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Advisory Boards: Questions You Should Be Asking

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Advisory Boards: Questions You Should Be Asking

Organisations of all shapes and sizes engage advisory boards for myriad purposes. Whether it is filling expertise gaps, demonstrating credibility to prospective customers, making the business more attractive to investors or all the above, entrepreneurs build ABs to inject value into their organisation that they don’t have (and probably can’t afford) on full-time headcount.

There is much discussion and disagreement as to whether these bodies are truly valuable or whether they are simply costs to businesses with at least hidden return on investment, and possibly none.

This article takes the view that the advisory board is an inherently positive force, the real variable being whether such an asset is designed and managed adequately by the organisation.

There are four questions every entrepreneur should be asking in the AB design and implementation stages. Below we explain and contextualise each one of them:

What is an Advisory Board?

Let’s start by explaining what ABs are typically responsible for and what they are not. Advisory boards do just that – they advise. They do not directly oversee, reward or reprimand on an operational level anything occurring within the company. They serve to augment the activities of the main board and management team by providing:

  • Social access to a previously unavailable network of investors, thought leaders and industry luminaries
  • A view ‘from the outside looking in’ to the business, forcing management into seeing the business as the market sees it
  • First-hand support and the voice of experience in the development of business functions such as corporate governance frameworks

How robust is the interviewing process?

For young entrepreneurs, validating their venture by engaging a ‘big name’ advisor is often too great a short-cut opportunity to ignore. Certainly, this individual can bring contacts and experience, but has their ability to advise really been tested? Good advisors should not only possess the right credentials but also be skilled in the art of communicating their knowledge constructively. Businesses that conduct competency interview processes ascertaining advisor strength in this area stand higher chances of running a successful AB than those that don’t.

Which came first, the advisor or the strategy?

An advisory board member’s time can be extremely costly. According to advisorycloud average yearly remuneration per advisor is between $1,000 and $6,000 USD for small businesses (seed and concept stage businesses typically hand over between 0.1% and 1% equity). With such substantial resource expenditure, it is imperative that each board member has an unambiguous set of objectives to work to before they come onboard. All too often advisory boards are made up of highly qualified individuals who were either brought in based on reputation and only retrospectively have a function assigned to them, or worse, never receive a clear mandate at all.

The order of events should be the following:

  1. Decide what you want your AB to achieve
  2. Pursue the talent most befitting of those aims
  3. Nail down your advisors as regularly as required
  4. Squeeze all possible value out of the meetings

Don’t shy away from ad hoc phone and email contact, particularly where equity has been offered and it is in the direct interest of the advisor to get back to you ASAP.

Are you just hiring your fan club?

Sometimes the truth hurts. Whether it comes from market research, investors, customers or technological limitations, businesses must fend off a perpetual barrage of reality checks that get hurled their way. The most successful companies don’t take it personally but learn and make the necessary adaptations. This resilience should be mirrored when putting your AB together. Forming your AB exclusively from your fan club will limit its effectiveness, or worse – blind you to imminent threats. Bringing in people willing to contradict your business narrative will enable you to continually reassess your value proposition’s validity and come up with unique solutions to capitalise on opportunities you didn’t even know existed.

Let’s summarise the key points raised

  1. When you meet prospective advisors, don’t simply read their resumés and say yes. Ask yourself “can this person truly translate their credentials into value for my company?” and then test this with competency questions.
  2. Define a clear vision for the AB and split this into component parts with the requisite skill sets. Only then go find the advisors
  3. Enrich your world view by stocking your AB with a wealth of different opinions. Ferment disagreement and healthy debate as much as possible.
  4. Squeeze every last morsel of value out of the time you have paid for.

 

With over 8,500 successful placements in 37 countries and counting, Guided Solutions is Europe’s largest search & selection consultancy operating exclusively within Medical Devices.

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

Anatomy of a CEO

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Anatomy of a CEO

Most people are aware that a CEO sits at the top of the corporate leadership pyramid with responsibility for captaining the ship and overseeing strategic direction. But what exactly does it mean to be a CEO in a small, growth-led business?

