Module 5: Product Development

STAGE 1: Human Factors Engineering

Beyond design according to the needs and specifications for the intended global health challenge, it is important that medical devices fit the context of their use. Specifically, this refers to engineering for human factors, a field of study known as ergonomics. Human factors engineering focuses on the device-user interface, refining components or aspects used to operate the device. Intended to reduce or eliminate ineffectiveness due to human error, ergonomics aims to “[simplify] the operation of devices…to enhance patient safety, whatever the resources of the country, but particularly for low-resource countries with few trained personnel.”(1) Although simplicity does not imply patient safety, simpler protocols in operation often minimize the probability of usage error that leads to diminished efficacy.

Thus, the U.S. Food and Drug Administration (FDA) has defined rules for ergonomic design:(2)

• Make the design intuitive to user expectations

• Consider the user’s previous experience with use and conventions of appliance

• Design according to basic user capabilities (strength, dexterity, memory, reach, vision, and hearing)

• Maintain organized and uncluttered displays

• Create obvious associations between controls and displays to aid in recognition and reduce user memory load

Designing in accordance with these rules can facilitate the eventual consumer uptake of intended medical devices, reducing the likelihood of error that could deter people from adopting devices, particularly if they are new technologies. Addressing human factors early on in the design process can also avoid future barriers to use that will be critical in later stages of Delivery.

Stage 2: Regulatory Strategy

A critical step for developers of new technology is the compliance with and approval from regulatory bodies prior to large-scale production and distribution. Such regulatory processes are in place to ensure that products are safe, authentic, and effective for patients. In the market of innovation, original designs need rigorous testing and clearance to qualify for the commercial setting. Design regulations, standards of internal review boards, and patent agencies or licenses present checkpoints at the regional, national, and global levels.(3)

Broadly, the key stages to attain regulatory approval (prior to subsequent steps in licensing and marketing of developed products) are: adequate and successful (preclinical and) clinical trials, assured compliance with World Health Organization (WHO) pre-qualifications, and evaluation by regulatory agencies.(4)

Clinical Trials

Various preclinical models may be used to guide formal clinical trials. Unlike the stage of testing design criteria, preclinical testing is performed with the finished product form to understand issues of safety, such as the toxicity of side effects and ideal level of doses. Many products in development do not meet minimum safety standards and fail to continue onto clinical trials. However, for those considered safe in these early trials, continued clinical development usually occurs in three phases, with each consecutive phase growing in sample size. In Phase 1, the product is tested for safety in groups of 20-80 healthy individuals. Phase 2 expands the study sample to include 100-300 individuals to continue the safety assessment and gather evidence of effectiveness. Phase 3 enlists even larger groups of up to 3,000 or more individuals to provide substantive evidence on the efficacy of the product against alternative options. Sometimes, a Phase 4 is used for monitoring purposes to ensure safety before widespread distribution. If a product reaches the later phases (3 and 4) with proven success, it is submitted for regulatory review.(5)

WHO Prequalification

As an indication of product quality, safety, and efficacy, the WHO prequalification program provides independent assessment of “drugs and vaccines required for purchase by United Nations procurement agencies,” evaluating the suitability of products for intended countries.(6) Though not an approved regulatory agency, the WHO prequalification assessment is important for use by developing countries that do not have sufficient regulatory capacity to oversee further evaluation.

Review and Approval

Typically, product review is conducted by the national regulatory authority in the country where the product is intended for distribution. Ultimately, the regulatory authority determines “whether a product is safe for widespread use within that jurisdiction and whether manufacturers can consistently produce high-quality products.”(7) Specifically, the Global Health Technologies Coalition cites that countries need the resource capacity to:

• Review clinical trial applications

• Oversee the design of, conduct site inspections for, and monitor trials (in accordance with international standards)

• Determine standards for approval and registration of health technologies

• Conduct inspections of manufacturing facilities and oversee quality assurance over the product supply chain used to test and make the technology

• Explain to professionals and the public how to use the technology properly and ensure appropriate labeling

• Routinely monitor the quality of health products being distributed in the country(8)

For instance, the U.S. FDA maintains the responsibility of and jurisdiction to ensure consumer safety and product effectiveness for food and drugs circulating in the U.S. market. In the developing world, many countries still lack sufficient resources to meet all of the needs listed above. Collaboration among international and regional networks aims to build capacity for stronger regulatory systems that will bring safe and effective technologies to populations in need. This framework inspired the FDA in 2008 to issue guidelines on reviewing applications for vaccines against diseases common to the developing world. Similarly, the regulatory agency for the European Union, the European Medicines Agency, established a policy in 2004 to review vaccines and drugs planned for markets outside of the EU.(9) Such examples of international cooperation have enabled the exchange of pertinent information to streamline evaluation processes. Yet there remains room for improvement. Globally, all regulatory systems need to be strengthened. Although there have recently been shifts in vaccine development policies, the same consideration is necessary to address diagnostics and devices geared toward the developing world.(10) 

Without proper regulatory protocols, the ultimate consequence is that people’s health suffers. Critical products may never reach patients, and even if they do, patients cannot be assured of their quality and safety. Populations are placed at risk for the proliferation of ineffective and potentially harmful counterfeit products, in addition to the compromised safety and efficacy of products used in clinical trials.(11) Although progression through the protocols of regulatory agencies requires patience and discipline, this stage is crucial for product success beyond the design table. From the perspective of any stakeholder in the product (consumer, developer, or manufacturer), the adherence to strong and appropriate regulatory strategy may effectively determine whether health products reach populations in need.

Stage 3: Finding Support

Despite marks of approval from regulatory bodies, new innovations typically need a “critical mass” of champions to overcome an expected resistance to behavioral change. For many potential users of new technology, observable benefits and peer approval are the strongest winds of persuasion. Unless the technology is inherently suitable for behavior change, the new product requires validation that builds evidence for widespread acceptance. Specifically, “fostering champions requires good evidence, good management, transparency of process, and willingness to share the ownership of the project.”(12)

In many cases, donors or funders will wait until the product has met regulatory standards before submitting further investment to bring the product to market. This is especially important in the course of licensing, when development costs may double or triple according to demands of industrial world organizations.(13)

Footnotes

(1) World Health Organization. “Medical Devices: Managing the Mismatch.” Geneva: WHO Press, 2010.

(2) Ibid.

(3) Free, M. “Achieving appropriate design and widespread use of health care technologies in the developing world.” International Journal of Gynecology and Obstetrics. 85.1(2004): S3-S13.

(4) “Innovation in Action: Policies to Accelerate Development and Delivery of Global Health Tools.” Washington, DC: Global Health Technologies Coalition, 2010.

(5) Elias, C. “Policies and Practices to Advance Global Health Technologies.” A Report of the CSIS Global Health Policy Center. Center for Strategic & International Studies (CSIS). Apr. 2009.

(6)“Innovation in Action.” Global Health Technologies Coalition. https://www.ghtcoalition.org/.

(7) Ibid.

(8) Ibid.

(9) Ibid.

(10) Elias, C. “Policies and Practices to Advance Global Health Technologies.” A Report of the CSIS Global Health Policy Center. Center for Strategic and International Studies. April 2009.

(11) “Innovation in Action.” Global Health Technologies Coalition. https://www.ghtcoalition.org/.

(12) Free, M. “Achieving appropriate design and widespread use of health care technologies in the developing world.” International Journal of Gynecology and Obstetrics. 85.1(2004): S3-S13.

(13) Ibid.