Can medtech start-ups show us where the industry is headed?

Insights from MedTech Innovator and industry leaders

Can medtech start-ups show us where the industry

is headed? Insights from MedTech Innovator and
industry leaders
Executive summary
Medical technologies are often the result of years of research and • Start-ups and strategics are expanding beyond episodic
development. In the US, they are a foundation of a rich ecosystem care and procedures: Companies that have historically
of innovation. Start-ups offer advanced technologies that hold targeted specific therapeutic areas defined by a procedure
the promise of producing data, delivering better care, and driving (e.g., implanted devices) are adding products and solutions to
insights that can improve patient outcomes. These products, their portfolios to help address the full patient journey—from
services, and capabilities show that we are rapidly moving toward diagnosis to rehabilitation. Nearly half of start-ups (46%) have
our vision of the Future of Health™ where real-time, interoperable a focus on prevention and/or wellness or detection/diagnosis,
data enable prevention and early detection, and shift the focus and only 19% include a focus on treatment.
away from acute intervention. • Care is shifting away from the traditional inpatient setting:
In spring 2021, Deloitte’s Center for Health Solutions collaborated Ambulatory clinics, at-home care, self-administered diagnostics,
with MedTech Innovator (MTI)—the world’s largest health care and always-on remote monitoring are growing areas of interest.
accelerator for medical devices, digital health, and diagnostic Seventy percent (70%) of start-up companies in the diagnostics
companies—to evaluate trends across the medical technology sector have a product applicable to the point-of-care.
start-up landscape. We analyzed MTI’s database of 1,000 These trends have implications for reimbursement and
start-ups that applied in 2021 to participate in the organization’s clinical support.
global competition for support from MTI’s accelerator • Medical technology is getting smarter: Seventy percent (70%)
program. To deepen our understanding and learn about where of start-up technologies include digital capabilities such as
stakeholders think the industry is going, we also interviewed artificial intelligence (AI) and machine learning (28%).
leaders from start-ups and medtech companies that could be Strategics seeking acquisition targets might be looking for
strategic acquirers (“strategics”). these capabilities.

Through our data analysis and interviews, we quantified the • Start-ups are choosing less burdensome regulatory paths: A
following trends: majority of innovators are planning to enter the market with
510(k) (47%) or unregulated (29%) products.

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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

• Pre-seed rounds have been commonplace, with significant trends in all aspects of health care, with a focus on the Future
step-ups in average round sizes, and limited runway: In their of Health™. Over the next 20 years, we expect the health care
most recently closed funding, the average round size for pre- industry will shift from a reactive focus on care to a proactive
seed (39%) was $0.25M, seed (42%) was $1.31M, and series A focus on wellness and prevention, which will all be centered
(13%) was $4.85M. The average seed stage company has six around the consumer. While we might never completely
months of funding before it will need to find additional capital. eliminate disease, we expect that breakthroughs in science, data,
• Series A Investors are looking beyond proof of concept: and technology will make it possible to identify disease in its
Investors have become more astute over the last few years in earliest stages, intervene proactively, and understand disease
assessing value, clinical efficacy, and reimbursement potential. progression. These anticipated trends could help consumers
Innovators have gotten the message that investors may be less more effectively and actively manage their own care and sustain
willing to make significant investments without clinical evidence their well-being. Specifically, we expect:
or near-term regulatory approval. Most companies seeking • An explosion of data access and analytics will shift us to real-
series A are clinical or later in their development stage (66%). time, pervasive computing that enables earlier detection and
COVID-19 has been both a positive and a negative from the intervention.
business perspective. Interviewees told us they are largely • Consumers will no longer be led by doctors but will instead be
recovering financially from having fewer elective surgeries in empowered to bring ideas to the table.
2020. They have learned how to engage with physicians—and
• The health care system will transition from a provider-centric
support their products—remotely. Funding for medtech and
model to a consumer-centric model.
health-tech innovation has remained strong, reaching record
• Well-being and care enablement will eclipse sick care.
levels in 2020. Moreover, the commitment to developing
innovative products that support the whole patient journey To play a larger role in the health system of the future, medtech
appears to be even stronger than it was before the pandemic. companies will likely need to expand both their scope and
their capabilities. One route may be through partnerships with
In addition, we found that both start-ups and strategics are
consumer health organizations1. Another could be through new
addressing diversity and health equity. Nearly all of the company
business models that could include managing the entire patient
executives we interviewed—and 83% of the companies in the
journey around a disease or becoming an ecosystem data and
MTI database—have diversity and inclusion strategies for talent,
analytics provider2. Start-up partnerships and acquisitions might
though representation still has room for improvement. While 49%
offer another important pathway for strategics to explore new
of start-ups have female employees in leadership positions, only
models and remain relevant.
16% have BIPOC leadership, and 35% have other POC leadership.
Medtech companies are also working to: Given that start-up companies reflect the leading edge of
innovation, we analyzed MedTech Innovator’s (MTI) database
• Make their products broadly accessible
of early-stage innovators to determine if start-ups could serve
• Keep diversity in leadership in mind as a part of M&A as the backbone for the strategic shift in the medtech industry.
• Use real-world data to look at outcomes by race and gender The database includes a wide variety of medical technologies
that address a wide range of therapeutic areas and needs. The
Introduction
database also indicates whether the start-up community’s efforts
Deloitte’s Center for Health Solutions continually evaluates align with our vision for the Future of Health.

