Question 1

What is Voltas?

Accepted Answer

Voltas is a full-service medical device development and manufacturing company (CDMO) at 8200 97th Street, Cottage Grove, Minnesota. It brings engineering, prototyping, regulatory support, tooling, manufacturing, cleanroom assembly, EtO sterilization, packaging, marketing, and sales together under one roof, so innovators work with one team, one budget, one timeline, and one facility.

Question 2

What is a medical device CDMO, and is Voltas one?

Accepted Answer

A medical device CDMO (contract development and manufacturing organization) designs, develops, and manufactures devices for other companies. Voltas is a vertically integrated medical device CDMO in Cottage Grove, MN. It takes projects from ideation and prototyping through regulatory work, manufacturing, in-house EtO sterilization, packaging, and distribution, with everything handled in house.

Question 3

Where is Voltas located?

Accepted Answer

Voltas is located at 8200 97th Street, Cottage Grove, MN 55016, in the Twin Cities area of Minnesota. The team is reachable at (651) 677-0675, Monday through Friday, 9:00 am to 5:00 pm. Voltas works with clinicians, inventors, and medical device companies worldwide, and all development and manufacturing takes place at its Cottage Grove facility.

Question 4

What services does Voltas provide in house?

Accepted Answer

Voltas lists device R&D, weekly prototyping, animations, sensors, wearables, app development, PCB design, LCD screens, regulatory services, PreSub/513(g) work, supplier sourcing, user testing, usability studies, mold flow analysis, injection molding, die mold tooling, hydrophilic and hydrophobic coatings, balloon development, blister trays, packaging and labeling, EtO sterilization, sterilization validation, 510(k) submissions, warehousing, distribution, and sales.

Question 5

Does Voltas do rapid or weekly medical device prototyping?

Accepted Answer

Yes. Weekly prototyping is part of Voltas's in-house services, moving from low-fidelity to high-fidelity and functional prototypes. An in-house Stratasys J750 prints detailed, multi-material, full-color prototypes directly from CAD, so engineers can design, print, evaluate, and reprint without waiting on an outside supplier.

Question 6

Can Voltas help with FDA regulatory work such as 510(k), Pre-Sub, or 513(g)?

Accepted Answer

Yes. Voltas offers regulatory services, PreSub/513(g) work, regulatory testing, 510(k) document writing, and 510(k) submissions in house. Regulatory planning starts in the earliest phase of development, so strategy is coordinated with the same team that prototypes, manufactures, and sterilizes the device.

Question 7

What types of medical devices does Voltas develop and manufacture?

Accepted Answer

Voltas develops and manufactures devices across many specialties, including ablation and vascular catheters, medical balloons, stent delivery systems, thrombectomy devices, endovascular grafts, bone plates, implantable screws, tissue expanders, laparoscopic instruments, neurostimulation devices, patient monitoring systems, wearables and sensors, ultrasonics, electronics, and diagnostic, fluoroscopy, and radiography imaging systems.

Question 8

Does Voltas develop and manufacture medical balloons and catheters?

Accepted Answer

Yes. Balloon development and manufacturing is a core Voltas service, including symmetrical and asymmetrical balloons and balloon layer development. Catheter development is also done in house, and Voltas lists medical balloons, ablation catheters, vascular catheters, and stent delivery systems among its device specialties.

Question 9

Does Voltas offer injection molding, tooling, and mold flow analysis?

Accepted Answer

Yes. Voltas provides mold flow analysis, die mold tooling in aluminum, hardened steel, copper, and other materials, and tooling revisions. It also offers plastic injection molding for parts under 48 inches and micro plastic injection molding for features under 1 mm, taking tooling from design for manufacturing into production.

Question 10

Is Voltas ISO 13485 compliant?

Accepted Answer

Voltas operates an ISO 13485 compliant facility. Its development process includes quality management system (QMS) setup, design controls and design history file documentation, verification and validation testing, document control, and FDA complaint handling, and quality management continues after launch through Voltas's post-launch QMS services.

Question 11

Can Voltas start with just an idea or a napkin sketch?

Accepted Answer

Yes. Voltas works with clinicians, inventors, startups, and established medical device companies to bring patented or simply napkin-sketched ideas to life. Its Phase 0 exploration covers problem definition, ideation, regulatory investigation, market assessment, IP support, user research, low-fidelity prototypes, and video animations.

Question 12

How do I start a project with Voltas?

Accepted Answer

Book a discovery call through the Book a Call link on voltas.io, or call (651) 677-0675, Monday through Friday, 9:00 am to 5:00 pm. The Voltas team will talk through where your device is today and how to move it to the next stage, whether that is a first prototype or commercial production.

