She was born Loretta Enjoyable. For most of her lifetime, she was acknowledged as Henrietta Lacks. Due to the fact the 1950s, generations of mobile biologists have acknowledged her — mainly without becoming mindful of it — as HeLa, the nickname for the line of cells that inaugurated a new era in healthcare exploration.
The medical odyssey that manufactured Lacks’ cells a cornerstone of fashionable medication, chronicled in Rebecca Skloot’s 2010 bestseller “The Immortal Lifetime of Henrietta Lacks,” is a amazing item lesson in knowledgeable consent and bioethics and a sobering chapter in the very long, shameful background of racial inequity and exploitation in medicine.
On April 11, Skloot, together with Shirley Lacks and Jeri Lacks Whye, will notify Lacks’ tale and explore the troubling historical and moral concerns woven by means of it in a lecture on Virginia Tech’s Blacksburg campus.
The series of events that put Lacks at the centre of a revolution in clinical analysis commenced in 1951, when the Black mom of five sought cure at Johns Hopkins Medical center for what turned out to be an aggressive cervical cancer. All through the class of her cure, doctors gathered cells from her tumor and passed them along to a Johns Hopkins researcher wrestling with the obstacle then consuming the professional medical group: expanding human cells outside the house the human physique.
Lab-developed cells would permit scientists to perform experiments and examination remedies without the need of endangering human sufferers. But until eventually the cells from Lacks’ tumor showed up, no sample experienced at any time survived for for a longer time than a several days.
Lacks’ cells have been unique. They doubled their populace each individual 24 hrs in an seemingly inexhaustible offer of equivalent copies. Lacks died in August 1951, but her cells — which she did not know had been being cultured and hadn’t supplied researchers consent to use — divided above and above all over again in the laboratory, turning out to be the initial “immortalized” human mobile line.
This limitless offer of cells transformed healthcare investigate. The vaccine for polio was designed by way of experiments conducted on HeLa cells. Scientists have relied on them to study diseases, which includes measles mumps, HIV, and ebola, and to produce treatment options for cancers and viruses. HeLa cells were being the very first to be cloned and the first to be sent to room. They supplied the backdrop for essential discoveries in genetics and other facets of cell biology.
All of this was finished with no consulting, or even informing, Lacks’ relatives, who only became informed that the cell line existed in the 1970s when they started acquiring requests from scientists for blood samples. As aspect of the massive scientific and revenue-earning business that was by then running all around HeLa cells, members of the spouse and children had been utilised in investigate — all over again, without the need of their consent — and their health-related documents shared.
It wasn’t right up until Skloot began the reporting that in the end grew to become “The Immortal Lifestyle of Henrietta Lacks” that the Lacks spouse and children grew to become knowledgeable of the magnitude of Henrietta’s transformative contributions to medicine — and the profitable biotech enterprise that fueled this investigate bonanza. Lacks’ organic materials experienced allowed companies to rake in enormous income offering HeLa cells by the trillions, but her descendants — who shared the same biological product — hadn’t gained any of that windfall.
Skloot utilised some of the book’s proceeds to build The Henrietta Lacks Basis, which has assisted aid some of the family’s costs. Some biotech firms have considering the fact that contributed to this fund. But the ongoing discussion over the accountable solution to Lacks’ legacy highlights the necessity of continuing to wrestle with these problems.
Sloot’s perform, which handles topics from foodstuff politics to the intersection of race and medication, has been featured inThe New York Momentsand on Nationwide General public Radio, CBS Sunday Early morning, the podcast “Radiolab,” and several other stores.
She has been acknowledged with awards from organizations such as the National Academies of Science, the American Association for the Advancement of Science, and the Wellcome Have confidence in.
She holds a bachelor’s degree in biological science and a master’s diploma in innovative nonfiction.
The Hugh and Ethel Kelly Lecture Sequence is built possible by a fund from the estate of Ethel Kelly, who generously supported Virginia Tech and the College or university of Engineering in honor of her husband, Hugh. Hugh Kelly acquired bachelor’s and master’s degrees from the university and went on to enjoy important roles in multiple groundbreaking initiatives around a long vocation at Bell Laboratories.
To honor Hugh Kelly’s technical achievements and the couple’s assist of Virginia Tech, the University of Engineering and the Institute for Critical Technology and Used Science founded the lecture series and renamed the institute’s headquarters creating Kelly Corridor in 2013. The Kellys’ generosity has allowed the institute to bring Nobel laureates, Pulitzer Prize winners, and other visionary leaders and thinkers to Blacksburg to share their get the job done with the Virginia Tech group.
Organization’s Core Goal: Helping Others Find and Take Steps Toward Their Own Possible
NEW YORK, March 28, 2023–(BUSINESS WIRE)–Peter Kirk, CEO of Sermo, has launched Be Your Possible, a global charitable organization committed to raising funds for medical research and inspiring others to take steps towards their “possible”.
Be Your Possible’s mission to inspire others and fundraise for research was born from Kirk’s own harrowing experience of surviving Acute Myeloid Leukemia, a rare cancer of the blood and bone marrow. After receiving a terminal diagnosis and being intubated in the ICU with double lung pneumonia, Kirk received a blood stem cell transplant that saved his life.
“A 25-year-old man named Sam saved my life when he donated 850 million wonderful stem cells that ultimately made my transplant possible,” Kirk said. “A kind stranger gave me another chance at life, and this wouldn’t have been conceivable without the decades of medical research that went into advancing the transplant process and the work of oncologists around the world. Through Be Your Possible, we’re aiming to expand access to life-saving medical treatments to people on a global scale by funding vital medical research, moving scientific breakthroughs forward, and offering support to those who receive critical diagnoses like mine.”
Peter’s “possible” is running 1,000 half marathons by the 10th anniversary of his transplant to raise $1 million for blood stem cell cancer research at Memorial Sloan Kettering Cancer Center, where he received his own life-saving transplant. Be Your Possible will also offer opportunities and events to empower not only other patients, but everyone to take steps toward finding their own possible, from exercise to education and personal growth.