Background and Methodology

MedTech Innovator (MTI), the world’s largest health care More than 6,000 companies have applied to MTI since 2013.
accelerator, has a particular emphasis on medical devices, MTI is highly selective, with less than a 5% acceptance rate.
digital health, diagnostics, and life science tools. MTI is a Within its portfolio of 340 alumni companies, 95% are still
501(c)(3) non-profit, purpose built to ensure that viable operating and 85% have raised equity funding. Graduates have
innovations successfully reach patients and with maximum raised nearly $3 billion in follow-on equity funding, achieved 17
value. Companies apply with no fees or strings attached and acquisitions, and brought 85 products to market.
are selected solely based on merit. For this report, Deloitte analyzed 1,000 companies applying
Incentives to apply are corporate mentorship and access to MTI to participate in MTI’s 2021 program. This database reflects
partners, industry recognition, visibility and exclusive ability applicants who have developed at least a prototype and have
to pitch at leading conferences, education via the MTI LIVE not progressed beyond a series D round of funding. Some
webinar series, investor introductions and showcases, access to highlights about this pool of companies:
a peer network, and cash awards in competitions on the “main
• 76% of applicants have raised equity funding, collectively
stages” of The MedTech Strategist Summit, WIlson Sonsini’s
raising $3.9 billion.
Medical Device Conference, and AdvaMed’s The MedTech
Conference. Across all cohorts, $1M in non-dilutive funding will • Applicants hail from 43 countries and 48 US states
be awarded in 2021 by MTI. • 33% percent are pre-clinical; 28% are clinical / pre-approval;
To learn about MTI, visit https://medtechinnovator.org 9% are approved, and 22% have customers

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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

For each company in the MTI database, data was analyzed in • Intellectual property
the following areas: • Regulatory path and status
• Development stage • Validations, traction, and sales
• Product categorization (clinical and technical) • Revenue model
• Completed milestones • Team
• Completed funding amounts, rounds, and investor sources • Diversity, equity, and inclusion
• Upcoming fundraising and milestones In addition to analyzing the MTI dataset, Deloitte also
• Customer types and healthcare economics interviewed 14 leaders from start-ups and executives from
established medtech companies that could be strategic buyers.
• Market access plans
They offered their perspectives on the start-up landscape,
• Competitive advantage trends in the industry, and barriers to successful innovation.

Research Findings
Most start-ups are focusing on prevention, wellness, and Our interviews confirmed that the industry is trending toward
diagnosis, rather than treatment prevention, wellness, and diagnosis. This is in addition to many
innovations that support treatment and post-acute monitoring.
Among the 1,008 companies in the 2021 MTI database, nearly half
Strategics that have built businesses around specific therapeutic
(46%) have a focus on prevention and/or wellness or detection/
areas defined by a procedure (e.g. where the technology is an
diagnosis. Just 19% of companies are focusing on treatment.
implant) told us they are adding products and solutions to their
Within the prevention/wellness category, companies indicated a
portfolios to address the full patient journey—from diagnosis
variety of clinical areas. Cardiology was the most common.
to rehabilitation.

Figure 1

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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

In addition, executives from 705 of the 1,006 companies in the MTI database (70%) said they had advanced digital capabilities. The most
common type was AI/machine learning (28%). A wide range of other capabilities were also represented, including mobile app/platform,
wearables, and sensors, which likely could enable interventions along the patient journey

