Prospect Life Sciences

What Prospect Life Sciences does

Prospect Life Sciences (PLS) is a privately held contract medical device developer and manufacturer headquartered in Westminster, Colorado. Founded around 2015, the company operates an integrated end-to-end service platform consisting of four stages: Research & Design, Product Development / New Product Introduction, Manufacturing Transfer, and Production. The Production stage is delivered through a dual-footprint model combining US-based manufacturing in Colorado with a Costa Rica partnership established in November 2024 to access free-trade-zone economics for high-volume production.

The company's underlying technology platform centers on a fully integrated Quality Management System certified to ISO 13485:2016 by BSI and registered with the FDA under Registration Number 3014680149, with processes audited to 21 CFR 820. PLS maintains codified methodologies for Design History File (DHF) and Device Master Record (DMR) development, risk management per ISO 14971, software development aligned with IEC 62304, and process validation (IQ, OQ, PQ). Customers include startups, university spin-outs, and enterprise medical device and pharmaceutical companies spanning spinal implants, dental instruments, mobility assistive devices, GI endoscopy, sterile injectables (503B), and diagnostic kitting.

PLS generates revenue through professional services engagements (contract development, regulatory submission support, and quality system consulting) and hardware sales (contract manufacturing under both US and Costa Rica footprints). Pricing is quote-based, supported by a freemium 'Free Roadmap' entry point for FDA Clearance, CE Marking, or Quality System Implementation, with a paid 'Premium Roadmap' tier for detailed project proposals. Go-to-market is direct enterprise field sales, relationship-based, and supported by the company website, LinkedIn, and industry events such as MPO's Med Device Forum.

Name

Prospect Life Sciences

Legal name

Prospect Life Sciences

Website

https://prospectlifesciences.com

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

11–50 employees

Short description

Prospect Life Sciences is a US-based, ISO 13485-certified and FDA-registered contract developer and manufacturer offering end-to-end medical device services from R&D through production in Colorado and Costa Rica for medical device and biotech clients.

Ownership category

akta.pro rank

Product category

Medical Device Contract Manufacturing

NAICS

Research and Development in the Physical, Engineering, and Life Sciences (54171), Other Scientific and Technical Consulting Services (54169)

SIC

Services-Commercial Physical & Biological Research (8731)

akta.pro primary industry

Process Development & Tech Transfer Services (CDMO) (HLAGABAL)

Keywords

• Medical device development
• Contract medical manufacturing
• ISO 13485 certification
• FDA regulatory compliance
• Medical device design

Headquarters

HQ city

Westminster

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Personnel, Operations, Technology or R&D, Infrastructure, Supply Chain, Marketing or Sales

Revenue model

1. Contract Medical Device Development: Full-service medical device development from concept through regulatory approval, including research and design, product development, and manufacturing transfer services
2. Medical Device Manufacturing: Scalable production solutions with USA manufacturing for small to large-volume production and Costa Rica partnership for high-volume cost-effective manufacturing
3. Quality System Implementation Services: Consulting and implementation services for ISO 13485 and FDA QSR compliance, gap assessments, and auditing
4. Regulatory Submission Support: Preparation of regulatory submission packages for 510(k), PMA, or CE marking pathways

Pricing tiers

Go-to-market motion1 record

Distribution channels1 record

Marketing channels5 records

Core offering

Prospect Life Sciences is a contract medical device developer and manufacturer that takes products from initial concept through to global market fulfillment. It offers four sequential service modules—Research & Design, New Product Introduction/Product Development, Manufacturing Transfer, and Production (USA & Costa Rica)—supported by an ISO 13485:2016 certified and FDA-registered Quality Management System.

Product overview

Prospect Life Sciences offers an integrated, end-to-end medical device development and manufacturing platform consisting of four core service modules: Research & Design (R&D), New Product Introduction (NPI)/Product Development, Manufacturing Transfer, and Production (USA & Costa Rica). These services are designed to take medical device innovations from initial concept through to global market fulfillment, providing a unified pathway that bridges the gap between development and production.

Differentiator

Problem solved

Functional benefit

Products and services

• Research & Design (R&D)

Quantifiable outcome

• Products taken from early development to clinical trials to CE mark under budget and on-time
• +1 more outcomes

Named customers6 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature6 records

Partnerships

Three partnerships are on record, tiered minor and core.

• MedTechForum / MPOminorGTM or Marketing Partner · 5 May 2025Prospect Life Sciences attends MPO's Med Device Forum in Costa Rica, an industry event bringing together medical device professionals from across the industry to discuss current trends, issues, challenges and concerns.
• Costa Rica Manufacturing PartnercoreStrategic or Co-development Partner · 1 November 2024Prospect Life Sciences established a partnership in Costa Rica for high volume medical device production. Having reliable resources in strategically smart locations allows them to further meet customer needs and retain added control of the supply chain. Costa Rica's free trade zones provide ideal manufacturing environment with generous tax and duty exemptions.
• Spinal Stabilization TechnologiescoreStrategic or Co-development Partner · 10 December 2022Partnership with Spinal Stabilization Technologies (SST) for development of the PerQdisc Nucleus Replacement Device (NRD). PLS helped guide the product from early development to clinical trials to CE mark under budget and on-time. SST enrolled their first U.S. patient in the LOPAIN2 clinical trial for the PerQdisc device.

Scale indicators4 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• StarFish Medical: Canadian medical device contract design, development, and manufacturing organization offering end-to-end services from concept through production. Closely matches PLS's integrated model and target customer base of startups and mid-sized medtech companies.
• Meddux Development Corporation: Colorado-based medical device development and manufacturing firm offering R&D, design, prototyping, and low-volume production. Directly comparable to PLS in terms of size, location footprint, and full-lifecycle service offering for medical device clients.
• Tegra Medical: Medical device contract manufacturer specializing in complex components and assemblies for surgical and interventional devices. Comparable to PLS in regulatory rigor and complex-device capability, though larger and broader in scope.
• Donatelle: Medical device contract manufacturer providing design support, molding, assembly, and packaging with FDA-registered and ISO 13485 facilities. Comparable mid-size competitor in the medical device CDMO space.
• Mack Molding: Custom contract manufacturer with a dedicated medical division providing molding, assembly, and packaging for medical devices and diagnostics. Comparable to PLS in serving both medical device and diagnostic customers.
• Resonetics: Medical device contract manufacturer specializing in laser micromachining, nitinol components, and finished device assembly for interventional and minimally invasive applications. Comparable niche-focused CDMO serving complex regulated devices.

Broad incumbents

• Viant Medical: Large-scale medical device contract manufacturer with capabilities spanning design, molding, assembly, packaging, and sterilization. Represents the scale-tier competitor that PLS would face as clients move from development to high-volume commercial production.
• Jabil Healthcare: Global manufacturing services provider with a large healthcare and medical device division offering design, manufacturing, and supply chain services. Represents a much larger incumbent that competes for outsourced medical device production at scale.
• Integer Holdings: Large medical device contract manufacturer with development, manufacturing, and sterilization services across cardio, vascular, and other specialty therapy areas. Represents a much larger public-company CDMO with overlapping end-to-end capabilities.

Emerging players

• Eurofins Scientific: Global contract testing and laboratory services group that also supports medical device validation, regulatory testing, and quality assurance. Comparable to PLS for the testing/validation component of PLS's NPI services.

Market position

Weaknesses5 records

Competitive moat4 records

Key risks5 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/prospect-life-sciences/?trk=similar-pages_result-card_full-click&originalSubdomain=de

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles5 records

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Prospect Life Sciences