In this first of an article series dissecting and demystifying the SME C-Suite, we will break down the anatomy of the CEO by delving deeper into 3 key dimensions associated with the role:

  • The Behavioural Archetype
  • Key Relationships
  • Key Activities

1. The Behavioural Archetype:

Relentless Reliability

In their recent study ‘The CEO Next Door’, Elena Botelho and Kim Powell interviewed more than 2,500 leaders and identified four key traits which all CEOs need to be successful. They were:

  • Decisiveness
  • Engaging for impact
  • Relentless reliability
  • Adapting boldly

Of those four, relentless reliability was singled out as the most important trait, way ahead of any stereotypical notions of extroversion and risk readiness (in fact a related study by Harvard Business Review found that Introverted CEOs were slightly more likely to meet and surpass expectation than extroverted ones). Indeed, Botelho and Powell’s research suggested that reliable CEOs are 15x more likely to be high-performing, than those deemed not reliable.

Internally, reliability is a sense of calm created by the CEO that the steps the team has taken to date have been the correct ones, and that key strategic considerations concerning future prosperity have been arrived at methodically, ensuring a strong probability of success. Externally, the CEO must play the role of chief publicist, demonstrating to end users, investors and potential counterplayers the efficacy of the product/technology, instilling the idea of minimal risk in backing the venture. The research suggests that these external players must have confidence in the CEO’s reliability to deliver to consider any collaboration.

Tolerance for Ambiguity

Between securing and finalising Seed through to Series funding, overseeing clinical trials, obtaining international accreditation, setting up and optimising manufacturing processes as well as continually engaging KOLs and drumming up interest for the product, it’s clear that a CEO must have visibility and knowledge of an almost incomprehensibly complex web of inputs and outputs to the business.

The CEO must be prepared for and indeed thrive within an environment where these concepts and milestones exist in a state of tension and the correct route and prioritisation are at the mercy of uncontrollable transience. The CEO must have the drive and self-belief to plot a course through this landscape and retain the ability to continually assess its correctness, entertaining alternative views, shifting and reassessing as necessary.

Prioritisation

Taking risks and acting fast are both traits immediately associated with the modern CEO in any business size or industry. These are truths often held in and of themselves to be reasons for CEO success, but how doe taking risks and acting quickly translate into competent performance?

The study by Harvard Business Review found that more successful CEOs tended to make decisions ‘earlier, faster, and with greater conviction’, than those who were more inclined to deliberate in search of greater precision. To maintain momentum, CEOs need to make decisions based on imperfect information and prioritise the relative exposure that they have to different subject areas in the business, and then they need to fully believe in their decisions.

Deliberating CEOs with a capacity for complexity were found to be guilty of intellectually-driven ‘bottle-necking’ with not enough decisions being made. This bottle-necking was found to be contagious within some organisations as senior leaders and line managers mirrored the CEO’s pursuit of accuracy, leading to organisational stagnation.

2. Key Relationships:

The multi-faceted role of the CEO lends itself to an equally diverse web of relationships with both internal and external stakeholders. But which relationships are typically most important and how are these cultivated and sustained?

CEO and Chair of the Board

The CEO is charged with turning ideas into strategy and strategy into action, and whilst they can consult other senior leaders or even subordinates, very often the CEO is the only individual within the organisation with the foresight to direct these processes and so advice is limited. One of the key duties of the Chair of the board is to fill this knowledge gap and provide the mentorship that the CEO is expected to provide to the rest of the organisation. It is essential for the viability of this dynamic that the CEO and chair communicate early and often. Both parties must develop an intimate understanding of the other’s skills, intentions, successes and challenges in order to maximise the effectiveness of the relationship, and ultimately act as one and work with unified purpose.