Figure 2

The site of care is shifting away from traditional

inpatient settings
Business development leaders at strategics said they are seeing a particularly around testing or technology at the point of care.
significant shift in areas where products are used, moving toward According to analysis of the MTI database, over the last three
less acute settings: years (2019 to 2021) the share of point-of-care products has
grown significantly—from 62% of companies to 70%-among
• For cardiology procedures and implants, they anticipate
start-up companies that have diagnostic products. Somewhat
increased opportunities to offer products along the patient
fewer companies were focused on genomics/sequencing during
journey and sites of care—from traditional inpatient settings to
the same period. The share of company executives that said this
ambulatory care settings.
category applied to their product declined from 12% to 7%.
• For diagnostic products and services, interviewees expect to
Investors are interested in medtech, but start-ups may
see more offerings and opportunities in point-of-care and
need more money to survive
home settings.
The COVID-19 pandemic spurred changes to funding, innovation, The MTI database shows that early-stage medtech companies
payment policies, and strategies that support virtual health are typically funded by founders, family and friends, and angels
across multiple dimensions. Our interviewees discussed the (see figure 3). Founder interviewees told us that they have started
increased emphasis on virtual health, which includes ambulatory to turn to high-net-worth individuals and/or family offices for
care clinics, at-home care, self-administered diagnostics, and funding when more traditional sources, like venture capitalists,
always-on remote monitoring. are not ready to invest. This is a continuation of trends we saw in
a 2017 research study that focused on the medtech
Detection and diagnostics are a key focus of innovation,
innovation ecosystem.

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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

Figure 3

We found a few surprises when we examined which investors through product development.
contributed the most to companies: (Figure 4) • Corporate Venture Capital groups (CVCs) were listed as a source
• Only a quarter of companies (228) reported being supported of funding by the fewest early-stage companies (92, see Figure
by government grants. This was especially true in the early 3); they made up only 3% of the investor mix in pre-seed rounds
stages of product development. One possible funding avenue and 11% in seed rounds.
for products at this stage is small business innovation research • About a third (n=303) of surveyed founders said they have been
(SBIR) grants—non-dilutive funding that can help companies get supported by an accelerator.

Figure 4

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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

Looking at investments by medical area (Figure 5), companies that have products in cardiology, radiology/nuclear medicine, or
nephrology appeared in the top five, totaling nearly $400m through Series C funding.

Figure 5

Medtech start-ups raised $1.8 billion in funding in their most recent rounds; the top three
medical areas were cardiology, radiology, and nephrology
Pre-Seed Seed Series A Series B Series C Series D or later

Funding # of Funding # of Funding # of Funding # of Funding # of Funding # of Total funds Total # of

secured companies secured companies secured companies secured companies secured companies secured companies secured companies

Cardiology $5M 19 $45M 25 $26M 7 $13M 3 $70M 2 $158M 56

Radiology / Nuclear
$3M 6 $30M 14 $16M 5 $85M 1 $133M 26
Medicine
Top 5 medical areas

Nephrology $0M 5 $7M 3 $6M 1 $105M 2 $119M 11

Orthopedic Surgery /
$2M 18 $18M 14 $50M 8 $39M 5 $110M 45
Sports Medicine

Cardiac, Thoracic,
$3M 10 $33M 12 $57M 6 $4M 1 $5M 2 $101M 31
Vascular Surgery

Other medical areas $68M 266 $332M 286 $383M 84 $233M 20 $66M 8 $86M 3 $1,170M 667

Grand Total $82M 324 $463M 354 $538M 111 $394M 31 $142M 12 $171M 4 $1,790M 836

Average funding
$0.25M $1.31M $4.85M $12.71M $11.83M $42.75M
secured per round

Survey question: Most recent equity round total closed (by top five medical area); choose all the rounds that you have already completed.
Notes: Blank space indicates no companies reported funding for those phases; All dollar amount are in USD; N=836.
Source: Deloitte analysis of the MTI database, 2021.

Cardiology is the dominant category for funding sought overall ($403m) (Figure 6). Products related to infectious disease—perhaps
spurred on by the pandemic—also appeared in the top five, as did preventive medicine, with funds sought totaling $700m.

Figure 6

Most medtech start-ups are seeking series A funds, with cardiology being a prominent
medical area of focus
$700M Medical area (primary)

Cardiology $403M
$600M
Infectious disease $374M
$187M
Preventive medicine and wellness $322M
$500M
Cardiac, thoracic, vascular surgery $317M
Amount sought (in $M)

$400M Neurology $287M

$140M $70M
Key: Top five medical area based on investments sought
$86M
$300M
$99M
$42M $98M
$200M
$73M $40M
$148M
$103M $51M
$100M $90M $18M
$15M $42M
$81M $74M $50M
$35M $42M
$0M
Preseed Seed Series A Series B Series C Series D or later
$96M $761M $1,940M $1,581M $563M $334M
Total amount of funding sought in each stage (in $M)

Survey question: If you are not currently raising a round, specify the round that you will next be seeking; How much funding are you seeking?
Notes: Total dollar amounts per medical area reflect additional, smaller, non-series-based fundraising efforts (not shown); N=Bases vary.
Source: Deloitte analysis of the MTI database, 2021.

