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The Cost of a Bad Hire in MedTech – and How to Avoid It

Thu, 19 Jun 2025 10:22:43 GMT

THE COST OF A BAD HIRE IN MEDTECH - AND HOW TO AVOID IT

BY PROJECTUS

INTRODUCTION .

A bad hire in any industry is costly. But in MedTech, where precision, regulation, and innovation intersect, the impact is magnified. Whether you're scaling a commercial team post-Series A or hiring a Head of Regulatory ahead of a product launch, the wrong person can delay growth, drain resources, and damage your credibility. So how do you avoid it?

1 . The Real Cost of a Bad Hire

Financial Impact

It’s estimated that the cost of a bad hire can reach up to three times the individual’s salary. That includes recruitment fees, onboarding costs, lost productivity, and the cost of rehiring. In early-stage MedTech, where budgets are tight and speed matters, this is a hit most can’t afford.

Cultural Disruption

A misaligned hire can disrupt team cohesion. In smaller, fast-moving companies, this can lead to friction, low morale, and attrition - especially if the hire is in a leadership role. In MedTech, where cross-functional collaboration is crucial, one wrong fit can set progress back months.

Reputational Risk

A poorly performing commercial hire can alienate key customers or KOLs. A sub-par RA/QA leader can damage your credibility with regulators. These risks don’t just affect the individual - they reflect on your brand and long-term prospects.

2 . Why the Wrong Hires Happen

Rushed Decisions
Startups often hire under pressure - whether from investors, market demands or timelines. In the rush, red flags get overlooked, or the hiring process is truncated.

Poorly Defined Roles
Sometimes companies hire based on generic job descriptions or what they think they need - rather than clearly defining the outcomes required from the role. That’s particularly dangerous in MedTech, where regulatory environments and commercial pathways are niche and varied.

Overvaluing Pedigree
It’s easy to be swayed by impressive CVs. But what works in a large, established business may not translate to a 20-person startup. Startups need hands-on doers who thrive in ambiguity - not just strategic thinkers.

3 . Getting It Right: Practical Steps to Avoid a Bad Hire

Start with Clarity
Be clear on what success looks like in the role. What do you expect them to deliver in the first 6–12 months? What kind of person fits your culture - not just your current team, but the one you’re trying to build?

Use Structured Interviews
Standardised, consistent questions help reduce bias and compare candidates more objectively. Include scenario-based questions that reflect real challenges the candidate will face.

Prioritise Fit for Stage
Early-stage MedTech requires a different mindset. Look for people who have built things, not just managed them. Ask about how they’ve worked with limited resources, regulatory constraints, or ambiguous go-to-market strategies.

Backchannel References
Don’t rely solely on formal references. Backchannel through mutual connections where possible. People are more candid when they’re not constrained by corporate policy.

Partner with Specialists
MedTech is complex. Working with recruiters who understand the space - and can challenge you on your brief, market expectations, and candidate quality - saves time and improves outcomes.

4 . The Role of Data in Better Hiring

Using data to inform hiring decisions is becoming standard practice. Skills assessments, behavioural profiling, and predictive hiring tools can all offer insights beyond the interview.

At PROJECTUS, we use a combination of market data, talent mapping and structured assessment to ensure our clients don’t just get a candidate - but the right candidate.

5 . Building a Hiring Culture

Ultimately, hiring should be a team effort. Create a culture where hiring is seen as a critical part of everyone’s job - not just HR or founders. Encourage team members to refer high-quality candidates, be involved in interviews, and understand what good looks like.

CONCLUSION .

In MedTech, the stakes are high. A single poor hire can stall momentum, cost money, and dent investor confidence. But by slowing down, defining roles clearly, and partnering with specialists, you can stack the odds in your favour. The cost of a bad hire is too high to leave to chance.

Why Top MedTech Startups Want Ex-Clinicians on Their Team

Thu, 12 Jun 2025 10:37:19 GMT

Why Top MedTech Startups Want Ex-Clinicians on Their Team

BY PROJECTUS

INTRODUCTION .

In the fast-moving world of MedTech, where product development, regulatory navigation and patient outcomes are all tightly interlinked, there's a growing trend: hiring former clinicians into non-clinical roles. Whether it's doctors, nurses, radiographers or physiotherapists, MedTech startups are increasingly bringing in healthcare professionals to help shape their teams. And with good reason.

These individuals bring a unique mix of hands-on experience, clinical credibility and system-level insight that few others can match. For scaling startups, particularly those aiming to sell into hospitals, clinics or directly to patients, ex-clinicians can be a game-changer.

1 . Clinical Insight That Speeds up Product-Market Fit

One of the biggest hurdles for any MedTech business is building something that clinicians will actually use – and trust. Having someone on the team who has lived through the frustrations of legacy systems or inefficient workflows can shortcut months of second-guessing.

Ex-clinicians can spot red flags early in the development process. They can tell when a product feature adds value versus when it just adds noise. Their input can help shape not only functionality but user experience, ensuring that what's built is something end-users genuinely want.

2 . Trusted Voices with End Users

Trust is everything in healthcare. Startups often face an uphill battle convincing hospital buyers or clinical stakeholders to trial a new product. This is where ex-clinicians add another layer of value – they speak the same language as those being sold to.

Whether in marketing, sales, customer success or product strategy, an ex-clinician’s voice carries credibility. They're not just repeating what they've been told; they’ve been there. This trust often translates into smoother product rollouts, better feedback loops and faster adoption.

3 . Better Cross-Functional Communication

MedTech teams often include engineers, commercial leads, regulatory experts and data scientists. One common challenge is aligning these functions around a shared understanding of the end-user.

Ex-clinicians are natural translators between clinical needs and technical execution. They can break down complex clinical problems into terms that product and tech teams can act on. Equally, they can explain technical constraints in a way that makes sense to non-technical stakeholders. This cross-functional fluency can significantly reduce friction and drive more effective collaboration.

4 . A Competitive Edge in Regulatory Strategy

Understanding clinical pathways and patient risk is crucial in navigating regulatory frameworks. Former clinicians are well placed to contribute to risk assessments, clinical evaluations and the documentation required for CE marking or FDA submissions.

They understand how outcomes are measured, what constitutes clinical evidence, and how devices will actually be used in practice. This practical grounding helps bridge the gap between theoretical compliance and real-world application – a critical advantage when speed to market is key.

5 . Fresh Energy and a Sense of Purpose

There’s also something else that startups benefit from: mindset. Many ex-clinicians move into MedTech because they want to make a broader impact. After years on the front line, they’ve seen where the system fails and are now motivated to fix it from the outside.

This sense of mission often aligns well with startup culture. They’re used to high-pressure environments, they’re problem solvers by nature, and they understand that outcomes matter. These attributes make them resilient, focused and highly engaged team members.

6 . Where They Add Most Value

While it’s tempting to bring clinicians into advisory roles only, many are looking for hands-on positions. Startups that integrate them properly tend to get the most value. Roles where they shine include:

Clinical Product Manager – shaping features and roadmaps with end-user needs front of mind
Sales Engineer or Clinical Liaison – helping customers understand how the product works in practice
Regulatory or Clinical Affairs Lead – grounding compliance in real-world clinical logic
Customer Success and Training – ensuring smooth onboarding and ongoing engagement
Strategy and Partnerships – guiding go-to-market plans with clinical credibility

CONCLUSION .

Hiring ex-clinicians isn’t a shortcut to product success – but it is a smart way to inject practical insight, accelerate adoption and build trust with your market. For startups aiming to scale effectively, particularly in a space as complex and human-centric as healthcare, their contribution is often the difference between a good idea and a usable, scalable solution.

Top 5 Traits to Look for in a High-Performing MedTech Sales Rep

Thu, 05 Jun 2025 10:40:17 GMT

Top 5 Traits to Look for in a High-Performing MedTech Sales Rep

BY PROJECTUS

INTRODUCTION .

Hiring salespeople in MedTech isn’t just about finding someone who can close deals – it’s about finding professionals who understand the complexity of your product, the nuances of the healthcare market and the patience it takes to build long-term relationships. Especially for early- and growth-stage MedTech companies, the right hire can be the difference between stagnant pipelines and accelerated growth.

So what should you be looking for in a high-performing MedTech sales rep? Here are the five traits that matter most.

1 . Clinical Fluency Without the Jargon

A top-tier MedTech sales rep doesn’t need to have a medical degree, but they should be comfortable speaking with surgeons, clinicians, procurement teams and technical staff. They need to understand the clinical environment well enough to ask smart questions, interpret pain points and position the product in a way that resonates.

They should be able to explain the clinical value of your solution in a language that adapts – whether talking to an end-user or a non-clinical buyer. That balance of credibility and clarity builds trust quickly.

