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Drug or Device: FDA’s Ongoing Struggle with Combination Products Pt.1

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March 15, 2019

Drug or Device: FDA’s Ongoing Struggle with Combination Products Pt.1

Since the beginning of the 21st century, we‘ve seen a massive upsurge of innovative combinations between drugs, devices, biologics, and most recently software and AI. Drug-eluting implants, ingestible electronics, smart pacemakers, insulin pumps, patches and all sorts of wearables that monitor, record, analyse and transmit data among multiple parties within increasingly complex infrastructures.

Hybrid medical products are creating paradigm shifts in medicine and healthcare with faster, cheaper, safer and more effective treatment programmes. However, whilst research keeps accelerating and novel tech multiply as you read this text, the FDA is increasingly left struggling to decide how exactly to regulate them.

Medical combination products, as they‘re officially termed, are not a recent phenomenon. Nor are the challenges they pose to traditional regulatory frameworks. Yet, the FDA has not to this date designed and launched a single market approval pathway for this unique category, but has been trying to fit it into its existing structures. As a result, the real issues associated with rapid technology development are not being adequately addressed, and innovations that have the potential to make treatments more affordable, effective and safe end up being slowed down rather than facilitated.

The Trailblazer

The first medical combination product that got FDA approval was the drug-eluting stent. It was first implanted into a human patient back in 1999, and became commercially available between 2002-2004, marking a historic revolution in interventional cardiology.

In December 2002, the FDA established a new entity to regulate such innovations – the OCP (Office of Combination Products), and rolled out a a definition whereby a combination product is any product which „constitutes a combination of a drug, device or biological product“. The newly established body complements the existing CDER (Center for Drug Evaluation and Research) and CDRH (Center for Devices and Radiological Health) sub-agencies, which are responsible for the regulation of drugs and devices, respectively.

Rather than serving as a single review point for the new product category in a similar way to the CDER and CDRH, however, the OCP has a purely administrative function – to assign a combination product for premarket review and postmarket regulation to either the CDER or CDHR based on a „primary mode of action“, and to resolve any internal disputes between or within the two centres regarding these processes. The primary mode of action is defined as “the single mode of action of a combination product that provides the most important therapeutic action.”

In the case of the drug-eluting stent, the OCP determined that the primary mode of action is that of a device, and assigned it for review to the CDHR. The CDHR classified the stent as Class III, which required an investigational device exemption and PMA. Regardless of its device status, though, due to the fact that the stent was coated with a drug there were significant concerns regarding safety and efficacy, which necessitated regulation from the CDER as well. Dual regulations and internal bureaucracy thus contributed to the considerable delay of the market approval.

Another 4 years passed until second generation drug-eluting stents became publicly available. They did not enjoy a shorter time-to-market, even though they were not fundamentally different to first generation ones in terms of design and function.

Nowadays, there are plenty of predicate drug-eluting stents on the market that could support a Class II downgrade, but the FDA still classifies these devices as Class III. Whilst the agency surely has good reasons for maintaining such stringent regulations, this case study should serve to inform designers and manufacturers about indicative timelines and regulatory hurdles they can expect to face when it comes to bringing combination products to market.

Despite all challenges, within 5 years of FDA‘s first approval, drug-eluting stents became a multi-billion dollar vertical market within medical implants. The industry was boosted even further in 2008, when the FDA issued a dedicated document providing detailed regulatory guidance on coronary drug-eluting stents.

Fast forward

In November 2017, the FDA approved the world‘s first smart pill, a tablet equipped with a sensor microchip that monitors whether bipolar disorder or schizophrenia patients have taken their medication. The sensor is ingested with the tablet and sends information to a wearable patch, which then transmits it to a smart phone app patients can use to track their treatment. If they wish, patients can provide access to the data gathered by the sensor to their doctors, caretakers or family.

As the system‘s primary mode of action was determined to be that of a drug, it was reviewed and granted market approval by the CDER. The sensor technology and patch designers claim that the low manufacturing cost and wide compatibility of the microchip are not only an appealing alternative to conventional drug treatment programmes but can open up a $100 billion industry niche.

Whilst CDER has the authority to regulate similar drug-delivery systems, it can also apply device regulations when necessary. Therefore, even though CDER would generally be the lead centre for the review and approval of smart pills, the process might as well involve CDRH regulations and authorities.

In an attempt to navigate intense scrutiny combined with relative lack of clarity and certainty more easily, smart pill developers thus tend to submit their tech to multiple approval processes simultaneously so that device and drug components can be regulated separately. If the FDA issues a dedicated regulatory guidance on smart pills just like it did with drug-eluting stents, we will surely see this novelty explode into a multi-billion dollar market, too.