CEO & CFO

Underneath the blue sky, helicopter, 10,000 or 30,000 foot thinking that is expected of the CEO as they drive the business into the future, is the bottom line. The company must make progress and make financial sense for investors and shareholders and it is the CFO’s task to provide an unequivocal, unbiased depiction of the business’ financial state. The CFO is the individual ultimately responsible for establishing the financial viability of all company initiatives and a close CEO/CFO relationship means that strategy can grow within a framework of reality and practicality. The CEO is responsible for investor relations and the acquisition of funds, by working closely with the chief allocator of the fund the CEO can understand how and where to focus efforts in the obtaining of funds, producing unique strategies and targeting investors who can best support specific business needs.

3. Key Activities:

Hopefully, this article has demonstrated that the work of a CEO is multifaceted and variable, based on the particular circumstances, objectives and goals a business is pursuing. That being said, however, there are some core activities and responsibilities which almost all small business CEOs must engage in to keep the wolves from the door.

Defining and Championing the Vision

This is not just about establishing plans for future financial success and then ensuring that this is carried out. It is about energising and inspiring the entire organisation to get behind a unified purpose and work as one indivisible entity towards achieving greatness. Doubtless, the CEO can draw on various sources in the creation of the vision, but the eventual manifestation must come directly from them for it to achieve the desired effect.

By 2020, half of the world’s workforce will be millennial and this has a large bearing on CEOs and the need for clearly defined vision. A recent study found that 72% of Millennials desired the autonomy to be their own boss, whether that is as an entrepreneur or within a company which fosters such behaviours. Developments in access to previously hidden or unknowable information has made this generation and those that will follow increasingly mistrusting of doing any work without a clearly defined, impactful vision. This in turn makes it increasingly imperative for CEOs to define their vision, in terms of both talent attraction and retention.

Human Capital Investment

Hiring is sometimes about replacing skills the business has lost, and sometimes about recognising that a certain skill is yielding great results and hiring more people with those skills to meet demand. These represent downstream hiring practices where the need has been established and the recruitment is based on finding an individual to match what is a known quantity for the business. For the CEO however, the recruitment question is altogether more forward-looking and often based on imperfect information. To achieve growth, CEOs must look to identify talent and acquire skills based on upstream principles regarding what the business will need to remain competitive and prosper well into the future, and not simply satisfy short term requirements.

 

Since 2000 Guided Solutions has been the Executive Search & Selection partner of choice for the Medical Device industry.

We connect growth-focused, technology-driven companies with our continually expanding global network of 120,000+ industry professionals, delivering impactful talent at all seniority levels across the entire product lifecycle:

  • R&D, Software & Mechanical Engineering
  • Quality Assurance & Regulatory Affairs
  • Market Access & Reimbursement
  • Sales & Marketing
  • Clinical Applications & Support

Visit our website to find out more.

Building a Medtech Career: The Shadowing Process

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Building a Medtech Career: The Shadowing Process

If you are looking to build a career in medical devices, you are most likely going to start your journey with a job as a medical sales representative. Medical sales is a field-based, face-to-face job that is always in high demand. However, like any other entry-level job, competition here can be quite fierce. What makes the challenge even greater is also the fact that medtechs can be extremely picky about who they hire.

Why is medtech different from any other sales field?

The medical device industry sells items that can potentially kill people. That is why companies are so careful about who they choose to sell and distribute such products. Depending on the therapy area, and potentially varying from department to department, medical device businesses will look for candidates who can demonstrate that they have done research in person into what a medical sales rep’s work really involves. This is a process commonly known as shadowing. Medtech employers and recruiters alike really like candidates who have some shadowing experience as this demonstrates not just a responsible, proactive and positive attitude but also willingness to put in the time and effort the job itself demands.

The shadowing process explained

Shadowing is the process of gaining direct experience of a person’s job without actually doing the job itself. Within medical devices, shadowing effectively means spending some time with a medical sales representative. It involves following them around and observing them work, typically for a half or full day.