2 . Strategic Patience

Unlike in fast-turnover B2B SaaS, MedTech sales often involve long cycles, multiple stakeholders and procurement hurdles. The best reps are persistent without being pushy. They know when to drive momentum – and when to hold back.

Strategic patience means they keep deals warm without burning bridges. They understand that timing in healthcare is dictated by many external pressures, and they know how to remain relevant and helpful over time.

3 . Curiosity About the Product (and the Patient)

Top-performing salespeople in MedTech genuinely care about how the product impacts patient care. They go beyond the spec sheet and want to understand how it fits into clinical pathways, improves workflows or enhances outcomes.

That curiosity leads to better discovery calls, smarter demos and more meaningful follow-ups. It also means they feed useful insights back into the business – spotting trends, objections and opportunities from the front line.

4 . Discipline with CRM and Data

Scaling startups rely on visibility. A sales rep who treats CRM like an afterthought makes it harder to forecast, coach and grow. High performers are disciplined with their data – not because they’re told to be, but because they understand its value.

They track their activity, reflect on their pipeline and manage their territory like a business. This operational maturity gives you the clarity needed to make smarter hiring, marketing and product decisions.

5 . Comfortable With Ambiguity

In an early-stage MedTech company, not everything is figured out – and the best salespeople don’t wait for perfect process or polished collateral. They’re proactive, creative and self-sufficient. They test different approaches, learn from what doesn’t work and share what does.

They’re also resilient. MedTech sales comes with rejection, delays and hard-won wins. A strong rep knows how to bounce back, keep the team energised and stay focused on the longer-term goals.

CONCLUSION .

It’s easy to be wowed by someone’s network or CV – but those surface indicators don’t always translate into high performance. When building your sales team, focus on behaviours over background. Look for curiosity, communication style, resilience and structure in their approach. Ask how they manage a long sales cycle. Dig into how they prepare for clinical meetings. Understand how they think.

Because in MedTech, selling isn’t just about persuasion – it’s about insight, trust and value. And the reps who get that will be the ones who deliver results.

HOW TO FOSTER AN ENVIRONMENT OF CONTINUOUS LEARNING?

Wed, 22 Feb 2023 11:21:41 GMT

HOW TO FOSTER AN ENVIRONMENT OF CONTINUOUS LEARNING?

BY PROJECTUS

INTRODUCTION .

In today's rapidly evolving MedTech industry, fostering a culture of continuous learning is essential for companies to remain competitive and for employees to stay engaged and motivated. A MedTech company that fosters an environment of continuous learning not only retains its top talent but also improves employee performance, innovation, and competitiveness.

In this article, we will breakdown the ways in which MedTech companies can create a culture of continuous learning and development.

1 . Provide training and development opportunities

To create an environment of continuous learning, it is essential to provide employees with training and development opportunities. This could include internal training programs, mentorship, or attending conferences and events related to the industry. Employees should be given the opportunity to learn new skills, gain knowledge, and develop their expertise in specific areas. This will help employees identify areas where they need to improve, which can lead to better performance.

2 . Encourage a growth mindset

A growth mindset is the belief that skills and abilities can be developed through dedication and hard work. Encouraging a growth mindset in employees can help them embrace new challenges and view mistakes as opportunities for learning and growth. MedTech companies can foster this mindset by promoting a learning culture and providing opportunities for employees to take risks and learn from their mistakes.

3 . Create a knowledge-sharing culture

A knowledge-sharing culture encourages employees to share their knowledge and expertise with each other. This not only fosters continuous learning but also improves communication and collaboration within the company. Creating a knowledge-sharing culture can be achieved by organizing regular knowledge-sharing sessions or setting up a platform for employees to share their insights and experiences. This can lead to the development of new ideas and innovations that can help the company to stay ahead of the competition. When employees are encouraged to learn and experiment, they are more likely to come up with innovative solutions to complex problems.

4 . Offer career development opportunities

Employees are more likely to stay with a company that offers career development opportunities. MedTech companies should provide opportunities for employees to progress in their careers, whether that is through promotions, cross-functional training, or mentoring programs. It is one way to keep employees engaged and motivated. When employees feel that their employer is investing in their development, they are more likely to stay with the company long-term. Providing employees with opportunities for learning and growth also helps to attract top talent to the company.

5 . Provide feedback and recognition

Feedback and recognition are essential for employee development and motivation. MedTech companies should provide regular feedback to their employees, highlighting areas of improvement and acknowledging their achievements. Recognition can be given through awards, promotions, or simply by giving employees the opportunity to lead projects or take on new responsibilities.

CONCLUSION .

Fostering an environment of continuous learning in MedTech companies is critical for retaining top talent and improving employee performance. Providing training and development opportunities, encouraging a growth mindset, creating a knowledge-sharing culture, offering career development opportunities, and providing feedback and recognition are all key ways to achieve this. By investing in their employees' growth and development, MedTech companies can not only improve their bottom line but also positively impact the lives of patients who benefit from their solutions.

HOW TO ACE YOUR INTERVIEWS?

Tue, 21 Feb 2023 15:23:17 GMT

HOW TO ACE YOUR INTERVIEWS?

BY PROJECTUS

INTRODUCTION .

Interviewing with a MedTech company can be a challenging experience. MedTech companies are at the forefront of medical innovation, so they are looking for candidates who not only have the technical skills but also the right attitude, passion, and dedication to make a difference in the industry. To help you ace your interview with a MedTech company, we've compiled some top tips to help you stand out from the competition.

DO YOUR RESEARCH .

Before your interview, research the company and its products. You should know what they do, how they do it, and what sets them apart from other MedTech companies. Check out their website, social media pages, and recent press releases to get a sense of the company's mission, values, and achievements. This will help you understand the company's culture and show the interviewer that you're serious about working for them.

Hot Tip: Use their vision and mission statement to pitch a plan on how to work towards this goal when asked what difference you could make in the company.

UNDERSTAND THE INDUSTRY .

MedTech is a complex industry with a lot of regulations, technologies, and stakeholders. Before your interview, make sure you have a solid understanding of the industry, including its challenges, trends, and opportunities. This will help you demonstrate your knowledge and passion for the industry and show the interviewer that you're up-to-date with the latest developments.

Hot Tip: An interview is often conversational and in order to appear a top candidate, slip bits of industry knowledge when talking about the future of the MedTech industry and ideate some ways to keep up with the challenges.

SHOWCASE YOUR SKILLS .

MedTech companies are looking for candidates with technical skills, such as software development, engineering, or data analytics. During your interview, be prepared to showcase your skills by providing examples of your previous work, highlighting your technical expertise, and explaining how you can apply your skills to the company's products or services. You should also be able to demonstrate your ability to work in a team and communicate effectively with different stakeholders.

Hot Tip: It is always a good idea to use precise examples that also show overcoming issues through the application of your skills to highlight the relevance of them.

HIGHLIGHT YOUR PASSION FOR HEALTHCARE .

MedTech companies are driven by a mission to improve healthcare outcomes and patient care. They want employees who share their passion and commitment to making a difference in the industry. During your interview, make sure to highlight your passion for healthcare and how you want to contribute to improving patient outcomes. You should be able to articulate your values and how they align with the company's mission.

Hot Tip: Your passion for healthcare ties closely to your industry research. If you’ve kept up with current industry trends and projections, it shows a genuine interest on where the MedTech industry is, where it will in the future and how you’d like to be a part of it.

ASK QUESTIONS .

An interview is not only an opportunity for the company to assess your fit but also for you to learn more about the company and the position. Come prepared with a list of questions that will help you understand the company's culture, challenges, and expectations. This will also show the interviewer that you're genuinely interested in the company and the position.

Hot Tip: Make sure to ask at least 5-6 questions regarding their culture, values and especially their future plans to incorporate how you can fit into them. Definitely ask questions about their products linking it to current research and advancements to show both your interest and knowledge of their company and the industry.

CONCLUSION .

Preparing for an interview with a MedTech company requires research, knowledge, and passion. By doing your homework, showcasing your skills, highlighting your passion for healthcare, and asking the right questions, you'll be able to stand out from the competition and impress the interviewer. Remember to be confident, authentic, and enthusiastic, and you'll be one step closer to landing your dream job in the MedTech industry.

THE ETHICS OF AI IN HEALTHCARE: BALANCING ADVANCEMENTS WITH PATIENT PRIVACY

Mon, 20 Feb 2023 13:55:09 GMT

The Ethics of AI in Healthcare: Balancing Advancements with Patient Privacy

BY PROJECTUS

INTRODUCTION .

Artificial intelligence is rapidly changing the healthcare industry, with many promising advancements in medical research, treatment, and diagnosis. However, as AI becomes more prevalent in healthcare, concerns over patient privacy and ethical implications are also growing. In this article, we will explore the ethics of AI in healthcare and how we can balance advancements with patient privacy.