End of part 1

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Guided Solutions connects growth-focused, innovation-driven medtechs with a continually expanding global network of 120,000+ industry professionals, delivering impactful leadership talent across the entire product lifecycle.

Visit our website to find out more.

5 Easy Ways to Optimise Your Startup Hiring Process

Guided Solutions

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March 12, 2019

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5 Easy Ways to Optimise Your Startup Hiring Process

So, your company is up and running, you’ve built your business from the original concept and the green shoots of commercialisation are now beginning to appear.

The trials and tribulations you have gone through to reach this point have been shared with your close-knit team of founders, largely cocooned from outside influence. External consultants have come and gone, but the business’ journey belongs to this nucleus, the lives of its constituents have become one with each other’s, in pursuit of making the venture a success.

The business has reached a zenith in terms of what can be achieved with the skills of the current team, In order to evolve, a new permanent dimension needs to be added. All things considered, the benefits of increasing the skills diversity in the team now outweigh the costs, provided you can get it right. To ensure you make well-rounded hiring decisions which reflect not only the skills you need but the culture you have cultivated, follow these 5 crucial steps:

Clearly define your objectives and your expectations for the role from the outset

It’s about quantifying and mapping the everyday life and habits that you expect the new CxO to have in the company. When you picture the blueprint CxO, what activities will take up their time? what kind of persona do you imagine fits with the completion of these tasks? How does what they do and the habits they have formed augment the activity of the rest of the team? This will provide a logical starting point for developing the two key hiring criteria, skillset and cultural fit.

Make sure that these objectives and expectations are agreed by the entire team

It may well be the case that certain members of the leadership team see their skills far removed from recruitment. This does not mean that they should not be intimately involved in the design of the person and role specification! Everyone in the business will live with the consequences of the hiring decision and no vision for the position should be developed without the input and express agreeance of the entire team.

Define the process as clearly as you have defined the role

You want to generate the interest of the best possible candidates for the position and keep that interest until the end of the hiring process. The first real interaction candidates will have had with your business will be the process you put them through. Doubtless one of the key reasons that the candidates you have shortlisted made it onto that list is because of their desire for excellence, your assessment should mirror this desire by clearly defining an exhaustive recruitment chronology and sticking to it.

Don’t neglect quantitative assessment

Build in a selection of testing mediums with easy to interpret, objective results as an outcome to compliment the qualitative, intuition lead conclusions you are drawing from the candidates during interviews. The human mind is hopelessly fallible, quantitative assessment will enable you to consciously assess and stringently qualify the biases you have naturally developed during the process.

Startup as you mean to go on

If you have found the individual you believe is the right person to play a key role in the future of your business, make the right offer and get them on board. Delays at this sensitive stage of the process suggest a lack of buy-in to the candidate and can only lead to negative outcomes. Truly great talent is always in high demand, and if you fail to make a definitive play for your dream candidate in a reasonable time-frame, the chances are that another company will, leaving you to count the cost of the lost hire and ultimately fruitless commercial downtime of your team.

At Guided Solutions, we specialise in assisting small to medium-sized medtechs to identify, recruit and then retain, rare and specialist talent. To learn more about our range of recruitment services contact us today for a no-obligation consultation with a member of our executive team.

The MDSAP: In Pursuit of Regulatory Harmonisation

Guided Solutions

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February 27, 2019

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Why create the MDSAP?

Since the foundation of the Global Harmonisation task force in 1993, medical device institutional bodies have been working to bring uniformity and simplicity to international accreditation, removing barriers to increased trade and improving patient access to emergent technologies. The Medical Device Single Audit Programme (MDSAP), another step on this path, is a system by which the Quality Management System (QMS) of a medical device manufacturer is audited with a view to satisfying regulatory requirements across multiple authorities. Participating authorities currently include:

Health Canada
Brazil (ANVISA)
Japan (MHLW/PMDA)
USA (FDA)
Australia (TGA)

Birth of the MDSAP

The MDSAP was conceived of at the Inaugural meeting of the International Medical Device Regulators Forum (IMDRF) (formally GHTF) in Singapore Feb 2012. The initiative drew on the spirit of harmonising adaptations being made to ISO:13485 by the same organisation. A work group was then formed to develop – ‘a standard set of requirements for auditing organisations performing regulatory audits for medical device manufacturers’ quality management systems.’

The FDA pilot programme for the MDSAP ran from January 2014- December 2016 assessing eight Proof of Concept Criterions (PoCCs). Though not all the PoCCs were met, (notably PoCC2, which set out that 80% of reports evaluated would substantiate a regulatory approval in each of the participating authorities. A figure of only 59% was eventually achieved) the overall pilot was deemed a success however, and the FDA deemed that it would accept MDSAP reports in lieu of agency inspections.

