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We consult with Social Entrepreneurs who are developing Medical Devices and need assistance with Commercialization, specifically with Quality System requirements for the device and organization.

By doing this, we help turn Technology into Products that make an impact on Global Health.

Learn more about:

Who we work with

We work with many groups that develop medical devices; they can be grouped into these categories:

Social Entrepreneurs

Social Entrepreneurs work to further a social goal, not for monetary profit. Many different groups fall into this category: student groups, non-governmental organizations (NGOs), or just people and companies with ideas that they think can help the less fortunate. They do not have to be not-for-profit entities, though they usually are.

We work with Social Entrepreneurs whose projects can be considered medical devices aimed at low-resource settings or otherwise fill an unmet need in a neglected population. Devices like these are sometimes referred to as "appropriate technology."

Design Groups

Design groups or Designers engaged in the development of low-resource high-impact medical devices are a particular kind of Social Entrepreneurial venture. They usually have a great idea and proof-of-concept prototype, but they may or may not have realistic plans for expanding development and distribution. Remember that once the fun of creating a new idea wears off, there can't be any real impact without scaling up to responsible, quality-controlled production and distribution!

Student groups usually fall into this category, as well as several professional groups and individuals.

These Quality System elements are especially important for Designers:

  • Document Controls
  • Design Controls
  • Design Transfer
  • Risk Management
  • Labeling

Contracted Local Manufacturers / Distributors 

Designers must work with one or more manufacturers to make their device a reality. Ideally, this manufacturer will take responsibility for the project and will also assist with distribution and maintenance, but this is not always the case. Sometimes these functions need to be fulfilled by other third parties, and these must also follow your Quality System. It makes sense for these manufacturers to be local to the target market for the device.

These Quality System elements are especially important for Contract Manufacturers:

  • Management Responsibility
  • Process Controls & Validation
  • Risk Management
  • Document Controls
  • Storage, Distribution, Handling
  • Control of Nonconforming Product
  • Mistake-Proofing
  • Supplier Controls
  • CAPA
  • Change Management
  • Labeling
  • Training Procedures

These Quality System elements are especially important for Distributors:

  • Training Procedures
  • Risk Management
  • Control of Nonconforming Product
  • Document Controls
  • Storage, Distribution, Handling
  • CAPA

Original Equipment Manufacturers (OEMs)

When one company creates, brands, and distributes a product they are considered an OEM, or Original Equipment Manufacturer. Social Entrepreneurs starting at the ground level in communities and taking responsibility for the entire process surrounding the design, manufacture, distribution, training and education on their device, are considered the OEMs of their products.

All elements of a robust Quality System are necessary for an OEM.

Quality Systems

When you turn to commercialization, you need to keep a careful eye on the quality of your products - and the organization itself!

What is a Quality System?

A Quality System is the framework of operation used by an Organization to ensure that it can consistently and reliably design, manufacture, distribute and service safe and effective products.

This includes the policies, procedures, processes and resources that an Organization uses to develop its products to meet customer requirements for what the product must do, and then to safely and responsibly produce these products at the scale needed to serve its customer base while ensuring the product's fitness for use, safety, performance and availability.

Who needs a Quality System?

If a medical device is being created, manufactured, distributed, and used on patients - the entities which are involved in these processes need quality controls, no matter their good intentions (or tax code)!

Where do Regulations fit in?

Many developing countries do not have mature regulations for medical device development, but this does not mean that the safety of their medical devices isn't important! And while regulations may not exist for a specific device in a given country at this time, regulations are probably on their way (and will probably resemble Global Harmonization Task Force (GHTF) guidelines).

We develop Quality Systems that are aligned with the GHTF and with requirements of the FDA, ISO, and other global regulations as applicable for the target market. Of course, there is no one-size-fits-all quality system. We work closely with our clients to develop the system correct for them, with all the particulars of the regulatory environment appropriate for their product and market.  

What are some benefits of a Quality System?

Safe, reliable products and consistency in design and manufacturing are just the beginning. Other benefits include:

  • Root cause problem solving instead of constant firefighting
  • Staff competence and output is maintained with personnel changes
  • Generation of metrics that gauge performance
  • Cost lowering through scrap reductions
  • Constant self-improvement of your organization through internal audits and management commitment
  • and much more...


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