Hayag Corp
Architecting a Compliance Turnaround
Hayag Corp

Hema Lakkaraju, Founder & CEO, Hayag CorpHema Lakkaraju, Founder & CEO
Product launches can be exhilarating and overwhelming. When charting a game plan to accelerate product launches and gain the early mover advantage, organizations strive to get all the cogs to work cohesively. Today, as the COVID-19 pandemic stretches on, the healthcare and life sciences industry is all hands on deck to fast track innovation. The heightened need is to develop and deploy products faster and reduce time to market to reach patients quickly. However, even as ideas constantly spring from the drawing board, most often, there is a crucial part that weighs businesses down in their quest to get them to the market faster—the compliance factor. While most companies give much thought to their business and marketing strategies right from the beginning, compliance is often an afterthought. As the health and life sciences industry expands its digital footprint, strategical partnerships and integrated products and services have become the norm. Yet, when it comes to compliance, organizations still follow a siloed approach and comply with one regulation after another, which detrimentally impacts the modernization and digitalization of products. In today’s integrated and digitally transformed health and life sciences industry, the impact of cybersecurity, privacy, FDA, and other regulations is more than ever. Against this backdrop, a compliance environment within the organization must help accelerate the innovation—not block it.

The time proved ripe for Hayag Corp to disrupt the traditional approach toward quality and compliance implementation within an organization. “We have created an integrated, customized holistic data driven compliance approach for health and life sciences innovators to accelerate product launches in a safer and secure way that builds trust among customers and helps serve them better,” says Hema Lakkaraju, founder, and CEO of Hayag Corp. In the hard times of the pandemic, when the compelling need of the hour is faster service and greater and safer products, Hayag employs a two-pronged approach providing compliance as a service tool that brings out of the box data-driven approach coupled with a strategic approach toward meeting all regulations and standards.

Changing the Game

With over a decade of experience in the compliance arena, Hema has witnessed the health and life sciences industry embracing digital transformation and the astonishing innovation rate. But the gap between compliance and development teams seems to only increase with the traditional siloed approach to compliance resulting in the inability of the product teams to get the products to market quickly because they lack the strategic guidance in terms of regulations. The internal compliance teams’ expertise is often limited, and companies have to knock on the doors of multiple compliance firms to become compliant with various regulations. And unfortunately, it takes up to one and a half years to be compliant with one regulation. In the case of multiple regulations, the long drawn out process adversely impacts productivity and performance. The result is that products that could be launched within a year get delayed by four to five years.

Against this backdrop, Hema draws attention to the fact that a product team understands the product better than the compliance leaders.

We also want to change the perspective of quality and compliance leaders portrayed as blockers to accelerators for the product launch

“Hence, they should have access to tools whereby they can define what the product stands for and be able to get the regulatory controls that are specially designed or applicable for the product,” she points out. With HAYAG PROD+, the first product in Hayag’s compliance management software suite, the product teams can define what the product stands for and automatically get the regulatory controls in under five minutes.
“We also want to change the perspective of quality and compliance leaders portrayed as blockers to accelerators for the product launch,” states Hema. Hayag creates an environment where compliance leaders can be thought leaders complying with privacy, security, and other regulations and creating a competitive advantage for the market’s products.

The Swiss Army Knife of Compliance

Hayag’s solution portfolio comprises—HAYAG PROD+, HAYAG PROJ+, and HAYAG ALM underpinned by its consulting arm, HAYAG CONSULTING.
HAYAG PROD+ is a complete product management and compliance assessment tool that helps organizations to assess the product and obtain a whole set of applicable regulations and compliance design controls within a minute. The specially designed SaaS platform has a unique dashboard where product teams can add multiple products, revise their product configuration, and get their updated regulations at any time. Using their unique user ID, they can manage, assess, and control their assessments.

Hayag’s second product, HAYAG PROJ+, helps in deploying the projects at a faster rate. In the highly regulated health and life sciences industry, projects have to comply with multiple locations, and HAYAG PROJ+ takes care of all the needs of the various departments right from HR to IT and R&D to finances. “It is again a data-driven approach where the teams can define their project nature, the information they handle and the location and more and get the applicable cybersecurity, privacy and regulation controls that need to be put in place,” says Hema.

The third product line, HAYAG ALM, is an application lifecycle management tool designed as a complete end-to-end service. Organizational teams can comprehensively assess projects and products’ compliance requirements and manage the whole product through the ALM tool. It has portfolio management, task management, document management, risk management, and vendor management, which is sold separately. HAYAG ALM is an all-inclusive management tool that helps modern organizations avoid hopping between different tools and agencies to manage one product or project.

While the software solutions automatically provide the strategic compliance controls, Hayag also offers consulting services. Considering the 3Ps of organizational success—product, process, and people—the software solution addresses the projects and products part while consulting comes into the picture to create new procedures, processes, or policies.

In a nutshell, Hayag is the one-stop-shop bringing all skillsets, offering customized compliance solutions and strategic, lean, and tailored compliance frameworks that help organizations meet various regulation standards from FTA, ISO, cybersecurity to privacy based on their unique requirements.

Faster Time to Market

Hayag brings manifold advantages to the table. Today, it takes four to five years for a product to meet all the regulations and get FDA approval before its launch. The collaboration with Hayag drastically saves time and money. As the software gives all the strategic solutions under minutes rather than months, well ahead of the game, companies can easily save up to 50 percent of the time, as opposed to the traditional process, by complying with all regulations simultaneously and accelerating the product launch. Moreover, product teams need not repeatedly explain their products to multiple consultants. Companies can save up to 60 percent on operation costs because compliance is created by design done by design.

Hema recalls an instance where a big medtech company trying to deploy a product had to contact multiple consulting firms as most of them were often well versed only in one regulation. They got a huge invoice and an estimated timeframe of about three to four months to comply with the various regulations. When Hayag came onboard, the team said all they needed was under an hour to understand the client’s product, the information they handle, and their regional market to run their software and leverage their consulting expertise to create a comprehensive compliance roadmap. The Hayag team gave them the strategic plan with a full set of applicable regulations control from FDA to cybersecurity and privacy, within a day, against the estimated timeframe of three months. The roadmap included product design, controls strategy, processes, and general policies. It covered the people, process, and product compliance strategy and detailed controls from cybersecurity, privacy, FDA, and other regulations. The client was fascinated to have a clear roadmap in less than 24 hours. They could accelerate the product launch, saving around two to three months and a substantial cost on the business and operational front while gaining a competitive advantage.

"We have created an integrated, customized holistic data-driven compliance approach for health and life sciences, innovators, to accelerate product launches in a safer and secure way"

At the core of Hayag’s solutions is a unique data-driven approach. “We believe that even as technology changes, data is core and its sensitivity doesn’t change,” explains Hema. Hayag’s compliance models based on a data-driven approach are futuristic, helping companies meet all regulations simultaneously.

Disrupting the Compliance Trail

Over the last two years, Hema and her team have left no stone unturned to disrupt the traditional approach to compliance in a market rife with stories of product teams weighed down by the rigors of achieving compliance. “Since we are not compromising on anything from a regulations, safety, and security point of view but giving a better pathway to compliance, people are understanding and echoing our vision,” says Hema.

When the overall market for compliance and regulatory world is transitioning from an operational to a much more strategic role, Hayag brings that concept of change of the roles. As the company gears to extend its footprint globally, Hema signs off with these lines, “Our vision is to help innovative health and life sciences companies build products safely and securely and launch them in a faster manner for the greater good.”