How to arrange it

Start off with your social networks – online as well as offline. Do you know anyone who is in the industry or might know someone they can connect you with? If there is no one within your immediate or extended social circles who can introduce you to a medtech sales representative, then try your luck on LinkedIn.

Using LinkedIn

Do you have a LinkedIn profile? If no, then take the time and build one that reflects your interest in the sector. Once your profile is ready, perform a search for sales representatives or territory managers within your geographical area. Then try and connect with them. Explain that you are interested in a career in the industry and you are keen to gain some shadowing experience, and then ask if they or someone within their company would be willing to do that with you. A good strategy is to reach out to larger companies first – Stryker, J&J, Bard, and similar. You might have to send out 100 connection requests before you can actually get hold of someone, and prepare to see a lot of people declining your request. This is something you should not take personally, as sales representatives are busy people who not always have the time to help. Keep going and eventually you will find someone who will say yes.

What to expect on the day of shadowing

Medical device sales reps spend the majority of their time travelling around their designated field. Therefore, it is very likely that you will accompany them on trips to different clients, which are typically hospitals. You might not be admitted into all areas of the hospital or get to meet all contacts that the sales representative is meeting. If this happens indeed, they will tell you why, and where to wait.

Making the most out of it

To make the most out of your shadowing experience before, during and after, consider the following:

Before:

  • Thoroughly read the LinkedIn profile of your chosen sales rep
  • Research their company website, paying specific attention to different product lines
  • Find out the therapy areas where the different products have their application
  • Think of questions you would like to ask and put them down in writing

During:

  • Take notes
  • Don’t be shy to ask about how this person got into the company they work for; what the company is looking for when evaluating candidates; what the job interview looks like, etc.

After:

  • Send a formal thank you note. This is not only polite but opening the door to a positive relationship with that person if your paths within the industry cross again some day!
  • Repeat! The more shadowing experience you can obtain, the better picture you will develop of what it is to work within medical devices.
  • Make sure you update your CV to reflect the experience you’ve gained.
  • Write a report. Detail out what you have seen and done, as well as who you met and what you learned during your day of shadowing. You can then use this to present alongside your CV during interviews.

Can I get a medical sales job without this shadowing experience?

Everything is possible. However, as we already mentioned above, the world of medical devices is demanding and extremely competitive. If you have no industry experience whatsoever and you haven’t done any kind of prior research such as shadowing, there is little point in applying for medical device sales jobs and going to interviews. You will not shine your best light and companies will reject you not because you don’t have potential but because you haven’t done the research. If a career in medical devices is something you truly want to pursue, then get that research done!

 

With 20 years of experience, Guided Solutions is Europe’s largest search & selection consultancy recruiting exclusively within Medical Devices. Our dedicated international team comprising 6 nationalities and 11+ languages operate across different market segments, offering a full service approach and the ability to recruit across all functions and levels.

Contact us today if you are looking to make your next career move in medical devices or need top-tier industry talent for your business.

Medtech Employers: How to Not Lose Your New Investment

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Medtech Employers: How to Not Lose Your New Investment

Recently, one of our candidates started a new job as a Director of Sales with a Healthcare IT start-up.

The tech was interesting, the career progression opportunities even more so, and the pay was not bad either. But the thing that charmed our candidate the most was the fact that the company went out of their way to make them feel welcome and part of the team the minute they got the offer.

Not only did their VP of Sales dedicate a full day to fly to the UK from Germany and hand our candidate their contract in person, but he also made sure to travel down to HQ and be the one to walk through the doors alongside them on their first day. He then personally introduced them to the rest of the team.

Our candidate felt a real sense of belonging and welcoming rather than the doubtful optimism that is so familiar to many new employees.

Our client had understood a vital truth:

Your staff is one of the most important investments you can make. Get this wrong and you risk wasting valuable time and money only to have to start the recruitment process all over again.

Many companies think successful on-boarding is all about showing off – from popping bottles of champagne to giving out flashy tech.

But as the example above demonstrates, there is no need for any of that really. Simply treat your candidates and new-hires like you do your customers.