Anatomy of an MDSAP Audit

The audit falls into three sub-audits ran over a three-year period:

Initial Certification Audit
Surveillance Audit
Recertification Audit

The MDSAP audit follows a process approach as recommended by ISO. The audit begins with a thorough examination of SOPs, this takes the form of a questionnaire checklist, the content of which does not alter between different Auditing Organisations (AOs), the questionnaire can be requested ahead of time when the manufacturer has selected an AO.

The FDA website houses a 96-page ‘bible’ enabling manufacturers to adequately prepare for the MDSAP with a walkthrough of the expected activities and outputs of each component part. The table below is a numerical overview of each chapters’ activities and outputs, all of which must be addressed.

Chapter	Outcomes	Tasks	Links
Management	9	11	7
Device Marketing Authorisation & Facility Registration	4	3	4
Measurement, Analysis and Improvement	6	16	10
Medical Devices Adverse Events and Advisory Notices Reporting	3	2	3
Design and Development	9	17	7
Production and Service Controls	6	29	9
Purchasing	5	12	7

Figure 1: Taken from the FDA MDSAP ‘bible’

Below is a top-level summary diagram of the component parts included in the audit, though there is no requirement for the stages to run uniformly in this order for each manufacturer, AOs tend not to deviate from this structure to enable the information used to flow logically from one component part to the next, easing decision making processes and overall grading assignment.

Figure 2: The MDSAP Audit diagram

In summary

The MDSAP forms a small part of what is a regulatory revolution in medical devices. Developments in supply chain, technological innovation, and continuing improvements in patient access to information have created a growing need for manufacturers and institutions to reflect this new era in device development regulations.

At Guided Solutions, we help businesses to identify regulatory and quality focussed individuals who are ahead of the curve and capable of managing QARA transitions with minimal disruption. Contact us today to learn more about our search services.

A Day in the Life of a Medical Sales Representative

Guided Solutions

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February 25, 2019

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A Day in the Life of a Medical Sales Representative

This article was originally published by Ashfield.

I applied to Ashfield because I knew it was a leading company providing services for the healthcare industry. It’s also a company that puts extra effort into developing its employees. There’s lots of opportunity to grow with the company and progress up the career ladder.

For anyone considering a career in medical sales, be it through applying directly or working with a medical device recruitment agency, I hope my experience gives you a good idea of what the job is really like.

What is a medical sales representative (rep)?

Put simply, my job is to help keep GPs, nurses and other healthcare professionals (HCPs) aware and informed about a company’s products.

I receive intensive training on the therapy areas and products I work with as well as the structure and roles within the NHS. I research the needs of my customers and set up appointments with them to discuss where these particular products are best suited to their needs.

This provides an important link between pharmaceutical companies and the HCPs that will prescribe their drugs, medicines and medical devices.

So what does a day as a medical rep look like?

An average day can be varied and challenging. You have to have excellent planning skills as you need to ensure your targets are met.

Learning to manage your own diary is essential

It’s your best friend and dictator! When my diary is full, seeing customers is easier but the days are hectic.

My territory includes a variety of customers and some are easier to see than others. I adapt my schedule to accommodate customers at a convenient time for them and it’s important to work efficiently to get the most out of every day. This could mean some days I’ll have an early one-to-one with a GP before their surgery in one town, then drive to the next town for a lunch meeting with another.

Each day as a medical rep can be a real game of two halves; one moment you’re flying high following a call and two hours later your key appointment has been rearranged.

Territory knowledge as well as relationships with receptionists is vital

(and a little bit of luck is helpful!)

I make sure I’m busy every day to improve my chances of catching nurses before clinic, or GPs in between patients. Throughout the day I drop off my business cards with staff at the clinics and surgeries, asking them to call me back if the GP or nurse has time to see me.

Card dropping is an important part of the job

It helps you get to know your accounts and when best to put them in your diary. I have a call target to be made each day with GPs, nurses and pharmacists. All three have different but equally important interactions with a patient’s treatment and I tailor my approach for each one accordingly.

When I’m out in the field, it’s critical I’m effective and achieve the objectives set for my client. I report daily on who I’ve seen and the impact that I’ve had, and I regularly discuss my performance with my manager.

Conversations with healthcare professionals can vary, so understanding the person you’re calling upon is key.

Prior research, knowing when to engage and how to begin the conversation is crucial

Discussions can cover lots of topics, from patient profiles to the cost effectiveness of my product compared to the competition.

I’m knowledgeable of the NHS and provide support whenever possible. This can be done by showing how my product helps customers achieve their own goals and targets, reduces secondary care referrals or supports their patients.

In summary…

As a medical sales representative I help healthcare professionals meet the needs of their patients. I work to be the best I can be and make a difference in the big wide world of medical devices, healthcare and pharmaceuticals.