Be Your Possible’s flagship event is Run with Peter-Run for Research, a global doctor-led run that takes place annually in June. Inspired by Kirk’s incredible completion of the NYC Marathon five months post-transplant, the inaugural event mobilized thousands of physicians in 77 countries to run or walk with Kirk in support of medical research causes, chosen by physician runners themselves. Founding partner Sermo donated $250,000 to the various causes chosen by physician participants, including the American Heart Association, St. Jude Children’s Research Hospital, and Memorial Sloan Kettering Cancer Center, where Kirk received his life-saving blood stem cell transplant.
Our core belief is that anything is possible, taking one step at a time TOGETHER. To learn more, visit beyourpossible.com
About Be Your Possible:
Born from Founder and Sermo CEO Peter Kirk’s harrowing experience with Acute Myeloid Leukemia, journey to recovery, and commitment to inspiring others to be their possible, Be Your Possible is a global charitable organization committed to raising awareness and funds for medical research to help others benefit from life-saving treatments, such as Peter’s own blood stem cell transplant.
The organization was founded in 2022 launching its first initiative, Run with Peter-Run for Research, a global movement mobilizing thousands of physicians to run or walk in support of medical research.
Peter’s “possible” is running 1,000 half marathons by the 10th anniversary of his transplant.
We pledge to empower not only other patients, but everyone to take steps toward finding their own possible, from exercise to education and personal growth. Our core belief is that anything is possible, by taking one step at a time, TOGETHER. To learn more, visit beyourpossible.com
About Sermo:
Sermo is the largest global healthcare research company and the most trusted physician engagement platform. Sermo engages with more than 1.3 million HCPs across 150 countries and has reach into the U.S. Payer market that now exceeds 230M commercial lives covered.
For over 20 years, Sermo has been turning physician experience, expertise, and observations into actionable business insights that benefit pharmaceutical companies, healthcare partners, and the medical community at large. Sermo offers on-demand access to physicians via a proprietary health-tech ecosystem to gain targeted HCP insights that inform strategic decisioning in real-time. Visit www.sermo.com/business
Four RHODE ISLAND overall health care organizations have been awarded a full of $9.1 million from the U.S. Office of Wellness and Human Services to reinforce expert services throughout the point out and aid clinical investigation, U.S. Sen. Jack Reed introduced Monday.
PROVIDENCE – Four Rhode Island wellness care businesses will share $9.1 million from the U.S. Division of Wellness and Human Services to bolster providers across the point out and aid clinical research, Sen. Jack Reed, D-R.I., declared Monday.
The federal funding will assist numerous vital well being initiatives, including giving medical care and treatment method for people residing with HIV/AIDS, unexpected emergency medical solutions for young children, expansion of most important care medical professional and dental residency schooling, supply voluntary household scheduling companies to Rhode Islanders who want them and bolster well beingtreatment solutions for people in will need.
The funding will also support important exploration initiatives into mind science, habit and nourishment.
“This federal funding will assistance produce complete, obtainable clinical and dental care to those in require and advance crucial investigate at Brown College,” Reed said. “Every Rhode Islander deserves obtain to quality, cost-effective wellbeing care.”
Those people obtaining funding include things like:
R.I. Division of Wellness, $3.2 million to administer Ryan White Title II Components Grants Program to assistance strengthening HIV/AIDS care and treatment providers in Rhode Island, $1.4 million to assistance supplying voluntary loved ones preparing expert services to Rhode islanders who need them, specifically family members with very low incomes and $190,650 for Emergency Professional medical Companies for Children Partnership Grants to help projects to expand and boost crisis health care expert services for small children who want procedure for trauma or important treatment.
Wood River Wellbeing Products and services Inc., $1.8 million to assistance delivering significant-high quality, cost-effective healthcare, dental and social solutions to the communities of southwestern Rhode Island.
Brown College, $1.8 million for 3 initiatives: $771,600 to aid investigation on drug abuse, dependancy and addressing key boundaries within just the therapy process $558,534 for Potent Family members Start at Residence investigation, a research examining household-based meals parenting/nutrition intervention to boost the diet regime top quality of reduced-profits children and $541,675 to guidance mind science analysis screening neural mechanisms of sequence checking in the frontal cortex across species.
Thundermist Wellbeing Center’s Training Wellness Heart, $500,000 for its Preparing and Advancement Plan to assist bettering and expanding key care health practitioner and dental residency instruction in neighborhood-centered, affected person-treatment configurations.
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Before the COVID-19 pandemic, Texas Biomedical Research Institute had established itself as a go-to researcher of infectious diseases, along with therapeutics and vaccines to combat them. It was recognized by the federal government, though not necessarily among the top contractors able to take on more government-funded bioscience research.
Since the pandemic began, the independent San Antonio nonprofit has expanded its reputation with government and within the private sector, namely the pharmaceutical industry. And that has widened Texas Biomed’s potential customer and revenue base at a time that it’s undergoing an expansion and modernization plan estimated at more than $300 million.
Texas Biomed, which seeks to increase its staff from 430 to 700 employees in the next decade, is looking to strengthen partnerships with pharmaceutical companies like Pzifer and Regeneron Pharmaceuticals. After being contracted by those two companies to study and develop COVID-19 vaccines and therapeutics, more calls have come from the industry seeking Texas Biomed’s help to streamline the path from research to market.
On ExpressNews.com: Texas Biomed elevated to state’s only prime contractor in U.S. response to pandemic, bioterrorism
With a new financial strategy, the institute is ready to engage with Big Pharma and high-dollar contracts. Its researchers boast access to high-level containment labs and a primate center, confident that they can help pharmaceutical companies move scientific discoveries to preclinical studies and commercial adoption.