AI has the potential to revolutionize healthcare by improving diagnosis accuracy, predicting potential health issues, and providing personalized treatment plans. However, AI can only provide such benefits by using patient data, including personal health information (PHI). This raises concerns over how patient data is used and shared, and whether it is being used ethically and responsibly.

AI models that are trained on large datasets of patient data can sometimes unintentionally identify patients, even when the data is anonymised. This can result in privacy breaches that could compromise patient trust and confidentiality.

1 . Patient Privacy

Patient privacy is a very important issue. Most people in the world consider it an absolute right, but how can we ensure that our patients' data will be treated with care?

We need to understand that patient data is sensitive and should be treated with care. It can be anonymized, which means removing all identifying information from the data so that it cannot be linked back to its original owner or creator, this process is called "anonymisation". However, if you're reading this article on your phone and someone else has access to your internet connection, they would still be able to tell who you are because they know where they found out about your medical history. Therefore, there are limits on what kind of information should remain anonymous; some things might not be possible without exposing too much personal information about yourself--or even worse: getting into trouble with law enforcement agencies.

It is, however, now possible to design algorithms that reinforce each other in their collective analyses without exchanging data. This is accomplished by calculating and sharing technical features that are meant to preserve patient privacy and the intellectual property of the underlying data and models.

2 . PHI isn't used in AI models or algorithms.

If a patient's data isn't anonymised before then, any AI model trained on their PHI could identify them. For example, if an algorithm uses genetic information to predict how long someone will live and shows it to family members without obtaining their consent, this could be considered an invasion of privacy.

Anonymising data is a complex process that requires careful consideration of how much risk there would be for identification if such information were disclosed publicly or used by other parties outside the original owner's control.

3 . Potential for bias

Another ethical concern with AI is the potential for bias. AI algorithms are only as unbiased as the data they are trained on. If the data used to train an AI model is biased, the algorithm may produce biased results. This could lead to discrimination against certain populations, resulting in unfair treatment and a lack of access to care.

Healthcare providers and technology companies must ensure that AI algorithms are unbiased and do not discriminate against certain populations. This requires careful consideration of the data used to train the AI model and ongoing evaluation of the model's performance to ensure it is producing accurate and unbiased results.

4 . Transparency and Accountability

An ethical framework for responsible AI development and use is needed to ensure transparency and accountability in decision-making processes related to all stages of technology development and implementation. The framework should be flexible enough to accommodate new technologies in the future, while being structured around principles that can guide all stakeholders involved in AI systems development.

The current state of affairs is that we have no clear guidelines on how we should apply ethics, let alone whether or not our application of ethical frameworks will lead us down an ethically murky path. We need a set of standards that can guide us through these complicated issues so we can make better decisions about what kind of future awaits us as a society with this new power source at our disposal: artificial intelligence.

5 . Patient Privacy must be a Priority

In a world where patient privacy is a priority, it's important to remember that it's not just the doctor-patient relationship that needs to be protected. The healthcare system as a whole depends on public trust in what it does and how it operates. That trust can only be maintained if the public understands that data is being collected and handled responsibly, which means transparency about how personal health data is being used.

In addition to protecting our own privacy, we need to ensure that patients have access to information about their own care so they can make informed decisions about whether or not they want treatment based on its potential risks or benefits for them--and whether those risks outweigh any potential benefits for others.

Conclusion .

In conclusion, AI has the potential to revolutionize healthcare, but it is important to balance advancements with patient privacy and ethical considerations. Healthcare providers and technology companies must take a proactive approach to ensure that AI is developed and used in a responsible and transparent way. By following ethical principles such as transparency, data privacy, and unbiased algorithms, we can ensure that AI is used to improve patient outcomes without compromising patient privacy or ethics.

THE IMPORTANCE OF SEEKING STRATEGIC PARTNERSHIPS

Thu, 09 Feb 2023 09:20:35 GMT

THE IMPORTANCE OF SEEKING STRATEGIC PARTNERSHIPS IN MEDTECH

BY PROJECTUS

INTRODUCTION .

Strategic partnerships are a vital aspect of the MedTech industry as they provide a platform to facilitate innovation and growth. The fast-paced nature of the healthcare industry and the increasing demand for new and advanced medical technologies have made strategic partnerships a crucial aspect of the industry.

Innovation :

The MedTech industry is characterized by rapid changes and the introduction of new technologies. Strategic partnerships allow companies to collaborate with other organizations and tap into their expertise, resources, and networks to bring new and innovative products to market faster. This collaboration can help to reduce the time and cost involved in bringing new products to market, as well as minimize the risk associated with investing in research and development. In fact, the implementation of AI to analyse big data, especially in the area of imaging and to develop new algorithms for medical treatment is at the heart of any emerging strategic partnerships.

Research & Development :

Strategic partnerships between MedTech companies and academic institutions, research organizations, and other healthcare providers can help to speed up the process of developing new medical technologies. These partnerships can provide access to specialized knowledge and resources, such as clinical trials and access to patient data, which are critical for the development of new medical technologies.

Access to new markets :

Strategic partnerships can help MedTech companies expand their reach into new and untapped markets. By partnering with companies in other countries, MedTech companies can gain access to new customers, new distribution channels, and new technology. These partnerships can help MedTech companies to increase their market share, reach new customers, and expand their business globally.

Cost-effectiveness :

Strategic partnerships can help MedTech companies reduce their operational costs by sharing resources and knowledge. For example, by partnering with suppliers and distributors, MedTech companies can reduce their procurement and distribution costs. Additionally, strategic partnerships can help MedTech companies to leverage the strengths of their partners, such as their marketing and sales networks, to increase their overall efficiency and cost-effectiveness.

How can this be achieved? Below, we’ve listed down key essentials for a successful strategic partnership.

CONCLUSION .

Strategic partnerships present a new business model to help healthcare leaders better manage the cost and complexity of their technology investments while expanding access to advanced medical care to improve patient outcomes. The strategic guidance and collaborative approach to new challenges creates opportunities to co-innovate and co-create solutions. In an industry characterized by rapid change and increased demand for new and advanced medical technologies, strategic partnerships are an essential tool for success.

FDA CLEARANCES - JANUARY 2023

Mon, 06 Feb 2023 16:27:35 GMT

FDA APPROVALS – JANUARY 2023

BY PROJECTUS

INTRODUCTION

The medical technology industry is constantly evolving and improving, with new devices and technologies being developed all the time. While these advances have the potential to greatly improve patient care and outcomes, it is important to ensure that these devices are safe and effective before they are made available to the public. So, here is a recap of the key FDA approvals in January 2023.

1 . Vivos bounces back from FDA rejection to land 510(k) clearance for sleep apnea treatment

Vivos Therapeutics has received 510(k) clearance of a daytime-nighttime appliance, known as a DNA appliance, for the treatment of obstructive sleep apnea after a second attempt to win approval.

The DNA device is part of a set of products intended for use in a procedure to expand the palate and train the tongue to rest in the “proper position.” By doing so, Vivos thinks it can convert patients to nasal, as opposed to oral, breathing by addressing the root cause of OSA, and thus provide an alternative to continuous positive airway pressure machines.

The U.S. Food and Drug Administration had earlier rejected an application for the product in 2021 but has now reversed its ruling.

“For the first time, the FDA has formally recognized the benefits of our proprietary core technology in our DNA appliance (without mandibular advancement) as an effective treatment for mild-to-moderate OSA in adults,” Vivos CEO Kirk Huntsman said in a statement.

2 . Tidepool lands long-awaited FDA nod for artificial pancreas app connecting CGMs, insulin pumps

More than two years after submitting it for FDA review, Tidepool has scored the agency’s clearance for a smartphone app that allows people with Type 1 diabetes to build their own closed-loop “artificial pancreas” system.

The app connects wirelessly to certain continuous glucose monitors and insulin pumps that are compatible with alternate controllers. From there, rather than managing each device separately and manually updating insulin dosages, users can monitor both devices in one place, and the app automatically tweaks basal insulin doses based on CGM readings. Loop’s algorithm can also predict spikes in glucose and recommend correction doses of bolus insulin—which users have to manually accept.

“We knew this day would come, but we couldn’t have achieved it without the support of the entire diabetes community, including the FDA,” CEO Howard Look said in a company announcement Tuesday, offering his specific thanks to the “DIY” diabetes community and all participants in clinical studies of Loop. The technology was cleared for all Type 1 diabetes patients aged 6 and older

3 . Realize Medical clears FDA hurdle for better VR surgical planning software

Ottawa-based start-up Realize Medical Inc. reported U.S. FDA clearance of virtual reality (VR) surgical planning software to help physicians create and share complex patient anatomy from CTs and MRIs in an immersive 3D environment.

