Contract partner

Contract designer & contract manufacturer & contract X in medtech

Nowadays, the medical device industry involves multiple stakeholders specializing in critical processes such as design, development, testing, production, distribution, and sales. Legal manufacturers increasingly outsource processes to third parties with specialized expertise. This article highlights opportunities for contract designers and contract manufacturers to collaborate and thrive in this ecosystem.

Contract designers (often start-ups in their early stages) typically focus on prototyping with limited or no production capacity. Contract manufacturers, on the other hand, are tasked with producing devices designed by their clients.

1. Quality management

Either as contract designer (start-ups) or contract manufacturers should have ISO 13485:2016 or at least ISO 9001:2015. This is a good qualification for legal manufacturer.

For contract manufacturer for finished medical device will with higher likelihood be under inspection by legal manufacturer, notified body and authority. For part design and production partner it is a nice to have qualification against competitor.

Key documents required:

Design history file
Device master record
Management review
Internal audit
Training records
Complaint management
Supplier management
Validation of machine
Validation of process

2. Technical documentation

Technical documentation is general documents to be submitted to authority to get product approved. For future legal manufacture, he may request extensive documentation depending on submission requirements and regulatory scrutiny.

For contract designer besides the physical prototypes except medical software, you should consider as early as following technical documentation:

Product specification
Risk management
Product description
Draft of labelling (IFU and Labelling)
Verification and validation plan and report
Clinical evidence
Design input, design output and design control
Software file
List of applied standard

TD is less critical for contract manufacturer. Nevertheless many contents in country specific registration are not to avoid as:

Production workflow
List of production machine and instrument
Datasheet of material
Certificate of critical component
V&V report of critical component

3. Design transfer

We would limit this chapter to contract manufacturer and legal manufacturer.

Design transfer between contract designer and legal manufacturers is rarely seamless due to gaps in R&D continuity and evolving regulatory requirements. There are too many R&D activities in terms of design history file after taking prototype over.

The design transfer between contract manufacturer and legal manufacturer is also a lifecycle activity which must be maintained due to evolving regulation and design change. For the first design transfer record these should be taken into account:

Product specification and BOM
Incoming-, in process and final inspection
Workflow of production
Supplier of component and material
Packaging
Labelling
Change management
Complaint management (e.g. non-conforming products)

4. Who could be legal manufacturer?

All can be legal manufacturer who wants to place the medical device (IVD) in subject market.

Compliant to regulation in each market the legal manufacturer has to fulfil his obligatory. The prominent regulation is article 10 at MDR in EU: general obligations of manufactures. The typical role of legal manufacturers is for quality management, technical documentation, and post market surveillance.

We list some examples in best practise:

Contract designer who outsources production
Contract manufacturer who places medical device in market with and without own R&D
Investor (global player) who takes design or/and production over and place product on market
Private labelling manufacturer who places product on market in his name, normally without any R&D and production activities
Distributor (importer) who not only distributes product and is willing to be legal person in subject market
Consulting who not only registers product and is willing to be legal person in subject market
Combination of different stakeholders as joint venture owns brand and entity in in subject market

5. Where is regulation?

Unfortunately there is no regulation how to master this complex complaint move. However any stakeholder should monitor these regulations of medical device (IVD)

ISO 13485:2016, Medical devices — Quality management systems — Requirements for regulatory purposes
ISO 9001:2015, Quality management systems — Requirements
Regulation of quality management system where production is located
Local law MDR in EU and in Food, Drug, and Cosmetic Act (FD&C Act) in US
E.g. Canada: Private Label Medical Devices
E.g. China: state council order 739
Product specific guidance and standards

6. EU MDR Implications

The constellation of Original Equipment Manufacturer (=contract manufacturer, OEM) and Own Brand Labeler (=Private labelling manufacturer, OBL) DO NOT exist after new MDR.

Nevertheless legal manufacturer may outsource design and production in third party. The active role is on site of legal manufacturer who takes manufacturers obligation over.

Depending on requirement on critical supplier of diverse notified body it is unpredictable to have a golden standard. As contract designer or contract manufacturer, it is recommended to bind legal manufacturer as soon as possible if prototype bears solid evidence for performance and safety.

7. At international market

The international cards are flexible. In some country local distributor can act as marketing holder of product certificate as MAH in Japan.

With scenario of venture capital or wholly foreign-owned enterprise (WOFE) in China, the legal manufacturer could benefiting “made in China” product, local to transfer abridged registration and act as new owner of product in China.

8. For venture capital: Fueling Innovation Across the MedTech Value Chain

Venture capital is the lifeblood of medical device innovation, enabling breakthroughs from concept to commercialization. With global MedTech investments surpassing $28.3B in 2023 (Rock Health), the sector offers lucrative opportunities for VCs to engage at every stage of the value chain:

Why Invest in MedTech’s Early-Stage Startups (Contract Designers):

High-growth potential: Startups specializing in AI-driven diagnostics, minimally invasive surgical tools, or connected devices are attracting early-stage funding at 3x the rate of traditional biotech (McKinsey, 2023).

De-risked prototyping: Platforms like us curate startups with validated prototypes, ISO 13485 compliance, and preliminary clinical data—reducing due diligence burdens.