Texas Biomed CEO Dr. Larry Schlesinger said Big Pharma has “reduced its investment” in developing new drugs to treat infectious diseases in recent years, to a large extent out of concern that their shelf lives are too short. And the resulting void is where the research institute can play a key role.
“They need a nonprofit to do the hard development work they could then take over and commercialize,” Schlesinger said.
At the same time, Schlesinger believes the nonprofit can grow its basic science research like medical schools or universities that have long histories of working with industry partners.
“Based on the need to really handle infection, we need to have more products,” he said. “We don’t convert our scientists to businessmen. We just help them understand how there’s a very fine line between cutting-edge, basic science discovery and a possible application.”
Diversifying revenue
Texas Biomed reported revenue of $70 million this year, up 38.6 percent from $50.5 million in 2017. It secured $108 million in grants and contracts in 2022, up significantly from $27 million in 2017.
As part of the institute’s expansion plan, it broke ground on a $15 million-plus animal care complex and is ramping up efforts for its new Global Center for Bioscience, which is known as “the future home for multidisciplinary team science,” director of public relations Nicole Foy has said.
Federally funded work won’t be enough to help bring Texas Biomed’s vision to fruition.
“Funding (from the National Institutes of Health) for biomedical research is tight,” Schlesinger said. “When we ask for $1 for an experiment, the NIH pays us $1.98. The 98 cents is the indirect revenue on every dollar to fund the lights and the mortar and the bricks to help the research. That alone is not enough money actually to sustain the expense of science.”
He said the nonprofit aims to diversify its revenue.
His rough idea is to generate 50 percent of Texas Biomed’s revenue from NIH funding, with the rest coming from current government grants and increased private sector contracts from Big Pharma, which would provide indirect funding for research, the expansion of the campus and hiring scientists.
“For institute’s that don’t diversify, they either close or they are in slow decline, because you can’t support the cost of the science,” he said. “I would say diversification is critical.”
Big Pharma is also interested in engaging scientists to work on lucrative biological data projects. Besides studying infectious diseases, scientists might be involved in collecting biological data — a lucrative market. For Texas Biomed, it’s a new practice with the potential to yield tension among scientists.
Schlesinger hopes to find an “aligned strategy” to complete such data projects while keeping scientists on task to research infectious diseases. He doesn’t want to “get into the business of ripping off the scientists to do contract work.”
“We need to resource both properly to avoid that tension,” he said. “We’re growing, and there’s tension that comes with growth. But tension needs to be in right-sizing both sides of the house at the same time, trying to keep a handle on administrative costs so we have the money available to do that science.”
Since 2015, the nonprofit has received about $46 million through subprime contracts with the authority. The new status puts it in the top ranks of the authority’s limited network and enables it to receive up to $100 million in federal funding over five years. It’s now the only researcher in Texas with the designation.
It will also continue to seek funding from the city of San Antonio, philanthropists and private sector contracts. In 2022, the San Antonio City Council voted to give $10 million in federal COVID-19 relief money to the nonprofit.
Infectious disease a ‘growth area’
Texas Biomed’s revenue from contract research — much of it involving projects that are confidential — jumped 187 percent from 2017 to 2022, the nonprofit reported.
And it expects contract revenue to grow based on the threat of infectious diseases, a threat it considers to be massive, so much so that its executives believe infectious diseases may become the leading cause of death by 2050.
Such projections are based on a groundbreaking report — by the United Nation’s ad hoc Interagency Coordination Group on Antimicrobial Resistance — that estimated drug-resistant diseases could cause 10 million deaths per year by that time, up from about 700,000 today. The U.N. said the economic damage from such a level of deaths could be as “catastrophic” as the global financial crisis of 2008-09 and push millions of people into poverty.
“From a business perspective, this is a growth area,” Schlesinger said.
To that end, Schlesinger said Texas Biomed has found created a business model “at the cutting edge of infectious disease research and development model that you’re going to see more of,” Schlesinger said. “The world is demanding more options to treat infection.”
Texas Biomed has existing partnerships with MAPP Biopharmaceuticals in California and the nonprofit Sabin Vaccine Institute in Washington, D.C., involving recent Sudan Ebolavirus vaccines and therapies. It has also re-established existing models for mpox, formerly called monkeypox, to support therapy studies for Regeneron.
“Our business is science,” Cory Hallam, vice president of business development and strategic alliance, said. “Our currency is quality science regardless of who the audience is, whether it’s your collaborators and fellow researchers that are pushing the boundaries and discovery or partners or clients you’re working with to actually do science for them.”
‘Primed’ for the pandemic
Yale-educated oil man Tom Slick founded Texas Biomed in 1941, and he started the nonprofit Southwest Research Institute seven years later.
Ever since, Texas Biomed scientists have primarily worked on independent projects funded by the NIH, part of the U.S. Department of Health and Human Services, Foy said.
They studied diabetes, obesity, cancer and aging. But under the leadership of Schlesinger, who became CEO in 2017, the institute pivoted to focus on researching infectious diseases.
That year, an internal audit found that 70 percent of the institute’s research involved infectious disease, a category that drove about 80 percent of its revenue. Another 10 percent of revenue came from contracts, almost exclusively in high-containment work in Texas Biomed’s biosafety level 4 lab, known as BSL-4.
On ExpressNews.com: National group says San Antonio shouldn’t give COVID-19 relief funds to Texas Biomed
Then, in early 2020, amid the coronavirus pandemic’s initial stages, Schlesinger issued funding calls to local donors — including H-E-B, USAA and the McCombs Foundation — to collect nearly $3.5 million for five COVID-19 research projects.
The nonprofit also received a $60,000 grant from the NIH to help it determine which animal — baboon, macaque or marmoset — could produce best test subjects.
Scientists conduct research on primates in the BSL-3 and BSL-4 labs — the same facilities they used to study Ebola, hepatitis C, Zika and SARS, a coronavirus genetically related to the strain that caused COVID-19.