The company said in a news release that FDA clearance marks “a significant milestone.”

“We’re often told that Elucis represents the most advanced offering in the mixed reality space,” said Realize Medical CEO Justin Sutherland. “But with powerful image processing, modeling, and collaboration tools, it’s also a comprehensive and complete platform for serving the full suite of growing 3D needs in medicine. With FDA clearance, we’re truly excited to enable an expanding era of procedure planning and collaboration.”

4 . First 4K single-use surgical arthroscope wins FDA clearance

The FDA-cleared Summit is a first-of-its-kind 4K single-use surgical arthroscope designed to improve the efficiency, consistency, and safety of arthroscopic procedures. Summit combines a 4K single-use surgical arthroscope with cloud-based software – Pristine Connect™ – to deliver a high-definition image, every time, with a device that is always new and never obsolete.

The scope is simple to set up and 100% sterile, ensuring patient and staff safety. Its transparent pricing model and automated inventory management also improve predictability and workflow.

“The Summit single-use arthroscope represents a new paradigm in arthroscopy, improving a procedure that hasn't changed much in my 42 years of practice and beyond," said Dr. Stephen Snyder, chief medical officer of Pristine Surgical and a recognized pioneer in the field of arthroscopy. “We’re removing the well-known barriers of legacy, reusable systems that eventually become obsolete by offering a new 4K single-use scope that improves safety and reliability while decreasing room turnover time and the cost of arthroscopic treatment.”

5 . Abbott receives FDA approval for diabetic peripheral neuropathy device

Abbott announced today that the FDA has approved its Proclaim™ XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. The Proclaim XR SCS system can provide relief to DPN patients in need of alternatives to traditional treatment approaches, such as oral medication. People who receive therapy from the Proclaim XR SCS system will also be able to use Abbott's NeuroSphere™ Virtual Clinic, a connected care app that allows people to communicate with a physician and receive treatment adjustments remotely.

"As a leader in diabetes care, Abbott is intimately familiar with the challenges people with diabetes encounter daily. This new indication for Proclaim XR will drive meaningful change in the treatment of pain associated with diabetic peripheral neuropathy and will be an important tool for physicians and patients in managing this debilitating condition," said Pedro Malha, vice president, neuromodulation, Abbott.

MERGERS & ACQUISITIONS - JANUARY 2023

Mon, 06 Feb 2023 15:31:45 GMT

MERGERS & ACQUISITIONS – JANUARY 2023

BY PROJECTUS

INTRODUCTION.

It's a new year and the MedTech Industry has already seen timulating growth, increased market shares and opportunity for innovation in the form of key mergers and acquisitions. Below, we’re listing down our top 5 picks for eye catching mergers and acquisitions in the MedTech Industry.

1 . GE HealthCare to buy France’s IMACTIS in first acquisition as independent firm

GE HealthCare, days after establishing itself as an independent company, agreed to acquire France-based IMACTIS, which uses computed tomography (CT) interventional guidance to aid surgeons in minimally invasive operations.

In an interview last month, GE HealthCare CEO Pete Arduini told MedTech Dive that “M&A has been and always will be an important part of [our] strategy.” adding that “Now, we’re starting to see fruits of that activity, which started years ago.”

The company said it plans to expand the technology to its image-guided therapy business to “drive further growth” as demand for the product grows in care areas including oncology, cardiology, urology, nephrology and gastroenterology.

2 . Shockwave to pay $100M for Neovasc, adding refractory angina treatment to device pipeline

Shockwave Medical said it agreed to buy Neovasc for about $100 million to gain control of an investigational minimally invasive treatment for refractory angina.

The device, Reducer, is an adjunctive therapy to treatments of coronary heart disease that is implanted to redistribute blood to ischemic areas of the heart. Neovasc already has a CE mark for the device and last year said it was targeting a 2025 approval in the U.S.

“We’ve been looking for novel therapies that have the potential to treat a large, poorly served patient population, much like lithotripsy for treating calcified arteries was when we started. We’ve stayed away from opportunities that would be a distraction to our U.S. sales team in the next couple of years as we need to maintain our focus on aggressively growing our IVL franchise,” Godshall said on a conference call with investors to discuss the acquisition.

3 . Bayer to buy AI imaging platform Blackford Analysis to bolster radiology growth strategy

Pharmaceutical company Bayer agreed to buy Blackford Analysis as part of a broader focus on radiology innovation.

Edinburgh, Scotland-based Blackford built a software platform to help healthcare providers manage multiple imaging applications and AI algorithms through one system.

Bayer said the acquisition will help bolster its radiology portfolio, which also includes contrast media for imaging and informatics solutions. In 2021, Bayer’s radiology segment brought in €1.8 billion ($1.95 billion).

“Adding Blackford and its AI technology to our radiology portfolio secures Bayer an excellent position in the fastest growing segment within the overall global radiology industry,” Bayer Pharmaceutical Division President Stefan Oelrich said the statement. “This acquisition complements our comprehensive radiology portfolio and nourishes our engagement to drive innovation in digital health.”

4 . Relive acquires Co.don to expand global footprint

ReLive Biotechnologies has announced it has completed the acquisition of all operating assets of Germany-listed biotech company Co.Don AG, taking over the global patent rights of its flagship products "Spherox" and "Chondrosphere".

"Spherox" is one of the only two authorized cell therapies for the regenerative treatment of articular cartilage defects globally. It was authorized by the European Medicines Agency (EMA) for distribution across Europe in 2017.

"ReLive's acquisition of Co.Don AG will underpin ReLive's multiple R&D projects on the universal cell therapies for cartilage treatments. It also marks one of ReLive's internationalization efforts, as the company aims at building a true global platform for regenerative medicine." said Dr. Xing Zhao, ReLive's founder, Chairman and CEO.

5 . Companion Spine acquires Backbone, expanding its degenerative disc product portfolio

Companion Spine has announced the acquisition of Backbone SAS, a company based in Bordeaux, France, that designs, develops, manufactures and markets functional motion restoration implantable devices to treat spinal disorders.

The acquisition expands Companion Spine’s portfolio of medical implant solutions with the inclusion of Backbone’s main medical device, the LISA (Lumbar Implant for Stiffness Augmentation) implant. The move allows Companion Spine to complete its line of treatment solutions for spine diseases, most notably lumbar stenosis and degenerative disc disease, matching implants to the degree of severity of the disease.

Erick Cloix, CEO and co-founder of Companion Spine, said: “The acquisition of Backbone and its leading technology, the LISA implant, is a further development and solidification of Companion Spine’s industrial effort. We are very pleased to be able to expand the continuum of solutions aligning the proper spine implant for the therapeutic goals of the patient.”

HOW TO SPOT TOXIC LEADERSHIP

Tue, 31 Jan 2023 15:40:54 GMT

HOW TO SPOT TOXIC LEADERSHIP

BY PROJECTUS

Introduction .

If you've ever worked for a boss who was toxic, you know how difficult it can be to cope. Toxic bosses tend to foster environments of fear and mistrust at work, which can influence employee performance (and their health). Here are some signs to recognize toxic leadership.

Insults disguised as advice (aka " I'm just saying... " ) .

A lack of respect for the people you work with is a sign of a toxic boss. If you see your boss insulting your co-workers, it's time to consider switching jobs. You may be thinking that this kind of behaviour is normal since we're all in an office setting and sometimes it's just "the way things are." But if you notice that this type of demeaning language is habitual or even systematic (for example: when a certain type of person will be called out), then there's something more serious going on here.

The insults are disguised as advice because they make the recipient feel bad about themselves or inadequate in some way. The boss knows that by pointing out specific flaws or mistakes made by others, they can gain control over their behaviour while keeping them dependent on them for guidance and approval—which means more opportunities for manipulation down the line!

Consistently undermined in front of colleagues .

Toxic bosses do not respect you and they don't care about how you feel. They will find ways to undermine you in front of your colleagues, which is a sign of weakness and not respect. Don't let this happen! Be brave enough to confront your boss and ask them why they are treating you like this, because no one deserves to be treated so poorly by their superiors.

Remotely shows you how they would do your job better than you .

I t is a sign of toxic leadership if your boss believes they know how to do your job better than you. This can come in many forms:

The boss may directly ask for your advice, but then dismiss it as “stupid” or “unimportant.”
The boss may take over from you on projects, only to be caught red-handed making mistakes that they could have easily avoided if they had let you handle them yourself.
When the boss gives an assignment or makes a suggestion, it is clear that their idea is unworkable and will never work out well (for example, asking someone else to do something that no one on Earth could possibly accomplish).

They lie , lie , lie - and know how to get away with it .

A toxic boss is a leader who lies to cover up their own mistakes. They are masters at manipulating and controlling information to make you think that they are right, when, they are not. They know how to get away with it because of their charisma and charm.

