Developing a medical device can be a complex and costly process. From research and design to prototyping, testing, and regulatory compliance, every stage of the development cycle requires attention to detail and significant investments of both time and resource. Design Director, Mark, shares 8 valuable tips for reducing medical device development costs while maintaining regulatory compliance and ensuring high standards of quality:

Streamlining the design and development will ultimately reduce costs. Here are some ways of ensuring you avoid un-necessary delays and can progress your medical device project in the most efficient way:

1. Investigate grants and funding opportunities available.

We often successfully help clients accelerate their project through recommending funding that might be available to them locally or nationally. Universities may also be able to offer their time and expertise or help with research they’ve already carried out.

2. Partner with experienced suppliers.

If you’re not familiar with the medical device regulations it is well worth partnering with, or outsourcing to, an ISO 13485 certified development consultancy or seek guidance from regulatory consultants. Outsourcing can help you access specialized skills and expertise at a lower cost. HD have a breadth of experience designing & developing a range of drug delivery and other medical devices for healthcare, pharma and med tech clients globally. We can help solve your problems and speed up your projects!

3. Conduct thorough market research to understand the demand for your product, competition, and regulatory requirements.

This will help you make informed decisions and avoid costly mistakes. Understand your user and device requirements to ensure you’re designing to the right brief.

4. Carry out formative human factors studies.

Carrying out usability studies as soon as possible in the process will help validate the direction you are taking before committing too much time and investment into the development. 

5. Test and validate your medical device early in the development process to catch any potential issues before they become costly to fix.

This can help you reduce the overall cost of development by avoiding expensive rework.

6. Keep It Simple!

Focus on essential features that are required to make your medical device functional and effective. Avoid adding unnecessary features that can increase the cost of development. The less parts, features or functions you have in your device, the less there is to develop, less risk of supply chain complexity or hold ups, less parts to fail in the field! Commonize parts where possible but avoid over-complicating parts to achieve it.

7. Take advantage of simulation software to get the design as close as possible before physically testing prototypes.

Once you get your first moulded parts, you can validate the material model used in the simulation software and then have confidence that you can accurately simulate any design changes to the part moving forwards.

8. Choose the correct prototyping process for the part requirements.

Battling with un-representative prototypes that keep breaking will just delay the project, prevent effective user studies and can lead to either over-engineered parts or un-necessary failures during testing. Ensure you consider what you need to test and learn from specific prototypes and select the correct prototyping process for the requirements.

 

Reducing medical device development costs is crucial for improving affordability and accessibility in healthcare. By implementing the tips discussed in this blog, including leveraging existing technologies, optimizing design and manufacturing processes, collaborating with partners, and considering regulatory requirements early on, pharmaceutical, healthcare and med-tech companies can effectively lower their development costs without compromising quality or efficacy.

It is important to remember that cost reduction efforts should be balanced with the need to maintain high standards of quality and safety. Close collaboration between engineers, designers, manufacturers, and regulatory experts is key to ensure that cost-saving measures do not compromise the efficacy or safety of the final product.

Furthermore, continuous evaluation and improvement of development processes, as well as exploring innovative approaches such as virtual prototyping and simulation, can further enhance cost-effectiveness in medical device development.

By following these tips, you can optimize your resources, streamline processes, and bring innovative and affordable solutions to patients and practitioners. Lowering medical device development costs not only benefits the bottom line of companies but also contributes to improving patient care and outcomes, making healthcare more accessible and affordable for all. Please get in touch to discuss how Haughton Design could help accelerate your medical device development.

 

Mark Heynes - Medical Device Design Director at Haughton Design Mark Heynes 12 April 2023

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Get in Touch with Mark Heynes

Design Director

Mark ensures that projects are delivered on time and are suitably resourced to guarantee quality of output. Mark is heavily involved in our design services, having a wealth of experience in healthcare devices, trainer devices, IVD’s, and inhalation. ​

Mark holds a Bachelor’s Degree in Product Design along with 20 years’ experience working on a wide range of design projects. 

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