Texas Biomed established partnerships with pharmaceutical giant Pfizer and biotechnology company Regeneron Pharmaceuticals, both based in New York. It also worked with Novavax, a biotechnology firm in Maryland, as well as Gilead, a pharmaceutical company in California.
The institute’s staff gained national recognition for its contributions to researching COVID-19 and for helping the government and Big Pharma get therapeutics and vaccines onto market.
“Being primed helped us when the pandemic hit,” Schlesinger said.
Watch the CBS Reports documentary “Body Brokers” in the video player above.
Every year, an estimated 20,000 people donate their bodies to science for the purpose of medical research and education. But unlike organ donation, these body parts can be bought and sold for profit — a market with very few federal regulations.
Special Agent Paul Micah Johnson, an investigator for the FBI’s Detroit Division, has spent the last decade looking into what he called a “vast gray and black market of dead human bodies.”
The Uniform Anatomical Gift Act, a statute adopted by 47 states, is one of the few regulations governing the non-transplant tissue industry. It outlines the standards for body donation, and most significantly, it requires that donors, or their loved ones, must provide informed consent before donation takes place.
These consent agreements between donors and tissue banks typically stipulate that the body will be used for research and education — but what that means in practice can vary.
“Medical research and education, particularly education, is a vague term and it is not clearly defined even in the Uniform Anatomical Gift Act,” says Johnson. “The misleading of families across the industry is quite common.”
Special Agent Paul Micah Johnson
CBS News
While most donors consent to donation for research and education, legally, the agreements can include addendums that allow for donors to be used for “non-medical projects” that can include “crime scene investigation” and “vehicle safety.”
Steve Hansen had always wanted to be an organ donor, but when he died in 2012 from cirrhosis of the liver, doctors said his organs were not healthy enough to be transplanted. Steve’s wife Jill Hansen says hospice workers at the time suggested whole body donation as an alternative.
“What I envisioned was him being in some medical facility,” Hansen says. “I just thought, what a great candidate for them to learn about the results of alcoholism and what it does to a body.”
Steve and Jill Hansen
CBS News
Steve’s body was eventually sent to the Biological Resource Center in Phoenix, Arizona, which then sold his remains to the Department of Defense.
“They told me specifically that my husband had been used as a crash test dummy in a simulated Humvee explosion,” Hansen says.
Hansen’s husband’s body was sold by Biological Resource Center founder Stephen Gore to the DOD without her consent. Court records showed that those donors were used in a variety of military and ballistics testing, with some resulting in “the complete mutilation and desecration of the donor’s body.”
“I was devastated,” Hansen says. “I would’ve never done it if I had known. I just kept telling him I was sorry.”
When the FBI raided Gore’s warehouse in 2014, they found conditions of the donors’ remains so abhorrent that agents “required trauma therapy due to the disturbing, graphic scene they encountered.”
Gore pleaded guilty to Illegal Control of an Enterprise for violating donor consent agreements and was sentenced to four years probation and one year in jail. Because there are few laws defining ethical treatment of remains, no charges were filed relating to the warehouse conditions.
Disturbing evidence also emerged during Special Agent Johnson’s investigation into body broker Arthur Rathburn, whose Detroit warehouse was later described by investigators as a “house of horrors.”
“He cut up bodies with a chainsaw. He cut up bodies with a bandsaw,” Johnson says. “He had a bucket filled with brown liquid that had fetuses and human brains floating in it.”
As in the case with Gore, prosecutors had no way of charging Rathburn for how donors’ bodies were treated. Rathburn was ultimately sentenced in 2018 to nine years in prison for falsifying his donor’s medical information in order to fraudulently sell bodies infected with hepatitis and HIV.
“He had trash cans filled with human heads,” Johnson says. “Just the disrespectful way of treating the remains. And yet we prosecuted him for fraud.”
In 2009, Donor Referral Services owner Philip Guyett Jr., pleaded guilty to wire fraud for falsifying medical information in order to offload tissue designated for transplant with infectious or communicable diseases. He was sentenced to eight years in prison.
“As I told the judge, I had no business being in this business,” Guyett says in an interview with CBS News. “A person with no medical experience, no funeral director’s license, was able to open up a whole body donation program, take possession of a human body, dismember it, send it throughout the nation without any type of licensing oversight. It’s harder to sell hot dogs on a cart than it is to get into this business.”
Philip Guyett Jr.
CBS News
Before opening his own tissue bank, Guyett got his start running a university’s Willed Body Program, overseeing the donations of bodies for research education.
In the wake of industry controversies, some tissue bankers have been working to promote trust with potential donors.
Garland Shreves is the founder of Research For Life, a non-transplant tissue bank based in Phoenix that distributes body parts for use towards the advancement of science in lifesaving fields like first-responder training, medical device development and surgical practice.
“I don’t think we can ever lose sight of the fact that these are human beings and they have so graciously donated their body to the advancement of medicine,” Shreves says. “Whole body donation and my organization, through the wonderful gift of that donor, makes it possible for us to have the innovative medicine that we do today in this country.”
Shreves says the best way to clean up the industry is transparency.
Paramedic training at Research For Life
CBS News
“Bad actors are bad for business. If the consumer is being harmed by a business that’s not operating at a very high level of professionalism, everyone in the industry suffers,” he says. “It is that transparency, the sunlight, the disinfectant, if you will. It’s what we need to do as an industry and we haven’t done enough of it.”
Johnson says the whole body donation industry is necessary for the advancement of science, and that it is vital the industry works to restore the public’s trust.
“It would be nice if there was one playbook for everyone. And so that would ideally be federal and it would cover everyone that deals with human body parts — for-profit, nonprofit, all of them under one set of rules.”
In September 2022, a body broker bill was introduced in the U.S. Senate which would impose federal regulations on the process of body donation, but no vote has been scheduled.
Despite the advances in medical technology and the increased availability of mobile app solutions in medicine, there are major misconceptions among clinicians involved in building a mobile app (Fig. 1).