For someone wanting to grow their career in an exciting and fast-paced environment, this is one of the most rewarding jobs you can do. Achieve targets, enjoy meeting customers, and make a difference in healthcare.

Guided Solutions is a UK market leader in Medical Device Recruitment. Subscribe to our email updates to receive Medical Device Recruitment content straight to your inbox.

A Medical Device Recruiter’s Practical Guide to Successful CV Writing

Guided Solutions

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February 10, 2019

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A Medical Device Recruiter’s Practical Guide to Successful CV Writing

To start off, a great tip is to write a CV for the job you are looking for, not one for the job that you already have.

Put yourself in the hiring manager’s shoes

Make sure that you have covered all elements of what they would be looking for when making such a hire. Ensuring you cover the skills required in the job description is a good start.

A hiring manager cannot guess what skills make you relevant, what makes you stand out from your peers, or even where in an organisation you would fit. You must spell it all out. Do this by providing concrete, qualified, and quantified examples.

Stand out from the crowd

Just as you would when selling a product; think about your unique selling points and added value, and make sure they are clear from your CV. A candidate who comes across as too generic and does not inspire, is unlikely to progress in the hyper-competitive world of medical devices.

Hiring managers are spending an average of 5 to 7 seconds per CV, forming opinions about candidates as they scan for relevant keywords and numbers. If these are missing, it is unlikely they will move on to read yours in more detail. For this reason, bear in mind that initially the readability and overall layout of a CV are just as important as, if not even more important than, the actual content.

Make sure your relevance and suitability are clear from the very first glance. Stick to bullet points with keywords and figures, and make sure layout is clean and uniform. Ask yourself if your chosen style (spacing, font etc.) adds to the readability of the CV, or if it detracts from it.

When working with a medical device recruiter, make sure you send them a Word doc version of your CV with very basic formatting. This is so that they can easily upload it on internal systems and/or remove any details as needed, preventing your application from getting delayed.

Test yourself

Look at your CV for seven seconds and ask yourself if you have enough information and incentive to progress your application. Is it clear what you did, and, how this contributed to the overall success of the company you worked for?

Is your relevance for the role immediately clear from merely scanning the CV? Does it provide concrete examples and figures? Does it paint big enough a picture? Can you quickly understand your added value and unique selling points? Do you come across as an energetic individual with an impressive track-record, ready for the next step in their career?

For the purpose of applying for a job in medical devices, a CV should read between 2 to 5 pages at the very longest.

Most effective naming convention is:

First name + Last name, “CV”, Month + Year

The CV should run in chronological order (most recent role first, least recent one last).

Example Sequence:

1. Personal

Name
Location
Contact details

2. Executive Summary*

3. Key Skills*

4. Career History* (most recent job at the top)

Company Name + Dates
Job Title
Division + Territory + Reporting Line
Main Tasks & Responsibilities
Key Achievements

5. Education

Where
Degree + Areas of focus (major, minor etc.)
Relevant certificates achieved
Relevant additional training

6. Personal Achievements

Awards
Patents
Languages spoken

*Further Thoughts

The Executive Summary

The purpose of the executive summary is to tell the hiring manager who you are, what you have done, and what makes you stand out from other applicants; as well as giving them an idea as to the type of roles you fit into.

This is particularly important as there might be other, confidential, vacancies in the business.

Your Key Skills

This section allows you to highlight the relevant skills you have. Stick to keywords and choose a good mixture of hard and soft skills. The job description is a good place for guidance on key skills the hiring manager will be looking for.

For example: Six Sigma, Intercultural Communication, KOL management, Kaizen, B2B, Change Management, New Product Development, FMCG, Sales Training, ISO13485 etc.

Your Career History

The purpose of this section is to succinctly, and chronologically, tell the reader up where you have been professionally; and hopefully, where this collection of experiences will take you next.

It should include a brief description of each business, focused on information relevant to your own profile, such as medical device products, customer base and services provided. Avoid lengthy descriptions of the inner-workings of the company.

Each role should be detailed in bullet points with clear, quantifiable, fully qualified tasks and achievements. Each time, make sure it is clear what you did, and how this contributed to the overall success of the company.

Examples of meaningful inclusions in this section are: Business functions you were responsible for; Size of the team and P&L managed; Products and Services dealt with; Stakeholders you worked with; Length of the sales cycle; Value of the product or service; Main customers; Sales or account size achieved or increased by; New Products Developed and Launched; Strategies devised and implemented; M&A realised and funding raised; Examples of projects managed.

Since its inception in 2000 Guided Solutions has placed more than 8500 candidates in over 37 countries.