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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

Most of the start-ups in the MTI database (77%) said they have • License agreement: One party gives another party the rights to
only enough capital to continue operations through the end use its technology, intellectual property (IP), and brands in their
of 2021. Without additional cash, 96% of them could run out business and operations.
of money at some point in 2022. This includes companies that
• Co-marketing: Two or more companies jointly market
currently have paying customers.
each other’s products. Each company’s team shares sales
Companies that have a product prototype supported by clinical responsibility. These companies typically split roles by market
and feasibility data are more likely than companies with concept- geography or customer type. The companies do not create new
stage products to attract attention from institutional investors products, services, or brands.
and strategics. But without adequate funding during the earlier
• Co-development: Two or more companies jointly develop a
stages of development, it can be difficult to generate the data
product, technology, or service.
needed to attract interest from institutional investors. Start-up
companies often struggle to make it out of the so-called “valley • Joint venture (JV): Two or more parties form a legal entity to
of death” period between initial investment and the development undertake economic activity. The parties agree to create a
of a commercially viable product, according to our previous new entity by contributing equity and/or assets. They share
research with AdvaMed. While strategic acquirers depend on a revenues, expenses, and control of the enterprise. The venture
thriving external innovation ecosystem for acquisition targets can be dedicated to a specific project or it can be an ongoing
and new sources of growth, many of them shy away from making business relationship.
investments in early-stage, unproven technologies3. Strategics Some large companies run their own accelerators for early-
told us that acquisition hurdles are getting higher. They said stage technologies. Other companies are active participants
they often look beyond the technology and whether it fits in accelerators run externally by organizations such as MTI. An
their portfolio and consider clinical evidence, the likely path to additional and perhaps complementary option for engaging
regulatory approval, and reimbursement and sales potential. with innovators is to take an equity stake in a start-up. This can
Start-ups need money to generate the clinical evidence necessary provide an opportunity to potentially earn a financial return
to demonstrate commercial potential. Initial Public Offerings from their investments. These options, coupled with the types
(IPOs) via the open market can provide start-up companies with of partnerships mentioned above, can reduce the investment
public capital while Special Purpose Acquisition Companies risk for strategics. It also can provide start-ups with the capital
(SPACs) can also, in some cases, offer an alternative to both an needed to move forward in the development process, and
IPO and traditional M&A. to generate the evidence required. However, while start-ups
increasingly are looking to CVCs as a source of funding, only 6%
But like the biopharma industry, large medtech companies,
of founders said CVCs had invested in their pre-clinical stage
entrepreneurs, and the venture funds that back them should
product vs. 13% in approved or later-stage products. If start-ups
consider engaging in strategic partnerships—such as co-
cannot get the funding they need early on, important innovations
development, co-marketing, or contingent merger and acquisition
might never reach a single patient.
(M&A) deals—which can take many forms, including:

Many new medtech companies are exploring the

510(k) regulatory pathway to approval as well as
multiple revenue models

Regulatory pathways
More than two-thirds of the start-ups in the MTI database premarket approval (PMA) (8%). Given the investment dynamics
are in the pre-approval development stage, and 22% have described earlier, this is not a surprise. The de Novo and PMA
paying customers. pathways are more stringent than the 510(k) pathway, for
example, and require more clinical evidence to support the
Nearly half (47%) of start-ups are pursuing a 510(k) regulatory
application. Consequently, companies could incur higher costs
pathway to approval, and 29% said that approval is not required
when seeking approval of products via the de Novo or PMA
for their product. Under the 510(k) pathway, infectious disease
pathways. One start-up founder described being caught in a
(likely reflective of the pandemic), and emergency medicine were
vicious cycle of not having the clinical data required to attract
the most common primary medical areas. Preventive medicine/
investors because there was no money to run a clinical trial
wellness was the top medical area reported under the ‘not
that would generate the clinical data. This was despite having
applicable’ pathway—likely referring to digital apps. It is possible
demonstrated that the novel product could address a significant
that products that do not currently require approval might need
unmet need in a large market. While higher-risk products can
approval in the future.
provide a more direct route to payment in the end, fundraising
Notably, only one fifth of company founders said they are plans (Figure 7) indicate that most companies are not seeking
developing products that would require de Novo (13%) or dollars to pursue the more stringent pathways to approval.

Changing regulations aim to expand access to digital health products

Today, digital medicine products are treated as medical devices or software as a medical device (SaMD) and reviewed and
approved through traditional medical device pathways, including the 510(k) and De Novo.