Fig. 1
Common misconceptions of medical mobile app development
Misconception #1—the investigator fully understands the problem they are trying to solve and the users they intend to help
Reality
Before the development process can start, the competitive landscape should be assessed to confirm that there is not already an identical or similar goal solution. Next, the intended users must be interviewed to ensure that the solution solves a relevant problem for them. This user research should be incorporated throughout the development process to assure that the users are continually being considered. An effective team must also be formed with the required expertise to handle every phase of the development lifecycle, from clinical problem identification, user research, design, development, and product release. Finally, a strategy must be developed to market the product so that users discover and adopt the app.
Misconception #2—app development does not require much effort
Reality
Reality
A common phrase we hear among our clinical colleagues when we are approached with an idea for a mobile medical solution is “…and I’d like to build an app.” This statement can be interpreted as, “I would like to hire a contractor to turn my idea into an app.” This line of reasoning underestimates the investigator commitment required to turn an idea into a mobile app. Throughout the development process, the investigator must play an active role in the development team. This process frequently takes months of user research, design, development, and testing in an iterative fashion.
Misconception #3—the app should easily integrate into the electronic health records (EHR) system
Reality
The electronic medical records in the USA and many countries are highly fragmented, with individual hospital systems using their own 3rd party vendors to manage their records [11, 12]. Accessing a single institution’s EHR requires multiple levels of approvals at the principal investigator and administrative levels and then requires significant technical collaboration with the institution’s information technology department to connect. While Fast Healthcare Interoperability Resources (FHIR) standard has been adopted to facilitate a consistent format of healthcare information for simple transmission and sharing of data, the lack of a consistent EHR framework significantly impacts the ability of a 3rd party app to integrate into the EHR’s of a geographically diverse user base [13].
Misconception #4—app development is a single-step “one and done” process
Reality
The development process is not complete when the app is launched. A continuity plan must be in place to maintain and update the app throughout its lifecycle. Technology changes rapidly, operating systems update, and smartphone manufacturers develop and release multiple new phone models annually. An app must be maintained to adapt to these advancements. The request to “build an app” does not accurately convey that app development is a process that does not end with an app launch.
These misconceptions underscore a clear need for a liaison between clinicians and the app development community to facilitate the development of robust, maintainable, mobile apps. To address these misconceptions, we set up an academic sub-unit within the Georgia Clinical and Translational Science Alliance (Georgia CTSA), which we call the AppHatchery, with the goal of supporting clinical investigators in their endeavors to create and clinically translate their mobile medical app ideas. Care was taken to structure the AppHatchery to enable this end goal, with a mix of relevant expertise and experience. This initiative is led by a physician scientist who runs a laboratory that has a proven track record of developing and publishing medical apps as well as conducting clinical research using apps. We hired a product manager from the industry with expertise in managing mobile app development teams for a large organization. We have a designer on the team who specializes in user research and design thinking. Finally, we have multiple full-time developers to carry out mobile development work. We structured the group this way to ensure that we had members of the team with expertise in each phase of medical app development, specifically (1) clinical research expertise, (2) design, and (3) mobile app development. Given these diverse skillsets with every team member having some exposure to both clinical science and app development, we have created the perfect team to bridge the skillset gap between clinicians and software developers and develop mobile medical apps. Furthermore, the existence of team members fully dedicated to this initiative allows us to maintain continuity throughout each stage of the project at hand.
We first rely on internal marketing for project solicitations. When a project is onboarded, we perform a multi-disciplinary research process where we identify and explore the clinical and practical need for the given solution and its place within the current regulatory landscape and market. We use a combination of design thinking (DT) and human-centered design (HCD) framework to tackle app development challenges [14] from ideation through delivery. The design research process begins by conducting a deep dive into the problem as it pertains to end users and key stakeholders. Target users are interviewed to better understand their challenges, and we identify and/or verify the important features and aspects of the proposed app and get feedback on the design requirements that our research has identified. Simultaneously, we begin working with the principal investigator (PI) to craft the research study that will determine the efficacy of the tool we develop. Next, we begin the app development process, beginning with the design of wireframes and culminating with software development, where we conduct user research throughout the process to iteratively improve the app. We finally transition to launch and support, where we work with the principal investigator to release the app and support the clinical validation study. In this manuscript, we will describe the lessons learned from our journey and make recommendations for how other medical app developers should operate to successfully develop and translate clinical app ideas.
App development principles and structure
Design approach
What makes our approach to building digital tools unique in the clinical space is our emphasis on both DT and HCD (Fig. 2). We use DT to focus on understanding who the users are, uncovering their needs, and empathizing with their situation first before kicking off the product design and development process [15]. In addition, we strategically consider user needs in relation to clinical objectives to form design recommendations [16, 17]. We then kick off the development phase which incorporates HCD fundamentals, bringing the end user’s voice and opinions into the development process. Collaborative strategies are noted as vital to sustaining growth in mobile health applications [18]. HCD has been demonstrated to be an effective innovation tool in the digital clinical and health space where a focus on end users (patients, clinicians, or others) during the design process improves adoption rates [19,20,21] as well as patient engagement and satisfaction [22].