Their goal is not to help the company succeed but rather to advance themselves at the expense of others. As a result, you see your work suffer and other team members' morale decline because of this toxic behaviour.

A disruptive force .

Interrupts conversations and leaves meetings early, leaving their colleagues to pick up the pieces. Managers who do this may be trying to show their power and dominance; they may also have little interest in what others are saying and want to move on immediately to the next item on their agenda (which is likely about them).

This can cause frustration among co-workers who feel like they're not being heard or taken seriously—and it can also lead people working for such a manager to feel like their time is being wasted because of last-minute changes and erratic schedules that don't give employees enough advance notice about upcoming tasks or objectives for completing those tasks successfully.

Threatens to fire you for no real reason .

One of the most common signs of a toxic boss is their tendency to threaten to fire you for no real reason. When you're working for them, no matter how much you do, they will always find something wrong with your work. They will make it seem like you are the problem and not them. This person might also use intimidation tactics in order to get what they want from employees such as threats of being fired or poor performance reviews if employees don't follow through with their demands.

You might think that this would be enough motivation for an employee to leave this type of manager on their own accord but unfortunately if there isn't another job opportunity available then employee only has two choices: stay at the current job under this leader or find another one somewhere else.

This means that sometimes we have no choice but deal with these toxic leaders because we need our paycheck! But don't let this stop us from trying our best every day so that one day maybe things will improve?

Conclusion .

As you can see, there are many ways that toxic leadership can affect your work and your team. But don’t think that it’s hopeless! There are ways to deal with it. If you feel like your boss is becoming more toxic over time, then consider finding someone else who will listen to what you have to say. If that doesn't work out, try talking with HR about what's going on so they can help mediate a solution between all parties involved. In the end though, remember sometimes we just need a break from toxic people because they drain our energy and make us feel bad about ourselves.

HOW TO RECOGNIZE ITS TIME TO MOVE ON FROM A JOB?

Wed, 25 Jan 2023 15:03:48 GMT

HOW TO RECOGNIZE ITS TIME TO MOVE ON FROM A JOB

BY PROJECTUS

INTRODUCTION .

Would you say that you are passionate about your work? Would you say that you feel satisfied after a long and difficult day at work? Answering these questions can be difficult and justifying your reasoning can be even more challenging. According to Gallup's State of the Global Workplace research, only 15% of employees are engaged at work, a big issue for companies trying to retain top talent.

It is a well-established fact that change is an integral aspect of professional advancement and personal growth. Internal factors, such as a lack of motivation or interest, or poor work practices, as well as external factors, such as limited opportunities for professional development, inadequate salary, or an unsatisfactory work environment, may necessitate a change in one's career path. Moreso, it is important to recognize the significance and potential long-term ramifications of these negative emotions that may be prevalent in our daily perspective, as they are often overlooked.

Scroll down to have a look at signs you should look out for that may indicate its time for a change.

1 . FRIGHTENING MONDAY

Dreading work: Finding yourself dreading the beginning of a work week, whether it’s facing your workload or your colleagues is certainly not a good attitude to bring into work. Liking what you do and where you work is so important to bring in job stability and satisfaction.
Finding the right cop out: Looking for excuses to get out of work, thinking of every reason to avoid work.
Being systematically late for work can reflect an unmotivated attitude towards work.
Counting down the hours till work ends, counting down the days till the weekend reiterates dreading your work and coming to work.

2 . SENSE OF WORTHLESSNESS

Feeling underappreciated: Feeling like the work you do isn’t meaningful, and your presence or contribution is not beneficial to the company in any way.
Salary: Knowing your worth is important, and considering the current economic instability we’re all experiencing it is perfectly alright to have certain salary expectations. Feeling like you’re being underpaid is demoralising and an important factor to initiate change.
Finding your work monotonous: Feeling like your work is weighing you down and you’re subjected to a dull routine can be stagnating.
Additional bonuses or commissions seem inconsequential: The perks and benefits fail to outweigh the mental taxation caused by your work.
Your skills are not fully utilized: This can make one feel like their optimum potential is being limited instead of being encouraged.

3 . IRRITATION AND NEGATIVE EMOTIONS

Overusing the word ‘too’ to negatively describe your work (‘too boring’, ‘too much’, ‘too hectic’) may be an indication that your sensitivity may be at its limit.
Not finding your values and views aligned with the company any longer: It is important to be proud of the work you do and for the company you work at. However, when you find yourself not agreeing to company policies or protocols, you can be left with feelings of dissatisfaction despite putting in the necessary hard work.

4 . FEELING OF ‘ TOO SIMPLE ’

Not being challenged enough: Being challenged in the workplace is an important factor in ensuring employee engagement. It is important to feel stimulated at work, to not only create job satisfaction but to also maintain skill building and application. A dull environment is transferable and reflective in your attitude and actions towards your work, and can essentially demotivate you in your journey for growth.
Feeling like you’ve outgrown your role: Finding no more room for professional growth in your work can make one complacent. An attitude where you don’t care about doing or learning anything new anymore can be dangerous because it can set you into an uninspiring work routine.

5 . FEELING OF ‘ TOO MUCH ’

Feeling overloaded with your workload: Feeling overworked can cause burnout symptoms that can be detrimental for your mental well-being in the long run.
Your responsibility outweighs your salary: Feeling like you’re under-compensated for the work you do can cause an influx of negative emotions towards your superiors, your work and your company. This can lead to poor working practices due to the lack of effort and motivation you may feel.

CONCLUSION .

Of course, being mindful of the timing for a change like this is an important factor to consider. Don’t make a change when its too late, when you’re already burnt out or mentally exhausted from a bad work experience, but also be mindful of the timing when you’re at the cusp of a recession, when the competition is fierce and it may be difficult to find your right fit.

Regardless, change can be scary but sometimes necessary. Some factors are too important to ignore when it comes to work: feeling motivated, a deserving salary, a stimulating work environment, job satisfaction and opportunities for growth. These factors are important to consider when it comes to finding the right job for you.

HOW TO CREATE A COMPETITIVE ADVANTAGE IN MEDTECH DURING ECONOMIC INSTABILITY

Wed, 04 Jan 2023 16:50:33 GMT

HOW TO CREATE A COMPETITIVE ADVANTAGE IN MEDTECH DURING ECONOMIC INSTABILITY

BY TIM LAWRIE

INTRODUCTION

If you're in the medical device or pharmaceutical industry, you've probably heard a lot of talk about how the global economy has been affecting your business. If not, here's a quick rundown: economic instability is having a negative impact on nearly every aspect of our day-to-day lives - from food prices to housing costs and everything in between. But if you're reading this article, chances are that your company has managed to stay afloat during these tumultuous times by adapting and adjusting accordingly. After all, being flexible and adaptable is one-way companies can gain an edge over their competitors who are struggling with cash flow issues or other financial issues brought on by economic instability. Here are some tips for how to do just that:

1 . ESTABLISH A SOLID BUSINESS PLAN

Companies with solid business plans understand their customer needs and can cut unnecessary costs, using their capital more efficiently.

Once you have established a competitive advantage, make sure it doesn't go to waste by identifying your competitors and how they operate. This will allow you to better understand their strengths and weaknesses so that when it comes time for negotiation, you know what points of leverage exist which can help achieve favorable results for your company.

2 . KNOW YOUR NUMBERS

Understanding spending initiatives and knowing your numbers is crucial to establishing credibility in a volatile market.

Understand your customer needs: In an economic downturn, it’s even more important to understand the needs of your customers. If you know what they want or need, then you can use that information to help them make purchasing decisions within their budget.
Cut unnecessary costs: Now more than ever it is critical to cut any unnecessary costs that could affect profits down the road. This may include salary cuts and staff reductions if needed; however, this should only be done after careful consideration because there may be other ways to reduce expenses without having such drastic measures put into place.
Use capital more efficiently: It’s also important during times like these for businesses not just generate revenue but also save money for future projects which might require capital funding from investors or creditors if needed later on down the line (i.e., loans).

3 . PLAN FOR SUPPLY CHAIN PROBLEMS

Begin supplier qualifications that align with your QMS as soon as possible so that backup suppliers for your component parts can be engaged immediately.

Proactive supplier qualification is an important part of any quality management system. It’s essential that you understand the technical specifications and requirements for your components, as well as their manufacturing processes. This will help you identify suppliers with a high probability of meeting those specifications and requirements, as well as providing timely delivery of the component parts required by your QMS.

It also allows them to work with a smaller number of qualified suppliers who are more likely to be able to provide consistent performance in terms of meeting customer expectations (quality, availability), while reducing risk through redundancy or contingency plans where appropriate.