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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

Some industry observers think that these pathways are not optimally suited for software-based digital medicine products, which
need to be updated periodically in response to real-world performance and user feedback4. developers to go through a typically
lengthy and expensive 510(k) process. This can limit their ability to bring new products to market or to make changes to
existing products.
In response to this challenge, the US Food and Drug Administration (FDA) created the Digital Health Software Precertification (Pre-
Cert) Pilot Program. The program aims to develop an innovative approach for accelerated review and oversight of digital health
products by “looking first at the digital health technology developer, not the product.” This involves pre-certifying companies that
demonstrate a commitment to a culture of quality and organizational excellence and monitoring real-world performance of their
products. Pre-certified companies would likely be able to market their lower-risk products with only a streamlined premarket
review or bypass the premarket review altogether5. For more, see Deloitte publication Reimagining Digital Health Regulation.
In 2019, the FDA launched a pilot to evaluate the feasibility of the Pre-Cert model. The goal was to determine if this model for
premarket review can provide the same quality of information on safety and effectiveness as traditional approaches. Going
forward, FDA will continue to test and iterate the model.

Figure 7

Most medtech start-ups seeking investments are pursuing the 510(k) regulatory pathway

Combination Product Combination Product

510 (k) Not applicable De Novo PMA
(CBER) (CDRH)

Funding # of Funding # of Funding # of Funding # of Funding # of Funding # of

sought companies sought companies sought companies sought companies sought companies sought companies

Concept to
Prototype: pre- $560M 178 $211M 79 $185M 47 $252M 42 $55M 6 $20M 10
clinical

Prototype: clinical
to Product: pre- $571M 137 $127M 41 $614M 59 $332M 26 $23M 1 $41M 6
approval

Product: approved $338M 38 $102M 30 $52M 7 $25M 2 $20M 4

Paying customers $808M 72 $660M 109 $101M 8 $18M 2 $23M 2

Grand Total $2,277M 425 $1,100M 259 $952M 121 $627M 72 $101M 9 $81M 20

Survey question: Which of the following best describes your product’s US regulatory pathway?; How much funding are you seeking?
Note 1: “Not applicable” mostly consists of innovations categorized under the digital category.
Note 2: The Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) are two FDA centers that regulate combination products.
Note 3 : Blank space indicates no companies reported seeking funds for those pathways; All dollar amount are in USD; N=906.
Source: Deloitte analysis of the MTI database, 2021. Response options were single-select.

Interviewees told us they understood the regulatory processes Reimbursement

and noted that regulatory agencies have worked hard to
Reimbursement is typically challenging, particularly when
improve the pace of approvals. They said regulators are also
a technology is new. This adds uncertainty to whether the
accommodating new forms of technology, such as software as a
technology will be covered by payers, whether there will be a new
medical service. However, even as the pandemic begins to wane,
code for the technology, and how much the payment rate will be.
the FDA has indicated that backlogs and staffing shortages could
The shifting site of care has reimbursement implications. Medtech
lead to delays in reviewing products6.
companies could see increased price pressure on products used
Cyber threats are another emerging regulatory issue. As medtech in lower-acuity settings. Interviewees told us that investors have
companies increase connectivity of their products, they also become more knowledgeable about these challenges. This means
increase their vulnerability to cyber threats. Regulators in start-ups might need to provide detailed information about likely
Europe have taken a strong approach to this vulnerability, and reimbursement. Companies should consider taking advantage of
US regulators might follow. Medtech companies—both start-ups the parallel review process offered by CMS and FDA7.
and strategics—should have a thoughtful approach to managing
cyber risk.

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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

Several people we interviewed expressed frustration at the Business models

late release of regulations related to the Breakthrough Device
SaaS/subscription-based models (49%) and single use
coverage pathway. The Medicare Coverage of Innovation
disposables (48%) are the most preferred current/expected
Technology (MCIT) regulation would automatically grant four
revenue models by start-ups; other models such as licensing
years of immediate coverage to FDA-breakthrough-designated
(37%) and equipment/capital sales (35%) are also well
medical devices concurrently with regulatory approval8. In May
represented. Interestingly, 65% of start-ups reported a diversified
2021, the Biden administration announced that it would delay this
revenue model approach where two or three or more models are
regulation until December 2021, citing concerns that the Centers
pursued at once. This could include efforts to monetize digital
for Medicare and Medicaid Services (CMS) would have less
aspects of new products, including data.
authority to revoke coverage if it turned out that the approved
breakthrough technologies were harmful9.

