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What is critical when introducing digital applications in a regulated environment?

Starting reading this interesting post – and from its title – I had the impression that some sort of ROI indications will be disclosed. While ROI is often mentioned, it is not the key subject nor the key learnings I took with me after reading it.

For me, this article is much more an initial, but good structured workbook on how to align different functions to achieve a high grade of efficiency and effectiveness in a process, which is becoming more and more critical today: introduction of digital applications in a regulated environment.

Under the subject of my service “Product Evaluation”, that’s why I decided to keep it in my blog.

Thank you to Ilyssa Levins for this post.

Increasing ROI for Digital Tactics from the Inside Out

By Ilyssa Levins

Measuring the ROI of approved digital tools once they are in the marketplace is a hot topic. The quest to generate a high ROI is an ongoing one and metrics to measure success in digital are often debated. What should not be debated, however, is the value of increasing a company’s ‘internal ROI’ when readying digital tools for promotional review. ‘Internal ROI’ reflects the efficient use of time and money spent internally getting digital promotion approved for use in the marketplace.

This is only possible when Marketing and review team members collaborate upstream before a digital tool is even submitted for approval. Perhaps if we spent more time collaborating earlier in the process, we would deliver a higher ROI from the inside out.

Measuring Digital ROI is No Easy Feat

There’s little agreement that traditional metrics such as click-through, download and open rates are ideal measurement tools even though they do quantify physical engagement with the digital tactic.

“These metrics are really just digital impressions,” explains Alexis Pone, VP, Strategy and Business Development, MedEdNow. “They do not provide insight as to whether tactics have made a positive impact on users or provide any value in everyday experience.”

On the other hand, there are patient apps, which provide obvious patient benefits, for example drug dosing reminders, but Pone states that, “It’s hard to measure the ROI here because the tactic is not directly linked to sales.”

Digital Applications Continue to Expand

The value of apps is becoming more and more important since they help keep patients on therapy. Apps can provide ongoing education and messages to patients about adhering to medicines prescribed by their physician. In addition to dosing reminders, there are now checklists for symptom management, planning tools, and links to patient support information.

According to marketing and communications strategist, Liz Kay, “These smart tools require product marketers, medical legal and regulatory teams, and IT to be aligned early on in the process. When these functions, each with their own internal goals and objectives, have an open and honest dialogue, and align and share the same language around the initiative, these digital tools can come together more efficiently and effectively.”

Pressures Overriding Basic Considerations

Internal ROI can be overlooked when commercial teams are focused on getting their digital initiatives into the field as quickly as possible to help reach marketing goals. Furthermore, this push and pressure to get the materials out can end up overriding even the most basic considerations.

Too often, review teams are asked to evaluate digital initiatives for regulatory compliance, which do not deliver a good consumer experience. For example, the function of the digital tool is not immediately obvious, or it is difficult to navigate without lengthy instructions. In some cases, digital tools are submitted which can’t even be technically executed. All these oversights negatively impact internal ROI.

In addition, according to Katherine Norris, Director of Corporate Compliance & Risk Management, BRG, “One of the most morale- and collaboration-killing events in the life of a PRC committee is one where the company realizes too late that it simply does not have the infrastructure to support the risk inherent with a new tool, but for which the marketing idea engine and investment has already been made. Not only are there sunk costs involved, but dashed hopes as well. Forethought and collaboration around these novel tools goes a long way in building relationships and optimizing outcomes around these digital initiatives.”

When Review Teams are Business Partners, Internal ROI Increases

There are a number of fundamental requirements for promotional review teams when evaluating proposed digital tactics. Reviewers must:

  • Understand the digital platform (e.g., Web page, Twitter, Facebook, app)

  • Be fully versed on the risks and requirements for the recommended platform

  • Evaluate cases (internal and from other companies/products from which to draw best practices and regulatory history)

  • Involve the appropriate stakeholders in the concept review and/or development of the digital tactic (e.g., Medical Info/Med Affairs, IT, PR)

  • Have internal SOPs in place related to producing this type of digital tactic

  • Ensure content is fairly balanced, truthful and accurate.