4 . BUILD STRONG RELATIONSHIPS

Establish strong relationships with potential commercial partners and customers early so that you have solid footing with important stakeholders when competition gets fierce, or frustrations arise due to price increases and/or delays.

Create a network of innovation communities and alliances that allow for collaboration between entrepreneurs, investors and industry experts. These networks serve as an essential resource for gaining insight into trends in your industry, accessing new technology platforms or technologies for product development, identifying mentors who can help you navigate challenges in your business strategy development process, finding potential investors who understand the value of your company's products (and can help get them to market), etc.

5 . GET TECHY

Lean on technology where you can to streamline processes and costs. Technology can help you improve business processes, cut costs and streamline your customer relationships. It can also help you stay competitive in the face of economic instability.

To start improving your processes using technology, think about how your company currently operates and what could be done to make it more efficient or effective. Then look at what technology has to offer that could make this happen. If appropriate, invest in new software or hardware solutions that will allow you to do things better than before. You might add or replace systems that are outdated or inefficient with ones that work better for the current environment.

CONCLUSION

Economic instability is an unpleasant environment to be a part of. But the aspiring part is to survive and thrive beyond it. An advantage MedTech companies have had historically is the focus on revenues over profits, meaning shareholders are often accepting of companies re-investing in growth strategies to create more products to sell versus focusing intensely on the bottom-line. If this trend remains during this recession, investing in truly disruptive technologies would be beneficial for MedTech investors and strategics alike, as they are more likely to invest in technologies with a moveable pricing scale.

FDA CLEARANCES DECEMBER 2022

Wed, 04 Jan 2023 16:13:29 GMT

FDA APPROVALS – DECEMBER 2022

BY PROJECTUS

INTRODUCTION

1 . BIOCORP’s Mallya Devices Receives FDA 510(k) Clearance

By obtaining a 510(k) approval, BIOCORP will be able to expedite the submission of Mallya's future generations in the diabetes field and in other therapeutic areas where the company has partnered with others.

The Mallya medical device is a smart sensor that is directly attached to insulin pen injectors, making them connected devices. Mallya automatically collects and records key treatment information (selected insulin units, date, and time of injection) and transmits it to a dedicated digital application.

Eric Dessertenne, CEO of BIOCORP, said, "This approval is a major achievement for BIOCORP and all of our employees who have been heavily involved in this regulatory process. This approval marks a historic achievement for BIOCORP as it allows the commercial launch of our Mallya device in the United States and illustrates BIOCORP's ability to meet the highest regulatory requirements.”

2 . IRRAS Receives US FDA 510(k) Clearance For Its Next Generation IRRAflow Control Unit

IRRAS received US FDA 510(k) clearance for its class II next-generation IRRAflow control unit that enhances the procedural workflow for health care professionals treating critically ill patients suffering from intracranial bleeds.

"IRRAS prides itself on consistently upgrading its products to better meet the needs of its customers, and the US regulatory clearance of the next generation IRRAflow control unit is the latest example of our team delivering upon that promise," said Will Martin, President and Chief Executive Officer of IRRAS. "Our team remains focused upon incorporating customer feedback into our technologies to enhance the user experience and optimize care for their critically ill patients. Being able to introduce the latest IRRAflow functionality is the exciting next step toward accomplishing our mission to becoming a global leader in the neurocritical space."

3 . Click Achieves FDA Breakthrough Designation For Prescription Digital Migraine Therapy

The FDA granted the designation to Click’s CT-132 as an adjunctive preventive treatment for episodic migraine in adults, given that many patients have difficulty accessing specialty care or experience incomplete remission. The designation should help expedite the development and review of Click’s device.

Click is saying little about the migraine product, only revealing that the candidate “combines multiple clinically-validated mechanisms of action” with its platform “to reduce the number of migraines per month in patients with four or more migraine days per month.”

“Breakthrough further affirms that our unique approach to unlock undruggable CNS targets has merit through the combination of digital neuroactivation and modulation and neurobehavioral interventions. Through this new paradigm, we aim to restore lives ravaged by debilitating brain diseases like migraine,” said Dr. Shaheen Lakhan, chief medical officer of Click.

4 . Ultromics Receives FDA Clearance For AI Diagnostic Heart Failure

Ultromics' EchoGo Heart Failure, an AI solution for echocardiography uses AI to accurately detect HFpEF from a single echocardiogram image, which accounts for 50% of the 64 million cases of heart failure worldwide and has overtaken heart failure with reduced ejection fraction (HFrEF) as the most prevalent form of the deadly disease.

Dr Ross Upton, CEO and founder of Ultromics, said, "We are delighted that the FDA has recognised EchoGo Heart Failure as a breakthrough device and has cleared the technology to provide reliable detection of HFpEF. The technology improves the accuracy of HFpEF detection, enabling more patients to receive treatment which will reduce the significant burden on patients and healthcare systems alike.”

"Although compelling progress has been made in the diagnosis and treatment of many forms of heart disease, heart failure hospitalisations and mortality continue to rise globally. It is now time to make a change. Together with our FNIH AMP HF partners, we aim to redefine the heart failure care pathway and improve world-wide patient outcomes."

MERGERS & ACQUISITIONS – DECEMBER 2022

Wed, 04 Jan 2023 15:02:30 GMT

MERGERS & ACQUISITIONS – DECEMBER 2022

BY PROJECTUS

INTRODUCTION

This month has seen stimulating growth, increased market shares and opportunity for innovation in the form of key mergers and acquisitions. Below, we’re listing down our top 5 picks for eye catching mergers and acquisitions in the MedTech Industry.

1 . Boston Scientific Makes Offer For Majority Stake Of Acotec

Boston Scientific will make a partial offer to acquire a majority stake, up to a maximum of 65%, of shares of Acotec, a Chinese medical technology company that offers solutions designed for a variety of interventional procedures.

Art Butcher, executive vice president and group president, MedSurg and Asia Pacific, Boston Scientific, said: "Acotec is a profitable, fast-growing company with a strong portfolio and innovative pipeline of medical technologies, and we believe this investment will generate growth opportunities for both companies. We expect completion of the partial offer to further strengthen our presence in China and create the potential for commercialization of Acotec products globally, providing an increased number of physicians and patients access to our robust and complementary product portfolios."

2 . Cochlear’s $120M Purchase Of Hearing Implant Maker Stirs European Scrutiny

Cochlear’s proposed DKK 850 million ($120 million) takeover of Oticon Medical has sparked concerns by European competition authorities.

Authorities in the European Union and U.K. are reviewing the proposed merger. The U.K.’s Competition and Markets Authority (CMA) found Cochlear would have 90% to 100% share of the bone conduction market after the takeover.

“We’re concerned that this deal could lead to higher costs for the NHS and worse outcomes for patients who rely on life-changing hearing implants. The merger will wipe out one of the main suppliers and leave Cochlear with a near monopoly in the supply of bone conduction implants,” Sorcha O’Carroll, senior director of mergers at the CMA, said in a statement.

The European Commission said the acquisition “threatens to significantly affect competition in the market for cochlear implants and bone condu ction solutions” and told Cochlear it can’t close the deal before getting its clearance.

3 . Ekso Bionics Buys Indego Lower Limb Exoskeleton Business From Parker Hannifin For $10M

Parker Hannifin sells motion and control technologies that are used by customers in industries including constru ction, mining, transportation and oil and gas.

Ekso paid $5 million upfront and committed another $5 million spread across quarterly installments to buy the human motion and control unit.

The focus, now, will be on whether Ekso, a much smaller but more specialized business, can drive growth of the device. Ekso’s sales over the first nine months of the year were $9.4 million. At $17.5 million, its market capitalization is a fraction of that of Parker Hannifin.

“This is a great technology with an outstanding team that has built a highly differentiated product offering to help improve gait performance and outcomes for people living with mobility impairments,” Mark Czaja, chief technology and innovation officer at Parker Hannifin said, “The acquisition will allow Ekso to leverage their robust commercial and clinical teams to ultimately enable this important technology to reach more patients in need across the continuum of care.”

4 . Integra To Buy Surgical Innovation Associates For $50M In Bid To Lead Growing Breast Reconstruction Niche.

Integra LifeSciences plans to buy Surgical Innovation Associates for $50 million upfront in a bid to build a leading position in the changing breast reconstruction business.

Over the next few years, Integra expects its SurgiMend PRS and Surgical Innovation’s DuraSorb will become the first two implant-based breast reconstruction (IBBR) surgical matrices to win premarket approval. Surgical Innovation is developing a synthetic matrix, while Integra’s SurgiMend is a xenograft, using bovine tissue.

Currently, human-derived surgical matrices dominate the market, but Interga thinks synthetic and xenograft devices will gain ground, driving it to try to establish leadership positions in the niches.

