The Pros and Cons of Designing a New Medical Device vs. Extending the Life of an Existing Medical Device

When considering revenue opportunities and medical device development, medical device companies often face a critical decision: should they design an entirely new product or extend the life of an existing design? Both approaches have their merits and drawbacks.  Both strategies come with their unique advantages and challenges. 

Ultimately, the decision between designing new and extending existing products depends on various factors, including market dynamics, technological advancements, regulatory landscape, and company resources. A balanced approach, combining both strategies, often yields the best results for medical device companies aiming to innovate while managing risks and resources effectively.

Let's explore the key pros and cons to consider. Understanding these can help businesses make informed choices that align with their goals and resources.

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

Decision Time: Design a new medical device or Extend the life of an existing medical device design?

(continued from above)

Below is a list of pros and cons to help your discussions around the import decisions that need to be understood:

Benefits of Designing a New Medical Device

1. Innovation: New designs allow for cutting-edge technology and novel approaches to patient care.
    
   • This could involve integrating emerging technologies like artificial intelligence, nanotechnology, or advanced materials.
   • Novel approaches might include minimally invasive techniques, personalized medicine solutions, or devices that enable remote monitoring and telemedicine.
   
   
   
2. Market differentiation: A unique product can help stand out in a competitive landscape.
    
   • This could mean offering features or capabilities that no other device currently provides.
   • Differentiation might also come from improved user experience, enhanced ergonomics, or better integration with existing hospital systems.
   
   
   
3. Addressing unmet needs: New designs can tackle previously unsolved medical challenges.
    
   • This could involve creating devices for rare diseases or conditions that lack effective treatments.
   • It might also mean developing solutions for underserved populations or healthcare settings with specific constraints.
   
   
   
4. Improved patient outcomes: Innovative devices may offer better efficacy or safety profiles.
    
   • This could include more precise diagnostic tools, more effective treatment delivery, or reduced side effects.
   • Improvements might also come from better patient compliance due to more user-friendly designs.
     
     
     
5. Intellectual property: New designs create opportunities for patents and market exclusivity.
    
   • This can provide a competitive advantage and potential licensing opportunities.
   • Strong IP protection can also make the company more attractive to investors or potential acquirers.
     
     

Potential Issue of Designing a New Medical Device

1. Higher development costs: Designing from scratch requires significant R&D investment.
    
   • This includes costs for research, prototyping, testing, and clinical trials.
   • It may also involve hiring specialized expertise or investing in new equipment and facilities.
   
   
   
2. Longer time to market: New products face a more extensive regulatory approval process.
    
   • This could involve multiple rounds of clinical trials and regulatory submissions.
   • The process may be particularly lengthy for high-risk devices or those using novel technologies.
   
   
   
3. Increased risk: Novel designs may encounter unforeseen challenges or complications.
    
   • This could include technical issues that only become apparent during large-scale use.
   • There may also be unexpected biological interactions or long-term effects that weren't evident in initial testing.
     
     
     
4. User adoption hurdles: Healthcare providers may need training on entirely new systems.
    
   • This involves time and resources for education and training programs.
   • There may be initial resistance or skepticism from healthcare providers accustomed to existing methods.
     
     
     
5. Manufacturing complexity: New designs often require new production processes and equipment.
    
   • This could involve significant capital investment in new manufacturing facilities or equipment.
   • It may also require developing new quality control processes and supply chains.

AL & ML in Health Care - The Medical Workplace Multiplier

In this new Whitepaper, learn how AI and ML can enhance the medical workforce’s abilities and improve patient outcomes. 

While some view AI as a potential job replacement threat, the reality is that these advanced capabilities are better positioned as “workforce multipliers” that will amplify the abilities of doctors, nurses, technicians and other medical professionals.

Download your Free Copy Today!

Artificial intelligence and machine learning are emerging technologies that have immense potential to reshape healthcare delivery and medical practice.

(continued from above)

Benefits of Extending the Life of an Existing Medical Device Design

1. Cost-effective: Incremental improvements are generally less expensive to develop.
    
   • This leverages existing research, development, and manufacturing infrastructure.
   • It often involves optimizing or upgrading specific components rather than complete redesigns.
   
   
   
2. Faster time to market: Modifications to existing designs often have a smoother regulatory path.
    
   • This can involve abbreviated approval processes for certain types of changes.
   • Existing safety and efficacy data can often be leveraged to support modifications.
   
   
   
3. Established user base: Healthcare providers are already familiar with the core product.
    
   • This reduces training requirements and can lead to faster adoption of improvements.
   • Existing users may be more likely to upgrade to a new version of a familiar product.
   
   
   
4. Proven track record: Extended designs build on known safety and efficacy profiles.
    
   • This can provide confidence to healthcare providers and patients.
   • Long-term data from existing versions can support the safety of modifications.
   
   
   
5. Streamlined manufacturing: Existing production lines can often be adapted for updates.
    
   • This minimizes disruption to manufacturing processes and supply chains.
   • It can allow for more efficient scaling of production for improved versions.

Potential Issue of Extending the Life of an Existing Medical Device Design

1. Limited innovation: Incremental changes may not keep pace with technological advancements.
    
   • This could result in products that feel outdated compared to newer competitors.
   • It may limit the ability to incorporate cutting-edge technologies or approaches.
   
   
   
2. Market saturation: Extended designs may struggle to differentiate in mature markets.
    
   • This can lead to price competition rather than feature-based competition.
   • It may be harder to generate excitement or media attention for incremental improvements.
   
   
   
3. Missed opportunities: Focusing on existing products could mean overlooking emerging needs.
    
   • This might result in failing to address new market segments or clinical needs.
   • It could lead to being blindsided by disruptive innovations from competitors.
   
   
   
4. Diminishing returns: Each iteration may offer less significant improvements than the last.
    
   • This can make it harder to justify upgrades to customers.
   • It may lead to a plateau in performance or capabilities.
     
     
     
5. Competitive pressure: Rivals may leapfrog extended designs with more innovative offerings.
    
   • This could result in sudden obsolescence of a product line.
   • It may require reactive rather than proactive product development strategies.

New eBook Available Now! 

"Leveling Up Existing Products through DFX" 

-Download Insights from a DFX Subject Matter Expert- 

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.

Imagine your Impact: Stay up-to date- with the latest insights and trends we're watching. Add your email address below and sign up for a Monthly Summary of our most impactful posts!