Figure 8

Medtech start-ups prefer SaaS, subscription-based, single-use, and disposable revenue

models

Multiple revenue model breakup

Single-use or disposable, equipment and capital sales 7%

SaaS or subscription-based, licensing 4% Single revenue model breakup

Single-use or disposable, licensing 3%

Single-use or disposable 17%
Equipment and capital sales, SaaS or subscription-based 3%
SaaS or subscription-based 12%
Single-use or disposable, licensing, transaction fees or royalties 3%
35% Equipment and capital sales 4%
Single-use or disposable, equipment and capital sales, licensing 2%
Licensing 1%
SaaS or subscription-based, freemium-to-premium 2%
65%
Transaction fees or royalties 1%
SaaS or subscription-based, data, licensing 2%

Single-use or disposable, SaaS or subscription-based 2% Data 0%

Single-use or disposable, equipment and capital sales, SaaS or Single revenue model Freemium-to-premium 0%
2%
subscription-based
Multiple revenue model
Others 35%

Survey question: What is your revenue model or anticipated revenue model? (Check all that apply)
Note 1: N=950.
Source: Deloitte analysis of the MTI database, 2021.

The impact of COVID-19 on the

innovation ecosystem

The impact of COVID-19 on the medtech innovation ecosystem it possible to bring new products to market more quickly.
depends on the types of technologies that companies offer. Some
Consistent with previous years, the number of companies in MTI’s
companies were at the forefront of addressing the pandemic.
database for 2021 remains high. This suggests there is no lack
They developed tests, supplies, and protective equipment as well
of ideas for new products or any drop in interest in incubator
as technology that supported patients who received treatment
support. Unsurprisingly, virtual health was a hot investment
in the hospital. Many of these companies have experienced
area in 2021, which was driven by a surge in use during the early
unprecedented demand and regulatory flexibility, which made
months of the pandemic.

Earlier Deloitte report finds very high investment interest in health technologies

Although medical technology is the focus of this study, Deloitte also recently analyzed investment trends in health technology. In
that study, we found that health tech innovators that are focused on the Future of Health will likely continue to receive the lion’s
share of funding in 2021 and beyond. Innovators that are focused on well-being and care delivery models received a record $6.4
billion funding in 2020 in the US. The pandemic accelerated funding for innovators that offer alternative forms of care delivery,
such as remote monitoring and virtual health.

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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

This was driven by health systems and health plans that had not already invested in these technologies and had to pivot to them
quickly. Interest in virtual health is expected to continue, even as in-person visits have recovered. Finding an effective, scalable
balance between virtual and in-person visits could be a challenge. Interviewees suggested that major focus areas for 2021 and
beyond include on-demand health outside of traditional health care settings, mental health, and fitness10 .

Many companies that had been developing technologies to of the company executives we interviewed, as well as companies
address more traditional and complex technologies used in in the MTI database, have diversity and inclusion strategies for
surgeries saw a drop in clinical-trial enrollment and sales. talent. Strategies include a focus on making products more
Interviewees—both innovators and strategics—told us they broadly accessible, keeping diversity of leadership in mind as a
are recovering financially from the drop in elective surgeries part of M&A, and using real-world data to look at outcomes by
that reduced revenue in 2020. They are now able to meet with race and gender.
physicians and support the use of their products in clinical
MTI asked this year’s applicants to describe how they are
settings. Some interviewees noted some challenges in recruiting
approaching health equity along four potential dimensions that
patients for clinical trials. While the threat of the pandemic has
Deloitte has been using in its Activating Health Equity approach.
diminished, some patients are still concerned about their ability
The four dimensions (and explanations given in the
to maintain social distance in a health care setting.
applications) include:
Incumbent medtech companies and start-ups are
• Company: Advancing internal initiatives to improve diversity,
addressing health equity in their businesses and products
equity, and inclusion in the company and understanding the
Issues related to systemic racism and health equity have been in needs of employees
the spotlight for much of 2020 and 2021. The moral imperative • Product designed for diversity: Assessing and changing
for health equity is undeniable, but there are also business core services and/or products to reduce disparities, such as
reasons for this focus. Many life sciences and health care improving access, reducing pricing, and showing diversity in
organizations have an especially strong interest in improving packaging and marketing
health equity, which could bolster their commercial success while
• Community: Taking a role to improve outcomes, including social
also saving lives and delivering more value to the individuals and
determinants of health in geographic and virtual communities
communities they serve11.
• Ecosystem, including policy: Actively reflecting a diversity
Many start-ups and strategics are addressing health equity within
leadership agenda through aligned suppliers/vendors,
organizations, products, communities, and ecosystems. Nearly all
establishing ecosystem relationships, and public advocacy

Figure 9
Medtech start-ups are thinking about health equity and are focused on diversity and
inclusion at the company level

83%

69%
67%

43%

Company Community Product Ecosystem

Survey question: As applicable, please let us know the status of initiatives in which you are setting policies as it relates to health equity. (Check all that apply)
Note: N=852.
Source: Deloitte analysis of the MTI database, 2021.