“The global breast reconstruction market represents an attractive growth opportunity for our surgical reconstruction business. By offering two distinct product solutions, SurgiMend and DuraSorb, to plastic and reconstructive surgeons, we aim to address various clinical, contracting, and economic needs across different sites of care,” Integra’s president of tissue technologies, Robert Davis Jr., said in a statement.

5 . Olympus Agrees To $80M Takeover Of Artificial Intelligence Endoscopy Startup Odin Vision

Olympus has struck a deal to buy artificial intelligence endoscopy startup Odin Vision for up to $80 million in upfront and milestone-based payments.

Odin is a London-based developer of Caddie and Cadu, cloud-based AI systems that are designed to help detect and characterize cancerous and precancerous tissues during colonoscopies and gastroscopies.

The acquisition furthers the strategy that Olympus outlined in 2019, when it set out plans to exit some of its businesses and increase focus on its endoscopic and therapeutic solutions units.

“Incorporating Odin Vision’s leading AI technology portfolio and innovation capabilities into the broader Olympus digital road map will create synergies that enable us to commercialize highly valuable endoscopy-focused software tools. Their product portfolio fits perfectly with our broader efforts to enhance the capabilities we bring in support of clinicians and to help care teams harness decision-driving data,” Nacho Abia, chief operating officer at Olympus, said.

FDA CLEARANCES - NOVEMBER 2022

Mon, 05 Dec 2022 16:08:06 GMT

FDA APPROVALS – NOVEMBER 2022

BY PROJECTUS

INTRODUCTION

Innovation is always key in MedTech. There is a constant need for progression within research and development of MedTech devices. This month saw various MedTech products receive FDA clearance, further improving early detection, monitoring and patient care.

1 . Zimmer lands 510(k) clearance for 3D-printed cementless knee replacement

Zimmer has been building out its cementless portfolio for years, securing FDA clearance for the Persona Trabecular Metal Tibia in 2018 and now adding a 3D-printed product to its arsenal.

Zimmer has pitched its latest product as having optimized fixation, rotation, and stability. Using anatomical data, the MedTech company has sought to reduce micromotion and improve bone coverage. The porous OsseoTi technology is designed for biological fixation.

Ivan Tornos, chief operating officer at Zimmer, outlined the perceived benefits of giving surgeons the option to perform cementless and cemented procedures. “Adding the Persona OsseoTi Keel Tibia to our well-established and clinically proven Persona Knee System allows surgeons to better address the needs of their patients with a comprehensive single system solution for a cementless or cemented application,” Tornos said in a statement on Zimmer’s website.

2 . Aidoc Secures New FDA Clearances Enabling Faster and More Accurate Detection of Critical Neurological and Cardiovascular Conditions

Aidoc, the leading provider of healthcare AI solutions, announced it has increased its FDA clearances to 11 with the addition of CT-based AI solutions - aortic dissection and all vessel occlusions. Aidoc's clinical AI improves clinician efficiency, decreases the length of stay, and reduces turnaround time to mitigate average hospital costs, rising 15-25% since 2020.

“Our continued momentum with FDA-cleared solutions are not only aiding radiologists to prioritize potential findings, but we are helping connect other care team members immediately to the data needed to drive next actions and an optimized care plan. This leads to improved patient outcomes, such as reduced length of stay, and eases the communication burden on the care team because the right people are notified and engaged together”, said Aidoc CEO Elad Walach.

3 . Silverlon Receives FDA 510k Clearance for Radiation Dermatitis and Cutaneous Radiation Injury

Argentum Medical , a medical device leader and pioneer of silver-plated dressing technology, announced that it received 510(k) clearance from the FDA for Radiation Dermatitis and Cutaneous Radiation Injury through dry desquamation for its Silverlon® Burn and Wound Care products.

Silverlon is the first medical device to be cleared in the U.S. for management of Cutaneous Radiation Injury through dry desquamation.

“This historic achievement is the culmination of more than 20 years of effort, thousands of hours of work and significant investment by our government. We are proud to provide an FDA-cleared product for the management of these injuries and further assist with disaster preparedness for our country,” states Raul Brizuela, CEO of Argentum Medical.

4 . Apple Watch Parkinson’s Disease Tracking App Cleared by the FDA

The FDA has given h2o therapeutics 510(k) marketing clearance for its Parky app that monitors motor symptoms in Parkinson’s patients via measurements recorded by an Apple Watch.

Currently compatible only with Apple’s iOS operating system, the Parky app uses an Apple tool called Motion Disorder API to measure and record, among others, two hallmark motor symptoms of Parkinson’s : tremors and dyskinesia, or uncontrolled movements.

“As a woman-founded, non [venture capital]-backed company based in Turkey, receiving our first 510(k) clearance is a huge milestone for us,” Yagmur Selin Gulmus, h2o’s founder, said in a company press release . “We believe Parky will bring great value to the Parkinson’s Disease community as an easily scalable and data-driven product,” Gulmus added.

MERGERS & ACQUISITIONS — NOVEMBER 2022

Mon, 05 Dec 2022 14:09:08 GMT

MERGERS AND ACQUISITIONS — NOVEMBER 2022

BY PROJECTUS

INTRODUCTION

This month has seen stimulating growth, increased market shares and opportunity for innovation in the form of key mergers and acquisitions. Below, we’re listing down our top 4 picks for eye catching mergers and acquisitions in the MedTech Industry.

1 . Johnson & Johnson to Acquire Abiomed

Johnson & Johnson, the world’s largest, most diversified healthcare products company, and Abiomed, a world leader in breakthrough heart, lung and kidney support technologies, announced their partnership by entering into a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Abiomed, for an upfront payment of $380.00 per share in cash, corresponding to an enterprise value of approximately $16.6 billion which includes cash acquired.

The acquisition broadens Johnson & Johnson MedTech’s position as a growing cardiovascular innovator, advancing the standard of care in one of healthcare’s largest unmet need disease states: heart failure and recovery.

Joaquin Duato, Chief Executive Officer of Johnson & Johnson said, “We have committed to enhancing our position in MedTech by entering high-growth segments. The addition of Abiomed provides a strategic platform to advance breakthrough treatments in cardiovascular disease and helps more patients around the world while driving value for our shareholders.”

2 . Boston Scientific Announces Agreement to Acquire Apollo Endosurgery, Inc.

Boston Scientific Corporation announced its acquisition of Apollo Endosurgery, Inc. for a cash price of $10 per share, reflecting an enterprise value of approximately $615 million. The Apollo Endosurgery product portfolio includes devices used during endoluminal surgery (ELS) procedures to close gastrointestinal defects, manage gastrointestinal complications and aid in weight loss for patients suffering from obesity.

"Endoluminal surgery is an emerging field and a core focus for our Endoscopy business," said Mike Jones, senior vice president and president, Endoscopy, Boston Scientific. "We intend to expand our global capabilities in ELS with the differentiated innovation that Apollo Endosurgery offers, and we will continue to focus on procedural adoption as well as professional education in this exciting space. This acquisition also enables us to enter a new adjacency – the endobariatric market – and deliver strong, continued growth across our business."

3 . ResMed Completes Acquisition of MEDIFOX DAN, a German Leader in Out-of-Hospital Care Management Software Solutions

ResMed announced it has completed its €958.6 million acquisition of MEDIFOX DAN, a German leader in software solutions for a wide variety of out-of-hospital care providers. This acquisition expands ResMed’s SaaS business to Germany, first non-U.S. market. ResMed intends to retain MEDIFOX DAN’s employees, locations, and business processes. MEDIFOX DAN will report into ResMed SaaS President Bobby Ghoshal.

4 . Integra LifeSciences to acquire Surgical Innovation Associates

I ntegra LifeSciences signed a definitive agreement to buy Surgical Innovation Associates ( SIA ), a spin-out from Northwestern University , Illinois, US. Under the deal terms, Integra will pay $50m at the closing of the deal, as well as up to $90m more upon achieving certain revenue and regulatory milestones. SIA develops advanced solutions for reconstructive and aesthetic surgery to improve the experience of both surgeons and patients. Integra LifeSciences expects the deal to advance its global strategy in breast reconstruction. It will also support the company’s plans to enter the US market with Food and Drug Administration (FDA)-approved devices that are designed for use in implant-based breast reconstruction (IBBR) procedures.

DON'T HIRE PEOPLE PLEASERS

Tue, 29 Nov 2022 17:42:13 GMT

DON'T HIRE PEOPLE PLEASERS

BY TIM LAWRIE

INTRODUCTION .

If you're a manager, you've probably heard the phrase “people pleaser”. You know that person in your office who always agrees with everything you say and never challenges anything?

Yeah, they're not great to have around. In fact, one of the biggest mistakes CEOs can make is surrounding themselves with people who never challenge them or their ideas. This is especially true if it means shying away from hiring strong personalities who don't fit into an organization's corporate culture quite right (or at all).

