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Biotech and Medical Device Development

Beyond solving the unique technical challenges faced when creating a new product, medical and biotech devices are subject to regulations requiring specific risk reduction and design control activities throughout the product development cycle.

These quality requirements ensure a well-documented and reviewable design process — and ultimately, a safe product. At Simplexity, our core design philosophy is that the best solution is the simplest one to reliably accomplish your goals. This has particular relevance in the medical device space where reliability, safety, and intuitive design are of the utmost importance.

Quick links for Biotech and Medical Device Development:

Challenges of biotech and medical device development

Biotech instruments have become more broadly used and widely adopted, so the incentives for developing lower-cost systems has increased. Simplexity’s expertise in low-cost consumer products has led to a growing number of successful partnerships within the biotech industry. Common challenges that bring clients to Simplexity are:

  • Ground-up, full system development.
  • Proof-of-concept devices for technology demonstration.
  • Design of a cost-reduced and design-optimized next-generation product.
  • Translation of a low-volume design to a higher volume, production-ready design.
  • Technology feasibility evaluation or isolated technical hurdle resolution.
  • Develop product architecture.
  • Comprehensive program planning, phase gate build objectives, risk assessment, development budget, product cost estimation.
  • Manufacturing strategy. (contract manufacturing selection, tooling strategy, test planning, quality management)

Simplexity’s priorities for device design

As product realization experts, our priority is to work collaboratively with our clients to meet both the technical and business goals of a new product. Our team commonly augments the client’s core expertise, enabling rapid transformation of benchtop concepts to finished products.

Together, we comprise an expert product development team, continually focused on project priorities like:

  • Product performance.
  • Device and consumable cost.
  • Manufacturable design.
  • Intuitive, safe, and reliable operation.
  • Speed to market.
  • Development cost.

Simplexity’s capabilities and expertise

As an engineering and technology-focused design company, our goal is to create the best design team of mechanical, electrical, and firmware engineers and technicians in the industry around the core competencies of product design. These include:

  • Design for reliability, testability, usability, and manufacturability.
  • User experience design and workflow analysis.
  • Liquid handling and pump systems.
  • Sensor development.
  • Motors, actuators, and control.
  • Integrated sensors and electronics.
  • Displays.
  • Low-power wireless communications.
  • Disposable and rechargeable battery systems.
  • Test and assembly automations.
  • Precision temperature control.
  • Designing for medical device standards, including ISO 13485, IEC 62304, ISO 14971, IEC 60601, and IEC 61010.

Our product engineers and project managers have worked with biotech clients to design products and systems within the product categories of:

  • Library preparation instruments.
  • IVD sample prep instruments.
  • Cell therapy manufacturing tools.
  • Liquid handling systems.
  • Point-of-care diagnostics instruments.
  • High-precision, low-volume fluidic systems.
  • Opto-mechanical engineering.
  • Thermo-control systems.
  • Motion subsystems (firmware, electronics, and all mechanical components).
  • Medical wearables.

Simplexity's design partners

If your project requires capabilities outside of Simplexity’s core competency, we will work with you to identify and partner with external companies to complement our expertise, such as:

  • Industrial and interaction design.
  • Usability engineering.
  • Optical engineering.
  • Microfluidics and cassette design.
  • Contract manufacturing organizations.
  • Software application development.

CASE STUDIES IN BIOTECH DEVELOPMENT

 

During a highly collaborative development effort, the Health and Safety Institute (HSI) provided information on CPR technique and they crafted an engaging software interface. Simplexity carried out the detailed engineering utilizing the “simpler is better” approach. Together the companies solved some challenging issues.

SEE CASE STUDY

When converting from off-the-shelf motion technology to a customized embedded solution, a major life sciences company chose Simplexity to minimize development risk. 

SEE CASE STUDY
 
 

With Simplexity, they don’t say simplification, it’s organic. It’s how they think. The result is exactly the new tool we need to train more students all over the world and save more lives with better CPR.

— Frank Powers,
Chief Technology Officer, Health and Safety Institute 

Download our brochure to learn more about Simplexity’s capabilities in biotech.

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Simplexity is your partner with a proven team to reduce risk and simplify your biotech design.

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