We identify and recruit medical device specialists at all seniority levels, enabling our clients to connect with associate through to board-level talent.

Visit our website to find out more about our comprehensive range of search & selection services or get in touch via +44 1904 72 00 40.

Industry 4.0: How It’s Disrupting Leadership

Guided Solutions

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February 4, 2019

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Industry 4.0: How It’s Disrupting Leadership

Industry 4.0 or the ‘fourth industrial revolution’ refers to an ongoing process whereby manufacturing technologies are moving into the realm of the Cyber-Physical, gradually replacing the processes and technologies of the ‘digital’ or ‘third’ industrial revolution. Indicative elements of this new wave include advances in robotics, artificial intelligence, blockchain, and the internet of things.

In his work, ‘The Fourth Industrial Revolution’ Klaus Schwab concludes that this latest revolution will differ greatly from the previous three, which were, to all intents and purposes, simply more efficient uses of technology towards achieving the same end.

According to Schwab, this new revolution will focus on greater connectivity and communication between people, with technological advancement serving as a means rather than an end in itself. This fundamental motivational shift has the potential to change much of what we take as read about modern business, not least the way businesses are led, managed and motivated. This article will explore some of the behavioural shifts leaders can expect to make to keep their businesses relevant in the era of industry 4.0.

Caution is the new risk

In their recent study Success Personified in the Fourth Industrial Revolution, Deloitte interviewed more than 2000 CEOs and identified the following four shortcomings leaders will face in industry 4.0:

• Too much choice in technology (and lack of understanding of functional differences)
• Talent shortages in key areas
• Managing the pace of change and staying up to date
• A paralysis and fear of failure.

It’s clear from these self-confessed failings, that indecision, lack of confidence and lack of knowledge is holding some leaders back. Behaving cautiously is now fraught with danger as businesses continually leverage new technologies to disrupt accepted practices across various industries, those left behind may find their entire way of doing business has been replaced.

Society before shareholders

Much is made of the social inclination exhibited by millennials and younger when selecting their employer or choosing a company to engage with as a consumer. This soundbite is part of a much wider pivot from the maximisation of profit at any cost to a more socially engaged, human-centric industrial model. The recent report by Deloitte found that 34% of leaders value societal impact as their key success metric versus 18% for customer satisfaction, and 17% for financial performance.

These emerging technologies are built around reducing the burden on humans to perform manual tasks, it’s this inherent humanity at the core of the usage of these technologies that is working to change some notions of why businesses operate.

Brokering the deal between tech & talent

In 1900, recorded human knowledge doubled every 100 years, by 1945 this had cut to 25 years and now the figure is approaching just 12 hours. The knock-on effect for data facing employees is that they are in the midst of a battle to synthesise and utilise a continually expanding body of actionable information with emerging technologies as their chief ally.

Leaders must be able to manage and control the ever-changing interactions between technologies and people as the two develop (sometimes independently) to extract the maximum benefit from the two elements.

Standing product-first policy on its head

Manufacturing innovation is typically drawn from a small number of skilled inventive teams developing augmentations and improvements to existing products, with employees further down the supply chain asked to get up to speed or risk losing their Jobs. Previous business generations have had the luxury of surpluses in manufacturing talent, industry 4.0 does not offer this luxury to leaders, demand outstrips supply in almost all areas where industry 4.0 is coming to the fore.

This means that not only do manufacturing leaders need to think about switching to a people first policy of new product development but when they have these people in place they must work extremely hard to instil the correct values so that they can retain and properly energise them.

Since 2000, Guided Solutions has been connecting revolutionary medtechs with top-level industry professionals, fulfilling the potential of technology and talent.

Contact us today to find out how our executive search & selection expertise can help your business.

5 Ways Your Small Medtech Can Punch Above Its Weight in Talent Attraction

Guided Solutions

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January 24, 2019

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Multinational medical device businesses are allocating up to 12% of their gargantuan revenues on Marketing and Brand Awareness initiatives. Due to this spend, when it comes to influencing and educating potential employees about the joys of joining their companies they have a considerable head-start over small and medium-sized competitors.

Since it’s not feasible for smaller medtechs to match this investment level, we’ve developed a list of 5 effective and affordable methods to help these businesses acquire transformative talent.

1. Embrace your idiosyncrasies

When communicating your story to the market, focus on your individuality and what makes your mission and vision remarkable. You have an opportunity to paint a vivid picture of what a career in your company really means, you should exploit this to demonstrate the personality of your culture and the boundlessness of your aspirations.

2. Talent comes in many forms

Not all the functions that you need to hire for will require highly experienced, top-tier employees. Developing links with academic institutions and online graduate communities can open up a world of potential at a much much lower cost. Hiring intelligent, hungry but as yet untried grads for internship style or even entry level positions will inject fresh perspective and creative problem solving into the business, not to mention forge early links with leaders of the future.