Fig. 2
Design thinking framework
A recent narrative review of 82 health innovation papers mentioning HCD found most (70{bf0515afdcaddba073662ceb89fbb62b6b1bf123143c0e06b788e1946e8c353f}) discussed using an HCD approach and all included a focus on users’ needs and the participatory and iterative nature of the design process [14]. More salient limitations to the HCD approach include sampling bias and small sample size as users must opt into the research to participate in the design process and are not necessarily the profile of users who may need the app the most. This may lead to a misalignment of the design with the intended user’s needs. Finally, few apps have been tested in randomized controlled trials, and so limited evidence is available on the long-term benefits of app products arising from HCD approaches [23]. Specifically, in using HCD, there are instances where the approach did not lead to significant improvement in the intervention outcomes. For example, Gallagher et al. conducted a study using a game-based app that was co-designed to improve cardiovascular risk factors and lifestyle behaviors and found no improvement after the intervention [24]. Similarly, Haque et al. evaluated a user-centered mHealth app in promoting physical activity and found very low compliance at the end of the study which limits the generalizability of the results [25]. Furthermore, alternatives to DT and HCD such as user experience (UX) design frequently focus on the way users interact with apps and strive to provide the most convenient use for the people who actually use the app, rather than the ideal users that HCD and DT strive for [26]. In light of these findings, it is important to note that HCD methodology allows for subjectivity in terms of which aspects of user experience to prioritize, which can result in varied outcomes. Additionally, as previously discussed in the literature, HCD is susceptible to sampling bias, which can impact the apparent effectiveness of an intervention. Thus, it is crucial to consider both the strengths, limitations, and alternatives to DT and HCD and to employ a multi-disciplinary approach that considers various perspectives and factors in the design and evaluation process. This design strategy accurately defines the user, their needs, the problem most important to solve for that user, how those needs intersect with research goals, and which design directions are most effective at maintaining engagement and delivering results. It provides the foundation for the team who then focuses on the users and their needs throughout the app project development process.
Building a team
A development team must be created to begin the development process. A software development team has three distinct yet overlapping roles, the product manager, the designer, and the developer. In addition to these key roles, multiple supporting roles may be created for handling regulatory requirements necessary in medical app development.
Product manager
The product manager is responsible for the overall strategy of the mobile app. This includes the macro strategy of why and how to build the app in the first place as well as a more detailed strategy about which features to build, what order to build these features, and how to measure if the features are a success. The product manager is also responsible for creating the requirements in sufficient detail so the remainder of the team can execute their jobs effectively. These might be technical requirements, design requirements, or requirements from the clinical team. The product manager is also responsible for the lifecycle of the mobile app. This includes releasing the app through testing platforms, releasing the app publicly, working through approval processes at the institution, and maintaining the app’s public information on the app stores.
The product manager is responsible for ensuring the app meets guidelines. This is important especially for medical apps that may need to comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA) [27]. In our experience, projects are hindered at the beginning stages by focusing on these compliance issues instead of focusing on the core value of the mobile app. Compliance needs to be addressed at the beginning of a project when architecture is being designed and before the app is released publicly to ensure it meets all the required standards for privacy and security. The product manager is responsible for analytics and measuring the mobile app experience. These analytics are tied to the goals and objectives of the app (e.g., reducing missed follow-up visits) but also user experience metrics such as app crashes, screen views, and user interactions.
Software developer
The developer is responsible for writing the software code that will control the mobile app. This role is critical as there will be no software created without team members who can code the mobile app.
Designer
The designer is the empathizer in chief; it is their responsibility to always be the voice of the user throughout the app development process. This is a critical role as academic medical apps are often conceived without direct consultation of patients or users.
Other team roles
Developing mobile apps within an academic medical center requires knowledge of how Institutional Review Boards (IRB) review requests to conduct clinical research. It is useful to have an IRB expert on the team to answer nuanced questions about data collection and privacy that may differ from IRB to IRB and can be unique to clinical research involving mobile apps. While not critical in the early clinical research phases, it can be useful to have a regulatory expert on the team who is familiar with the relevant regulation, specifically around HIPAA and managing protected health information (PHI).
Full time vs part-time staff
Many academic medical centers operate on a shared time model where the staff dedicate a portion of their time to projects. While this can work, we have found it is better to have full-time staff dedicated to the development of mobile apps. Likewise, many software development projects are outsourced to other groups. While this can work, we have found it is best to work cohesively as a team throughout the development process to streamline communication and align expectations throughout.
Applying the app development process
Competitive and regulatory landscape survey and literature review
Before accepting any new project, it is important to meet with the PI to understand their clinical and application vision before conducting an extensive search of the major app stores to see what similar apps currently exist, as well as related platforms, tools, books, and/or educational materials in the space. After the search is completed, the list of these competing resources should then be presented to the PI to discuss how or if the value proposition of their idea merits the effort to build a homegrown solution. If the concept meets the acceptance criteria set by the team (i.e., is novel, addresses a real need, and the development team has capacity and knowledge), the project can proceed (Fig. 3).
Fig. 3
App project development process
When researching and deciding the intended use case of the app, research into the regulatory pathway required to market the product must be conducted. In the United States of America (USA), the US Food and Drug Administration (FDA) approves medical devices for sale in the US market. FDA guidance regarding software as a medical device (which includes medical apps) is governed specifically by the 21st Century Cures Act [28]. Section 3060 of this legislation defines what software the FDA considers to be a medical device that requires regulatory approval via the 510(k) premarket notification pathway, versus lifestyle tools that can immediately enter the market [28]. Ultimately, the distinction is determined based on the function and intended use of the software. Software becomes a medical device when the intention and function are to diagnose, cure, treat, prevent, or mitigate a specific disease or condition [28].
Should the app require premarket notification, multiple steps must be taken to satisfy the complex risk management strategies and regulatory requirements set by the FDA to release the app publicly. Rigorous clinical testing must be conducted to ensure that the device performance (1) is in line with the claimed performance and use case and (2) is similar in performance to the most analogous device currently approved and on the market (the claimed predicate device that must be identified for FDA submission). In addition to performance, the app must apply appropriate human factors and usability engineering processes, which must be assessed in standalone usability studies with at least 15 users in the desired user population [29]. Finally, a quality management system (QMS) must be in place to ensure that procedures and processes enable a reliable, safe, and effective software tool [30]. The QMS begins with the leadership and management plan to ensure that relevant stakeholders manage the medical app throughout its lifecycle. The support plans for the system must also be defined, with appropriate documentation of all development and design, disaster recovery plans, and processes for regularly updating the app for performance, usability, cybersecurity, and technology modernization. The implementation must be then considered, with regular validation, cybersecurity monitoring, and maintenance of all key infrastructure, to ensure that end users can interact with a stable version of the medical app throughout the duration of its lifecycle as a medical device.