So how do we hire "people displeasers" instead of "people pleasers"?

DON'T HIRE

‘ PEOPLE PLEASERS ’

Stagnation is death for a business. Blockbuster in the face of Netflix, Nokia in the face of Apple. Both clung to outdated methods while the world changed around them.

When you're curating leadership teams, it can be tempting to want to hire people who agree with you. The more “people pleasers” you have on your team, the easier it is for everyone to get along. You might feel like this is a good idea because these employees will be less likely to challenge your decisions or argue against them in meetings. There is a need for fresh perspective and progressive ‘out-of-the-box’ thinking to help your business grow.

However, there are some serious problems with hiring 'people pleasers.' First of all, if someone's opinion doesn't matter enough for them to express an opinion or question their assumptions about something, then they probably aren't a particularly valuable employee anyway! They're not going to bring much insight into a situation or challenge anything except maybe some of their own personal assumptions—if anything at all!

Secondly and most importantly, however, is that this kind of blind agreement leads down dangerous paths where decisions are made based on feelings instead of data or logic (that’s a whole other topic to discuss).

CHALLENGE THE PROCESS ; YOU SHOULD NEVER BE AFRAID TO DISCARD THE OBSOLETE .

Challenging the process is a great way to get better results. It's also a great way to innovate and save money, but most importantly, it's a fantastic way to get more out of your employees in less time.

Challenging the processes that have been in place for years lets you find flaws in them while they're still small enough to fix without too much disruption or cost. Those flaws can be something simple like an inefficient workflow or something deeper like an organizational structure that doesn't actually support what needs doing most efficiently. If you don't challenge these things, then nothing will change and your company won't grow as fast as it could be growing if you did challenge them (or even just slowed down).

‘People pleasers’ as leaders are dangerous because they cannot lead their employees in the right direction. There is no innovation for ideas or proactive thinking that can benefit the company’s progression. This leads not only bad decisions being made but also good ones being ignored or dismissed because someone else said no before anyone had even had time for consideration about whether it was actually a good idea or not!

CONCLUSION .

In conclusion, we believe that the best leaders are those who can see what needs to be done and do it. They don't need a yes man or woman at their side. They have a vision for where things should go and how they can get there, but they also know when it's time for new ideas or changes in direction. In short, these leaders lead by example—and as long as you keep this in mind when hiring people for your team, you'll be well on your way to success!

WHY YOU NEED A KICK-ASS CFO

Tue, 29 Nov 2022 17:33:10 GMT

YOU NEED A KICK-ASS CFO

BY TIM LAWRIE

INTRODUCTION

The partnership between Elon Musk and CFO Deepak Ahuja saved Tesla from not one but two near-bankruptcy crises, putting the company on a path to becoming the world’s most valuable car company. Here’s what we can learn from that:

(If you’re reading this article as a CFO, here’s an insight on how to stand out and be a kickass CFO).

1 . THE GLUE THAT HOLDS YOUR BUSINESS TOGETHER

CFOs keep their eyes on the bottom line, making sure each dollar is being spent wisely and efficiently, that inventory is being managed properly, and that budgets are met. They know how to manage risk so your company can grow without worrying about going under. They're also responsible for preparing financial statements for external stakeholders—the people who invest in your company or loan money to you—as well as board members who have oversight over strategic direction of your firm.

2 . YOUR CFO IS YOUR BUSINESS STRATEGIST

The CEO and CFO are a team. Their job is to take the business where it needs to go, and they can't do that alone. As the chief financial strategist of your company, the CFO plays an important role in helping you figure out how you're going to get there.

A good relationship between CEO and CFO means that:

The two parties understand each other's roles within the company.
They can help each other fulfil their responsibilities; and
They don't waste time on unnecessary tasks (like fighting over who gets credit for something).

3 . HONESTY IS KEY

You need to think about the future. You need to think about the big picture, and you need to think about your business strategy. If you’re building a business, then it’s not just about making a product and selling it today—it's also about keeping that product relevant five years from now or ten years from now. And if you don’t have any ideas for how things are going to change in the next few years, then you might want an outside perspective on where your company is headed.

Honesty is a key characteristic to look for in a CFO. The CFO is often the one person the CEO can rely on to deliver the unvarnished truth, even if its painful. A good CFO can help with this kind of thinking because they know how businesses work and how money flows through them; they're able to put these two things together so that their companies make decisions based on what's best for them financially in both short-term and long-term situations (and beyond!).

Your CFO cannot be a lapdog. They need to have their own voices, there should be healthy debates sometimes and that’s good for business.

4 . THE CFO CAN HELP YOU SEE THE BIGGER PICTURE

As a CEO, you are in charge of the company’s finances and understand the current state of things, but your CFO will have a much broader perspective. As the top financial leader, they can look at everything from macroeconomic trends to industry dynamics to competitor behavior. They may be able to help you see where your business stands with respect to other companies in your industry or market. They can help you see what’s moving or changing so that you don't find yourself on the back foot when there's an opportunity for growth or change.

5 . THERE IS MASSIVE VALUE IN A GOOD CFO/CEO RELATIONSHIP

As a CEO, there is a lot of value in having a good relationship with your CFO. They are your right hand who can help you keep your company on track and get the most out of it. They also make great sounding boards when it comes to making the best decisions for your company.

As the head honcho, it’s easy for CEOs to get caught up in their own heads about what needs to be done next and how they can do it better than anyone else—which is why it’s so important to have someone like this by your side who will point out all of those areas where maybe there are some other options that aren’t immediately obvious but could still be effective at solving some of those problems.

CONCLUSION

There’s a reason why CEOs and CFOs are often seen together. They need to work closely with each other to make sure they’re on the same page and helping each other out. A good relationship between the two can be extremely beneficial, but only if you put the time into it.

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The Cost of a Bad Hire in MedTech – and How to Avoid It

THE COST OF A BAD HIRE IN MEDTECH - AND HOW TO AVOID IT

BY PROJECTUS

Why Top MedTech Startups Want Ex-Clinicians on Their Team

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Top 5 Traits to Look for in a High-Performing MedTech Sales Rep

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HOW TO FOSTER AN ENVIRONMENT OF CONTINUOUS LEARNING?

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HOW TO ACE YOUR INTERVIEWS?

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THE ETHICS OF AI IN HEALTHCARE: BALANCING ADVANCEMENTS WITH PATIENT PRIVACY

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THE IMPORTANCE OF SEEKING STRATEGIC PARTNERSHIPS

BY PROJECTUS

FDA CLEARANCES - JANUARY 2023

BY PROJECTUS

2 . Tidepool lands long-awaited FDA nod for artificial pancreas app connecting CGMs, insulin pumps

3 . Realize Medical clears FDA hurdle for better VR surgical planning software

4 . First 4K single-use surgical arthroscope wins FDA clearance

5 . Abbott receives FDA approval for diabetic peripheral neuropathy device

MERGERS & ACQUISITIONS - JANUARY 2023

BY PROJECTUS

2 . Shockwave to pay $100M for Neovasc, adding refractory angina treatment to device pipeline

3 . Bayer to buy AI imaging platform Blackford Analysis to bolster radiology growth strategy

4 . Relive acquires Co.don to expand global footprint

5 . Companion Spine acquires Backbone, expanding its degenerative disc product portfolio

HOW TO SPOT TOXIC LEADERSHIP

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BY PROJECTUS

Introduction .

Insults disguised as advice (aka " I'm just saying... " ) .

Consistently undermined in front of colleagues .

Remotely shows you how they would do your job better than you .

They lie , lie , lie - and know how to get away with it .

A disruptive force .

Threatens to fire you for no real reason .

Conclusion .

HOW TO RECOGNIZE ITS TIME TO MOVE ON FROM A JOB?

HOW TO RECOGNIZE ITS TIME TO MOVE ON FROM A JOB ﻿

HOW TO CREATE A COMPETITIVE ADVANTAGE IN MEDTECH DURING ECONOMIC INSTABILITY

BY TIM LAWRIE

FDA CLEARANCES DECEMBER 2022

BY PROJECTUS ﻿

MERGERS & ACQUISITIONS – DECEMBER 2022

BY PROJECTUS

FDA CLEARANCES - NOVEMBER 2022

FDA APPROVALS – NOVEMBER 2022

MERGERS & ACQUISITIONS — NOVEMBER 2022

MERGERS AND ACQUISITIONS — NOVEMBER 2022

BY PROJECTUS

DON'T HIRE PEOPLE PLEASERS

DON'T HIRE PEOPLE PLEASERS

BY TIM LAWRIE

WHY YOU NEED A KICK-ASS CFO

HOW TO RECOGNIZE ITS TIME TO MOVE ON FROM A JOB

BY PROJECTUS