Openly appreciate the commitment they have just made to you and make sure they have all the tools and information needed in order to enter into a successful collaboration.

This is literally as simple as greeting them at the door on their first day, setting up their desk, and checking if they have understood both the written and unwritten (!) rules of your organisation.

Even if this takes away some time from other tasks, it is an investment that will pay off with a positive, constructive, and longer-lasting working relationship.

Companies that neglect this run the risk of dampening their new employee’s enthusiasm or even worse, losing their new investment altogether. We’ve known candidates to leave because they weren’t provided access to the internal intranet or because they had to wait for their company car for months!

Just as you invest time, energy and effort in recruiting the right people, you should spend time, energy and effort in welcoming them on board.

After all, companies prosper or fail based on the connections forged between their people. Investing in people means investing straight into your own success.

Since 2000, Guided Solutions has been helping growth-focused, technology-driven Medical Device SMEs reach their potential by connecting them with the industry’s top leadership talent.

Whether you have a priority hire requiring immediate attention or you are simply exploring the idea of adding to your team and would like some advice, get in touch and we will guide you through the hiring journey.

5 Ways to Get Your Offer Accepted

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5 Ways to Get Your Offer Accepted

When you finally meet the right candidate for your business there is an inevitable mixture of emotions. Firstly, relief, you’ve identified the skillset you know the business needs. Secondly, excitement, the realisation of what this person could help you to achieve. And thirdly anxiety, this is a special individual, you don’t want to now lose out on them and waste the already considerable time and resources spent in unearthing and engaging them.

To ensure these efforts and emotions are not for nothing, the final step you take, the offer, must be an assured one.

We’ve highlighted 5 elements:

1) Move quickly

Delays kill deals and this is especially true at the offer stage. High-quality candidates are often exposed to competing offers, if you delay your offer you can bet that another company, or worse, a competitor will not delay theirs.

2) Make it personal

The offer letter is essential, and a thoughtful companion email is useful, but make sure both of these channels are backed up by a phone or skype call to formally make the offer. This personal touch demonstrates your enthusiasm for the candidate and gives you a useful opportunity to understand their commitment level.

3) Embrace and combat the counteroffer

That doesn’t mean telling the candidate about the pitfalls of accepting counteroffers and how unhappy they will eventually become if they do. It’s about understanding the stresses and anxieties implicit in the resignation process

4) Make sure the offer reflects the process

Job interviewing processes continually evolve and change until they reach their conclusion. Your image of the candidate, what drives them and what they can do will naturally develop over time and your eventual offer should reflect the specifics of what you have learned as far as you have the flexibility to do this.

5) Don’t waste this final opportunity for appraisal

When the offer letter is signed and the candidate has resigned you have a new employee. Up until this point, you have the right (and indeed the obligation) to maximise the use of time (without lollygagging) to learn all you can about the person you are building this offer for. When taking references for example, do not view this task as a tick box exercise, use these live conversations to learn as much as you can about your prospective new employee and continue to complete the puzzle, if the references throw up questions, find answers to those questions.

Read the next in the series to discover the ‘4 secrets to start up onboarding success’   

Global Team Build – Oncology

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Global Team Build – Oncology

The Context

Our client is a high technology oncology business operating at the forefront of innovation within their field. When our partnership began more than 4 years ago the business was over 10 years old, with a market leading technology and an ambitious CEO looking to build out the organisation to let the product to reach as many physicians and patients as possible.

Through a number of key hires in strategic leadership functions Guided Solutions has helped to catalyse growth in almost all areas of the business, enabling further investment in talent, R&D and global market access. Since the beginning of the relationship, headcount has increased by more than 150% alongside exponential global revenue growth of 900%.

The Campaign: Key hires and outcomes

Global Sales

The first key hire the business made through Guided Solutions was a VP of Global Sales. At the time of the appointment the US arm of the business dominated commercial activity. The CEO intended, through the new VP, to redress this imbalance and open up key markets in Europe and beyond. Four years later the VP is still in place and has grown the OUS sales organisation from one (himself) to 15 international sales leaders, enabling OUS sales to match and surpass the US in terms of revenue for the last two years.