Design strategy
Once engaged on a project, a development team should schedule a design strategy session with the investigator and project team to gain a full understanding of the desired goal of the app from the perspective of all stakeholders (Fig. 4). While investigators often have a passionate idea about what problem they wish to solve with their app, additional examination can help dial into precisely who will use their tool and what problems their app user(s) seek to solve. To prepare for this session, which is usually 1–2 h, the team conducts secondary research from published academic papers, review articles, and meta-analyses to familiarize themselves with the outcome goals of the project and specific aims of the research. The team generates clarifying questions for the investigator and research team to respond to. Sample questions may include the following:
Who will use this app? Is the patient or a family member the primary user?
What benefit will the user get out of using this app?
What data (if any) do you expect the app to collect?
Fig. 4
Collaborative design strategy discussions set the parameters of the project. Left: a design strategy session in person. Right: results of a design strategy session using an online collaboration tool like Miro
Post-It notes or a collaborative whiteboard digital tool such as Miro (Miro, Inc., San Francisco, CA) may be used to capture ideas that can be sorted and prioritized as seen in the image below. This allows the team to gather insights from the session to form a user research approach to test assumptions, write and vet a discussion guide, and then recruit 5–15 individuals from the intended user group to interview. Insights across all interviews are pooled together and sorted to surface themes and areas of importance for the user. As the themes and key features emerge from the insights, the team can refine the insights into design recommendations.
App design
Once the research team has a clear idea of the needs and wants of the users, designs for the app should be created (Fig. 5). It is very important that these designs come from actual user insights, rather than from pre-conceptions the research team had prior to beginning the work, unless these pre-conceptions had been validated by the user research.
Fig. 5
From sketches to wireframes. Left: pictures of preliminary sketches of the layout of the application. Right: functional (clickable) wireframes of an app
Given the number of apps that exist already, it is worth spending some effort looking to find similar apps that incorporate design patterns that could be implemented in the app. This is a separate step from the competitive analysis where rather than looking at apps that perform a similar function, you are looking for individual features (i.e., how search functions, how do other apps offer content layout).
Taking from the design recommendations generated in the prior phase. The designer can begin creating low-fidelity sketches, which they can turn into generalized flows and wireframes of the app (Fig. 5, left). The key is the use of wireframing and prototyping as an early way to evaluate whether the tool being created meets users’ expectations. To evaluate those wireframes, standard usability testing techniques can be used such as remote or in-person unmoderated observation sessions or task-based evaluations where the user is given tasks within the app to accomplish.
App development
The most common app development methodologies are the waterfall and agile methods [31]. The agile methodology is an iterative approach that leverages frequent releases that provide incremental functionality improvements that can be tested and refined in the production environment. The waterfall methodology completes the holistic build which then moves into a testing phase and then a launch phase, yielding a polished product. We prefer to utilize the agile methodology as the iterative development process enables more testing and feedback, which matches our design philosophy.
When an app development methodology has been selected, there are 2 major mobile app development frameworks: natively on each of the major operating system software tools (iOS or Android), or cross-platform (i.e., using React Native (Meta Platforms Inc., Menlo Park, CA), Flutter (Google LLC, Mountain View, CA), etc.) which supports one code base for both iOS and Android platforms (Table 1). The decision on what to use will largely depend on the expertise of the available developers in the team. This is the fundamental choice an app developer must make before developing an app.
Table 1 Overview of the development styles and platforms available
Native development has the advantages of dedicated functions and features specific to the hardware you are developing for (iOS vs Android), with the downside that effort must be duplicated to support both iOS and Android devices. Also, native development tends to be more well-maintained, as it is linked directly to the mobile devices operating system. This skillset is also much more readily available in the software developer talent pool. While cross-platform development is typically much faster and more efficient with respect to developer resources, it also relies on a much smaller developer community. Furthermore, many 3rd party tools common in app development (e.g., analytics, advertisements) have limited support for cross-platform development. The development framework should be chosen to suit the needs of the specific project.
Throughout the development process, it is generally good practice to beta test the app to ensure that what is being built is meeting the user’s expectations. To do this, it is best to test in a controlled environment to monitor who is using your app. To do this you will use either TestFlight for iOS (Apple In., Cupertino, CA) or Google Play Store Internal Testing for Android (Google LLC, Mountain View, CA).
Launch
Once the app is launched, it must be closely monitored for bugs, unforeseen issues for users, and ever-increasing software versions. Both iOS and Android release beta versions of the updates in advance of a public release so that developers have a chance to test the compatibility of their apps against these updates. Nevertheless, there are many apps that are no longer supported by new OS versions that plague the app stores, a situation that should certainly be avoided by a medical app developer! Some thought should be put towards maintaining support for the users that may not have updated to newer operating system (OS) versions. It is typical to set a supported version that dates back at least a few years to give users time to upgrade their devices.
Updates and maintenance
Finally, app maintenance must be considered. Funds must be allocated to support the continuity of the app development project before it begins. As described by Siegel et al. [10], there are a multitude of unsupported apps on the app stores that are born out of research projects and then abandoned, likely due to the lack of personnel to support them, lack of funds, or poor design and execution leading to a lack of traction to justify a larger time/monetary investment.
Simultaneously with the design thinking process, it is important to work with the PI to help design a research study and secure IRB approval for the study protocol that will be used to clinically validate the app upon release. This validation study typically occurs in 2 phases: Phase 1 is focused on usability and feasibility. In this phase, user feedback of the app is collected and used to iteratively improve the app. This can be done by identifying users to enroll in the clinical study and conducting a rolling enrollment process where a version of the app is developed and given to the users to collect their feedback, adjust the app, and then repeat. Phase 2 is a clinical trial where the app’s performance is analyzed in terms of a clinical endpoint. In this phase, a randomly controlled trial should be planned to assess the app in terms of a clinical endpoint of interest, i.e., a control (no app) and test (has the app). These results can then be published in a medical journal to provide credibility to the app as a medical tool.