3. You need a spectacular specification

A standard job specification suggests a standard job which in turn generates standard applicants. If you’re serious about finding impactful talent then use words and ideas with the requisite impact. In a sea of mass-produced advertising content, use your imagination to reach potential candidates on a deeper level and stand out from the multitude.

4. Clarify the picture internally

Look deeply at your current team and existing collection of skills to understand in detail where a new employee could fit in and add the greatest value. Developing a detailed skills gap analysis will lead to an accurate definition of the challenges and growth indicators that the highest quality talent craves.

5. Individualise the perks package

Large scale organisations often have rigid or set-menu benefits to offer their employees. Doubtless, they are often attractive and useful, but they are not personal. Within reason, your small scale gives you the opportunity to offer exactly what your employees really want without the headaches and delays inherent in attempting to achieve this with large scale finance or buying department input. Allowing employees to imprint individuality on their perks will only serve to reinforce their psychological link with your mission.

Guided Solutions is Europe’s largest search & selection consultancy operating exclusively within Medical Devices.

Contact us today to make sure your next hiring decision is done the right way.

Change or Die: How Does a Surgical Sales Rep Go from Hero to Zero?

Guided Solutions

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January 24, 2019

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Change or Die: How Does a Surgical Sales Rep Go from Hero to Zero?

This article was originally written by Jason Baker, Medical Device Sales Representative

If there was a dictionary where you could look up the term “surgical sales professional,” you would see Jack’s picture.

Jack was one of the best surgical sales professionals I ever met. He personified motivation in that he awoke at 4:00am every day to read journals, study product literature, and educate himself about the surgical specialty to which he sold. He would then hit the gym for an hour or so and arrive at his first hospital account before 7:00am.

When I walked through the hospital with Jack I felt like I was with the CEO.

He greeted everyone by name and everyone knew his name as well. Even the elderly Candy Stripers (hospital volunteers) knew Jack and they would stop what they were doing to hug him or shake his hand.

Jack had a relationship with everyone who worked in the cafeteria, the patient transporters, as well as housekeeping personnel and others.

As I met Jack’s customers, they acted as if he was not only a sales rep, but also a de facto staff member. Even the stodgy, smug, and generally unfriendly Director of Purchasing yelled from her office, “If that’s Jack’s voice I hear, he better come in here and say hello.”

And when Jack did, the supposedly difficult and salesperson-hating purchasing director smiled and thanked Jack for helping her to understand a complex pricing agreement, which she explained, was not by her request, but by Jack’s insistence to make sure she understood the document. When I walked through the surgeon’s lounge with Jack, not only did Jack know every surgeon passing through, but more importantly, each of them knew Jack.

This was surprising because Jack sold implants and instruments for Ophthalmology, yet he knew all of the cardiovascular guys, all of the general surgeons, orthopaedic surgeons, ob-gyns…everybody! I asked, “Jack, how do you know every surgeon in the hospital when only the eye surgeons can use what you sell?”

Jack said, “Every surgeon is an opportunity to learn more about medicine, more about the hospital, more about their challenges, and it’s an opportunity to get to know some influential people, even though they don’t buy or use what I sell. I want them to be as comfortable and welcoming of me as the rest of the hospital staff. Plus I like to hedge my bets. I can’t control my entire future. One day I might be selling ortho, or cardiovascular, or who knows what. Besides, most of them are really cool people and I like them.”

If you’re thinking that this was Jack’s only account, you’re wrong. I visited three accounts with him that day and it was déjà-vu in each. Jack worked every account to the max and had I visited his other 13 accounts, I have no doubt that the experience would have been the same. Talk about account penetration. He earned so many President Club rings that he used some for paperweights in his office at home.

At sales meetings, the junior sales reps would crowd around Jack to learn what they could from the master, hanging on his every word. And he earned an income that matched or exceeded what most of his physician-customers earned. Jack was truly at the top of his game.

Jack was a surgical sales superstar. Then the world changed.

Hospitals mandated a credentialing process that was required for surgical sales reps to do business. Jack disregarded the request for credentialing, believing that his relationships and tenure made him exempt. He convinced himself that the rules were different for him than for other surgical sales reps.

Then one day, a security guard who knew Jack by name said, “Jack, I’m sorry but I’m not allowed to let you in because you’re not on the credentialed vendors list.” Jack said, “Fine. You call Dr. Edwards and tell him that you won’t let me in for his case.” The doctor already knew. He was using a different company’s products. Another of Jack’s accounts requested a competitive bid for his products, which meant Jack’s company would have to discount its products significantly. Jack ignored it. He felt assured that his long term relationships with hospital staff and especially the surgeons would protect his business. He asked his surgeon-friends to go to bat for him. They said they wished that they could, but couldn’t.