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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

Eighty-three percent of companies in the MTI database are (as well as during the patient journey) while also plotting new
focused on health equity at the company level, but many growth strategies. Executives from start-up companies are
companies also indicated a focus on other aspects of health thinking about how to move outside of current operating
equity. Almost half (49%) of start-ups have women in senior boundaries in health care, not within them.
leadership positions (CEO, President, Founder/ Co-Founder); • Invest strategically and early: Traditionally, strategics grow
35% selected “other people of color” (e.g. Latinx, Asian, Indian) as through smaller tuck-in acquisitions. Instead, these larger
being in these same roles. However, Black, indigenous, and other medtech companies should consider strategic investments
people of color (BIPOC) representation is only 16%. earlier in the lifecycle of a product. This includes licensing, co-
Innovators noted that their companies are small, which often development, joint-venture arrangements, or taking an equity
means the range of potential impact is limited. Some innovators stake in a start-up company to build portfolios and help foster a
have been explicitly thinking about how to support broad access robust innovation ecosystem.
to their products as part of health equity and how the products • Revamp the product development process: Another important
themselves might help to improve equity. One start-up executive focus should be optimizing the product-development process
told us that because his product produces real-world data, it to deliver the right products to the market at the right time. This
is perfectly positioned to support the analysis of disparities in includes adopting agile processes and other techniques such
use and outcomes by all types of patient and health system as rapid prototyping (which are often absent in medtech today)
characteristics. However, another start-up executive noted but also refining the organizational culture, structure, and
that since his product is specialized, it will likely be adopted by talent strategy to develop new capabilities. This is key to driving
academic medical centers, which could limit most people’s access market share and offering value to patients and customers—in
to the product. addition to generating returns on investments. Companies that
Among business-development leaders at strategics, we heard a choose to sustain their existing product line, rather than buy or
range of responses to questions about diversity and equity. While build new and innovative products, run the risk of missing the
some of these leaders said they were aware of some of the health needs of the market in the future—and being left behind.
equity strategies within their companies, their functions were • Focus on reimbursement opportunities: Current payment
not leading these initiatives. However, other interviewees told us policies can put pressure on medtech manufacturers to
they try to achieve a balanced representation of leadership in the differentiate themselves and demonstrate value. Many
companies they acquire. companies are rising to the challenge by creating new
contracting and value-based arrangements, such as sharing
Conclusion risk with providers or payers for the total cost of care or clinical
As we have discussed in our Future of Health™ perspective, outcomes. Recent updates, such as the now-delayed MCIT rule,
health care is transitioning away from the historic model of which provides same-day national Medicare coverage for FDA-
reactively treating illness. By 2040, Deloitte estimates that two- designated breakthrough medical devices, will likely reduce the
thirds of health care spending will be related to well-being and the lag between approval and payment and are step in the right
early detection, prevention, and curing of disease12 . This is good direction. Medtech companies should also pay close attention
news for the medtech industry. Disease detection and prevention to cyber issues, as experts say regulatory guidance has not kept
will likely rely on sensor-driven, regulated medical devices, which up with the advancements in digital technology13.
could create a substantial new medical technology market. We Start-ups that want to be acquired by strategics need to
see a lot of focus among start-ups on precisely these areas. understand the opportunities and the challenges facing the
How and where heath care is delivered is becoming just as industry. These companies should ensure that their strategies
important as the care itself. In the future, we expect connected and products are well positioned for these trends. While there
ecosystems to transform where patients receive care, including are growing opportunities outside of traditional care settings and
through virtual and retail channels, and even at home. The along the patient journey, reimbursement could be challenging.
transition from episodic care to improving and maintaining well- A keen understanding of reimbursement, site of care shifts, and
being will put pressure on the traditional medtech alignment with existing product lines will increase the likelihood
business model. of acquisition or other financial support.