Research and Development

The CEO, as one of the inventors of the core technology, remained heavily involved in R&D whilst the business was still small enough in scale. With the commercial successes and subsequent expansion delivered by the new VP Global Sales, the CEO was no longer able to devote the necessary time and resource to the R&D function. Therefore, we were tasked with identifying and recruiting a new VP Product Development.

After a long search we were able to identify a candidate capable of meeting the expectations that the CEO had set for himself over so many years. The VP of Product Development, along with the CTO and a small R&D team, made great strides in the usability of the core technology and also in the identification of potential new applications for it. Commercial success enabled the business to greatly expand the R&D function and fully explore the potential the team had identified. Guided Solutions helped the business to identify 10+ Software Engineers from across the globe, including relocators from Hawaii and Russia to help the R&D team realise their vision.

Marketing

As much as this period can be characterised by financial growth, it can also be seen as a continuing process of sophistication in the strategies and tactics pursued across the business. Nowhere has this evolution been more evident than in the attitude towards marketing. As one of the first handful of new hires made, the new VP Marketing has overseen a paradigm shift in internal attitudes. Prior to their arrival marketing existed mainly in ad-hoc promotional activities, without measures of success or  a clear and coherent mission. The new VP Marketing brought with them ideas for directly targeting a global customer base in a sustained way through utilisation of communications tools, educational content generation as well as aggressive pursuit of Market Access in key emerging markets.

The early outputs of these initiatives, demonstrating clear return on investment enabled the VP to build out the department from one to eight persons in functions including Content Marketing, Market Access and Strategic Alliance building.

In total, Guided Solutions have been responsible for more than 75 hires across the business and continue to support further growth plans for the future. Over and above a market leading technology, what is clear is that the primary stimulus for development has been the identification of truly exceptional leaders who have clearly reflected the ambitions of the business and worked tirelessly, and often autonomously to achieve them.

Visit our website to learn more about our team build service, or contact us directly with your project for an exploratory discussion.

Medtech Employers: Ask This Question or Lose Top Candidates

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Medtech Employers: Ask This Question or Lose Top Candidates

Last week, one of our clients had their final interview cancelled by an extremely suitable candidate.

Rather than brushing this off as a one-off and starting the same process the exact same way all over again, the Hiring Manager asked me this important question:

“What could I do differently next time in order to prevent this from happening again?”

Whilst you should put a lot of focus on candidate engagement prior to the interview, the management of the interview process itself is just as important, if not more.

Interviewing a candidate is never just about you finding out whether or not the candidate is of value. It is also about whether or not you are of value to the candidate. And they have a lot more at stake than just a paycheck!

If a candidate has a negative experience – much like your customers – they will simply go elsewhere. They will also likely discourage their peers from considering your company as a potential employer. And no candidate engagement campaign in the world can save you from bad employer reputation!

Since the establishment of Guided Solutions back in 2000, we’ve seen way too often outstanding medical device professionals drop out after having been interested initially. More often than not, this is the result of a Hiring Manager’s failure to maintain interest as the process progresses.

But here is the good news: the solution is easier than you might think!

Treat a potential employee as you would a client

It’s no secret that a customer who cannot get a straight answer out of you or is being asked to commit an unreasonable amount of time or money up-front is probably going to reject you flat out.

So will a customer who is struggling to schedule a further meeting or has their follow up questions ignored or, even worse, gets continuously cancelled on.

Why would this be any different for a candidate who is not simply committing money but the majority of their waking day to you?

Rolling out the red carpet for each and every one of your potential new team members will help you keep your candidates engaged from application to offer stage.

Working together to pick a suitable date, follow up on any further questions, and always ask yourself: what could I do differently next time in order to prevent good candidates from dropping out?

