the entire lifecycle by improving manufacturability, testability, reliability, usability, and other critical characteristics. This avoids costly redesigns later on, facilitates high-quality products that satisfy customers, reduces manufacturing and service costs, and supports flexibility through modularity and platforms. The holistic perspective of DFX drives efficient, cost-effective delivery of successful products that provide competitive advantage. Investing in DFX early pays dividends across the entire product lifespan.

Do you offer training on DFX for your medical engineering teams?

Education is critical to effectively implement DFX principles. We provide training tailored to your engineers’ roles and product lines. This includes overall DFX methodology, deep dives into specific disciplines like design for reliability or manufacturability, and practical application workshops. Our hands-on approach combines real-world examples and case studies with tutorials on leading DFX software tools. The goal is building organizational DFX expertise and establishing repeatable processes that endure beyond individual projects. Investing in DFX knowledge pays dividends across your entire product portfolio. 

Ready to Begin your next medical device DFX Project? 

Impossible Challenge? Try Us. 

Selecting a partner to help you complete your design project is a valuable option to reduce project duration and save money.    

The Boston Engineering product development system encompasses DFX to ensure a smooth product launch and success in the marketplace.  Boston Engineering has DFX knowledge and experience to address aspects and values of a product such as manufacturability, test, reliability, safety, serviceability, cost, and compliance with industry standards and government regulations.

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