Medical devices play a vital role in improving the lives of patients with chronic conditions, healing complex wounds, and supporting caregivers and clinicians across healthcare settings. But behind every device, from skin-friendly adhesives to advanced wound dressings, lies a rigorous journey of innovation, testing, and refinement.
In this post, we’ll walk you through the lifecycle of a medical device, from concept to production, while highlighting how Sarasota Medical Products brings life-changing technologies to patients, clinicians, and caregivers with speed, care, and clinical precision.
Whether you’re a wound care nurse, ostomy patient, home health professional, or innovator, this guide will help you understand the innovation process and how Sarasota Medical’s U.S.-based team ensures safety, comfort, and efficiency at every stage.
Understanding the Medical Device Development Process
Medical devices like hydrocolloid dressings, ostomy barriers, and custom adhesives are not born overnight. They undergo a meticulous process that balances regulatory compliance, clinical effectiveness, and patient comfort.
As recommended by the FDA, the standard stages of medical device development include:
1. Ideation and Concept Design
Everything begins with a need—whether it’s for better wound exudate management, reduced peristomal irritation, or a longer-wear adhesive. Clinicians, researchers, or patients may identify gaps in care that spark a new idea.
At Sarasota Medical Products, our concept development starts with direct input from clinicians and real-world patient experiences. We prioritize:
- Hypoallergenic ingredients
- Comfort-driven designs
- Practical solutions for home health use
Learn more about how we transform ideas into real-world solutions on our Custom Product Development page.
2. Prototyping and Material Selection
Next comes transforming the idea into a physical form. During this stage, multiple versions of the product are created to test:
- Material flexibility and adhesion
- Skin compatibility
- Performance in real-use scenarios
Our team at Sarasota Medical focuses on developing skin-friendly solutions, including hydrocolloids, soft silicones, and breathable films, all manufactured and tested in-house in Florida.
Example: Choosing the Right Material
Here’s a simple comparison of common materials used in advanced wound care and ostomy products:
| Material | Common Use | Skin Sensitivity | Moisture Control | Cost |
| Hydrocolloid | Wound dressings, barriers | Gentle | Excellent | Moderate |
| Silicone Gel | Peristomal skin protection | Very gentle | Moderate | Higher |
| Non-woven Fabric | Adhesive backings | Moderate | Low | Low |
3. Bench Testing and Regulatory Compliance
Before any device reaches a patient, it must meet rigorous regulatory standards.
- Biocompatibility testing ensures the material doesn’t cause irritation, allergy, or cytotoxic effects.
- Adhesion testing measures how securely the device performs over time.
- Moisture vapor transmission rate (MVTR) is measured for wound dressings to ensure optimal healing environments.
As part of our commitment to safety, Sarasota Medical complies with FDA standards and partners with regulatory specialists to ensure all devices are properly classified, documented, and submitted.
We’re proud to be one of the leading Florida medical device companies with an in-house team experienced in 510(k) submissions and ISO 13485 standards.
4. Clinical Evaluation and Real-World Feedback
Clinical trials or post-market surveillance allow us to observe how the device performs across different patient populations. Sarasota Medical Products works directly with clinicians, wound care nurses, and home health professionals to gather valuable feedback and iterate quickly.
For example, our ostomy products have been praised by patients for reducing discomfort during hot Florida summers; thanks to breathable, sweat-resistant adhesives.
5. Manufacturing and Quality Control
Once approved, the device enters full-scale production. Sarasota Medical offers U.S.-based manufacturing for faster turnaround, consistent quality, and responsive customer service.
Key features of our process include:
- Batch testing for consistency
- Packaging designed for home and clinical use
- Custom production capabilities for OEM clients
Our facilities are equipped to produce small and large quantities quickly, an advantage for fast-tracking specialty wound care and ostomy solutions during shortages or emergencies.
Why Sarasota Medical’s Innovation Process Sets Us Apart
Sarasota Medical Products isn’t just a medical supply company. We are innovation partners to clinicians and caregivers, with a development process built on:
- Clinical collaboration: Products designed with input from WOCNs and medical professionals
- Skin health as priority: Every adhesive we develop is tested for sensitive skin
- Rapid prototyping: Faster timelines for bringing devices from idea to life
- Made in Florida: Supporting U.S.-based healthcare and reducing shipping delays
Learn more about our process on our About Us page.
FAQs: Bringing Medical Devices to Life
Q: How long does it take to develop a medical device?
A: It depends on the device class and regulatory path. Simple dressings may take 6-12 months, while higher-risk devices could take several years. Sarasota Medical helps accelerate development through in-house design, prototyping, and regulatory support.
Q: Can I create a private-label product through Sarasota Medical?
A: Yes. We work with brands and hospitals to develop custom-labeled wound care and ostomy products. Visit our Custom Product Development page to learn more.
Q: Are your adhesives safe for long-term wear?
A: Yes. Our adhesives are formulated to reduce skin stripping and irritation, even during prolonged use or in high-humidity environments.
Final Thoughts: Supporting Better Outcomes Through Innovation
As wound care professionals and ostomy specialists know, comfort and skin protection are non-negotiable. That’s why every Sarasota Medical device is engineered with the patient in mind, from the first sketch to the final seal on the package.
Whether you’re a clinician looking to solve a patient challenge or an entrepreneur with an idea for a better dressing, we’re here to help.
Innovating a new medical device? Contact Sarasota Medical Products to turn your idea into reality.
Let’s bring healing solutions from lab to life, together.