Guided Solutions is an international executive search consultancy focused solely on the Medical Devices sector. We work without any internal metrics and targets, providing forward-looking recruitment solutions that help Medical Device SMEs reach their full potential.

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

General Manager Regenerative Medicine – Germany

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General Manager Regenerative Medicine – Germany

The Context

Guided Solutions had a long-standing successful consulting relationship with a client who, up until the hiring need in question had kept their business operations within the UK and Ireland.

In the years preceding this appointment, the company had made a number of strategic acquisitions of smaller Medical Device manufacturers which gradually served to increase the scope of the overall commercial operations. One such technology manufacturer within the Regenerative Medicine space they had acquired had competitor products performing well in Germany, so the company decided to enter this market with a new national entity and national manager.

The Campaign

As this was the very first hire the company was making outside the UK and Ireland, the role would be defined by the successful applicant’s ability to build a viable entity in Germany through an incredibly driven, hands-on approach. Plotting which regional markets could be infiltrated, and building the direct sales force to carry out the strategy required an individual with deep experience in the market and the relevant network to populate the team quickly, and with high-quality sales people.

The product knowledge and networks of the two candidates who reached final interview stage were unquestionable. What followed was a stringent behavioural assessment over multiple rounds using our advanced psychometric profiling platform, GS Compass. The process was lengthy, but the eventual result was a deep understanding of the candidates’ personalities and motivations, and a guarantee of minimal on-boarding time. Within 6 months the direct sales force was at 7 representatives strong and an established 90% presence in the German market.

Since 2000, Guided Solutions has been helping the world’s most innovative Medical Device start-ups to navigate successfully through critical growth and transformative hiring journeys.

Are you facing a major hiring challenge? Get in touch to explore how our uniquely exhaustive multilingual search & selection process can help you reach your goals.

Willing to Relocate: Brexit and International Mobility

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Willing to Relocate: Brexit and International Mobility

3 days before 29 March, the outcome of Brexit is still up in the air. If the House of Commons does not approve the draft withdrawal agreement by this Friday, chances are the UK will leave the European Union without a deal.

So what is the UK’s current departure date?

In a “deal” scenario, the EU has agreed to extend the departure date to 22 May 2019. In a “no deal” scenario, the agreed extension is 12 April 2019.

If there is a deal…

Here is what you need to know if the draft withdrawal agreement is approved:

I am a UK citizen currently living and working in a EU member state

Your rights as a UK citizen in the EU are protected by the draft Brexit agreement.

I am an EU citizen currently living and working in the UK

If you are an EU citizen currently living and working in the UK, you are most likely worried about your rights to remain in the country after March 29, 2019. During the transition period, which is currently defined until December 31 2020, your rights will remain the same. As long as you hold a valid international passport or national ID card from your EU home country, you will be able to leave and re-enter the UK freely.

At the end of the transition period, there are two scenarios:

  • You have lived permanently in the UK for five years: you will be able to continue residing there with no further actions required;
  • You haven’t lived permanently in the UK for five years: you will still be able to acquire permanent residency by completing five years; however, you must apply for your permanent residence status no later than 6 months before the end of the transition period.

I am an EU citizen and I want to work and live in the UK after Brexit

If that future point is after the end of the transition period, you are swimming in a sea of uncertainty. The Brexit deal does not outline any information on your rights in that case, unfortunately.

I am a UK citizen and I want to work and live in the EU after Brexit

If you are a UK citizen living and working in the EU, but you hold no dual nationality, you might no longer enjoy the same rights and protections as EU citizens under EU law. You might need to provide proof of residency or demonstrate that you qualify for such. Any demands the UK imposes on EU citizens residing on the island could be expected to apply to UK citizens living in EU member states.

In its attempt to curb immigration, the UK has rejected freedom of movement, so there is now the possibility that UK citizens might also not be able to work or run business in the EU like they used to.

If there is no deal…

In the case of a no-deal Brexit the EU’s contingency plans state that the UK would immediately become a “third country”, without any transition like the two year implementation period envisaged in the draft deal.