A strategic reviewer can also ask the following questions to make sure the digital campaign is well thought out before promotional regulatory compliance is even considered:

  • How does the digital solution address the unmet needs or add value to the end user?

  • What are the goals of this tactic:

  • Raise awareness among HCPs to prescribe?

  • Improve informed decision-making among HCPs and patients?

  • Help patients increase their medication adherence? Facilitate access to providers or supportive care resources?

  • Improve name recognition or informational value during the patient visit?

  • Who will be responsible for monitoring any two-way communication or social posting that results from use of this digital tactic?

  • Do we need to consider whether it will work across a variety of digital platforms/social media?

  • Have you thought about the global implications of this initiative and do we need to address challenges and opportunities in all targeted regions?

According to Pone, “The review team could also suggest a pilot under the guidance of a virtual advisory board of actual users (the target audience). One of the benefits of utilizing a virtual advisory platform is that you gain insight on the value of the digital tactic before it’s in the field.”

Developing pilot programs may help to jumpstart a realization among all the participants that it’s actually possible to make digital be much more efficient.

The Power of Upstream Partnerships

Getting a digital campaign up and running may consume a significant amount of time and money, especially when a company is embarking on its first Facebook page or app.

In light of this, review teams and their marketing colleagues have an opportunity to save their company time and money by collaborating more effectively upstream in the review process before the tactic is presented for consideration.

“Digital experts, agency, brand and med/legal review teams are very often disconnected because of a lack of protocols or process,” explains pharma digital/social media consultant Bryan Kaye. “Being successful in digital and social media requires fluid internal collaboration in as close to real-time as possible across verticals because there are so many variables to consider, from technical functionality to regulatory concerns.”

Kaye continues: “Team structures, operations and communication must evolve to support a dynamic digital environment. It really relies on aligning internal education, subject matter experts and review teams to revamp the traditional review process.”

“The internal value of cross-functional stakeholder transparency and collaboration cannot be overstated when it comes to digital media. The manner in which the tool(s) will be used should be thoroughly evaluated up front, with contingency plans and risk management strategies identified to ensure these tools help, and do not hurt, your company once they are live,” affirms Norris.

“In particular, interactive digital tools pose the greatest potential risk so the company’s strategy and policies surrounding their implementation should be aligned early and calibrated often.”

It’s critical that commercial teams understand that partnering with their review team counterparts upstream will improve internal, and therefore, external ROI. Given that early concept reviews occur more frequently within companies, review team members should use this opportunity to pose targeted questions in order to elicit the information needed to improve digital tools before review upload. This upstream partnership will facilitate the development of initiatives more quickly and get them into the marketplace more efficiently than ever before. The debate is over: together, marketing, compliance and regulatory can improve – and approve – a company’s online materials and help drive commercial success.

A Look to the Future

Today’s patients expect cutting-edge digital solutions and new communication channels. This is particularly true with rare diseases.

“As the demand for new digital solutions grows, advocacy, marketing and regulatory must have strong relationships and collaborate closely to meet the needs of the different stakeholders, including patients, within the appropriate regulatory guidelines. It’s more important than ever to deliver on internal ROI as our healthcare system continues to change,” explains Wendy White, SVP, Rare Diseases, Dohmen Life Science Services.

2015 is poised be another banner year for digital health. The FDA is expected to review a record number of mobile health apps as digital health companies respond to demand for more sophisticated mHealth products. A new wave of wearable smart garments is in the market.

“The increasing availability of mobile sensors such as socks and vests and other new technologies are leading to a plethora of possibilities for digital health,” says Anita Burrell, formerly Head Commercial Operations Effectiveness, Global Diabetes at Sanofi. “We can look forward to a world where mHealth provides an opportunity to improve health outcomes, increase patient satisfaction and reduce costs.”

Concludes Stephanie Bova, Digital Commercial Lead at Takeda Pharmaceuticals Europe: “With ehealth a reality, ROI cannot simply be measured by reach, action, conversion or engagement, or measurements related to brand, content performance and commercial impact. Our ultimate ROI will be improving the lives of patients.”

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