Lessons learned: roadblocks, pivots, and best practices
App development costs
Funding for academic biomedical mobile apps can be difficult in our experience. The most common source of funding is through traditional National Institutes of Health (NIH) grants. These grants allow for setting aside resources in the budget to support mobile app development but do have some pitfalls. First, grants typically have a very long application and funding cycle, in the order of 12–18 months, which can delay a project. Second, funding amounts set aside for development tend to be small. In our experience, this has been $10,000–25,000 which is insufficient for the necessary costs associated with designing and developing an application (Tables 2 and 3). Beyond grants, academic medical centers often offer access to other seed or startup funds in the form of innovation awards, local organizations that offer awards or seed funds, and, as a last resort, projects can be funded through department funds if the funds and scope of the project are aligned.
Table 2 Personnel costs for mobile app development
Table 3 App development cost breakdown by stage
Staffing an academic medical center app development project is very different from a commercial software development project. The key differences are (1) the budget of the project is typically far lower (by an order of magnitude, typically), (2) the goal of the app is often non-commercial (e.g., it does not have a business model attached), and (3) the goals of the PI may include education and training for the full team, beyond only executing on the creation of the software. Therefore, staffing for mobile app projects will use a mix of resources available within academic medical centers and their affiliates. These include graduate or undergraduate students who may work on a project for free as part of a classroom learning experience, students who are hired outright or work through graduate research assistant positions, shared staff with other programs (e.g., bioinformatics), and partnership with other campus-based groups who are funded to support clinical research.
Managing investigator expectations
We often encounter requests that are in essence to “just build an app” from clinical PIs. It is important to diagnose this way of thinking early as it could reveal the propensity of a PI to disengage from the project prematurely, as it becomes clear the amount of effort and collaboration it takes to foster a successful partnership. PIs must be engaged often and richly with the team. The cadence of meetings will be project dependent, but we have found a weekly update, whether a meeting or email, maintain project members active and engaged.
Having a disengaged PI can lead to multiple points where the project can fail: (1) the problem is not defined appropriately, (2) the appropriate user research is not conducted (which can lead to the app not addressing all relevant user needs thus impacting adoption and use), and (3) usability/feasibility testing is not conducted in a robust and iterative fashion (which can lead to usability issues that will prevent users from adopting the app, even if the app has a strong value proposition that could significantly improve the life of the user). In addition, it taxes the rest of the team who must make clinical research decisions and navigate an unfamiliar research structure.
Understanding the users
It can be challenging to identify and access users to solicit feedback from. Clinician investigators typically have frequent interactions with the target user population. They have familiarity and a relationship built already (which is how the ideas for projects usually originate). However, they usually lack the time to conduct thorough user research that goes beyond the problem discovery. On the other hand, developers and designers do have the time and knowledge to conduct user research, albeit they lack access to patients. Bridging this gap, often by facilitating access to clinics and hospitals for the design team, can drastically improve a project’s chance of success. In one of our projects with Grady Memorial Hospital, we established a cadence of going to the hospital twice a week to enroll new subjects and check in on existing subjects. Furthermore, fostering a relationship with the clinical care teams of the subjects facilitates subject enrollment, a process that is much slower when only investigators are involved in subject recruitment. Additionally, by fostering that relationship with the clinical care of the subjects, it is possible to conduct user research with stakeholders through observation sessions and contextual inquiry. Which can help mitigate some of the overreliance on user input [32].
Beta testing recruitment
Recruitment can take place in person or virtually. Online recruitment tends to require less apparent overhead (although depending on the clinic setting it may be hard to capture patients online) while in-person recruitment has a higher overhead but tends to yield more numbers and more upfront engagement. Most of the recruitment that we have done has taken place in person at the hospital. Interestingly, we have found that subjects recruited in a clinical setting will remember everything about the app and the study until they leave the hospital/clinic, when study participation significantly wanes. To increase the chances of success, you must find the best method to follow up with your subject/users which could be via email, text, or phone calls so that you can maintain engagement with your study. This will be very study specific and dependent on the app you build. This is one area where sampling bias can impact the project as subjects who are more interested are more likely to respond and be engaged. That was our experience with that project, and we had very low compliance from the users we were trying to target, those who leave the hospital and do not return.
Beta testing process
Testing an app with users frequently is crucial to ensure the best possible version of the app is developed. In an in-patient setting, we have found it necessary to introduce users to the app in one session, and then follow up within a week, to see if the patient interacted with the app after the visit. There are multiple steps that can be taken to foster engagement:
a.
Delay the follow-up: A week might not be enough time for the user to have a need to open the app.
b.
Include push notifications: This system allows researchers to send messages through the app to specific segments of the study group (i.e., users who have not opened the app recently).
The goal of beta testing is to find encounter any bugs and errors and more importantly if the intended user audience finds the app useful. It is very challenging to design a research study surrounding a tool that will fit into a user’s life outside of the study. This is because study coordinators are actively looking for subjects to enroll, creating unnatural motivators to utilize the tool (i.e., participate in research, monetary compensation, curiosity), as opposed to an organic app search where users are looking for something. Thus, it is important to design an app such that the app fills a clearly defined and currently unmet need for a group of people (i.e., a medical reference guide, an appointment booking system, a prescribed training program). Otherwise, you run the risk of aiming to change a given behavior which has been identified as a limitation of traditional HCD and follows a different design process [32].
Furthermore, mobile apps have standardized evaluation frameworks such as the System Usability Scale (SUS) which provide a quantitative evaluation of the usability of a software tool. Note the difference between usability: Can somebody use the app without encountering errors that worsen their experience, and feasibility? Does the app effectively cover an unmet need for a user? Usability is an easier metric to quantify, and mobile apps for research should follow industry standards to validate the tools created are usable. These frameworks can be employed to glean valuable feedback during the beta testing process.
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