The surgeons no longer had complete authority to choose which products they used. A million dollars’ worth of business dropped off of Jack’s sales numbers at one of his biggest accounts. Unfortunately, the same scenario repeated itself at several other accounts. Jack eventually lost over 70% of his business and resigned from his position to sell home mortgages, a decision that eventually left him unemployed.

What happened?

How could one of the highest-earning, most successful surgical sales reps at the top of his game fall from grace?

Jack was doing all the things that were important then and are still important today. But Jack’s world changed and he didn’t change with it until it was too late. Jack clung to the belief that he needed to do nothing more than what had elevated and sustained him in the past. He was wrong. You might think that the take-home message from this article is to “change as the business of surgical sales changes.” It’s not.

That postulate used to suffice, but it no longer does. The changes in healthcare are accelerating. The penalty for falling behind the change curve is irrelevance, that is, customers will replace you with competitors who anticipated and integrated change sooner and faster than you did. The take-home message is that you must remain relevant and to do that you must stay ahead of the change curve. If you think your only job is to help your customers to provide care to their patients one day at a time, think again. Today’s healthcare customers expect suppliers to be able to anticipate and deliver what they will need tomorrow. Yes, you still must do almost everything you did to succeed in the past, but you also must anticipate change.

Your biggest surgical sales challenge is no longer your competition. Your biggest challenge is staying relevant.

How? Certainly by taking care of business today but you must also have regular “tomorrow conversations” with everyone on the expanding and changing list of decision-makers in your accounts.

Learn to ask the critical-thinking questions that prove you really are a “partner” and not just a vendor. Don’t be complacent and don’t allow your customers to be complacent either.

These tomorrow conversations may make your customers uncomfortable, but if you’re willing to discuss the things that your competition and your surgical sales colleagues are not willing to discuss because they’re reactive instead of proactive, you’ll have something that your competitors won’t have—relevancy. Change is inevitable and changes are occurring in healthcare faster than ever.

Do you need a crystal ball to avoid having what happened to Jack happen to you?

No, but you must be willing to ask the hard questions and be prepared to deliver the desired and necessary solutions to your customers before they ask for them.

The alternative is to risk becoming irrelevant at any moment. It is vital to become and stay a surgical device sales expert.

With more than 8500 successfully placed candidates in over 37 countriesand counting, Guided Solutions is the search & selection partner of choice to the medical device industry.

We identify and recruit medical device specialists at all seniority levels, enabling our clients to connect with associate through to board-level talent.

Visit our website to find out more.

Blockchain: Solving Modern Medtech Challenges

Guided Solutions

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January 15, 2019

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Blockchain: Solving Modern Medtech Challenges

For many of us, blockchain technology exists in our consciousness merely as a companion concept for cryptocurrency transactions. We understand that it has revolutionary capability because of this, but we know little else about the wider capability of blockchain to improve other industries. This article will outline the potential of blockchain to overcome existing and emerging challenges presented by the modern medtech and healthcare ecosystem.

Let’s start by defining the concept:

‘Blockchain is a decentralised, distributed ledger for maintaining a permanent and tamper-proof record of transactional data. The distributed ledger ensures the simultaneous recording of updates to the ledger in multiple places (i.e. the individual members of the community or stakeholders), the ledger record is updated based on the establishment of consensus among users within the network, be it public or private.’

(Investopedia & SearchCIO)

A device traceability solution:

The new EU Medical Device Regulation which enters into force next year is placing new obligations on manufacturers to improve individual device traceability (Articles 25 & 27) and supply chain effectiveness. The European Commission is seeking, through the MDR, to make vital product lifecycle information visible and accessible, with the intention of improving standards of care and more effectively isolating specific issues which lead to product recall and defectiveness.

In the supply chain

Through the distributed ledger system blockchain could be utilised by each supply chain stakeholder to independently log their phase of the product journey in real time. Any issue arising around defectiveness can be traced to the source quickly and resolved, minimising negative outcomes and overall disruption to continuity of supply.

Where fines and reprimands are necessary accredited bodies will look to ascertain the direct source of a malfunction to establish blame, accurate record keeping via the supply chain ledger would greatly streamline this discovery process.

Towards outcomes-based payment:

Outcomes-based payment has long been seen as the next phase of development in the way in which cost to the patient is calculated for healthcare treatments and services. In the US system cost is based on metrics such as the number of doctor visits or the number of drugs taken rather than outcome, leaving life science companies in a position where delivering innovation and improved treatment effectiveness is not necessarily synonymous with financial gain.