So where do we stand now?

Let’s admit it – we don’t know. In fact, no one does. Until the final outcome of Brexit is confirmed, we can neither hope for the best nor assume the worst.

Guided Solutions recruits medical device talent across the globe within multiple disciplines covering the entire product lifecycle at all seniority levels:

  • R&D, Software & Mechanical Engineering
  • Quality Assurance & Regulatory Affairs
  • Market Access & Reimbursement
  • Sales & Marketing
  • Clinical Applications & Support

Our multi-lingual team of consultants is always happy to hear from passionate medtech professionals looking to make their next career step. Visit our website to find out more. 

Drug or Device: FDA’s Ongoing Struggle with Combination Products Pt.2

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Drug or Device: FDA’s Ongoing Struggle with Combination Products Pt.2

Read part 1 here.

Where are we today?

Last month the FDA published a draft guidance document outlining principles of premarket pathways for combination products. The document lists 4 major types of combination products:

A “single entity” combination product (i.e. a pre-filled syringe or drug-eluting stent) comprising two or more regulated components, i.e., drug/device, biologic/device, drug/biologic, or drug/device/biologic, that are physically, chemically, or otherwise combined or mixed and produced as a single entity;

A “co-packaged” combination product (i.e. a surgical or first-aid kit containing bandages and an antiseptic drug) comprising two or more separate products packaged together in a single package or as a unit and comprised of drug and device products, device and biological products, or biological and drug products;

A “cross-labelled” combination product (i.e. a light emitting device and a light-activated drug indicated for use together for treatment of a dermatologic condition) whereby a drug, device, or biological product packaged separately is intended for use only with an approved individually specified drug, device, or biological product and both are required to achieve the intended use, indication, or effect and where upon approval of the proposed product the labelling of the approved product would need to be changed (e.g., to reflect a change in intended use, dosage form, strength, route of administration, or significant change in dose); or

Any investigational drug, device, or biological product packaged separately that according to its proposed labelling is for use only with another individually specified investigational drug, device, or biological product where both are required to achieve the intended use, indication, or effect (also a “cross-labelled” combination product).

The omission of any clear examples of digital health products is evident in these definitions. In addition, the FDA has kept the way combination products are being assigned and regulated internally effectively the same. Sponsors are advised to submit a single approval application depending on the product’s „primary mode of action“, i.e. whether it is drug-led, biologic-led or device-led, but a footnote indicates that multiple applications would generally remain a possibility for the constituent parts of cross-labelled products.

What does that say loud and clear?

Innovation acceleration continues to erode the traditional boundaries between drugs, devices and biologics. With the advent of the 4th industrial revolution, combination products no longer fit neatly into categories and regulatory frameworks established many decades ago. Rather than facing reality and working towards a solution that acknowledges the novelty of these products as a starting point and working from there, the FDA keeps trying to fit them into one if its three established centres, stretching the limits of definitions and overlooking the fact that combination products are more than the mere sum of their constituent parts.

As history demonstrates, unclear regulations often lead to unnecessary delays, which in turn hinder medtech pioneers from fully realising the potential of their inventions. By definition, the regulatory function of the FDA means it can never be as innovative and fast-adapting as the technology it oversees. However, it can definitely do a better job in keeping pace with emerging technologies and improving its structures to adequately address modern industry challenges.

Doing your own part

Until changes within the FDA eventually happen, combination product makers should anticipate scenarios involving multiple market approval pathways. Better awareness of the differences in safety and effectiveness requirements, approval times, application fees, product liability, etc. across different FDA sub-centres can help navigate regulatory labyrinths more easily and result in cheaper and faster market access.

In a recent statement, resigned FDA Commissioner Scott Gottlieb acknowledges that the agency’s current approach to novel tech regulation is hindering rather than fostering innovation. As clinicians and consumers increasingly embrace hybrid products, we keep a keen eye on the reforms the FDA undertakes to advance its practices and better align with the realities of today and tomorrow.

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