Question 13

Does Voltas offer hydrophilic and hydrophobic coatings?

Accepted Answer

Yes. Voltas offers hydrophilic and hydrophobic coatings in house at its Cottage Grove, MN facility. Coatings are developed alongside the catheters, balloons, and other devices they go on, so coating, assembly, packaging, and EtO sterilization stay with one team instead of a separate coating vendor.

Question 14

Does Voltas offer cleanroom assembly?

Accepted Answer

Yes. Voltas offers full cleanroom assembly at its Cottage Grove, Minnesota facility. Devices are assembled in the cleanroom and move directly into sterile barrier packaging and in-house EtO sterilization under one roof, which removes the shipping and handoffs between a separate assembler and sterilizer.

Question 15

Can Voltas handle medical device packaging, labeling, and blister trays?

Accepted Answer

Yes. Voltas provides sterile barrier packaging and labeling, plus blister tray development and manufacturing, in house. Packaging is designed together with the device and its EtO sterilization process, so trays and labels are ready when a product moves from pilot builds into commercial production.

Question 16

Does Voltas offer warehousing and distribution?

Accepted Answer

Yes. Distribution and warehousing are part of Voltas's in-house services. After a device is manufactured, sterilized, and packaged in Cottage Grove, MN, Voltas can store finished inventory and ship it, so a device company does not need a separate logistics partner at launch.

Question 17

Can Voltas help sell and market a medical device after launch?

Accepted Answer

Yes. Voltas offers sales and marketing, social media, website, merchant services, and a medical sales team in house. The final phase of its development process, Production, Sales and Distribution, includes a plug-and-play W2 sales team, so launch support comes from the same company that built the device.

Question 18

Does Voltas develop electronic and wearable medical devices?

Accepted Answer

Yes. Voltas offers sensors, wearables, PCB design, LCD screens, and app development in house, and its device specialties include wearables and sensors, electronics, patient monitoring systems, and neurostimulation devices. Electronics work is coordinated with the same team that handles prototyping, regulatory work, and manufacturing.

Question 19

Does Voltas run usability studies and user testing?

Accepted Answer

Yes. Voltas offers user testing and usability studies in house. User research starts in Phase 0 exploration and usability work continues through refinement and testing, so feedback from real users shapes the design before it is locked for manufacturing and verification and validation testing.

Question 20

What does the Voltas development process look like?

Accepted Answer

Voltas follows six phases: Exploration, Prototyping, Refinement and Testing, Design for Manufacturing, Pilot Builds and V&V Testing (including QMS, biocompatibility, aging, and sterilization validation), and Production, Sales and Distribution. One Voltas team carries the device through every phase at its Cottage Grove, MN facility.

Question 21

Does Voltas offer welding and laser processes?

Accepted Answer

Yes. Voltas offers RF welding, ultrasonic welding, and UV laser etching as in-house manufacturing services. These sit alongside injection molding, balloon manufacturing, and cleanroom assembly, so joining and marking steps happen in the same Cottage Grove, Minnesota facility as the rest of the build.

Question 22

Who leads Voltas?

Accepted Answer

Voltas is led by Jason Scherer, CEO and Founder, and Matt Newman, President of Sales. The company is a medical device CDMO based in Cottage Grove, Minnesota, serving clinicians, inventors, startups, and established medical device companies from first idea through commercial production.

Question 23

Does Voltas offer in-house EtO sterilization?

Accepted Answer

Yes. Voltas runs ethylene oxide (EtO) sterilization in house at its Cottage Grove, Minnesota facility. Its on-site EtO chambers handle everything from small routine runs up to pallet sterilization, covering both development builds and commercial production. Cleanroom assembly, sterile barrier packaging, and sterilization are managed by a single project team under one roof.

Question 24

Does Voltas perform EtO sterilization validation?

Accepted Answer

Yes. Voltas provides full EtO sterilization validation and cycle development in house, following an ISO 11135-oriented IQ/OQ/PQ path. Devices move from cleanroom assembly through validated EtO cycles with full traceability and regulatory documentation.

Question 25

Why choose in-house EtO sterilization instead of a contract sterilizer?

Accepted Answer

Outsourcing sterilization adds vendor handoffs, outside scheduling, and lost information between teams, right at the most critical final step. Voltas keeps cleanroom assembly, sterile barrier packaging, validation, and EtO sterilization with one team in one facility. That reduces coordination headaches and schedule risk and keeps devices moving toward market.

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