Steripack Group
Ensera
Ensera offers comprehensive design and manufacturing services for medical and pharmaceutical devices, specializing in user-centric solutions from concept to final product. They focus on innovation, efficiency, and regulatory compliance.
Ensera, formerly SteriPack, is a global expert in medical and pharmaceutical device design and manufacturing. They provide end-to-end solutions, from initial concept development and research to prototyping, engineering, and final packaging. Their services are tailored to meet complex go-to-market challenges, emphasizing a user-centric approach, outside-the-box thinking, and a can-do mindset. The company excels in various design disciplines, including Research & Strategy, Human Factors, Industrial Design, Digital UX & UI Design, Engineering, and Electronics & Software. They focus on creating products that are not only innovative and functional but also safe, usable, and efficient, adhering to strict regulatory frameworks. Ensera's expertise extends to designing for manufacture, ensuring smooth production processes, waste reduction, and sustainability. With a strong emphasis on collaboration, Ensera partners with leading healthcare organizations to optimize existing devices or drive new product innovation. They are committed to delivering fresh thinking, impeccable service, and flexible solutions to help clients navigate the rapidly evolving healthcare landscape and achieve market success.
About
**Who they are**
Steripack Group, operating as Ensera, is a comprehensive design and manufacturing partner for medical and pharmaceutical devices, focusing on user-centric solutions from concept to final product. They emphasize innovation, efficiency, and regulatory compliance.
**Expertise & scope**
* Concept development, user testing, and prototyping
* Component injection molding, assembly, and kitting
* Sterilization management and secondary packing
* Design for Manufacture
* Research & Strategy for market trends and user needs
* Human Factors engineering to ensure safety, comfort, and intuitive use, including formative and summative usability testing
* Industrial Design covering aesthetics, usability, functionality, and packaging design
* Digital UX & UI Design for embedded interfaces and connected product ecosystems
* Engineering, including design, analysis, simulation, and product testing
**Reputation / proof points**
* Over 40 years of experience in innovating and developing healthcare product solutions.
Steripack Group, operating as Ensera, is a comprehensive design and manufacturing partner for medical and pharmaceutical devices, focusing on user-centric solutions from concept to final product. They emphasize innovation, efficiency, and regulatory compliance.
**Expertise & scope**
* Concept development, user testing, and prototyping
* Component injection molding, assembly, and kitting
* Sterilization management and secondary packing
* Design for Manufacture
* Research & Strategy for market trends and user needs
* Human Factors engineering to ensure safety, comfort, and intuitive use, including formative and summative usability testing
* Industrial Design covering aesthetics, usability, functionality, and packaging design
* Digital UX & UI Design for embedded interfaces and connected product ecosystems
* Engineering, including design, analysis, simulation, and product testing
**Reputation / proof points**
* Over 40 years of experience in innovating and developing healthcare product solutions.
Additional information
Ensera's approach integrates various design and development disciplines to create holistic product solutions. They emphasize understanding user needs and market trends early in the process, leveraging research and strategy to inform design decisions. Their human factors engineering expertise is crucial for mitigating use-related risks and ensuring products are safe and intuitive across diverse user groups, including healthcare professionals and patients. Packaging design is also a key consideration, addressing usability, protection, sterility, and brand communication.
Key Highlights
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Offers comprehensive design and manufacturing services for medical and pharmaceutical devices.
Source
“From concept development, user testing and prototyping, through to component injection molding, assembly, kitting, sterilization management and secondary packing, our teams of diverse experts have the power to advise on and manage your project from start to finish”
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Specializes in user-centric solutions, focusing on innovation, efficiency, and regulatory compliance.
Source
“Ensera offers comprehensive design and manufacturing services for medical and pharmaceutical devices, specializing in user-centric solutions from concept to final product. They focus on innovation, efficiency, and regulatory compliance.”
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Provides human factors engineering to ensure products are safe, comfortable, and intuitive to use, mitigating potential use-related risks.
Source
“Usability and human factors engineering play a vital role in design of medical devices, ensuring that products are safe, comfortable, and intuitive to use. In the context of medical regulatory frameworks, human factors work includes focus on mitigating potential use-related risks.”
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Expertise in industrial design includes functional packaging design that addresses usability, product protection, sterility, and brand communication.
Source
“Packaging designs tackle the challenges of usability, product protection, sterility, disposal, sustainability, and brand communication – all of which must be clear from first glance.”
Certifications & Trust Signals
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Partner with healthcare design consultants with over 40 years’ experience.
Source
“Partner with our world-class healthcare design consultants with over 40 years’ experience in innovating and developing bold, user-centric product solutions.”
Buyer Snapshot
Best for
- Companies seeking end-to-end design and manufacturing for medical and pharmaceutical devices.
- Organizations needing specialized expertise in human factors, industrial design, and digital UX/UI.
- Clients looking for user-centric solutions that prioritize usability, efficiency, and sustainability.
How engagement typically works
- Collaborative partnership from concept to final product.
- Flexible engagement, offering solutions for specific pain points or full project management.
- Multidisciplinary team approach integrating diverse expertise.
Typical deliverables
- Market-ready medical and pharmaceutical devices.
- Comprehensive design documentation and prototypes.
- User-centric product designs with integrated digital components.
- Packaging designs addressing usability, protection, and communication.
Good to know
- Best when requiring a partner with extensive experience in medical device development and manufacturing.
- Ideal for projects where user-centricity and regulatory compliance are paramount.
HQ:
St. Paul, US
Languages:
English
Timezones:
UTC-6
Claim status:
Listed
Services & Capabilities
Packaging + Shelf-life + Distribution Testing
Industries:
Medical Devices
Pricing model:
Custom pricing
Packaging Tests Offered:
Package integrity, Seal strength, Burst strength, Compression, Vibration, Drop
Shelf Life Methods Offered:
Real-time aging, Accelerated aging, Both
Distribution Tests Offered:
Vibration, Shock, Drop, Compression, Climate
Standards Supported:
ISO 11607, ASTM D4169, ISTA, ISO 16775, ISO 13485, FDA Guidance
Is Accredited:
Yes
Has Climate Chambers:
Yes
Has Distribution Simulation:
Yes
Rush Available:
Yes
Nda Support:
Yes
Minimum Project Size:
$25-50k
Accreditation Body:
ISO 17025
Lead Time Band:
Start in 4-8 weeks
Quote SLA:
3-5 business days
Sample Return Policy:
Dispose
Additional packaging_shelf_life_testing Details
Packaging Tests Offered
Package integrity, Seal strength, Burst strength, Compression, Vibration, Drop, Climate
Standards Supported
ISO 11607, ISO 16775, ISO 13485
Shelf Life Methods Offered
Real-time aging, Accelerated aging
Distribution Tests Offered
Vibration, Drop, Compression, Stacking, Climate
Lead Time Band
Start in 4-8 weeks
Quote SLA
3-5 business days
Sample Return Policy
Dispose
Minimum Project Size
No minimum
Pricing Model
Custom