For strategics, this shift is creating new challenges. A mix of Working with accelerators such as MTI, can be extremely valuable
funding strategies is typically needed to optimize the ROI for the start-up community. Newer organizations can learn from
of innovation more experienced companies on how to position their products
and articulate their value. Worth mentioning is the material
Established medtech companies should prepare for the
financial support that winning companies can garner. In 2021,
future by also considering the following:
MedTech Innovator and its partners will give out $500K+ in cash
• Align to where the market is going: Embracing new business prizes as well as other awards in the US program. Although not
models will be a key to success. Some models are likely to the focus of our research, we heard a continued refrain that
become more consumer-centric. As health care shifts toward MedTech Innovator was a well-respected force in the
prevention and wellness, for example, medtech companies will innovation ecosystem.
likely need to engage consumers before they become patients
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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

Endnotes
1. https://www2.deloitte.com/us/en/insights/industry/health-care/future-of-medtech.html

2. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/medical-technology-trends-six-winning-roles.html

3. https://www2.deloitte.com/us/en/pages/life-sciences-and-health-care/articles/medtech-innovation-investments.html

4. https://www.raps.org/news-and-articles/news-articles/2019/5/regulating-software-as-a-medical-device-in-the-age

5. https://www.fda.gov/medical-devices/digital-health-center-excellence/digital-health-software-precertification-pre-cert-program

6. https://www.fda.gov/news-events/fda-voices/year-pandemic-how-fdas-center-devices-and-radiological-health-prioritizing-its-workload-and-
looking

7. https://www.policymed.com/2017/02/medical-device-parallel-review-program-made-permanent.html

8. https://www.federalregister.gov/documents/2021/01/14/2021-00707/medicare-program-medicare-coverage-of-innovative-technology-mcit-
and-definition-of-reasonable-and

9. https://www.federalregister.gov/documents/2021/05/18/2021-10466/medicare-program-medicare-coverage-of-innovative-technology-mcit-
and-definition-of-reasonable-and

10. https://www2.deloitte.com/us/en/insights/industry/health-care/health-tech-private-equity-venture-capital.html

11. https://www2.deloitte.com/us/en/insights/industry/health-care/developing-an-agenda-of-equity-in-health.html

12. https://www2.deloitte.com/us/en/insights/industry/health-care/future-health-care-spending.html

13. https://www.med-technews.com/medtech-insights/digital-in-healthcare-insights/on-guard-protecting-devices-against-cybersecurity-risk/

About the Deloitte Center for Health Solutions

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practice, delves deeper into your top-of-mind issues and provides fresh thinking around complex challenges. Timely, relevant research
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Can medtech start-ups show us where the industry is headed? Insights from MedTech Innovator and industry leaders

About the Authors

Glenn Snyder
Medical Technology Sector Leader
+1.415.699.4469
[email protected]

Glenn leads Deloitte LLP’s Medical Technology practice with more than 25 years of experience in medical technology, biotech, and
specialty pharmaceuticals. He helps clients grow through organic and inorganic means by entering new geographic markets, and
expanding into new product/service areas. Glenn also helps clients improve brand/commercial effectiveness by articulating product
economic value, applying innovative pricing, updating the commercial model, and rationalizing distribution networks.

Simon Gisby
Principal, Co-Lead Healthcare Strategy and Growth
+1.917.599.8550
[email protected]

Simon is a principal and the Life Sciences and Health Care Group leader with Deloitte Corporate Finance LLC (DCF) and a principal
in Deloitte Transactions and Business Analytics LLP. He has more than 20 years of investment banking experience focused on the
healthcare industry. Prior to joining DCF, Simon was a director with Houlihan Lokey where he specialized in the financial restructuring
of healthcare companies. Simon was previously a director in the Global Healthcare Investment Banking Group of UBS Investment
Bank, where he structured and completed numerous mergers and acquisitions, initial public offerings, and other capital markets
transactions. Simon’s clients include multinational medical device and pharmaceutical companies, national and regional health plans
and hospital systems, multi-specialty physician groups, and ancillary service healthcare companies.

Leena Gupta
Manager, Deloitte Center for Health Solutions
+1.212.436.5674
[email protected]

Leena Gupta is a manager with the Deloitte Center for Health Solutions. Her research focuses on emerging trends and issues in the
life sciences industry, with an emphasis on medical devices and technologies as well as emerging therapies in pharma. Gupta holds a
bachelor of science degree in biological sciences from the University of Missouri-Columbia and a master’s degree in public health in
Epidemiology from the Tulane University School of Public Health and Tropical Medicine.

Acknowledgements
Sarah Thomas provided invaluable guidance on shaping the project, interpreting findings, and writing and editing sections of the
paper. Debanshu Mukherjee, Apoorva Singh, and Bushra Naaz conducted the data analysis and also assisted with interviews and
interpretation of findings.

The authors would also like to thank Paul Grand, Brian Benson, and Kathryn Zavala from MTI for lending their expertise, assisting
in the interpretation of findings, and for editing sections of the paper. Additionally, the authors would like to thank Jason Asper, Sonal
Shah, Chris Comrack, Natasha Elsner, Steve Davis, Laura DeSimio, Zion Bereket, and the many medtech leaders who graciously
contributed their time and insights to this project.

13
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