Tracking the outcome and therefore the value of a round of treatments at the individual level is not currently viable, the administrative burdens are too great and no functionality exists which can allow the different stakeholders in the treatment process to interact effectively. Contracts, invoicing, patient group data are all generated manually at a great time and resource cost.

Blockchain technology has the potential to make outcomes-based payment a scalable reality by streamlining and automating the administrative and contractual processes of establishing the value of treatment at this individual level.

How can blockchain deliver this?

Blockchain has the functionality to facilitate ‘Smart Contracts’ which are conditional agreements coded into a private platform. A 3^rd party interlocutor provides access to the platform, contractual criteria are agreed by the healthcare stakeholders and fed into the system. Data is then run through and invoicing is triggered when conditions of the contract are met. The bureaucratic legwork does not increase if a contract increases in complexity.

When healthcare systems have the technology available to base payment on outcomes, innovation and treatment improvement will become intrinsically linked to financial success for manufacturers, competition will go hand in hand with continued increases in patient choice and quality of care.

To the future

Blockchain technology can empower the individual and erode some of our innately held beliefs on the supremacy of centralised, traditional institutions to connect us with our peers. The rise of connected devices and the Healthcare Internet of Things means patients can look to a future in which organisations with access to their information such as diet, sleeping, exercise, genetics, etc. can interact with other companies which may be monitoring blood pressure or heart rate. The resulting cocktail of information has the potential to deliver holistic healthcare solutions, where patients can be certain each aspect of their health has been taken into account.

6 CV Tips to Get You Invited to a Medical Device Job Interview

Guided Solutions

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January 10, 2019

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6 CV Tips to Get You Invited to a Medical Device Job Interview

With many people’s New Year resolutions kicking in, January brings about a wave of talented individuals looking for their next job opportunity in Medical Devices. As a result, we have seen a surge in the number of freshly updated CVs coming to our inboxes. Whilst some of these resumes are brilliant, as you might guess, the vast majority need some work.

For us, as specialist Medical Device recruiters, reading your CV to determine your suitability for a job is only a starting point. Whatever you tell us during our conversations with you is what really makes us make up our minds about you.

However, regardless of how much you manage to convince us of your skills and experience, it is ultimately our client’s Hiring Manager who decides whether or not to invite you in for an interview. And due to their busy schedules, most of our clients unfortunately do so based primarily on your CV.

In the fiercely competitive market of Medical Devices all it takes is a small oversight and a hiring manager will reject the candidate, no matter how perfect they might be for the job in reality. Do not worry, though, as we are about to share a few tips on how to make sure this does not happen to you!

In our experience as international medtech search & selection consultants what makes a good CV is at least partly culturally defined. But with a large amount of our executive candidates applying for international jobs, it is probably best to focus on the following universal commonalities:

1. Your job title is not that big of a deal

The responsibilities that come with a certain job title vary hugely amongst companies. What one company defines as a Key Account Manager might be called a Country Manager in another. It is therefore important that you briefly outline what your responsibilities were and who you reported into.

2. Make it concrete

There are many reasons why Hiring Managers want to talk to you. It might be your experience in talking to Lab Technicians or the fact that you volunteered to train up internal staff, etc. The more information we have, the more reasons we have to consider you. Make sure you therefore briefly outline what devices you dealt with, who your main customers were, what type of marketing strategies you devised, and so on. In short, make it specific.

3. Numbers matter

Consistently reached targets? Over-performed? Achieved a certain percentage of new market growth? Great! Do not be afraid to drop in a few figures to impress us further!

4. Stand out

Put some thoughts into what skills you bring to the table and briefly summarise these with a few keywords. We all know the standard list, but is there anything that makes you stand out from your peers? Think of the languages you speak, what your hobbies taught you or even what certain personal life experiences have made you grow as a professional.

5. Readability & accessibility

Make sure you have your CV in English as well as your native tongue at hand, even if you are just planning on roles in your native country. In our globalised society hiring managers are often located elsewhere or do not necessarily speak your language. In addition, if your CV is in PDF format always send your recruiter a Word version as well so they can correct any small mistakes. This way you help us eliminate delays in putting you forward.

6. Length

With all the above said in mind, do not forget that both recruiters and hiring managers often have to sort through large numbers of CVs for a single role. If yours is not quite to the point, you run the risk of boring the decision maker.

A great and elaborate resume rarely needs to exceed 2 pages.

Consider these tips and you will significantly improve your chances of ending up in the ‘YES’ pile. Then you have a chance to properly introduce yourself and impress your potential new employer during the job interview.

Since its inception in 2000 Guided Solutions has placed more than 8500 candidates in over 37 countries.

We identify and recruit medical device specialists at all seniority levels, enabling our clients to connect with associate through to board-level talent.

Visit our website to find out more or get in touch via +44 1904720040.